Asset Publisher
Biologic Immunomodulators Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-91002
This program applies to SourceRx formularies.
POLICY REVIEW CYCLE
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Effective Date |
Date of Origin |
|
07-01-2025 |
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FDA LABELED INDICATIONS AND DOSAGE
|
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
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Abrilada™ (adalimumab-afzb) Subcutaneous injection |
Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients 2 years of age and older Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (PsA) Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) Treatment of moderately to severely active Crohn's disease (CD) in adults and pediatric patients 6 years of age and older Treatment of moderately to severely active ulcerative colitis (UC) in adult patients
Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients Treatment of non-infectious intermediate, posterior, and panuveitis (UV) in adult patients |
Tumor Necrosis Factor (TNF) -Alpha Inhibitor |
83 |
|
Actemra® (tocilizumab) Subcutaneous injection |
Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs) Treatment of giant cell arteritis (GCA) in adult patients Slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis associated interstitial lung disease (SSc-ILD)
Treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older Treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older Treatment of chimeric antigen receptor (CAR) T-cell induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older
Treatment of Coronavirus disease 2019 (COVID-19) in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)
|
Interleukin-6 Inhibitor |
1 |
|
Amjevita® (adalimumab-atto) Subcutaneous injection |
Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA) Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older Treatment of moderately to severely active ulcerative colitis (UC) in adult patients
Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients Treatment of non-infectious intermediate, posterior, and panuveitis (UV) in adult patients |
Tumor Necrosis Factor (TNF) -Alpha Inhibitor |
71 |
|
Bimzelx® (bimekizumab-bkzx) Subcutaneous injection |
Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy Treatment of adult patients with active psoriatic arthritis (PSA) Treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation Treatment of adult patients with active ankylosing spondylitis (AS) Treatment of adults with moderate to severe hidradenitis suppurativa (HS) |
Interleukin-17A and F Antagonist |
84 |
|
Cimzia® (certolizumab pegol) Subcutaneous injection |
Reducing signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy Treatment of adults with moderately to severely active rheumatoid arthritis (RA) Treatment of adult patients with active psoriatic arthritis (PSA) Treatment of adults with active ankylosing spondylitis (AS) Treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation Treatment of adults with moderate-to-severe plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy Treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older |
Tumor Necrosis Factor (TNF) -Alpha Inhibitor |
2 |
|
Cosentyx® (secukinumab) Subcutaneous injection |
Treatment of moderate to severe plaque psoriasis (PS) in patients 6 years and older who are candidates for systemic therapy or phototherapy Treatment of active psoriatic arthritis (PSA) in patients 2 years of age and older Treatment of adult patients with active ankylosing spondylitis (AS) Treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation Treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older Treatment of adults with moderate to severe hidradenitis suppurativa (HS) |
Interleukin-17 Inhibitor |
3 |
|
Cyltezo®/Adalimumab-adbm Subcutaneous injection |
Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA) Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older Treatment of moderately to severely active ulcerative colitis (UC) in adult patients
Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients Treatment of non-infectious intermediate, posterior, and panuveitis (UV) in adult patients |
Tumor Necrosis Factor (TNF) -Alpha Inhibitor |
76 |
|
Enbrel® (etanercept) Subcutaneous injection |
Reduce the signs and symptoms, including major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients ages 2 and older Reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PSA) Reducing signs and symptoms in patients with active ankylosing spondylitis (AS) Treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy Treatment of active juvenile psoriatic arthritis (JPsA) in pediatric patients 2 years of age and older |
Tumor Necrosis Factor (TNF) -Alpha Inhibitor |
4 |
|
Entyvio® (vedolizumab) Subcutaneous injection |
Treatment in adults for moderately to severely active ulcerative colitis (UC) Treatment in adults for moderately to severely active Crohn's disease (CD) |
Integrin receptor antagonist |
5 |
|
Hadlima™ (adalimumab-bwwd) Subcutaneous Injection |
Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA) Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older Treatment of moderately to severely active ulcerative colitis (UC) in adult patients
Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients Treatment of non-infectious intermediate, posterior, and panuveitis (UV) in adult patients |
Tumor Necrosis Factor (TNF) -Alpha Inhibitor |
77 |
|
Hulio®/Adalimumab-fkjp Subcutaneous injection |
Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA) Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older Treatment of moderately to severely active ulcerative colitis (UC) in adult patients
Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients Treatment of non-infectious intermediate, posterior, and panuveitis (UV) in adult patients |
Tumor Necrosis Factor (TNF) -Alpha Inhibitor |
74 |
|
Humira® (adalimumab) Subcutaneous injection |
Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA) Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older Treatment of moderately to severely active ulcerative colitis (UC) in adults and pediatric patients 5 years of age and older
Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Treatment of moderate to severe hidradenitis suppurativa (HS) in patients 12 years of age and older Treatment of non-infectious intermediate, posterior, and panuveitis (UV) in adults and pediatric patients 2 years of age and older |
Tumor Necrosis Factor (TNF) -Alpha Inhibitor |
6 |
|
Hyrimoz®/Adalimumab-adaz Subcutaneous injection |
Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA) Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older Treatment of moderately to severely active ulcerative colitis (UC) in adult patients
Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients Treatment of non-infectious intermediate, posterior, and panuveitis (UV) in adult patients |
Tumor Necrosis Factor (TNF) -Alpha Inhibitor |
80 |
|
Idacio®/Adalimumab-aacf Subcutaneous injection |
Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA) Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older Treatment of moderately to severely active ulcerative colitis (UC) in adult patients
Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients Treatment of non-infectious intermediate, posterior, and panuveitis (UV) in adults |
Tumor Necrosis Factor (TNF) -Alpha Inhibitor |
75 |
|
Kevzara® (sarilumab) Subcutaneous injection |
Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs) Treatment of adult patients with polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper Treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients who weigh 63 kg or greater |
Interleukin-6 Inhibitor |
7 |
|
Kineret® (anakinra) Subcutaneous injection |
Reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA), in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs) Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)* Treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)* |
Interleukin-1 Inhibitor *- approved for use in pediatric patients as young as 1 month of age |
8 |
|
Litfulo™ (ritlecitinib) Capsule |
Treatment of severe alopecia areata in adults and adolescents 12 years and older
|
Janus Kinase (JAK) Inhibitor |
81 |
|
Olumiant® (baricitinib) Oral tablet |
Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers
Treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) Treatment of adult patients with severe alopecia areata
|
Janus Kinase (JAK) Inhibitor |
9 |
|
Omvoh® (mirikizumab-mrkz) Subcutaneous injection |
Treatment of moderately to severely active ulcerative colitis in adults Treatment of moderately to severely active Crohn’s disease in adults |
Interleukin-23 Inhibitor |
86 |
|
Orencia® (abatacept) Subcutaneous injection |
Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) Treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) Treatment of patients 2 years of age and older with active psoriatic arthritis (PSA) Prophylaxis of acute graft versus host disease (aGVHD), in combination with calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor
Limitation of Use:
|
T-cell Costimulation Blocker |
10 |
|
Otulfi™ (ustekinumab-aauz) Subcutaneous injection |
Treatment of patients 6 years of age and older with moderate to severe plaque psoriasis (PS) who are candidates for phototherapy or systemic therapy Treatment of patients 6 years of age and older with active psoriatic arthritis (PsA) Treatment of adult patients with moderately to severely active Crohn's disease (CD) Treatment of adult patients with moderately to severely active ulcerative colitis (UC) |
Interleukin-12 and -23 Antagonist |
105 |
|
Pyzchiva®/Ustekinumab-ttwe Subcutaneous injection |
Treatment of patients 6 years of age and older with moderate to severe plaque psoriasis (PS) who are candidates for phototherapy or systemic therapy Treatment of patients 6 years of age and older with active psoriatic arthritis (PsA) Treatment of adult patients with moderately to severely active Crohn's disease (CD) Treatment of adult patients with moderately to severely active ulcerative colitis (UC) |
Interleukin-12 and -23 Antagonist |
103 |
|
Rinvoq® LQ (upadacitinib) Oral solution |
Treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis (PSA) who have had an inadequate response or intolerance to one or more TNF blockers
Treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) who have had an inadequate response or intolerance to one or more TNF blockers
|
Janus Kinase (JAK) Inhibitor |
44 |
|
Rinvoq® (upadacitinib extended release) Oral tablet |
Treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers
Treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis (PSA) who have had an inadequate response or intolerance to one or more TNF blockers
Treatment of adult and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable
Treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers
Treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers
Treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers
Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy
Treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) who have had an inadequate response or intolerance to one or more TNF blockers
|
Janus Kinase (JAK) Inhibitor |
44 |
|
Selarsdi™ (ustekinumab-aekn) Subcutaneous injection |
Treatment of patients 6 years of age and older with moderate to severe plaque psoriasis (PS) who are candidates for phototherapy or systemic therapy Treatment of patients 6 years of age and older with active psoriatic arthritis (PsA) Treatment of adult patients with moderately to severely active Crohn's disease (CD) Treatment of adult patients with moderately to severely active ulcerative colitis (UC) |
Interleukin-12 and -23 Antagonist |
104 |
|
Siliq® (brodalumab) Subcutaneous injection |
Treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies |
Interleukin-17 Receptor Antagonist |
11 |
|
Simlandi®/Adalimumab-ryvk Subcutaneous injection |
Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients 2 years of age and older Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (PsA) Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) Treatment of moderately to severely active Crohn's disease (CD) in adults and pediatric patients 6 years of age and older Treatment of moderately to severely active ulcerative colitis (UC) in adult patients
Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients Treatment of non-infectious intermediate, posterior, and panuveitis (UV) in adult patients |
Tumor Necrosis Factor (TNF) -Alpha Inhibitor |
90 |
|
Simponi® (golimumab) Subcutaneous injection |
Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate Treatment of adult patients with active psoriatic arthritis (PSA) Treatment of adult patients with active ankylosing spondylitis (AS) Treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine for:
|
Tumor Necrosis Factor (TNF) -Alpha Inhibitor |
12 |
|
Skyrizi® (risankizumab-rzaa) Subcutaneous injection |
Treatment of moderate-to-severe plaque psoriasis (PS) in adults who are candidates for systemic therapy or phototherapy Treatment of active psoriatic arthritis (PSA) in adults Treatment of moderately to severely active Crohn's disease in adults Treatment of moderately to severely active ulcerative colitis in adults |
Interleukin-23 Inhibitor |
43 |
|
Sotyktu® (deucravacitinib) Tablet |
Treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
|
Tyrosine Kinase Inhibitor |
67 |
|
Stelara®/Ustekinumab® Subcutaneous injection |
Treatment of patients 6 years of age and older with moderate to severe plaque psoriasis (PS) who are candidates for phototherapy or systemic therapy Treatment of patients 6 years of age and older with active psoriatic arthritis (PsA) Treatment of adult patients with moderately to severely active Crohn's disease (CD) Treatment of adult patients with moderately to severely active ulcerative colitis (UC) |
Interleukin-12 and -23 Antagonist |
13 |
|
Steqeyma® (ustekinumab-stba) Subcutaneous injection |
Treatment of patients 6 years of age and older with moderate to severe plaque psoriasis (PS) who are candidates for phototherapy or systemic therapy Treatment of patients 6 years of age and older with active psoriatic arthritis (PsA) Treatment of adult patients with moderately to severely active Crohn's disease (CD) Treatment of adult patients with moderately to severely active ulcerative colitis (UC) |
Interleukin-12 and -23 Antagonist |
101 |
|
Taltz® (ixekizumab) Subcutaneous injection |
Treatment of patients 6 years of age and older with moderate-to severe plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy Treatment of adult patients with active psoriatic arthritis (PSA) Treatment of adult patients with active ankylosing spondylitis (AS) Treatment of adult patents with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation |
Interleukin-17 Inhibitor |
14 |
|
Tremfya® (guselkumab) Subcutaneous injection |
Treatment of adults with moderate-to-severe plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy Treatment of adult patients with active psoriatic arthritis (PSA) Treatment of adult patients with moderately to severely active ulcerative colitis (UC) Treatment of adult patients with moderately to severely active Crohn’s disease (CD) |
Interleukin-23 Inhibitor |
15 |
|
Tyenne® (tocilizumab-aazg) Subcutaneous injection |
Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs) Treatment of giant cell arteritis (GCA) in adult patients Treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older Treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older Treatment of chimeric antigen receptor (CAR) T-cell induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older
Treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)
|
Interleukin-6 Inhibitor |
50 |
|
Velsipity® (etrasimod) Tablets |
Treatment of moderately to severely active ulcerative colitis in adults |
Sphingosine 1-phosphate (SIP-1) receptor modulator |
85 |
|
Wezlana™ (ustekinumab-auub) Subcutaneous injection |
Treatment of patients 6 years of age and older with moderate to severe plaque psoriasis (PS) who are candidates for phototherapy or systemic therapy Treatment of patients 6 years of age and older with active psoriatic arthritis (PsA) Treatment of adult patients with moderately to severely active Crohn's disease (CD) Treatment of adult patients with moderately to severely active ulcerative colitis (UC) |
Interleukin-12 and -23 Antagonist |
91 |
|
Xeljanz® (tofacitinib) Oral Solution |
Treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers
|
Janus Kinase (JAK) Inhibitor |
16 |
|
Xeljanz® (tofacitinib) Oral tablet |
Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers
Treatment of adult patients with active psoriatic arthritis (PSA) who have had an inadequate response or intolerance to one or more TNF blockers
Treatment of adult patients with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers
Treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers
Treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers
|
Janus Kinase (JAK) Inhibitor |
16 |
|
Xeljanz® XR (tofacitinib extended release) Oral tablet |
Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers
Treatment of adult patients with active psoriatic arthritis (PSA) who have had an inadequate response or intolerance to one or more TNF blockers
Treatment of adult patients with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers
Treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers
|
Janus Kinase (JAK) Inhibitor |
16 |
|
Yesintek™ (ustekinumab-kfce) Subcutaneous injection |
Treatment of patients 6 years of age and older with moderate to severe plaque psoriasis (PS) who are candidates for phototherapy or systemic therapy Treatment of patients 6 years of age and older with active psoriatic arthritis (PsA) Treatment of adult patients with moderately to severely active Crohn’s disease (CD) Treatment of adult patients with moderately to severely active ulcerative colitis (UC) |
Interleukin-12 and -23 Antagonist |
102 |
|
Yuflyma®/Adalimumab-aaty Subcutaneous injection |
Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA) Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older Treatment of moderately to severely active ulcerative colitis (UC) in adult patients
Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients Treatment of non-infectious intermediate, posterior, and panuveitis (UV) in adult patients |
Tumor Necrosis Factor (TNF) -Alpha Inhibitor |
78 |
|
Yusimry® (adalimumab-aqvh) Subcutaneous injection |
Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PSA) Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) Treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older Treatment of moderately to severely active ulcerative colitis (UC) in adult patients
Treatment of adult patients with moderate to severe chronic plaque psoriasis (PS) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients Treatment of non-infectious intermediate, posterior, and panuveitis (UV) in adult patients |
Tumor Necrosis Factor (TNF) -Alpha Inhibitor |
79 |
|
Zymfentra™ (infliximab-dyyb) Subcutaneous injection |
Maintenance treatment of moderately to severely active ulcerative colitis in adults following treatment with an infliximab product administered intravenously Maintenance treatment of moderately to severely active Crohn’s disease in adults following treatment with an infliximab product administered intravenously |
Tumor Necrosis Factor (TNF) -Alpha Inhibitor |
89 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
|
RHEUMATOID DISORDERS - Ankylosing Spondylitis (AS) |
Ankylosing spondylitis (AS) is a form of chronic inflammatory arthritis characterized by sacroiliitis, enthesitis, and a marked propensity for sacroiliac joint and spinal fusion. AS is distinguished by universal involvement with sacroiliac joint inflammation or fusion and more prevalent spinal ankylosis. Goals of treatment for AS are to reduce symptoms, maintain spinal flexibility and normal posture, reduce functional limitations, maintain work ability, and decrease disease complications. The mainstays of treatment have been nonsteroidal anti-inflammatory drugs (NSAIDs) and exercise/physical therapy.(17,47) NSAIDs are used as first line therapy for patients with active AS, with continuous treatment with NSAIDs being preferred. In patients with stable disease, NSAIDs may be used on-demand to decrease the risk of adverse effects with long term use.(47,61,64) No particular NSAID is recommended as a preferred option.(64) Biologics should be used in patients who continue to have persistently high disease activity despite NSAIDs. Failure of standard treatment with NSAIDs can be defined as a lack of response (or intolerance) to at least 2 NSAIDs after at least a 4-week duration of therapy in total.(47,61) Tumor necrosis factor (TNF) inhibitors or interleukin (IL)-17 inhibitors are recommended as initial biologic therapy.(61,64) Other present comorbidities (e.g., inflammatory bowel disease, psoriasis, uveitis) can help guide selection of the initial biologic agent/drug class.(47,61,64) Patients who have an inadequate response to a TNF inhibitor or IL-17 inhibitor may switch to a biologic of the other drug class, or switch to a Janus kinase (JAK) inhibitor.(61,64) Patients with secondary failure to a biologic (presence of antidrug antibodies) may switch to another biologic of the same or different mode of action.(64) Systemic glucocorticoids should generally not be used in the treatment of AS. Short-term glucocorticoid injections may be used in select patients with peripheral signs and symptoms. Conventional disease-modifying antirheumatic drugs (cDMARDs) (e.g., methotrexate, sulfasalazine, leflunomide) are not recommended as treatment due to their lack of efficacy. However, sulfasalazine may be considered in patients with peripheral arthritis.(47,61,64) |
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RHEUMATOID DISORDERS - Nonradiographic Axial Spondyloarthritis (nr-axSpA) |
Nonradiographic axial spondyloarthritis (nr-axSpA) falls under the same spondyloarthritis family as ankylosing spondylitis (AS). Nr-axSpA is characterized by chronic back pain and features suggestive of spondyloarthritis (SpA), although advanced sacroiliac joint damage and spine ankylosis are absent. The goals of treatment are to reduce symptoms, maintain spinal flexibility and normal posture, reduce functional limitations, maintain work ability, and decrease disease complications. The mainstays of treatment have been NSAIDs and exercise/physical therapy.(17,47) NSAIDs are used as first line therapy for patients with active nr-axSpA, with continuous treatment with NSAIDs being preferred. In patients with stable disease, NSAIDs may be used on-demand to decrease the risk of adverse effects with long term use.(47,61,64) No particular NSAID is recommended as a preferred option.(64) Biologics should be used in patients who continue to have persistently high disease activity despite NSAIDs. Failure of standard treatment with NSAIDs can be defined as a lack of response (or intolerance) to at least 2 NSAIDs after at least a 4-week duration of therapy in total.(47,61) Tumor necrosis factor (TNF) inhibitors or interleukin (IL)-17 inhibitors are recommended as initial biologic therapy.(61,64) Other present comorbidities (e.g., inflammatory bowel disease, psoriasis, uveitis) can help guide selection of the initial biologic agent/drug class.(47,61,64) Patients who have an inadequate response to a TNF inhibitor or IL-17 inhibitor may switch to a biologic of the other drug class, or switch to a Janus kinase (JAK) inhibitor.(61,64) Patients with secondary failure to a biologic (presence of antidrug antibodies) may switch to another biologic of the same or different mode of action.(64) Systemic glucocorticoids should generally not be used in the treatment of nr-axSpA. Short-term glucocorticoid injections may be used in select patients with peripheral signs and symptoms. Conventional disease-modifying antirheumatic drugs (cDMARDs) (e.g., methotrexate, sulfasalazine, leflunomide) are not recommended as treatment due to their lack of efficacy. However, sulfasalazine may be considered in patients with peripheral arthritis.(47,61,64) |
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RHEUMATOID DISORDERS - Rheumatoid Arthritis (RA) |
Rheumatoid arthritis (RA) is an inflammatory autoimmune disease that primarily affects the joints but can also damage extra-articular organs. The main goal of therapy is to achieve remission, but additional goals include decreased disease activity, prevention of systemic complications, and improved physical functioning.(25) The choice of therapy depends on several factors, including the severity of disease activity when therapy is initiated and the response of the patient to prior therapeutic interventions.(18) The American College of Rheumatology (ACR) guidelines (2021) list the following guiding principles in the treatment of RA:(18)
ACR guideline (2021) treatment recommendations are broken down by previous treatment and disease activity:(18)
The European Alliance of Associations for Rheumatology (EULAR) guidelines for RA (2022 update) also recommend a treat-to-target approach in therapy. MTX is recommended as first line therapy and should be initiated as soon as the diagnosis of RA is made. If MTX is not clinically appropriate, then an alternative csDMARD should be used as part of the (first) treatment strategy. If initial csDMARD therapy does not produce adequate improvement after 3 months, another csDMARD may be added or switched to as long as poor prognosis factors are absent. In the presence of poor prognosis factors, a bDMARD or JAK inhibitor should be added to csDMARD therapy. If treatment failure occurs with the initial bDMARD or JAK inhibitor, another bDMARD or JAK inhibitor should be considered. If a TNF- or IL-6 receptor inhibitor therapy was initially failed, patients may receive an agent with another mode of action or a second TNF- or IL-6 receptor inhibitor.(26) Initial dosing of MTX for RA should optimally be 15 mg once weekly, with the dose increased as tolerated and as needed to control signs and symptoms. A fast dose escalation of 5 mg/month to 25-30 mg/week has been associated with higher efficacy, but toxicity with this dosing regimen is a limiting factor.(27) In the presence of sufficient folic acid supplementation, the MTX dose can be rapidly escalated to 25 mg once weekly.(26) The MTX target dose is 25 mg weekly, or the highest tolerable dose.(26,27) |
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RHEUMATOID DISORDERS - Polyarticular Juvenile Idiopathic Arthritis (PJIA) |
Juvenile idiopathic arthritis (JIA) is arthritis that begins before the 16th birthday and persists for at least 6 weeks with other known conditions excluded. Polyarticular juvenile idiopathic arthritis (PJIA) is a subset of JIA. The ACR defines PJIA as arthritis in more than 4 joints during their disease course and excludes systemic JIA. Treatment goals are aimed at achieving clinically inactive disease and to prevent long-term morbidities, including growth disturbances, joint contractures and destruction, functional limitations, and blindness or visual impairment from chronic uveitis.(34,35) The American College of Rheumatology (ACR)/Arthritis Foundation guidelines (2019) recommend the following treatment approach for PJIA:(34)
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RHEUMATOID DISORDERS - Systemic Juvenile Idiopathic Arthritis (SJIA) |
Systemic juvenile idiopathic arthritis (SJIA) is a subset of juvenile idiopathic arthritis (JIA). SJIA is distinct from all other categories of JIA due to fever, rash, and visceral involvement. Disease pathogenesis and cytokine involvement in SJIA are different than other JIA categories.(19) SJIA is now considered to be the same disease as adult onset Still's disease (AOSD) under the umbrella term Still's disease, recognizing that the previous distinction of the two disorders by age of onset (before or after 16 years of age) was mainly artificial.(93) SJIA has been defined as:(28,92)
The European Alliance of Associations for Rheumatology (EULAR)/Paediatric Rheumatology European Society (PReS) 2024 guidelines strongly recommend that the presence of arthritis not be mandatory for the diagnosis of Still's disease. Arthralgia is commonly present at disease onset, but arthritis often presents later with a median delay of 1 month. Requiring arthritis to make the diagnosis leads to unnecessary treatment delays. Instead, a patient with fever for at least 7 days, rash, arthralgia/myalgia, and elevated inflammatory markers should be sufficient to facilitate rapid diagnosis and initiate early treatment.(93) Macrophage activation syndrome (MAS), a secondary hemophagocytic syndrome, is a life-threatening complication requiring urgent recognition and treatment. MAS presents with fever, high ferritin levels, cytopenia, elevated liver enzyme levels, low fibrinogen levels, and high triglyceride levels. As it may occur at any point during the disease course, including during treatment, careful monitoring is necessary for children with or without MAS at presentation.(19) MAS is the most frequent complication, occurring in 15% to 20% of patients.(93) Goals of therapy for SJIA include control of active inflammation and symptoms, and the prevention of a number of disease and/or treatment related morbidities, such as growth disturbances, joint damage, and functional limitations.(28) An interleukin (IL)-1 or IL-6 inhibitor should be used as initial treatment for SJIA.(19,93) The IL-1/IL-6 should be initiated as early as possible when the diagnosis of SJIA is established or during a flare, irrespective of disease severity. Early initiation of an IL-1 or IL-6 inhibitor has been shown to have favorable outcomes, limit or avoid corticosteroid use, limit a chronic persistent disease course, and also does not interfere with the diagnostic work-up at onset. EULAR/PReS strongly recommends their use based on their efficacy to control all aspects of the disease, including both systemic and joint manifestations.(93) Glucocorticoids can be used short-term in patients with severe symptoms, risk of MAS, and/or severe pericarditis. High dose glucocorticoids are the mainstay of treatment in patients with MAS, being added on to biologic therapy.(93) For some patients with MAS, biologic therapy combined with glucocorticoids and calcineurin inhibitors may be necessary to control the disease.(19,93) Glucocorticoids may also be helpful at disease onset to control systemic and joint manifestations until IL-1 or IL-6 inhibitors can be started.(19) Non-steroidal anti-inflammatory drugs (NSAIDs) are sometimes used as a brief trial for initial treatment for SJIA without MAS. Studies suggest that a small proportion of patients will respond to NSAIDs alone, however many prescribers prefer that the use of NSAIDs be avoided altogether for SJIA.(19) NSAIDs are typically only used to assist in controlling symptoms, such as fever or arthralgia. Conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) have historically been used, but evidence supporting their efficacy is scarce.(93) Methotrexate is sometimes used in patients with arthritis.(19,93) |
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RHEUMATOID DISORDERS - Enthesitis Related Arthritis (ERA) |
Enthesitis related arthritis (ERA) is a form of juvenile idiopathic arthritis (JIA) with an onset at less than 16 years of age. ERA typically presents initially with musculoskeletal pain, followed by signs of inflammation typical of peripheral arthritis. Enthesitis is a distinct feature of ERA and is defined as inflammation of an enthesis, which is a site where a tendon, ligament, or joint capsule attaches to bone.(55) ERA is the pediatric counterpart of adult nonradiographic axial spondyloarthritis (nr-axSpA).(94) The American College of Rheumatology (ACR)/Arthritis Foundation guidelines (2019) recommend the following approach to treatment of children and adolescents with JIA and active enthesitis:(34)
Failure of standard treatment with NSAIDs can be defined as a lack of response (or intolerance) to at least 2 NSAIDs after at least a 4-week duration of therapy in total.(47,61) The interleukin (IL)-17 inhibitor secukinumab is approved by the Food and Drug Administration (FDA) for the treatment of ERA and has been shown to be effective in increasing the time to disease relapse. Studies have shown that the synovial fluid of children with ERA present high levels of IL-17.(55) |
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RHEUMATOID DISORDERS - Psoriatic Arthritis (PsA) |
Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disease associated with psoriasis (PS), most commonly presenting with peripheral arthritis, dactylitis, enthesitis, and spondylitis. Active PsA is defined as symptoms at an unacceptably bothersome level as reported by the patient due to one of the following: actively inflamed joints, dactylitis, enthesitis, axial disease, active skin and/or nail involvement, and/or extraarticular manifestations such as uveitis or inflammatory bowel disease (IBD).(29) Disease severity is based on the assessment of the level of disease activity at a given point in time, and the presence/absence of poor prognostic factors and long-term damage. Severe PsA is defined in the American College of Rheumatology (ACR) and the National Psoriasis Foundation (NPF) guidelines for PsA and includes the presence of one or more of the following:(29)
Treatment involves the use of a variety of interventions, including many agents used for the treatment of other inflammatory arthritis disorders, particularly spondyloarthritis and rheumatoid arthritis, and other management strategies of the cutaneous manifestations of psoriasis. Symptomatic treatments include nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, and local glucocorticoid injections.(29) Only patients with very mild peripheral disease may sufficiently benefit from NSAIDs as monotherapy, and instead patients are typically treated with disease-modifying antirheumatic drugs (DMARDs) and/or biologics. Efficacy of DMARD and biologic therapies should be assessed 3 months after initiation, and if adequate improvement is not seen then the treatment regimen should be updated or changed.(30) The ACR-NPF guidelines for PsA recommend a treat-to-target approach in therapy, regardless of disease activity, and treatment recommendations for active disease are as follows:(29)
The European Alliance of Associations for Rheumatology (EULAR) guidelines for PsA (2023 update) also recommend a treat-to-target approach in therapy. MTX (preferred) or another conventional synthetic disease-modifying antirheumatic drug (csDMARD) (e.g., sulfasalazine, leflunomide) should be used for initial therapy. If the treatment target is not achieved with a csDMARD, a biologic should be initiated with preference of product being based on patient specific disease characteristics. Biologics include TNF inhibitors, IL-12/23 inhibitors, IL-17A inhibitors, IL-17A/F inhibitors, IL-23 inhibitors, and cytotoxic T-lymphocyte–associated antigen 4 (CTLA4) analogs. No order of preference of biologics is provided since none have demonstrated superiority for joint involvement, however, CTLA4 analogs are least preferred due to limited efficacy in clinical trials. The use of a Janus kinase (JAK) inhibitor (e.g., tofacitinib, upadacitinib) may be used after failure of a biologic or if biologics are not clinically appropriate for the patient. However, careful consideration should be applied prior to using a JAK inhibitor due to the increased risk of cardiovascular and malignancy events in older patients with RA and cardiovascular risk factors. A phosphodiesterase-4 (PDE4) inhibitor (i.e., apremilast) may be considered in patients with mild disease and an inadequate response to at least one csDMARD, in whom neither a biologic nor a JAK inhibitor is appropriate. Patients with an inadequate response to a biologic or JAK inhibitor may switch to a different drug within the same class or switch to a different mode of action. Adding MTX to a biologic may increase drug survival by limiting the development of antidrug antibodies, especially for TNF inhibitors.(30) |
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RHEUMATOID DISORDERS - Polymyalgia Rheumatica (PMR) |
Polymyalgia rheumatica (PMR) is a rheumatic disorder associated with musculoskeletal pain and stiffness in the neck, shoulder, and hip area. The etiology is not fully understood, but there are associated environmental and genetic factors. The incidence of PMR increases with age and is rarely seen in people under the age of 50. Women are approximately 2-3 times more likely to be affected by PMR than men. A characteristic feature of PMR is a new and relatively acute onset of proximal muscle pain and stiffness in the neck, shoulders, upper arms, hips and thighs. Patients often suffer from a pronounced morning stiffness with difficulty turning in or getting out of bed in the morning with some spontaneous relief of symptoms later in the day. The nonspecific clinical presentation and the absence of specific laboratory findings or serologic features often leads to some diagnostic delay.(72) The American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) guidelines recommend the following for the treatment of PMR:(73)
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RHEUMATOID DISORDERS - Juvenile Psoriatic Arthritis (JPsA) |
Juvenile psoriatic arthritis (JPsA) is a relatively rare condition in childhood and represents approximately 5% of the whole JIA populations. JPsA is defined by the association of arthritis and psoriasis or, in the absence of typical psoriatic lesions, with at least two of the following:(87)
Recent studies however have shown that this classification system could conceal more homogeneous subgroups of patients differing by age of onset, clinical characteristics, and prognosis. Little is known about genetic factors and pathogenetic mechanisms which distinguish JPsA from other JIA subtypes or from isolated psoriasis without joint involvement, especially in the pediatric population.(87) Psoriatic arthritis of adulthood is a well-defined, although phenotypically heterogeneous, clinical condition. In the majority of cases, it is characterized by the onset of arthritis in patients with pre-existing psoriasis. An opposite scenario is seen in children: arthritis complicates only 2% of pediatrics psoriasis, whereas in JPsA skin disease typically occurs up to 10 years after the development of arthritis, making JPsA diagnosis often challenging. JPsA can be differentiated from adult PsA by several factors as follows:(87)
Psoriasis occurs in 40%-60% of patients with JPsA, usually the classic vulgaris form, although guttate psoriasis is also observed. Psoriasis in children tends to be subtle with thin, soft plaques that may be similar to atopic eczema. Onychopathy is reported in more than half of patients with JPsA, compared with 30% in childhood psoriasis in general. Onycholysis may also be observed but is much less common than in adults.(87) Nonsteroidal anti-inflammatory drugs (NSAIDs) and oral glucocorticoids, as well as intra-articular glucocorticoids, are indicated as initial steps for symptom relief and bridge therapies. Disease modifying antirheumatic drugs (DMARDs) represent the mainstay second line treatment of children with polyarthritis. The most used is methotrexate which is recommended over leflunomide or sulfasalazine. Biologic agents should be considered in case of DMARDs failure or intolerance, presence of risk factors, or high disease activities.(87) |
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DERMATOLOGICAL DISORDERS - Alopecia Areata (AA) |
Alopecia areata (AA) is a chronic autoimmune disease characterized by non-scarring hair loss of the scalp.(65) The most common pattern of presentation of hair loss is the patch subtype, with circular patches seen on the scalp or beard areas.(66) Hair loss may also affect other parts of the body, including the eyebrows, eyelashes, beard, and axillary. AA may also affect the nails and cause nail pitting, or in severe cases cause trachyonychia.(97) During early stages of the disease spontaneous hair regrowth is common, but this becomes more rare as the hair loss becomes more extensive. Patients may have a decreased quality-of-life or psychological burden associated with the disease.(65) Patients with AA tend to have a higher risk of both depression and anxiety.(66) AA is diagnosed based off of clinical presentation and patient history, but sometimes a biopsy is required. Active AA can be assessed with a pull test. A pull test involves firmly pulling 50 to 60 hairs close to the scalp, and a positive test is defined as greater than 10% of hairs being pulled out.(66) Severity of the disease is a strong predictor of long-term outcomes of the disease and can assist in guiding treatment.(97) The Severity of Alopecia Tool (SALT) involves splitting the scalp into four quadrants and determining the percentage of scalp area devoid of terminal hairs to provide a total affected area. One limitation of SALT is it does not account for hair loss of facial hair (eyelashes, eyebrows, beard) or body hair.(66) Severity of AA has been defined as follows:(96)
Pharmacologic treatment of AA includes topical/intralesional/systemic corticosteroids, systemic immunosuppressants (e.g., cyclosporine, azathioprine, methotrexate), and minoxidil, with the use of each intervention dependent on the severity of the disease and the area of the body affected. Janus kinase (JAK) inhibitors have been shown to be effective in adults and young people with severe AA and are strongly recommended for these patients.(95) |
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DERMATOLOGICAL DISORDERS - Psoriasis (PS) |
Psoriasis (PS) is a chronic inflammatory skin and systemic disorder. It is a complex disease that affects the skin and joints and is associated with numerous comorbidities, including obesity and inflammatory bowel disease. Psoriasis vulgaris, or plaque psoriasis, is a cutaneous form that often presents with pink plaques with silvery scale on the scalp, elbows, knees, or presacral region, but any area of the skin may be involved.(31,33) Plaque psoriasis is the most common form (affecting 90% of adults with psoriasis), but others include guttate, erythrodermic, pustular, inverse, nail, and psoriatic arthritis (PsA). PS is clinically diagnosed based on the presence of cutaneous and systemic symptoms, and treatment is similar for most forms but is guided by the body surface area (BSA) involved.(98) The American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) categorize psoriasis severity as mild (less than 3% of BSA), moderate (3% to 10% of BSA), or severe (greater than 10% of BSA). The AAD/NPF guidelines also note that psoriasis can be considered severe irrespective of BSA when it causes serious emotional consequences, occurs in select locations (e.g., hands, feet, scalp, face, or genital area), or when it causes intractable pruritus.(31) Topical therapies are most commonly used to treat mild to moderate PS, but they may be used in combination with phototherapy, systemic, or biologic therapies for the treatment of moderate to severe PS.(88) Topical therapies alone can be sufficient for managing limited disease and also have fewer significant adverse effects compared to systemic treatment options. However, topical therapies may be inadequate to obtain and maintain skin clearance, and systemic therapies may be warranted. Conventional systemic agents are widely used as monotherapy or in combination with biologics for moderate to severe disease, and they are beneficial for widespread disease and ease of administration.(33) Biologics are routinely used when one or more conventional agents fail to produce an adequate response, but are considered first line in patients with severe PS or patients with concomitant severe PsA.(29) The NPF medical board recommends a treat-to-target approach to therapy for psoriasis that includes the following:(32)
Selection of treatment is based on several factors including benefit-risk assessment, clinical presentation, disease severity, and comorbidities.(32) The AAD/NPF psoriasis treatment guidelines support the following treatment options:
Primary failure for biologics is defined as initial nonresponse to treatment. Primary failure to a tumor necrosis factor (TNF)-α inhibitor does not preclude successful response to a different TNF-α inhibitor, and failure of another biologic therapy does not preclude successful response to ustekinumab. All biologics may lose efficacy in a patient who initially responds favorably to the medication (secondary failure), and loss of efficacy may be attributed to the presence of antidrug antibodies. The concomitant use of MTX with a biologic may increase drug survival by limiting antibody formation.(31) For the treatment of PS in the pediatric patient population, topical corticosteroids are the mainstay option based on extensive clinical experience that supports efficacy. Topical calcineurin inhibitors are also a treatment option and may be preferred for psoriasis of the face, genitalia, and body folds. Vitamin D analogues are recommended as a treatment option for childhood plaque psoriasis and are considered safe, effective, and generally well tolerated. Other topical therapies that may be used for the treatment of pediatric psoriasis include tazarotene, anthralin, and coal tar. Phototherapy may be efficacious and well tolerated for pediatric patients with generalized psoriasis or localized psoriasis refractory to topical agents. Systemic non-biologic therapies, such as methotrexate, cyclosporine, and acitretin, are options for moderate to severe psoriasis. Biologic therapies (e.g., adalimumab, etanercept, infliximab, ustekinumab) have also shown efficacy in moderate to severe plaque psoriasis in this patient population.(20) |
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DERMATOLOGICAL DISORDERS - Hidradenitis Suppurativa (HS) |
Hidradenitis suppurativa (HS) is a chronic inflammatory disease causing painful nodules to form in the folds of the skin and often secrete puss and blood. HS can be described as mild (single or few lesions in one area of the skin, Hurley Stage I), moderate (repeated cycles of enlarged lesions that break open and occur in more than one area of the skin, Hurley Stage II), and severe (widespread lesions, scarring, and chronic pain; Hurley Stage III).(45,46) Pharmacological treatment for mild HS includes topical clindamycin, oral tetracyclines, hormonal treatment, retinoids, intralesional corticosteroid injections (i.e., triamcinolone), and deroofing. Oral tetracyclines are recommended for mild to moderate HS for at least a 12-week course or as long-term maintenance. Combination clindamycin and rifampin is effective second-line therapy for mild to moderate HS, or as first-line or adjunct therapy for severe HS. Combination rifampin, moxifloxacin, and metronidazole are recommended as second or third-line therapy for moderate to severe disease. Dapsone may be effective for a minority of patients with mild to moderate HS as long-term maintenance therapy. Oral retinoids, such as acitretin and isotretinoin, have also been used for mild HS as second or third-line therapy. Hormonal therapy may be considered in female patients for mild to moderate disease as monotherapy, or as adjunct therapy for severe disease, such as hormonal contraceptives, metformin, finasteride, and spironolactone.(45,46) Treatment recommendations for moderate to severe and refractory HS include immunosuppressants (e.g., cyclosporine and low dose systemic corticosteroids) and biologic agents. The TNF-inhibitors that are recommended are adalimumab, at doses within FDA labeling, and infliximab, but optimal doses have not been established. Anakinra and ustekinumab may be effective, but require dose ranging studies to determine optimal doses for management.(45,46) |
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DERMATOLOGICAL DISORDERS - Atopic Dermatitis (AD) |
Atopic dermatitis (AD), also known as atopic eczema, is a chronic, pruritic inflammatory dermatosis affecting up to 25% of children and 1-5% of adults. AD follows a relapsing course and is associated with elevated serum immunoglobulin (IgE) levels and a personal or family history of type I allergies, allergic rhinitis, and/or asthma. Onset is most common between 3 and 6 months of age, with approximately 60% of patients developing the eruption in the first year of life and 90% by age 5. While the majority of affected individuals have resolution of disease by adulthood, 10 to 30% do not, and a smaller percentage first develop symptoms as adults. AD has a complex pathogenesis involving genetic, immunologic, and environmental factors, which lead to a dysfunctional skin barrier and dysregulation of the immune system. Clinical findings include erythema, edema, xerosis, erosions/excoriations, oozing and crusting, and lichenification. These clinical findings vary by patient age and chronicity of lesions. Pruritus is a hallmark of the condition that is responsible for much of the disease burden borne by patients and their families. Typical patterns include facial, neck and extensor involvement in infants and children; flexure involvement in any age group, with sparing of groin and axillary regions.(56) Goals of treatment are to reduce symptoms (pruritus and dermatitis), prevent exacerbations, and minimize therapeutics risks.(60) Despite its relapsing and remitting nature, the majority of patients with AD can achieve clinical improvement and disease control with topical emollient/moisturizer use and conventional topical therapies (including corticosteroids and calcineurin inhibitors).(59,60) Moisturizers reduce signs, symptoms, and inflammation in AD, and can improve severity while also increasing time between flares. Moisturizers are considered generally safe and are strongly recommended to be used as part of a treatment regimen for AD, either as monotherapy or as concurrent use with pharmacologic treatments.(58) Topical therapies remain the mainstay of treatment due to their proven track record and generally favorable safety profile. They can be utilized individually or in combination with other topical, physical, and/or systemic treatments; as different classes of treatment have different mechanisms of action, combining therapies allows for the targeting of AD via multiple disease pathways. The American Academy of Dermatology (AAD) strongly recommends the following topical agents:(58)
TCS are the most commonly utilized FDA-approved therapies in AD and are commonly used as first-line treatment for mild-to severe dermatitis in all skin regions. TCS target a variety of immune cells and suppress the release of proinflammatory cytokines. High to very high (super) potency TCS can be used to control flares and treat severe disease, while medium potency TCS are utilized for longer courses and as maintenance therapy. Lower potency TCS may be used, and it is important to consider the anatomical site (i.e., using lower potency agents on the face, neck, genitals, and body folds) and severity of the disease when choosing a steroid potency. Most studies of TCS in AD management involve twice daily application, but some studies (particularly for potent TCS) suggest once daily use may be sufficient. Traditionally, TCS were stopped once AD signs and symptoms of an AD flare were controlled. Maintenance in between AD flares with once to twice weekly use of TCS is another approach.(58) TCIs are a safe anti-inflammatory option for mild-to-severe AD, particularly when there is concern for adverse events secondary to corticosteroid use. Both tacrolimus and pimecrolimus have been shown to be effective in treating AD, but pimecrolimus may be more appropriate for patients who have milder disease or are sensitive to local reactions.(58) Prescribing information for pimecrolimus cream and tacrolimus ointment indicate evaluation after 6 weeks if symptoms of AD do not improve for adults and pediatrics.(62,63). When AD is more severe or refractory to topical treatment, advanced treatment with phototherapy or systemic medications can be considered. Phototherapy is conditionally recommended by the AAD as a treatment for AD based on low certainty evidence. The AAD strongly recommends the following systemic therapies:(59)
In a change from the 2014 AAD AD guidelines, the use of systemic antimetabolites such as methotrexate, immunosuppressants such as systemic corticosteroids, mycophenolate mofetil, azathioprine, and cyclosporine are now conditionally recommended for AD only in a small number of select patients due to low or very low certainty of evidence and need for monitoring. The most favored first-line systemic is dupilumab.(59) There is no clear consensus on how to operationalize a definition of the FDA indication for treatment of patients with "moderate to severe" AD. The severity of AD can vary substantially over time and, from a patient's perspective, can include a complex combination of intensity of itch, location, body surface area (BSA) involvement, and degree of skin impairment. Given the variability of patient phenotype and lack of familiarity among clinicians with scoring systems used in clinical trials, it is advisable to create a broad clinically relevant definition inclusive of multiple specific measures of disease intensity for example:(82) One of the following:
OR One of the following:
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INFLAMMATORY BOWEL DISEASE - Crohn's Disease (CD) |
Crohn’s disease (CD) is an inflammatory condition that can affect any portion of the gastrointestinal tract from the mouth to the perianal area. Choice of therapy is dependent on the anatomic location of disease, the severity of disease, and whether the treatment goal is to induce remission or maintain remission.(21,36) The American Gastroenterological Association (AGA) 2021 guideline recommends the following:(21)
The 2018 American College of Gastroenterology (ACG) guideline recommends the following:(36)
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INFLAMMATORY BOWEL DISEASE - Ulcerative Colitis (UC) |
Ulcerative colitis (UC) is a chronic immune-mediated inflammatory condition affecting the large intestine associated with inflammation of the rectum, but that can extend to involve additional areas of the colon.(37) The American College of Gastroenterology (ACG) recommends a treat-to-target approach and recommends therapeutic management should be guided by diagnosis (i.e., Montreal classification), assessment of disease activity (i.e., mild, moderate, and severe), and disease prognosis. The ACG treatment recommendations are further broken down into induction therapies and maintenance of remission. The 2019 ACG treatment guidelines recommend the following for therapeutic management of UC:(37) Induction of remission:
Maintenance of remission:
The American Gastroenterology Association (AGA) published recommendations (2018) for the management of mild-to-moderate UC:(38)
The American Gastroenterology Association (AGA) published recommendations (2024) for the management of moderate-to-severe UC:(48) General treatment information:
Advanced therapy-naïve patients (first-line therapy):
Prior exposure to one or more advanced therapies, particularly TNF antagonists:
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OTHER DISORDERS - Uveitis |
Uveitis is characterized by inflammation of the portion of the eye known as the uvea, with the anterior portion of uvea including the iris and ciliary body and the posterior portion being the choroid. Uveitis can cause redness, pain, decreased or loss of vision, worsening field changes, and floaters involving the eye. Uveitis is subdivided into four types based on the primary anatomical location of the inflammation: anterior, intermediate, posterior, and panuveitis. Intermediate uveitis is defined by inflammation of the vitreous cavity and pars plana, posterior uveitis involves the retina and choroid, and panuveitis includes all layers. Uveitis can be caused by infections, inflammatory diseases, or trauma, or be idiopathic in nature.(22) The goal of treatment in uveitis is to suppress ocular inflammation and achieve an inactive disease state or drug-induced remission.(42) Treatment of non-infectious uveitis (NIU) depends on the location of inflammation. Intermediate, posterior, and panuveitis treatment is complex and should be guided by an ophthalmologist or uveitis specialist.(22) NIU should be treated early and aggressively to prevent complications and preserve sight, with corticosteroids being used initially to suppress inflammation.(39) Oral corticosteroids are the mainstay of treatment, but periocular or intravitreal corticosteroid injections may also be used to limit systemic effects. Treatment with conventional systemic agents (i.e., azathioprine, mycophenolate, methotrexate[MTX], cyclosporine, tacrolimus) may be introduced to control persistent or severe inflammation, or to prevent ocular structural complications. They may also be used if there is a need for a corticosteroid-sparing effect in chronic disease or to maintain disease remission.(42) MTX is used most commonly, with mycophenolate being used if MTX was ineffective, not tolerated, or contraindicated. A conventional immunomodulatory agent should be used for at least three months before assuming that it is not effective.(39) Adalimumab, a tumor necrosis factor (TNF)-inhibitor, is generally considered for treatment in patients whose disease is inadequately controlled by corticosteroids and conventional systemic agents.(42) TNF-inhibitors are effective in most cases, but they may eventually lose their effect and require an escalation in dose.(39) This loss of effect is primarily due to an immune response targeting the drug itself. The concurrent use of an antimetabolite (e.g., MTX or mycophenolate) may prolong the effectiveness of the biologic.(39,100) |
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OTHER DISORDERS - Giant Cell Arteritis (GCA) |
Giant cell arteritis (GCA) is a blood vessel disease that predominantly affects medium to large arteries in individuals older than 50 years of age, causing clinical manifestations in both cranial and extracranial locations. The cranial phenotype is characterized by headache, jaw claudication, and visual disturbance or loss. The extracranial phenotype is characterized by musculoskeletal involvement with symptoms associated with polymyalgia rheumatica, such as pain, stiffness, and limited range of motion around the shoulders, neck, and hips. Treatment should begin as soon as the diagnosis is made to prevent loss of vision or blindness.(23) The American College of Rheumatology/Vasculitis Foundation guidelines (2021) recommend high-dose systemic glucocorticoids as the mainstay of therapy for GCA. The guidelines provide the following recommendations for the management of GCA:(40)
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OTHER DISORDERS - Cryopyrin-Associated Periodic Syndromes (CAPS)/Neonatal-Onset Multisystem Inflammatory Disease (NOMID) |
Cryopyrin-associated periodic syndrome (CAPS) is a rare autosomal dominant hereditary autoimmune disorder associated with a defect in the cryopyrin protein. CAPS is caused by a gain-of-function mutation in the NLRP3 gene, the gene encoding cryopyrin, leading to over secretion of fever causing cytokine interleukin (IL)-1B. The CAPS spectrum includes mild, moderate, and severe phenotypes. The mild phenotype is familial cold autoinflammatory syndrome (FCAS), the moderate phenotype is Muckle-Wells syndrome (MWS), and the neonatal-onset multisystem inflammatory disease (NOMID)/chronic infantile neurologic cutaneous articular syndrome (CINCA) describes the severe phenotype. CAPS is diagnosed clinically and genetically. There are more than 240 sequence variants of the NLRP3 gene, and mutations in this gene are not inclusive of a CAPS diagnosis. The diagnostic criteria of CAPS recognizes that all but a few patients with CAPS have detectable systemic inflammation and use unique CAPS-specific clinical features along the whole disease spectrum to achieve reasonable specificity and sensitivity to aid clinicians in making the CAPS diagnosis.(24) The diagnostic criteria does not include genetic confirmation and can be applied to all CAPS subtypes regardless of NLRP3 mutation. The diagnostic criteria for CAPS are as follows:(49)
Goals of treatment include suppressing systemic inflammation, improving functionality, preventing organ damage, and improving quality of life.(24) IL-1 blocking therapy is the preferred treatment for CAPS and is the recommended standard of care. IL-1 blocking therapies control inflammation in the absence of corticosteroids. Current IL-1 blocking therapies include anakinra, canakinumab, and rilonacept. Each of these drugs blocks the effect of IL-1B on the IL-1 receptor and downstream signaling.(51) |
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OTHER DISORDERS - Deficiency of IL-1 Receptor Antagonist (DIRA) |
Deficiency of interleukin (IL)-1 receptor antagonist (DIRA) is a very rare, autosomal recessive inflammatory disease caused by biallelic deleterious loss-of-function mutations in the IL1RN gene, which encodes the IL-1 receptor antagonist (IL-1Ra). These mutations lead to the absence of IL-1Ra, which allows unopposed action of IL-1 and an increased response to proinflammatory cytokines IL-1α and IL-1β stimulation. This results in life-threatening systemic inflammation and marked skin and bone involvement.(57) DIRA presents in early childhood, sometimes at birth, with pustular rashes, osteomyelitis, and/or nail changes (onychomadesis). Which features a patient may present with is dependent on the domain affected by the mutation, with some patients presenting primarily with skin involvement and minimal bone involvement, or vice versa. Although inflammatory markers are typically highly elevated, patients rarely present with flare-associated fever unless an infection is present. The diagnosis of DIRA is typically suspected based on clinical features and confirmed on subsequent genetic testing. DIRA can only be diagnosed by genetic analysis and detection of mutations in the IL1RN gene. If untreated, DIRA can result in multiorgan failure and death in early childhood.(57) Aims of therapy are early control of disease activity, prevention of disease and treatment related damage, and optimal health-related quality of life. The ultimate goal of a treat-to-target approach is complete remission, with remission defined as an absence of clinical symptoms and normal inflammatory markers. In patients with DIRA, treatment with agents that block both IL-1α and IL-1β is recommended and includes anakinra and rilonacept. Both drugs have shown benefit in controlling disease flares and in preventing long-term complications. Anakinra is typically used initially in all patients with DIRA to achieve disease control, while rilonacept is used to maintain remission.(51) |
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OTHER DISORDERS - Systemic Sclerosis-Associated Interstitial Lung Disease (SScILD) |
Systemic sclerosis (SSc) is a connective tissue disease (CTD) that affects numerous organ systems, including skin, blood vessels, heart, lungs, kidneys, gastrointestinal, and musculoskeletal. Pulmonary disease is the leading cause of death in patients with systemic sclerosis, and interstitial lung disease (ILD) is a common manifestation that tends to occur early in the course of systemic sclerosis.(52) SSc-associated ILD (SSc-ILD) is diagnosed when there is radiographic evidence of diffuse parenchymal lung disease in patients with systemic sclerosis. ILD is defined as pulmonary fibrosis seen on high-resolution computed tomography (HRCT) or chest radiography, most pronounced in the basilar portions of the lungs.(54) All patients with suspected SSc-ILD should undergo HRCT of the chest at initial evaluation. HRCT is preferred over pulmonary function tests (PFTs) since patients with ILD can have normal PFTs or have difficulty performing them due to cough or microstomia. HRCT is also preferred over chest radiography due to its low sensitivity, which limits its use as a screening test for ILD.(41) The American College of Rheumatology (ACR) and American College of Chest Physicians (CHEST) guidelines (2023) recommend the following treatment options for SSc-ILD:(53)
The American Thoracic Society (ATS) guidelines (2023) state the following for the treatment of SSc-ILD:(70)
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Efficacy |
Cosentyx Psoriatic Arthritis The safety and efficacy of Cosentyx were assessed in 1999 patients, in 3 randomized, double-blind, placebo-controlled studies (PsA1, PsA2 and PsA3) in adult patients, age 18 years and older with active psoriatic arthritis (greater than or equal to 3 swollen and greater than or equal to 3 tender joints) despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid or disease modifying anti-rheumatic drug (DMARD) therapy. In PsA1, patients treated with 150 mg or 300 mg Cosentyx demonstrated a greater clinical response, including ACR20, ACR50, and ACR70 compared to placebo at Week 24 (Table 6). Responses were similar in patients regardless of concomitant methotrexate treatment. Responses were seen regardless of prior anti-TNFα exposure. Patients on placebo who received Cosentyx without a loading regimen achieved similar ACR20 responses over time (data not shown).(3) In PsA3 Study, inhibition of progression of structural damage was assessed radiographically and expressed by the modified mTSS and its components, the Erosion Score (ES) and Joint Space Narrowing Score (JSN), at Week 24 compared to baseline. Cosentyx 150 mg without load, 150 mg with load and 300 mg with load treatment significantly inhibited progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS at Week 24. The percentage of patients with no disease progression (defined as a change from baseline in mTSS of less than or equal to 0.0) from randomization to Week 24 was 75.7%, 70.9%, and 76.5% for Cosentyx 150 mg without load, 150 mg, 300 mg, respectively versus 68.2% for placebo.(3) Future 4 and Future 5 trials assessed the efficacy and safety of Cosentyx 150 mg with or without loading dose in patients with active psoriatic arthritis.(3) Future 4 trial was a randomized, double-blind, placebo-controlled phase 3 multicenter study of Cosentyx 150 mg, with and without a loading regimen, assessed the efficacy, safety and tolerability in patients with active psoriatic arthritis over 104 weeks. The primary end point was met by both secukinumab treatment regimens (150 mg and 150 mg no-loading dose), demonstrating a significantly higher ACR20 response with secukinumab compared with placebo at week 16. Both secukinumab 150 mg and 150 mg no-loading dose regimens improved other clinically important end points including DAS28-CRP, PASI 75, SF36 PCS, ACR50, ACR70, PASI 90, MDA, FACIT-Fatigue and HAQ-DI response and resolution of enthesitis and dactylitis through 2 years.(3)
The Future 4 trial indicated that there was no statistically significant difference between the loading dose and non-loading dose for all primary and secondary endpoints.(68) Future 5 was a double-blind, placebo-controlled, parallel-group phase III trial of Cosentyx 150 mg, with and without a loading regimen, and Cosentyx 300 mg, to assess the efficacy, safety and tolerability in patients with active psoriatic arthritis over 24 weeks. The primary endpoint, ACR20 response at week 16, was met for all secukinumab regimens, and secondary endpoints were significant for all secukinumab doses except for enthesitis and dactylitis resolution in the 150mg without LD group.(69)
The Future 5 trial did not assess if there were statistically significant differences between the loading vs non-loading doses for any endpoints.(69) Ankylosing Spondylitis The safety and efficacy of Cosentyx were assessed in 816 patients in three randomized, double-blind, placebo-controlled studies (AS1, AS2, and AS3) in adult patients 18 years of age and older with active ankylosing spondylitis. In AS1, patients treated with 150 mg Cosentyx demonstrated greater improvements in ASAS20 and ASAS40 responses compared to placebo at Week 16. Responses were similar in patients regardless of concomitant therapies. Patients on placebo who received Cosentyx without a loading regimen achieved similar ASAS20 responses over time. At Week 16, the ASAS20 and ASAS40 responses were 58.1% and 40.5% for 150 mg and 60.5% and 42.1% for 300 mg, respectively. Cosentyx treated patients showed improvement compared to placebo-treated patients in health-related quality of life as assessed by ASQoL at Week 16.(3) Non-Radiographic Axial Spondyloarthritis The safety and efficacy of Cosentyx were assessed in 555 patients in one randomized, double-blind, placebo-controlled phase 3 study (nr-axSpA1, NCT02696031) in adult patients 18 years of age and older with active non-radiographic axial spondyloarthritis. Patients were treated with Cosentyx 150 mg subcutaneous treatment with load (Weeks 0, 1, 2, 3, and 4) or without a load (Weeks 0 and 4) followed by the same dose every 4 weeks or placebo. In nr-axSpA1 Study, treatment with Cosentyx 150 mg resulted in significant improvements in the measure of disease activity compared to placebo at Week 16 and Week 52.(3)
Cosentyx treated patients showed improvement in both load and without load arms compared to placebo-treated patients at Week 16 in health-related quality of life as measured by ASQoL (LS mean change: Week 16: -3.5 and -3.6 vs - 1.8, respectively).(3) |
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|
Safety |
Adalimumab(6,71,74,75,76,77,78,79,80,83,90) Adalimumab products have the following boxed warnings:
Bimzelx(84) Bimekizumab-bkzx has no FDA labeled contraindications for use. Cimzia(2) Certolizumab has the following boxed warnings:
Certolizumab is contraindicated in patients with a severe hypersensitivity to certolizumab pegol or to any of the excipients. Cosentyx(3) Secukinumab is contraindicated in patients with a serious hypersensitivity reaction to secukinumab or to any of the excipients. Cases of anaphylaxis and angioedema have been reported during treatment with secukinumab. Enbrel(4) Etanercept has the following boxed warnings:
Etanercept is contraindicated for use in patients with sepsis. Entyvio(5) Vedolizumab is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to Entyvio or any of its excipients. Kevzara(7) Sarilumab has the following boxed warning:
Sarilumab is contraindicated in patients with a known hypersensitivity to sarilumab or any of the inactive ingredients. Kineret(8) Anakinra is contraindicated in patients with a known hypersensitivity to E.coli-derived proteins, anakinra, or any component of the product. Litfulo(81) Ritlecitinib has the following boxed warnings:
Ritlecitinib is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients. Olumiant(9) Baricitinib has the following boxed warnings:
Baricitinib has no FDA labeled contraindications for use. Omvoh(86) Mirikizumab is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients. Orencia(10) Abatacept has no FDA labeled contraindications for use. Rinvoq(44) Upadacitinib has the following boxed warnings:
Upadacitinib is contraindicated in patients with known hypersensitivity to upadacitinib or any of its excipients. Siliq(11) Brodalumab has the following boxed warning:
Simponi(12) Golimumab has the following boxed warnings:
Skyrizi(43) Risankizumab is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Sotyktu(67) Deucravacitinib is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in Sotyktu. Taltz(14) Ixekizumab is contraindicated for use in patients with serious hypersensitivity reaction to ixekizumab or to any of the excipients. Tocilizumab(1,50) Tocilizumab has the following boxed warning:
Tocilizumab is contraindicated in patients with a known hypersensitivity reaction to tocilizumab. Tremfya(15) Guselkumab is contraindicated for use in patients with serious hypersensitivity reaction to guselkumab or to any of the excipients. Ustekinumab(13,91,101,102,103,104,105) Ustekinumab is contraindicated for use in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients. Velsipity(85) Etrasimod is contraindicated in:
Xeljanz/Xeljanz XR(16) Tofacitinib has the following boxed warnings:
Tofacitinib has no FDA labeled contraindications for use. Zymfentra(89) Infliximab has the following boxed warnings:
Zymfentra is contraindicated in patients with a history of a severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients in Zymfentra, or any murine proteins. Reactions have included anaphylaxis. |
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55 |
Di Gennaro S, Di Matteo G, Stornaiuolo G, et al. Advances in the diagnosis and treatment of Enthesitis-Related Arthritis. Children. 2023;10(10):1647. doi:10.3390/children10101647 |
|
56 |
Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of Care for the Management of Atopic Dermatitis: Section 1. Diagnosis and Assessment of Atopic Dermatitis. J Am Acad Dermatol. 2014 Feb;70(2):338-51 |
|
57 |
Rivera-Sepulveda A, Colón-Fontánez F, López M, Puig-Ramos G. Deficiency of interleukin-1 receptor Antagonist: new genetic autoinflammatory disease as a diagnostic challenge for pediatricians. Journal of Pediatric Genetics. 2021;12(03):227-232. doi:10.1055/s-0041-1724113 |
|
58 |
Sidbury R, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol. 2023;89(1):e1-e20. |
|
59 |
Davis DM, Drucker AM, Alikhan A, et al. Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies. Journal of the American Academy of Dermatology. 2024;90(2):e43-e56. doi:10.1016/j.jaad.2023.08.102 |
|
60 |
Sidbury R, Tom WL, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014 Dec;71(6):1218-33. |
|
61 |
Ramiro S, Nikiphorou E, Sepriano A, et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Annals of the Rheumatic Diseases. 2022;82(1):19-34. doi:10.1136/ard-2022-223296 |
|
62 |
Pimecrolimus cream prescribing information. Oceanside Pharmaceuticals. September 2020. |
|
63 |
Tacrolimus ointment prescribing information. Glenmark Pharmaceuticals Inc., USA. August 2023. |
|
64 |
Bautista-Molano W, Fernández-Ávila DG, Brance ML, et al. Pan American League of Associations for Rheumatology recommendations for the management of axial spondyloarthritis. Nature Reviews Rheumatology. 2023;19(11):724-737. doi:10.1038/s41584-023-01034-z |
|
65 |
Egeberg A, Linsell L, Johansson E, Durand F, Yu G, Vano-Galvan S. Treatments for Moderate-to-Severe Alopecia Areata: A Systematic Narrative Review. Dermatology and Therapy. 2023;13(12):2951-2991. doi:10.1007/s13555-023-01044-5 |
|
66 |
Sibbald C. Alopecia areata: an updated review for 2023. Journal of Cutaneous Medicine and Surgery. 2023;27(3):241-259. doi:10.1177/12034754231168839 |
|
67 |
Sotyktu prescribing information. Bristol-Myers Squibb Company. September 2022. |
|
68 |
Kivitz AJ, Nash P, Tahir H, et al. Efficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study. Rheumatology and Therapy. 2019;6(3):393-407. doi:10.1007/s40744-019-0163-5 |
|
69 |
Mease P, van der Heijde D, Landewé R, et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Annals of the Rheumatic Diseases. 2018;77(6):890-897. doi:10.1136/annrheumdis-2017-212687 |
|
70 |
Raghu G, Montesi SB, Silver RM, et al. Treatment of Systemic sclerosis–associated interstitial lung disease: Evidence-based recommendations. An Official American Thoracic Society Clinical Practice Guideline. American Journal of Respiratory and Critical Care Medicine. 2023;209(2):137-152. doi:10.1164/rccm.202306-1113st |
|
71 |
Amjevita prescribing information. Amgen Inc. August 2024. |
|
72 |
Lundberg IE, Sharma A, Turesson C, Mohammad AJ. An update on polymyalgia rheumatica. Journal of Internal Medicine. 2022;292(5):717-732. doi:10.1111/joim.13525 |
|
73 |
Dejaco C, Singh YP, Perel P, et al. 2015 Recommendations for the Management of Polymyalgia Rheumatica: A European League against Rheumatism/American College of Rheumatology Collaborative Initiative. Arthritis & Rheumatology. 2015;67(10):2569-2580. doi:10.1002/art.39333 |
|
74 |
Hulio prescribing information. Mylan Pharmaceuticals. August 2023. |
|
75 |
Idacio prescribing information. Fresenius Kabi USA, LLC. June 2024. |
|
76 |
Cyltezo prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. April 2024. |
|
77 |
Hadlima prescribing information. Organon LLC. June 2024. |
|
78 |
Yuflyma prescribing information. Celltrion, Inc. January 2024. |
|
79 |
Yusimry prescribing information. Coherus BioSciences, Inc. September 2023. |
|
80 |
Hyrimoz prescribing information. Sandoz Inc. June 2024. |
|
81 |
Litfulo prescribing information. Pfizer Labs. July 2024. |
|
82 |
Institute For Clinical and Economic Review (ICER). JAK Inhibitors and Monoclonal Antibodies for the Treatment of Atopic Dermatitis: Effectiveness and Value. Final Evidence Report. August 2021. Updated February 2023. |
|
83 |
Abrilada prescribing information. Pfizer Laboratories Div Pfizer Inc. October 2023. |
|
84 |
Bimzelx prescribing information. UCB, Inc. November 2024. |
|
85 |
Velsipity prescribing information. Pfizer Labs. June 2024. |
|
86 |
Omvoh prescribing information. Eli Lilly and Company. January 2025. |
|
87 |
Brunello F, Tirelli F, Pegoraro L, et al. New insights on juvenile psoriatic arthritis. Frontiers in Pediatrics. 2022;10:1-7. doi:10.3389/fped.2022.884727 |
|
88 |
Elmets CA, Korman NJ, Prater EF, et al. Joint AAD–NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. Journal of the American Academy of Dermatology. 2021;84(2):432-470. doi:10.1016/j.jaad.2020.07.087 |
|
89 |
Zymfentra prescribing information. Celltrion Inc. October 2023. |
|
90 |
Simlandi prescribing information. Teva Pharmaceuticals USA, Inc. February 2024. |
|
91 |
Wezlana prescribing information. Amgen Inc. January 2025. |
|
92 |
Petty RE, Southwood TR, Manners P, et al. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. The Journal of Rheumatology. 2004;31(2):390-392. |
|
93 |
Fautrel B, Mitrovic S, De Matteis A, et al. EULAR/PReS recommendations for the diagnosis and management of Still’s disease, comprising systemic juvenile idiopathic arthritis and adult-onset Still’s disease. Annals of the Rheumatic Diseases. 2024;83(12):1614-1627. doi:10.1136/ard-2024-225851 |
|
94 |
Brunner HI, Foeldvari I, Alexeeva E, et al. Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial. Annals of the Rheumatic Diseases. 2022;82(1):154-160. doi:10.1136/ard-2022-222849 |
|
95 |
Harries MJ, Ascott A, Asfour L, et al. British Association of Dermatologists living guideline for managing people with alopecia areata 2024. British Journal of Dermatology. Published online October 21, 2024. doi:10.1093/bjd/ljae385 |
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96 |
King BA, Mesinkovska NA, Craiglow B, et al. Development of the alopecia areata scale for clinical use: Results of an academic–industry collaborative effort. Journal of the American Academy of Dermatology. 2021;86(2):359-364. doi:10.1016/j.jaad.2021.08.043 |
|
97 |
Lintzeri DA, Constantinou A, Hillmann K, Ghoreschi K, Vogt A, Peytavi UB. Alopecia areata - Current understanding and management. JDDG Journal Der Deutschen Dermatologischen Gesellschaft. 2022;20(1):59-90. doi:10.1111/ddg.14689 |
|
98 |
Garner KK, Hoy KDS, Carpenter AM. Psoriasis: Recognition and Management Strategies. Am Fam Physician. 2023;108(6):562-573. |
|
99 |
Elmets CA, Lim HW, Stoff B, et al. Joint American Academy of Dermatology–National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy. Journal of the American Academy of Dermatology. 2019;81(3):775-804. doi:10.1016/j.jaad.2019.04.042 |
|
100 |
Chauhan K, Tyagi M. Update on non-infectious uveitis treatment: anti-TNF-alpha and beyond. Frontiers in Ophthalmology. 2024;4:1-15. doi:10.3389/fopht.2024.1412930 |
|
101 |
Steqeyma prescribing information. Celltrion Inc. December 2024. |
|
102 |
Yesintek prescribing information. Biocon Biologics Inc. November 2024. |
|
103 |
Pyzchiva prescribing information. Samsung Bioepis. December 2024. |
|
104 |
Selarsdi prescribing information. Teva Pharmaceuticals USA, Inc. October 2024. |
|
105 |
Otulfi prescribing information. Fresenius Kabi USA, LLC. February 2025. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
|
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
|
||||||
|
Orencia clickject |
abatacept subcutaneous soln auto-injector |
125 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Orencia |
abatacept subcutaneous soln prefilled syringe |
125 MG/ML ; 50 MG/0.4ML ; 87.5 MG/0.7ML |
M ; N ; O ; Y |
N |
|
|
|
Humira ; Humira pediatric crohns d ; Humira pen ; Humira pen-cd/uc/hs start ; Humira pen-pediatric uc s ; Humira pen-ps/uv starter |
adalimumab auto-injector kit ; adalimumab prefilled syringe kit |
10 MG/0.1ML ; 20 MG/0.2ML ; 40 MG/0.4ML ; 40 MG/0.8ML ; 80 MG/0.8ML ; 80 MG/0.8ML & 40MG/0.4ML |
M ; N ; O ; Y |
N |
|
|
|
Adalimumab-aacf (2 pen) ; Adalimumab-aacf (2 syring ; Adalimumab-aacf starter p ; Idacio (2 pen) ; Idacio (2 syringe) ; Idacio starter package fo |
adalimumab-aacf auto-injector kit ; adalimumab-aacf prefilled syringe kit |
40 MG/0.8ML |
M ; N ; O ; Y |
N |
|
|
|
Adalimumab-aaty 1-pen kit ; Adalimumab-aaty 2-pen kit ; Adalimumab-aaty 2-syringe ; Adalimumab-aaty cd/uc/hs ; Yuflyma 1-pen kit ; Yuflyma 2-pen kit ; Yuflyma 2-syringe kit ; Yuflyma cd/uc/hs starter |
adalimumab-aaty auto-injector kit ; adalimumab-aaty prefilled syringe kit |
20 MG/0.2ML ; 40 MG/0.4ML ; 80 MG/0.8ML |
M ; N ; O ; Y |
N |
|
|
|
Adalimumab-adaz ; Hyrimoz ; Hyrimoz crohn's disease a ; Hyrimoz pediatric crohn's ; Hyrimoz pediatric crohns ; Hyrimoz plaque psoriasis ; Hyrimoz plaque psoriasis/ ; Hyrimoz sensoready pens |
adalimumab-adaz soln auto-injector ; adalimumab-adaz soln prefilled syr ; adalimumab-adaz soln prefilled syringe |
10 MG/0.1ML ; 20 MG/0.2ML ; 40 MG/0.4ML ; 40 MG/0.8ML ; 80 MG/0.8ML ; 80 MG/0.8ML & 40MG/0.4ML |
M ; N ; O ; Y |
N |
|
|
|
Adalimumab-adbm ; Adalimumab-adbm crohns/uc ; Adalimumab-adbm psoriasis ; Adalimumab-adbm starter p ; Cyltezo ; Cyltezo starter package f |
adalimumab-adbm auto-injector kit ; adalimumab-adbm prefilled syringe kit |
10 MG/0.2ML ; 20 MG/0.4ML ; 40 MG/0.4ML ; 40 MG/0.8ML |
M ; N ; O ; Y |
N |
|
|
|
Abrilada ; Abrilada 1-pen kit ; Abrilada 2-pen kit |
adalimumab-afzb auto-injector kit ; adalimumab-afzb prefilled syringe kit |
20 MG/0.4ML ; 40 MG/0.8ML |
M ; N ; O ; Y |
N |
|
|
|
Yusimry |
adalimumab-aqvh soln auto-injector |
40 MG/0.8ML |
M ; N ; O ; Y |
N |
|
|
|
Amjevita |
adalimumab-atto soln auto-injector ; adalimumab-atto soln prefilled syringe |
10 MG/0.2ML ; 20 MG/0.2ML ; 20 MG/0.4ML ; 40 MG/0.4ML ; 40 MG/0.8ML ; 80 MG/0.8ML |
M ; N ; O ; Y |
N |
|
|
|
Hadlima ; Hadlima pushtouch |
adalimumab-bwwd soln auto-injector ; adalimumab-bwwd soln prefilled syringe |
40 MG/0.4ML ; 40 MG/0.8ML |
M ; N ; O ; Y |
N |
|
|
|
Adalimumab-fkjp ; Hulio |
adalimumab-fkjp auto-injector kit ; adalimumab-fkjp prefilled syringe kit |
20 MG/0.4ML ; 40 MG/0.8ML |
M ; N ; O ; Y |
N |
|
|
|
Adalimumab-ryvk (2 pen) ; Simlandi 1-pen kit ; Simlandi 2-pen kit |
adalimumab-ryvk auto-injector kit |
40 MG/0.4ML ; 80 MG/0.8ML |
M ; N ; O ; Y |
N |
|
|
|
Adalimumab-ryvk ; Simlandi |
adalimumab-ryvk prefilled syringe kit |
20 MG/0.2ML ; 40 MG/0.4ML ; 80 MG/0.8ML |
M ; N ; O ; Y |
N |
|
|
|
Kineret |
anakinra subcutaneous soln prefilled syringe |
100 MG/0.67ML |
M ; N ; O ; Y |
N |
|
|
|
Olumiant |
baricitinib tab |
1 MG ; 2 MG ; 4 MG |
M ; N ; O ; Y |
N |
|
|
|
Bimzelx |
bimekizumab-bkzx subcutaneous soln auto-injector ; bimekizumab-bkzx subcutaneous soln prefilled syr |
160 MG/ML ; 320 MG/2ML |
M ; N ; O ; Y |
N |
|
|
|
Siliq |
brodalumab subcutaneous soln prefilled syringe |
210 MG/1.5ML |
M ; N ; O ; Y |
N |
|
|
|
Cimzia ; Cimzia starter kit |
certolizumab pegol for inj kit ; certolizumab pegol prefilled syringe kit |
200 MG ; 200 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Sotyktu |
deucravacitinib tab |
6 MG |
M ; N ; O ; Y |
N |
|
|
|
Enbrel ; Enbrel mini ; Enbrel sureclick |
etanercept subcutaneous inj ; etanercept subcutaneous soln prefilled syringe ; etanercept subcutaneous solution auto-injector ; etanercept subcutaneous solution cartridge |
25 MG/0.5ML ; 50 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Velsipity |
etrasimod arginine tab |
2 MG |
M ; N ; O ; Y |
N |
|
|
|
Simponi |
golimumab subcutaneous soln auto-injector |
100 MG/ML ; 50 MG/0.5ML |
M ; N ; O ; Y |
N |
|
|
|
Simponi |
golimumab subcutaneous soln prefilled syringe |
100 MG/ML ; 50 MG/0.5ML |
M ; N ; O ; Y |
N |
|
|
|
Tremfya ; Tremfya induction pack fo |
guselkumab soln auto-injector |
200 MG/2ML |
M ; N ; O ; Y |
N |
|
|
|
Tremfya ; Tremfya pen |
guselkumab soln auto-injector |
100 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Tremfya |
guselkumab soln prefilled syringe |
200 MG/2ML |
M ; N ; O ; Y |
N |
|
|
|
Tremfya |
guselkumab soln prefilled syringe |
100 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Zymfentra 1-pen ; Zymfentra 2-pen |
infliximab-dyyb soln auto-injector kit |
120 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Zymfentra 2-syringe |
infliximab-dyyb soln prefilled syringe kit |
120 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Taltz |
ixekizumab subcutaneous soln auto-injector ; ixekizumab subcutaneous soln prefilled syringe |
20 MG/0.25ML ; 40 MG/0.5ML ; 80 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Omvoh |
mirikizumab-mrkz subcutaneous auto-inj ; mirikizumab-mrkz subcutaneous soln auto-injector |
100 MG/ML ; 100 MG/ML & 200 MG/2ML |
M ; N ; O ; Y |
N |
|
|
|
Omvoh |
mirikizumab-mrkz subcutaneous pref syr ; mirikizumab-mrkz subcutaneous sol prefill syringe |
100 MG/ML ; 100 MG/ML & 200 MG/2ML |
M ; N ; O ; Y |
N |
|
|
|
Skyrizi ; Skyrizi pen |
risankizumab-rzaa soln auto-injector ; risankizumab-rzaa soln prefilled syringe |
150 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Skyrizi |
risankizumab-rzaa subcutaneous soln cartridge |
180 MG/1.2ML ; 360 MG/2.4ML |
M ; N ; O ; Y |
N |
|
|
|
Litfulo |
ritlecitinib tosylate cap |
50 MG |
M ; N ; O ; Y |
N |
|
|
|
Kevzara |
sarilumab subcutaneous soln prefilled syringe ; sarilumab subcutaneous solution auto-injector |
150 MG/1.14ML ; 200 MG/1.14ML |
M ; N ; O ; Y |
N |
|
|
|
Cosentyx ; Cosentyx sensoready pen ; Cosentyx unoready |
secukinumab iv soln ; secukinumab subcutaneous auto-inj ; secukinumab subcutaneous pref syr ; secukinumab subcutaneous soln auto-injector ; secukinumab subcutaneous soln prefilled syringe |
125 MG/5ML ; 150 MG/ML ; 300 MG/2ML ; 75 MG/0.5ML |
M ; N ; O ; Y |
N |
|
|
|
Actemra actpen |
tocilizumab subcutaneous soln auto-injector |
162 MG/0.9ML |
M ; N ; O ; Y |
N |
|
|
|
Actemra |
tocilizumab subcutaneous soln prefilled syringe |
162 MG/0.9ML |
M ; N ; O ; Y |
N |
|
|
|
Tyenne |
tocilizumab-aazg subcutaneous soln auto-inj |
162 MG/0.9ML |
M ; N ; O ; Y |
N |
|
|
|
Tyenne |
tocilizumab-aazg subcutaneous soln pref syr |
162 MG/0.9ML |
M ; N ; O ; Y |
N |
|
|
|
Xeljanz ; Xeljanz xr |
tofacitinib citrate oral soln ; tofacitinib citrate tab ; tofacitinib citrate tab er |
1 MG/ML ; 10 MG ; 11 MG ; 22 MG ; 5 MG |
M ; N ; O ; Y |
N |
|
|
|
Rinvoq ; Rinvoq lq |
upadacitinib oral soln ; upadacitinib tab er |
1 MG/ML ; 15 MG ; 30 MG ; 45 MG |
M ; N ; O ; Y |
N |
|
|
|
Stelara ; Ustekinumab |
ustekinumab inj ; ustekinumab soln prefilled syringe |
45 MG/0.5ML ; 90 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Otulfi |
ustekinumab-aauz soln prefilled syringe |
45 MG/0.5ML ; 90 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Selarsdi |
ustekinumab-aekn soln prefilled syringe |
45 MG/0.5ML ; 90 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Wezlana |
ustekinumab-auub inj ; ustekinumab-auub soln prefilled syringe |
45 MG/0.5ML ; 90 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Yesintek |
ustekinumab-kfce soln prefilled syringe |
45 MG/0.5ML ; 90 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Yesintek |
ustekinumab-kfce subcutaneous soln |
45 MG/0.5ML |
M ; N ; O ; Y |
N |
|
|
|
Steqeyma |
ustekinumab-stba soln prefilled syringe |
45 MG/0.5ML ; 90 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Pyzchiva ; Ustekinumab-ttwe |
ustekinumab-ttwe soln prefilled syringe |
45 MG/0.5ML ; 90 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Entyvio pen |
vedolizumab soln auto-injector |
108 MG/0.68ML |
M ; N ; O ; Y |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
|
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|
|||||||||
|
|
|
|
2 |
Pens |
28 |
DAYS |
|
|
|
|
Abrilada |
adalimumab-afzb prefilled syringe kit |
20 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Abrilada |
adalimumab-afzb prefilled syringe kit |
40 MG/0.8ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Abrilada 1-pen kit ; Abrilada 2-pen kit |
adalimumab-afzb auto-injector kit |
40 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Actemra |
Tocilizumab Subcutaneous Soln Prefilled Syringe 162 MG/0.9ML |
162 MG/0.9ML |
4 |
Syringes |
28 |
DAYS |
|
|
|
|
Actemra actpen |
Tocilizumab Subcutaneous Soln Auto-injector 162 MG/0.9ML |
162 MG/0.9ML |
4 |
Pens |
28 |
DAYS |
|
|
|
|
Adalimumab-aacf (2 pen) ; Idacio (2 pen) |
adalimumab-aacf auto-injector kit |
40 MG/0.8ML |
1 |
Kit |
28 |
DAYS |
|
|
65219055408 ; 65219061299 |
|
Adalimumab-aacf (2 syring ; Idacio (2 syringe) |
adalimumab-aacf prefilled syringe kit |
40 MG/0.8ML |
1 |
Kit |
28 |
DAYS |
|
|
|
|
Adalimumab-aacf starter p ; Idacio starter package fo |
adalimumab-aacf auto-injector kit |
40 MG/0.8ML |
1 |
Kit |
180 |
DAYS |
|
|
65219055428 ; 65219061269 |
|
Adalimumab-aacf starter p ; Idacio starter package fo |
adalimumab-aacf auto-injector kit |
40 MG/0.8ML |
1 |
Kit |
180 |
DAYS |
|
|
65219055438 ; 65219061289 |
|
Adalimumab-aaty 1-pen kit ; Adalimumab-aaty 2-pen kit ; Yuflyma 1-pen kit ; Yuflyma 2-pen kit |
adalimumab-aaty auto-injector kit |
40 MG/0.4ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Adalimumab-aaty 1-pen kit ; Yuflyma 1-pen kit |
adalimumab-aaty auto-injector kit |
80 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
72606002304 ; 72606004004 |
|
Adalimumab-aaty 2-syringe ; Yuflyma 2-syringe kit |
adalimumab-aaty prefilled syringe kit |
20 MG/0.2ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Adalimumab-aaty 2-syringe ; Yuflyma 2-syringe kit |
adalimumab-aaty prefilled syringe kit |
40 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
1 kit/28 days, per RX claims |
|
|
|
Adalimumab-aaty cd/uc/hs ; Yuflyma cd/uc/hs starter |
adalimumab-aaty auto-injector kit |
80 MG/0.8ML |
1 |
Kit |
180 |
DAYS |
|
|
72606002307 ; 72606004006 |
|
Adalimumab-adaz ; Hyrimoz |
adalimumab-adaz soln auto-injector |
40 MG/0.4ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Adalimumab-adaz ; Hyrimoz |
adalimumab-adaz soln prefilled syringe |
10 MG/0.1ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Adalimumab-adaz ; Hyrimoz |
adalimumab-adaz soln prefilled syringe |
20 MG/0.2ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Adalimumab-adaz ; Hyrimoz |
adalimumab-adaz soln prefilled syringe |
40 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Adalimumab-adaz ; Hyrimoz ; Hyrimoz sensoready pens |
adalimumab-adaz soln auto-injector |
80 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
61314032520 ; 61314045420 ; 83457010701 |
|
Adalimumab-adbm ; Cyltezo |
adalimumab-adbm auto-injector kit |
40 MG/0.4ML |
2 |
Pens |
28 |
DAYS |
|
|
00597049550 ; 00597057550;82009014422 |
|
Adalimumab-adbm ; Cyltezo |
adalimumab-adbm auto-injector kit |
40 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
00597037597 ; 00597054522;82009014822 |
|
Adalimumab-adbm ; Cyltezo |
adalimumab-adbm prefilled syringe kit |
10 MG/0.2ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Adalimumab-adbm ; Cyltezo |
adalimumab-adbm prefilled syringe kit |
20 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Adalimumab-adbm ; Cyltezo |
adalimumab-adbm prefilled syringe kit |
40 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Adalimumab-adbm ; Cyltezo |
adalimumab-adbm prefilled syringe kit |
40 MG/0.8ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Adalimumab-adbm crohns/uc ; Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.8ML |
6 |
Pens |
180 |
DAYS |
|
|
00597037516 ; 00597054566; |
|
Adalimumab-adbm psoriasis ; Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.8ML |
4 |
Pens |
180 |
DAYS |
|
|
00597037523 ; 00597054544; |
|
Adalimumab-adbm starter p ; Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.4ML |
1 |
Kit |
180 |
DAYS |
|
|
00597049540 ; 00597057540; |
|
Adalimumab-adbm starter p ; Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.4ML |
1 |
Kit |
180 |
DAYS |
|
|
00597049560 ; 00597057560; |
|
Adalimumab-fkjp ; Hulio |
adalimumab-fkjp auto-injector kit |
40 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Adalimumab-fkjp ; Hulio |
adalimumab-fkjp prefilled syringe kit |
20 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Adalimumab-fkjp ; Hulio |
adalimumab-fkjp prefilled syringe kit |
40 MG/0.8ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Adalimumab-ryvk (2 pen) ; Simlandi 1-pen kit ; Simlandi 2-pen kit |
adalimumab-ryvk auto-injector kit |
40 MG/0.4ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Adalimumab-ryvk ; Simlandi |
adalimumab-ryvk prefilled syringe kit |
40 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Amjevita |
adalimumab-atto soln auto-injector |
40 MG/0.4ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Amjevita |
adalimumab-atto soln auto-injector |
40 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Amjevita |
adalimumab-atto soln auto-injector |
80 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Amjevita |
adalimumab-atto soln prefilled syringe |
10 MG/0.2ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Amjevita |
adalimumab-atto soln prefilled syringe |
20 MG/0.2ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Amjevita |
adalimumab-atto soln prefilled syringe |
20 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Amjevita |
adalimumab-atto soln prefilled syringe |
40 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Amjevita |
adalimumab-atto soln prefilled syringe |
40 MG/0.8ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Bimzelx |
bimekizumab-bkzx subcutaneous soln auto-injector |
160 MG/ML |
2 |
Pens |
56 |
DAYS |
|
|
|
|
Bimzelx |
bimekizumab-bkzx subcutaneous soln auto-injector |
320 MG/2ML |
1 |
Pen |
28 |
DAYS |
|
|
|
|
Bimzelx |
bimekizumab-bkzx subcutaneous soln prefilled syr |
160 MG/ML |
2 |
Syringes |
56 |
DAYS |
|
|
|
|
Bimzelx |
bimekizumab-bkzx subcutaneous soln prefilled syr |
320 MG/2ML |
1 |
Syringe |
28 |
DAYS |
|
|
|
|
Cimzia |
certolizumab pegol prefilled syringe kit |
200 MG/ML |
2 |
Kits |
28 |
DAYS |
|
6 syringes allowed for 28 days of therapy (Week 0, 2, 4) of 400 mg dosing |
50474071079; |
|
Cimzia starter kit |
certolizumab pegol prefilled syringe kit |
200 MG/ML |
1 |
Kit |
180 |
DAYS |
|
|
50474071081; |
|
Cosentyx |
Secukinumab Subcutaneous Pref Syr 150 MG/ML (300 MG Dose) |
150 MG/ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Cosentyx |
Secukinumab Subcutaneous Soln Prefilled Syringe |
75 MG/0.5ML |
1 |
Syringe |
28 |
DAYS |
|
|
|
|
Cosentyx |
Secukinumab Subcutaneous Soln Prefilled Syringe 150 MG/ML |
150 MG/ML |
1 |
Syringe |
28 |
DAYS |
|
|
|
|
Cosentyx sensoready pen |
Secukinumab Subcutaneous Auto-inj 150 MG/ML (300 MG Dose) |
150 MG/ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Cosentyx sensoready pen |
Secukinumab Subcutaneous Soln Auto-injector 150 MG/ML |
150 MG/ML |
1 |
Pen |
28 |
DAYS |
|
|
|
|
Cosentyx unoready |
secukinumab subcutaneous soln auto-injector |
300 MG/2ML |
1 |
Pen |
28 |
DAYS |
|
|
|
|
Enbrel |
Etanercept Subcutaneous Inj 25 mg/0.5ml |
25 MG/0.5ML |
8 |
Vials |
28 |
DAYS |
|
|
|
|
Enbrel |
Etanercept Subcutaneous Soln Prefilled Syringe 25 MG/0.5ML |
25 MG/0.5ML |
4 |
Syringes |
28 |
DAYS |
|
|
|
|
Enbrel |
Etanercept Subcutaneous Soln Prefilled Syringe 25 MG/0.5ML |
25 MG/0.5ML |
4 |
Syringes |
28 |
DAYS |
58406-455-04 |
|
|
|
Enbrel |
Etanercept Subcutaneous Soln Prefilled Syringe 50 MG/ML |
50 MG/ML |
4 |
Syringes |
28 |
DAYS |
|
|
|
|
Enbrel mini |
Etanercept Subcutaneous Solution Cartridge 50 MG/ML |
50 MG/ML |
4 |
Cartridges |
28 |
DAYS |
|
|
|
|
Enbrel sureclick |
Etanercept Subcutaneous Solution Auto-injector 50 MG/ML |
50 MG/ML |
4 |
Syringes |
28 |
DAYS |
|
|
|
|
Entyvio pen |
vedolizumab soln pen-injector 108 mg/0.68ml |
108 MG/0.68ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Hadlima |
adalimumab-bwwd soln prefilled syringe |
40 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Hadlima |
adalimumab-bwwd soln prefilled syringe |
40 MG/0.8ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Hadlima pushtouch |
adalimumab-bwwd soln auto-injector |
40 MG/0.4ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Hadlima pushtouch |
adalimumab-bwwd soln auto-injector |
40 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Humira |
Adalimumab Prefilled Syringe Kit 10 MG/0.1ML |
10 MG/0.1ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Humira |
Adalimumab Prefilled Syringe Kit 20 MG/0.2ML |
20 MG/0.2ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Humira |
Adalimumab Prefilled Syringe Kit 40 MG/0.4ML |
40 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Humira |
Adalimumab Prefilled Syringe Kit 40 MG/0.8ML |
40 MG/0.8ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Humira pediatric crohns d |
Adalimumab Prefilled Syringe Kit 80 MG/0.8ML |
80 MG/0.8ML |
1 |
Kit |
180 |
DAYS |
|
|
|
|
Humira pediatric crohns d |
Adalimumab Prefilled Syringe Kit 80 MG/0.8ML & 40 MG/0.4ML |
80 MG/0.8ML & 40MG/0.4ML |
1 |
Kit |
180 |
DAYS |
|
|
|
|
Humira pen |
adalimumab auto-injector kit |
40 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
00074433902; |
|
Humira pen |
adalimumab auto-injector kit |
80 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
00074012402;83457012402 |
|
Humira pen |
Adalimumab Pen-injector Kit 40 MG/0.4ML |
40 MG/0.4ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Humira pen-cd/uc/hs start |
adalimumab auto-injector kit |
40 MG/0.8ML |
1 |
Kit |
180 |
DAYS |
|
|
00074433906; |
|
Humira pen-cd/uc/hs start |
adalimumab auto-injector kit |
80 MG/0.8ML |
1 |
Kit |
180 |
DAYS |
|
|
00074012403; |
|
Humira pen-pediatric uc s |
adalimumab auto-injector kit |
80 MG/0.8ML |
1 |
Kit |
180 |
DAYS |
|
|
00074012404; |
|
Humira pen-ps/uv starter |
adalimumab auto-injector kit |
40 MG/0.8ML |
1 |
Kit |
180 |
DAYS |
|
|
00074433907; |
|
Humira pen-ps/uv starter |
Adalimumab Pen-injector Kit 80 MG/0.8ML & 40 MG/0.4ML |
80 MG/0.8ML & 40MG/0.4ML |
1 |
Kit |
180 |
DAYS |
|
|
|
|
Hyrimoz |
adalimumab-adaz soln auto-injector |
40 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Hyrimoz |
adalimumab-adaz soln prefilled syringe |
40 MG/0.8ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Hyrimoz crohn's disease a ; Hyrimoz sensoready pens |
adalimumab-adaz soln auto-injector |
80 MG/0.8ML |
1 |
Starter Kit |
180 |
DAYS |
|
|
61314045436 ; 83457011301 |
|
Hyrimoz pediatric crohn's |
adalimumab-adaz soln prefilled syr |
80 MG/0.8ML & 40MG/0.4ML |
2 |
Syringes |
180 |
DAYS |
|
|
|
|
Hyrimoz pediatric crohns |
adalimumab-adaz soln prefilled syringe |
80 MG/0.8ML |
3 |
Syringes |
180 |
DAYS |
|
|
|
|
Hyrimoz plaque psoriasis ; Hyrimoz plaque psoriasis/ |
adalimumab-adaz soln auto-injector |
80 MG/0.8ML & 40MG/0.4ML |
1 |
Starter Kit |
180 |
DAYS |
|
|
|
|
Kevzara |
Sarilumab Subcutaneous Soln Prefilled Syringe 150 MG/1.14ML |
150 MG/1.14ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Kevzara |
Sarilumab Subcutaneous Soln Prefilled Syringe 200 MG/1.14ML |
200 MG/1.14ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Kevzara |
Sarilumab Subcutaneous Solution Auto-injector 150 MG/1.14ML |
150 MG/1.14ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Kevzara |
Sarilumab Subcutaneous Solution Auto-injector 200 MG/1.14ML |
200 MG/1.14ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Kineret |
Anakinra Subcutaneous Soln Prefilled Syringe 100 MG/0.67ML |
100 MG/0.67ML |
28 |
Syringes |
28 |
DAYS |
|
|
|
|
Litfulo |
ritlecitinib tosylate cap |
50 MG |
28 |
Capsules |
28 |
DAYS |
|
|
|
|
Olumiant |
Baricitinib Tab |
4 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
|
Olumiant |
Baricitinib Tab 1 MG |
1 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
|
Olumiant |
Baricitinib Tab 2 MG |
2 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
|
Omvoh |
mirikizumab-mrkz subcutaneous auto-inj |
100 MG/ML & 200 MG/2ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Omvoh |
mirikizumab-mrkz subcutaneous pref syr |
100 MG/ML & 200 MG/2ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Omvoh |
mirikizumab-mrkz subcutaneous sol prefill syringe |
100 MG/ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Omvoh |
mirikizumab-mrkz subcutaneous soln auto-injector |
100 MG/ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Orencia |
Abatacept Subcutaneous Soln Prefilled Syringe 125 MG/ML |
125 MG/ML |
4 |
Syringes |
28 |
DAYS |
|
|
|
|
Orencia |
Abatacept Subcutaneous Soln Prefilled Syringe 125 MG/ML |
125 MG/ML |
4 |
Syringes |
28 |
DAYS |
|
|
|
|
Orencia |
Abatacept Subcutaneous Soln Prefilled Syringe 50 MG/0.4ML |
50 MG/0.4ML |
4 |
Syringes |
28 |
DAYS |
|
|
|
|
Orencia |
Abatacept Subcutaneous Soln Prefilled Syringe 87.5 MG/0.7ML |
87.5 MG/0.7ML |
4 |
Syringes |
28 |
DAYS |
|
|
|
|
Orencia clickject |
Abatacept Subcutaneous Soln Auto-Injector 125 MG/ML |
125 MG/ML |
4 |
Pens |
28 |
DAYS |
|
|
|
|
Otulfi |
ustekinumab-aauz soln prefilled syringe |
45 MG/0.5ML |
1 |
Syringe |
84 |
DAYS |
|
|
|
|
Otulfi |
ustekinumab-aauz soln prefilled syringe |
90 MG/ML |
1 |
Syringe |
56 |
DAYS |
|
|
|
|
Pyzchiva ; Ustekinumab-ttwe |
ustekinumab-ttwe soln prefilled syringe |
45 MG/0.5ML |
1 |
Syringe |
84 |
DAYS |
|
|
|
|
Pyzchiva ; Ustekinumab-ttwe |
ustekinumab-ttwe soln prefilled syringe |
90 MG/ML |
1 |
Syringe |
56 |
DAYS |
|
|
|
|
Rinvoq |
Upadacitinib Tab ER |
45 MG |
84 |
Tablets |
365 |
DAYS |
|
|
|
|
Rinvoq |
Upadacitinib Tab ER 24HR 15 MG |
15 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
|
Rinvoq lq |
upadacitinib oral soln |
1 MG/ML |
360 |
mLs |
30 |
DAYS |
|
|
|
|
Selarsdi |
ustekinumab-aekn soln prefilled syringe |
45 MG/0.5ML |
1 |
Syringe |
84 |
DAYS |
|
|
|
|
Selarsdi |
ustekinumab-aekn soln prefilled syringe |
90 MG/ML |
1 |
Syringe |
56 |
DAYS |
|
|
|
|
Siliq |
Brodalumab Subcutaneous Soln Prefilled Syringe 210 MG/1.5ML |
210 MG/1.5ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Simlandi |
adalimumab-ryvk prefilled syringe kit |
20 MG/0.2ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Simlandi |
adalimumab-ryvk prefilled syringe kit |
80 MG/0.8ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Simlandi 1-pen kit |
adalimumab-ryvk auto-injector kit |
80 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Simponi |
Golimumab Subcutaneous Soln Auto-injector 100 MG/ML |
100 MG/ML |
1 |
Syringe |
28 |
DAYS |
|
|
|
|
Simponi |
Golimumab Subcutaneous Soln Auto-injector 50 MG/0.5ML |
50 MG/0.5ML |
1 |
Syringe |
28 |
DAYS |
|
|
|
|
Simponi |
Golimumab Subcutaneous Soln Prefilled Syringe 100 MG/ML |
100 MG/ML |
1 |
Syringe |
28 |
DAYS |
|
|
|
|
Simponi |
Golimumab Subcutaneous Soln Prefilled Syringe 50 MG/0.5ML |
50 MG/0.5ML |
1 |
Syringe |
28 |
DAYS |
|
|
|
|
Skyrizi |
Risankizumab-rzaa Soln Prefilled Syringe |
150 MG/ML |
1 |
Syringe |
84 |
DAYS |
|
|
|
|
Skyrizi |
Risankizumab-rzaa Subcutaneous Soln Cartridge |
180 MG/1.2ML |
1 |
Cartridge |
56 |
DAYS |
|
|
|
|
Skyrizi |
Risankizumab-rzaa Subcutaneous Soln Cartridge |
360 MG/2.4ML |
1 |
Cartridge |
56 |
DAYS |
|
|
|
|
Skyrizi pen |
Risankizumab-rzaa Soln Auto-injector |
150 MG/ML |
1 |
Pen |
84 |
DAYS |
|
|
|
|
Sotyktu |
Deucravacitinib Tab |
6 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
|
Stelara ; Ustekinumab |
Ustekinumab Inj 45 MG/0.5ML |
45 MG/0.5ML |
1 |
Vial |
84 |
DAYS |
|
Plaque psoriasis: less than or equal to 100kg: 45 mg SC on weeks 0,4 and every 12 weeks thereafter |
|
|
Stelara ; Ustekinumab |
Ustekinumab Soln Prefilled Syringe 45 MG/0.5ML |
45 MG/0.5ML |
1 |
Syringe |
84 |
DAYS |
|
Plaque psoriasis: less than or equal to 100kg: 45 mg SC on weeks 0,4 and every 12 weeks thereafter |
|
|
Stelara ; Ustekinumab |
Ustekinumab Soln Prefilled Syringe 90 MG/ML |
90 MG/ML |
1 |
Syringe |
56 |
DAYS |
|
Plaque psoriasis: greater than 100kg: 90 mg SC on weeks 0,4 and then every 12 weeks thereafter |
|
|
Steqeyma |
ustekinumab-stba soln prefilled syringe |
45 MG/0.5ML |
1 |
Syringe |
84 |
DAYS |
|
|
|
|
Steqeyma |
ustekinumab-stba soln prefilled syringe |
90 MG/ML |
1 |
Syringe |
56 |
DAYS |
|
|
|
|
Taltz |
Ixekizumab Subcutaneous Soln Auto-injector 80 MG/ML |
80 MG/ML |
1 |
Syringe |
28 |
DAYS |
|
|
|
|
Taltz |
ixekizumab subcutaneous soln prefilled syringe |
20 MG/0.25ML |
1 |
Syringe |
28 |
DAYS |
|
|
|
|
Taltz |
ixekizumab subcutaneous soln prefilled syringe |
40 MG/0.5ML |
1 |
Syringe |
28 |
DAYS |
|
|
|
|
Taltz |
Ixekizumab Subcutaneous Soln Prefilled Syringe 80 MG/ML |
80 MG/ML |
1 |
Syringe |
28 |
DAYS |
|
|
|
|
Tremfya |
guselkumab soln auto-injector |
200 MG/2ML |
1 |
Pen |
28 |
DAYS |
|
|
57894065101 ; 57894065102; |
|
Tremfya |
guselkumab soln prefilled syringe |
200 MG/2ML |
1 |
Syringe |
28 |
DAYS |
|
|
|
|
Tremfya |
Guselkumab Soln Prefilled Syringe 100 MG/ML |
100 MG/ML |
1 |
Syringe |
56 |
DAYS |
|
|
|
|
Tremfya ; Tremfya pen |
Guselkumab Soln Pen-Injector 100 MG/ML |
100 MG/ML |
1 |
Pen |
56 |
DAYS |
|
|
|
|
Tremfya induction pack fo |
guselkumab soln auto-injector |
200 MG/2ML |
3 |
Kits |
180 |
DAYS |
|
|
57894065104; |
|
Tyenne |
tocilizumab-aazg subcutaneous soln auto-inj |
162 MG/0.9ML |
4 |
Pens |
28 |
DAYS |
|
|
|
|
Tyenne |
tocilizumab-aazg subcutaneous soln pref syr |
162 MG/0.9ML |
4 |
Syringes |
28 |
DAYS |
|
|
|
|
Velsipity |
etrasimod arginine tab |
2 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
|
Wezlana |
ustekinumab-auub inj |
45 MG/0.5ML |
1 |
Vial |
84 |
DAYS |
|
|
|
|
Wezlana |
ustekinumab-auub soln prefilled syringe |
45 MG/0.5ML |
1 |
Syringe |
84 |
DAYS |
|
|
|
|
Wezlana |
ustekinumab-auub soln prefilled syringe |
90 MG/ML |
1 |
Syringe |
56 |
DAYS |
|
|
|
|
Xeljanz |
Tofacitinib Citrate Oral Soln |
1 MG/ML |
240 |
mLs |
30 |
DAYS |
|
|
|
|
Xeljanz |
Tofacitinib Citrate Tab 10 MG (Base Equivalent) |
10 MG |
240 |
Tablets |
365 |
DAYS |
|
|
|
|
Xeljanz |
Tofacitinib Citrate Tab 5 MG (Base Equivalent) |
5 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
|
Xeljanz xr |
Tofacitinib Citrate Tab ER 24HR 11 MG (Base Equivalent) |
11 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
|
Xeljanz xr |
Tofacitinib Citrate Tab ER 24HR 22 MG (Base Equivalent) |
22 MG |
120 |
Tablets |
365 |
DAYS |
|
|
|
|
Yesintek |
ustekinumab-kfce soln prefilled syringe |
45 MG/0.5ML |
1 |
Syringe |
84 |
DAYS |
|
|
|
|
Yesintek |
ustekinumab-kfce soln prefilled syringe |
90 MG/ML |
1 |
Syringe |
56 |
DAYS |
|
|
|
|
Yesintek |
ustekinumab-kfce subcutaneous soln |
45 MG/0.5ML |
1 |
Vial |
84 |
DAYS |
|
|
|
|
Yusimry |
adalimumab-aqvh soln pen-injector 40 mg/0.8ml |
40 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Zymfentra 1-pen |
infliximab-dyyb soln auto-injector kit |
120 MG/ML |
2 |
Pens |
28 |
DAYS |
|
|
72606002501 |
|
Zymfentra 2-pen |
infliximab-dyyb soln auto-injector kit |
120 MG/ML |
2 |
Pens |
28 |
DAYS |
|
|
72606002502 |
|
Zymfentra 2-syringe |
infliximab-dyyb soln prefilled syringe kit |
120 MG/ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Rinvoq |
Upadacitinib Tab ER |
30 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
ADDITIONAL QUANTITY LIMIT INFORMATION
|
Wildcard |
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Additional QL Information |
Targeted NDCs When Exclusions Exist |
Effective Date |
Term Date |
|
|
|||||||
|
6627001503F830 |
Adalimumab-aaty 2-syringe ; Yuflyma 2-syringe kit |
adalimumab-aaty prefilled syringe kit |
40 MG/0.4ML |
1 kit/28 days, per RX claims |
|
|
|
|
6629003000E525 |
Enbrel |
Etanercept Subcutaneous Soln Prefilled Syringe 25 MG/0.5ML |
25 MG/0.5ML |
58406-455-04 |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
|
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
Abrilada ; Abrilada 1-pen kit ; Abrilada 2-pen kit |
adalimumab-afzb auto-injector kit ; adalimumab-afzb prefilled syringe kit |
20 MG/0.4ML ; 40 MG/0.8ML |
SourceRx |
|
Actemra |
tocilizumab subcutaneous soln prefilled syringe |
162 MG/0.9ML |
SourceRx |
|
Actemra actpen |
tocilizumab subcutaneous soln auto-injector |
162 MG/0.9ML |
SourceRx |
|
Adalimumab-aacf (2 pen) ; Adalimumab-aacf (2 syring ; Adalimumab-aacf starter p ; Idacio (2 pen) ; Idacio (2 syringe) ; Idacio starter package fo |
adalimumab-aacf auto-injector kit ; adalimumab-aacf prefilled syringe kit |
40 MG/0.8ML |
SourceRx |
|
Adalimumab-aaty 1-pen kit ; Adalimumab-aaty 2-pen kit ; Adalimumab-aaty 2-syringe ; Adalimumab-aaty cd/uc/hs ; Yuflyma 1-pen kit ; Yuflyma 2-pen kit ; Yuflyma 2-syringe kit ; Yuflyma cd/uc/hs starter |
adalimumab-aaty auto-injector kit ; adalimumab-aaty prefilled syringe kit |
20 MG/0.2ML ; 40 MG/0.4ML ; 80 MG/0.8ML |
SourceRx |
|
Adalimumab-adaz ; Hyrimoz ; Hyrimoz crohn's disease a ; Hyrimoz pediatric crohn's ; Hyrimoz pediatric crohns ; Hyrimoz plaque psoriasis ; Hyrimoz plaque psoriasis/ ; Hyrimoz sensoready pens |
adalimumab-adaz soln auto-injector ; adalimumab-adaz soln prefilled syr ; adalimumab-adaz soln prefilled syringe |
10 MG/0.1ML ; 20 MG/0.2ML ; 40 MG/0.4ML ; 40 MG/0.8ML ; 80 MG/0.8ML ; 80 MG/0.8ML & 40MG/0.4ML |
SourceRx |
|
Adalimumab-adbm ; Adalimumab-adbm crohns/uc ; Adalimumab-adbm psoriasis ; Adalimumab-adbm starter p ; Cyltezo ; Cyltezo starter package f |
adalimumab-adbm auto-injector kit ; adalimumab-adbm prefilled syringe kit |
10 MG/0.2ML ; 20 MG/0.4ML ; 40 MG/0.4ML ; 40 MG/0.8ML |
SourceRx |
|
Adalimumab-fkjp ; Hulio |
adalimumab-fkjp auto-injector kit ; adalimumab-fkjp prefilled syringe kit |
20 MG/0.4ML ; 40 MG/0.8ML |
SourceRx |
|
Adalimumab-ryvk (2 pen) ; Simlandi 1-pen kit ; Simlandi 2-pen kit |
adalimumab-ryvk auto-injector kit |
40 MG/0.4ML ; 80 MG/0.8ML |
SourceRx |
|
Adalimumab-ryvk ; Simlandi |
adalimumab-ryvk prefilled syringe kit |
20 MG/0.2ML ; 40 MG/0.4ML ; 80 MG/0.8ML |
SourceRx |
|
Amjevita |
adalimumab-atto soln auto-injector ; adalimumab-atto soln prefilled syringe |
10 MG/0.2ML ; 20 MG/0.2ML ; 20 MG/0.4ML ; 40 MG/0.4ML ; 40 MG/0.8ML ; 80 MG/0.8ML |
SourceRx |
|
Bimzelx |
bimekizumab-bkzx subcutaneous soln auto-injector ; bimekizumab-bkzx subcutaneous soln prefilled syr |
160 MG/ML ; 320 MG/2ML |
SourceRx |
|
Cimzia ; Cimzia starter kit |
certolizumab pegol for inj kit ; certolizumab pegol prefilled syringe kit |
200 MG ; 200 MG/ML |
SourceRx |
|
Cosentyx ; Cosentyx sensoready pen ; Cosentyx unoready |
secukinumab iv soln ; secukinumab subcutaneous auto-inj ; secukinumab subcutaneous pref syr ; secukinumab subcutaneous soln auto-injector ; secukinumab subcutaneous soln prefilled syringe |
125 MG/5ML ; 150 MG/ML ; 300 MG/2ML ; 75 MG/0.5ML |
SourceRx |
|
Enbrel ; Enbrel mini ; Enbrel sureclick |
etanercept subcutaneous inj ; etanercept subcutaneous soln prefilled syringe ; etanercept subcutaneous solution auto-injector ; etanercept subcutaneous solution cartridge |
25 MG/0.5ML ; 50 MG/ML |
SourceRx |
|
Entyvio pen |
vedolizumab soln auto-injector |
108 MG/0.68ML |
SourceRx |
|
Hadlima ; Hadlima pushtouch |
adalimumab-bwwd soln auto-injector ; adalimumab-bwwd soln prefilled syringe |
40 MG/0.4ML ; 40 MG/0.8ML |
SourceRx |
|
Humira ; Humira pediatric crohns d ; Humira pen ; Humira pen-cd/uc/hs start ; Humira pen-pediatric uc s ; Humira pen-ps/uv starter |
adalimumab auto-injector kit ; adalimumab prefilled syringe kit |
10 MG/0.1ML ; 20 MG/0.2ML ; 40 MG/0.4ML ; 40 MG/0.8ML ; 80 MG/0.8ML ; 80 MG/0.8ML & 40MG/0.4ML |
SourceRx |
|
Kevzara |
sarilumab subcutaneous soln prefilled syringe ; sarilumab subcutaneous solution auto-injector |
150 MG/1.14ML ; 200 MG/1.14ML |
SourceRx |
|
Kineret |
anakinra subcutaneous soln prefilled syringe |
100 MG/0.67ML |
SourceRx |
|
Litfulo |
ritlecitinib tosylate cap |
50 MG |
SourceRx |
|
Olumiant |
baricitinib tab |
1 MG ; 2 MG ; 4 MG |
SourceRx |
|
Omvoh |
mirikizumab-mrkz subcutaneous auto-inj ; mirikizumab-mrkz subcutaneous soln auto-injector |
100 MG/ML ; 100 MG/ML & 200 MG/2ML |
SourceRx |
|
Omvoh |
mirikizumab-mrkz subcutaneous pref syr ; mirikizumab-mrkz subcutaneous sol prefill syringe |
100 MG/ML ; 100 MG/ML & 200 MG/2ML |
SourceRx |
|
Orencia |
abatacept subcutaneous soln prefilled syringe |
125 MG/ML ; 50 MG/0.4ML ; 87.5 MG/0.7ML |
SourceRx |
|
Orencia clickject |
abatacept subcutaneous soln auto-injector |
125 MG/ML |
SourceRx |
|
Otulfi |
ustekinumab-aauz soln prefilled syringe |
45 MG/0.5ML ; 90 MG/ML |
SourceRx |
|
Pyzchiva ; Ustekinumab-ttwe |
ustekinumab-ttwe soln prefilled syringe |
45 MG/0.5ML ; 90 MG/ML |
SourceRx |
|
Rinvoq ; Rinvoq lq |
upadacitinib oral soln ; upadacitinib tab er |
1 MG/ML ; 15 MG ; 30 MG ; 45 MG |
SourceRx |
|
Selarsdi |
ustekinumab-aekn soln prefilled syringe |
45 MG/0.5ML ; 90 MG/ML |
SourceRx |
|
Siliq |
brodalumab subcutaneous soln prefilled syringe |
210 MG/1.5ML |
SourceRx |
|
Simponi |
golimumab subcutaneous soln auto-injector |
100 MG/ML ; 50 MG/0.5ML |
SourceRx |
|
Simponi |
golimumab subcutaneous soln prefilled syringe |
100 MG/ML ; 50 MG/0.5ML |
SourceRx |
|
Skyrizi |
risankizumab-rzaa subcutaneous soln cartridge |
180 MG/1.2ML ; 360 MG/2.4ML |
SourceRx |
|
Skyrizi ; Skyrizi pen |
risankizumab-rzaa soln auto-injector ; risankizumab-rzaa soln prefilled syringe |
150 MG/ML |
SourceRx |
|
Sotyktu |
deucravacitinib tab |
6 MG |
SourceRx |
|
Stelara ; Ustekinumab |
ustekinumab inj ; ustekinumab soln prefilled syringe |
45 MG/0.5ML ; 90 MG/ML |
SourceRx |
|
Steqeyma |
ustekinumab-stba soln prefilled syringe |
45 MG/0.5ML ; 90 MG/ML |
SourceRx |
|
Taltz |
ixekizumab subcutaneous soln auto-injector ; ixekizumab subcutaneous soln prefilled syringe |
20 MG/0.25ML ; 40 MG/0.5ML ; 80 MG/ML |
SourceRx |
|
Tremfya |
guselkumab soln prefilled syringe |
200 MG/2ML |
SourceRx |
|
Tremfya |
guselkumab soln prefilled syringe |
100 MG/ML |
SourceRx |
|
Tremfya ; Tremfya induction pack fo |
guselkumab soln auto-injector |
200 MG/2ML |
SourceRx |
|
Tremfya ; Tremfya pen |
guselkumab soln auto-injector |
100 MG/ML |
SourceRx |
|
Tyenne |
tocilizumab-aazg subcutaneous soln auto-inj |
162 MG/0.9ML |
SourceRx |
|
Tyenne |
tocilizumab-aazg subcutaneous soln pref syr |
162 MG/0.9ML |
SourceRx |
|
Velsipity |
etrasimod arginine tab |
2 MG |
SourceRx |
|
Wezlana |
ustekinumab-auub inj ; ustekinumab-auub soln prefilled syringe |
45 MG/0.5ML ; 90 MG/ML |
SourceRx |
|
Xeljanz ; Xeljanz xr |
tofacitinib citrate oral soln ; tofacitinib citrate tab ; tofacitinib citrate tab er |
1 MG/ML ; 10 MG ; 11 MG ; 22 MG ; 5 MG |
SourceRx |
|
Yesintek |
ustekinumab-kfce soln prefilled syringe |
45 MG/0.5ML ; 90 MG/ML |
SourceRx |
|
Yesintek |
ustekinumab-kfce subcutaneous soln |
45 MG/0.5ML |
SourceRx |
|
Yusimry |
adalimumab-aqvh soln auto-injector |
40 MG/0.8ML |
SourceRx |
|
Zymfentra 1-pen ; Zymfentra 2-pen |
infliximab-dyyb soln auto-injector kit |
120 MG/ML |
SourceRx |
|
Zymfentra 2-syringe |
infliximab-dyyb soln prefilled syringe kit |
120 MG/ML |
SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
|
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
|
|
|
SourceRx |
|
Abrilada |
adalimumab-afzb prefilled syringe kit |
20 MG/0.4ML |
SourceRx |
|
Abrilada |
adalimumab-afzb prefilled syringe kit |
40 MG/0.8ML |
SourceRx |
|
Abrilada 1-pen kit ; Abrilada 2-pen kit |
adalimumab-afzb auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Actemra |
Tocilizumab Subcutaneous Soln Prefilled Syringe 162 MG/0.9ML |
162 MG/0.9ML |
SourceRx |
|
Actemra actpen |
Tocilizumab Subcutaneous Soln Auto-injector 162 MG/0.9ML |
162 MG/0.9ML |
SourceRx |
|
Adalimumab-aacf (2 pen) ; Idacio (2 pen) |
adalimumab-aacf auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Adalimumab-aacf (2 syring ; Idacio (2 syringe) |
adalimumab-aacf prefilled syringe kit |
40 MG/0.8ML |
SourceRx |
|
Adalimumab-aacf starter p ; Idacio starter package fo |
adalimumab-aacf auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Adalimumab-aacf starter p ; Idacio starter package fo |
adalimumab-aacf auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Adalimumab-aaty 1-pen kit ; Adalimumab-aaty 2-pen kit ; Yuflyma 1-pen kit ; Yuflyma 2-pen kit |
adalimumab-aaty auto-injector kit |
40 MG/0.4ML |
SourceRx |
|
Adalimumab-aaty 1-pen kit ; Yuflyma 1-pen kit |
adalimumab-aaty auto-injector kit |
80 MG/0.8ML |
SourceRx |
|
Adalimumab-aaty 2-syringe ; Yuflyma 2-syringe kit |
adalimumab-aaty prefilled syringe kit |
20 MG/0.2ML |
SourceRx |
|
Adalimumab-aaty 2-syringe ; Yuflyma 2-syringe kit |
adalimumab-aaty prefilled syringe kit |
40 MG/0.4ML |
SourceRx |
|
Adalimumab-aaty cd/uc/hs ; Yuflyma cd/uc/hs starter |
adalimumab-aaty auto-injector kit |
80 MG/0.8ML |
SourceRx |
|
Adalimumab-adaz ; Hyrimoz |
adalimumab-adaz soln auto-injector |
40 MG/0.4ML |
SourceRx |
|
Adalimumab-adaz ; Hyrimoz |
adalimumab-adaz soln prefilled syringe |
20 MG/0.2ML |
SourceRx |
|
Adalimumab-adaz ; Hyrimoz |
adalimumab-adaz soln prefilled syringe |
40 MG/0.4ML |
SourceRx |
|
Adalimumab-adaz ; Hyrimoz |
adalimumab-adaz soln prefilled syringe |
10 MG/0.1ML |
SourceRx |
|
Adalimumab-adaz ; Hyrimoz ; Hyrimoz sensoready pens |
adalimumab-adaz soln auto-injector |
80 MG/0.8ML |
SourceRx |
|
Adalimumab-adbm ; Cyltezo |
adalimumab-adbm auto-injector kit |
40 MG/0.4ML |
SourceRx |
|
Adalimumab-adbm ; Cyltezo |
adalimumab-adbm auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Adalimumab-adbm ; Cyltezo |
adalimumab-adbm prefilled syringe kit |
40 MG/0.8ML |
SourceRx |
|
Adalimumab-adbm ; Cyltezo |
adalimumab-adbm prefilled syringe kit |
40 MG/0.4ML |
SourceRx |
|
Adalimumab-adbm ; Cyltezo |
adalimumab-adbm prefilled syringe kit |
10 MG/0.2ML |
SourceRx |
|
Adalimumab-adbm ; Cyltezo |
adalimumab-adbm prefilled syringe kit |
20 MG/0.4ML |
SourceRx |
|
Adalimumab-adbm crohns/uc ; Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Adalimumab-adbm psoriasis ; Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Adalimumab-adbm starter p ; Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.4ML |
SourceRx |
|
Adalimumab-adbm starter p ; Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.4ML |
SourceRx |
|
Adalimumab-fkjp ; Hulio |
adalimumab-fkjp auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Adalimumab-fkjp ; Hulio |
adalimumab-fkjp prefilled syringe kit |
40 MG/0.8ML |
SourceRx |
|
Adalimumab-fkjp ; Hulio |
adalimumab-fkjp prefilled syringe kit |
20 MG/0.4ML |
SourceRx |
|
Adalimumab-ryvk (2 pen) ; Simlandi 1-pen kit ; Simlandi 2-pen kit |
adalimumab-ryvk auto-injector kit |
40 MG/0.4ML |
SourceRx |
|
Adalimumab-ryvk ; Simlandi |
adalimumab-ryvk prefilled syringe kit |
40 MG/0.4ML |
SourceRx |
|
Amjevita |
adalimumab-atto soln auto-injector |
40 MG/0.4ML |
SourceRx |
|
Amjevita |
adalimumab-atto soln auto-injector |
40 MG/0.8ML |
SourceRx |
|
Amjevita |
adalimumab-atto soln auto-injector |
80 MG/0.8ML |
SourceRx |
|
Amjevita |
adalimumab-atto soln prefilled syringe |
10 MG/0.2ML |
SourceRx |
|
Amjevita |
adalimumab-atto soln prefilled syringe |
20 MG/0.4ML |
SourceRx |
|
Amjevita |
adalimumab-atto soln prefilled syringe |
20 MG/0.2ML |
SourceRx |
|
Amjevita |
adalimumab-atto soln prefilled syringe |
40 MG/0.8ML |
SourceRx |
|
Amjevita |
adalimumab-atto soln prefilled syringe |
40 MG/0.4ML |
SourceRx |
|
Bimzelx |
bimekizumab-bkzx subcutaneous soln auto-injector |
320 MG/2ML |
SourceRx |
|
Bimzelx |
bimekizumab-bkzx subcutaneous soln auto-injector |
160 MG/ML |
SourceRx |
|
Bimzelx |
bimekizumab-bkzx subcutaneous soln prefilled syr |
320 MG/2ML |
SourceRx |
|
Bimzelx |
bimekizumab-bkzx subcutaneous soln prefilled syr |
160 MG/ML |
SourceRx |
|
Cimzia |
certolizumab pegol prefilled syringe kit |
200 MG/ML |
SourceRx |
|
Cimzia starter kit |
certolizumab pegol prefilled syringe kit |
200 MG/ML |
SourceRx |
|
Cosentyx |
Secukinumab Subcutaneous Pref Syr 150 MG/ML (300 MG Dose) |
150 MG/ML |
SourceRx |
|
Cosentyx |
Secukinumab Subcutaneous Soln Prefilled Syringe |
75 MG/0.5ML |
SourceRx |
|
Cosentyx |
Secukinumab Subcutaneous Soln Prefilled Syringe 150 MG/ML |
150 MG/ML |
SourceRx |
|
Cosentyx sensoready pen |
Secukinumab Subcutaneous Auto-inj 150 MG/ML (300 MG Dose) |
150 MG/ML |
SourceRx |
|
Cosentyx sensoready pen |
Secukinumab Subcutaneous Soln Auto-injector 150 MG/ML |
150 MG/ML |
SourceRx |
|
Cosentyx unoready |
secukinumab subcutaneous soln auto-injector |
300 MG/2ML |
SourceRx |
|
Enbrel |
Etanercept Subcutaneous Inj 25 mg/0.5ml |
25 MG/0.5ML |
SourceRx |
|
Enbrel |
Etanercept Subcutaneous Soln Prefilled Syringe 25 MG/0.5ML |
25 MG/0.5ML |
SourceRx |
|
Enbrel |
Etanercept Subcutaneous Soln Prefilled Syringe 25 MG/0.5ML |
25 MG/0.5ML |
SourceRx |
|
Enbrel |
Etanercept Subcutaneous Soln Prefilled Syringe 50 MG/ML |
50 MG/ML |
SourceRx |
|
Enbrel mini |
Etanercept Subcutaneous Solution Cartridge 50 MG/ML |
50 MG/ML |
SourceRx |
|
Enbrel sureclick |
Etanercept Subcutaneous Solution Auto-injector 50 MG/ML |
50 MG/ML |
SourceRx |
|
Entyvio pen |
vedolizumab soln pen-injector 108 mg/0.68ml |
108 MG/0.68ML |
SourceRx |
|
Hadlima |
adalimumab-bwwd soln prefilled syringe |
40 MG/0.8ML |
SourceRx |
|
Hadlima |
adalimumab-bwwd soln prefilled syringe |
40 MG/0.4ML |
SourceRx |
|
Hadlima pushtouch |
adalimumab-bwwd soln auto-injector |
40 MG/0.8ML |
SourceRx |
|
Hadlima pushtouch |
adalimumab-bwwd soln auto-injector |
40 MG/0.4ML |
SourceRx |
|
Humira |
Adalimumab Prefilled Syringe Kit 10 MG/0.1ML |
10 MG/0.1ML |
SourceRx |
|
Humira |
Adalimumab Prefilled Syringe Kit 20 MG/0.2ML |
20 MG/0.2ML |
SourceRx |
|
Humira |
Adalimumab Prefilled Syringe Kit 40 MG/0.4ML |
40 MG/0.4ML |
SourceRx |
|
Humira |
Adalimumab Prefilled Syringe Kit 40 MG/0.8ML |
40 MG/0.8ML |
SourceRx |
|
Humira pediatric crohns d |
Adalimumab Prefilled Syringe Kit 80 MG/0.8ML |
80 MG/0.8ML |
SourceRx |
|
Humira pediatric crohns d |
Adalimumab Prefilled Syringe Kit 80 MG/0.8ML & 40 MG/0.4ML |
80 MG/0.8ML & 40MG/0.4ML |
SourceRx |
|
Humira pen |
adalimumab auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Humira pen |
adalimumab auto-injector kit |
80 MG/0.8ML |
SourceRx |
|
Humira pen |
Adalimumab Pen-injector Kit 40 MG/0.4ML |
40 MG/0.4ML |
SourceRx |
|
Humira pen-cd/uc/hs start |
adalimumab auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Humira pen-cd/uc/hs start |
adalimumab auto-injector kit |
80 MG/0.8ML |
SourceRx |
|
Humira pen-pediatric uc s |
adalimumab auto-injector kit |
80 MG/0.8ML |
SourceRx |
|
Humira pen-ps/uv starter |
adalimumab auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Humira pen-ps/uv starter |
Adalimumab Pen-injector Kit 80 MG/0.8ML & 40 MG/0.4ML |
80 MG/0.8ML & 40MG/0.4ML |
SourceRx |
|
Hyrimoz |
adalimumab-adaz soln auto-injector |
40 MG/0.8ML |
SourceRx |
|
Hyrimoz |
adalimumab-adaz soln prefilled syringe |
40 MG/0.8ML |
SourceRx |
|
Hyrimoz crohn's disease a ; Hyrimoz sensoready pens |
adalimumab-adaz soln auto-injector |
80 MG/0.8ML |
SourceRx |
|
Hyrimoz pediatric crohn's |
adalimumab-adaz soln prefilled syr |
80 MG/0.8ML & 40MG/0.4ML |
SourceRx |
|
Hyrimoz pediatric crohns |
adalimumab-adaz soln prefilled syringe |
80 MG/0.8ML |
SourceRx |
|
Hyrimoz plaque psoriasis ; Hyrimoz plaque psoriasis/ |
adalimumab-adaz soln auto-injector |
80 MG/0.8ML & 40MG/0.4ML |
SourceRx |
|
Kevzara |
Sarilumab Subcutaneous Soln Prefilled Syringe 150 MG/1.14ML |
150 MG/1.14ML |
SourceRx |
|
Kevzara |
Sarilumab Subcutaneous Soln Prefilled Syringe 200 MG/1.14ML |
200 MG/1.14ML |
SourceRx |
|
Kevzara |
Sarilumab Subcutaneous Solution Auto-injector 150 MG/1.14ML |
150 MG/1.14ML |
SourceRx |
|
Kevzara |
Sarilumab Subcutaneous Solution Auto-injector 200 MG/1.14ML |
200 MG/1.14ML |
SourceRx |
|
Kineret |
Anakinra Subcutaneous Soln Prefilled Syringe 100 MG/0.67ML |
100 MG/0.67ML |
SourceRx |
|
Litfulo |
ritlecitinib tosylate cap |
50 MG |
SourceRx |
|
Olumiant |
Baricitinib Tab |
4 MG |
SourceRx |
|
Olumiant |
Baricitinib Tab 1 MG |
1 MG |
SourceRx |
|
Olumiant |
Baricitinib Tab 2 MG |
2 MG |
SourceRx |
|
Omvoh |
mirikizumab-mrkz subcutaneous auto-inj |
100 MG/ML & 200 MG/2ML |
SourceRx |
|
Omvoh |
mirikizumab-mrkz subcutaneous pref syr |
100 MG/ML & 200 MG/2ML |
SourceRx |
|
Omvoh |
mirikizumab-mrkz subcutaneous sol prefill syringe |
100 MG/ML |
SourceRx |
|
Omvoh |
mirikizumab-mrkz subcutaneous soln auto-injector |
100 MG/ML |
SourceRx |
|
Orencia |
Abatacept Subcutaneous Soln Prefilled Syringe 125 MG/ML |
125 MG/ML |
SourceRx |
|
Orencia |
Abatacept Subcutaneous Soln Prefilled Syringe 125 MG/ML |
125 MG/ML |
SourceRx |
|
Orencia |
Abatacept Subcutaneous Soln Prefilled Syringe 50 MG/0.4ML |
50 MG/0.4ML |
SourceRx |
|
Orencia |
Abatacept Subcutaneous Soln Prefilled Syringe 87.5 MG/0.7ML |
87.5 MG/0.7ML |
SourceRx |
|
Orencia clickject |
Abatacept Subcutaneous Soln Auto-Injector 125 MG/ML |
125 MG/ML |
SourceRx |
|
Otulfi |
ustekinumab-aauz soln prefilled syringe |
90 MG/ML |
SourceRx |
|
Otulfi |
ustekinumab-aauz soln prefilled syringe |
45 MG/0.5ML |
SourceRx |
|
Pyzchiva ; Ustekinumab-ttwe |
ustekinumab-ttwe soln prefilled syringe |
90 MG/ML |
SourceRx |
|
Pyzchiva ; Ustekinumab-ttwe |
ustekinumab-ttwe soln prefilled syringe |
45 MG/0.5ML |
SourceRx |
|
Rinvoq |
Upadacitinib Tab ER |
45 MG |
SourceRx |
|
Rinvoq |
Upadacitinib Tab ER 24HR 15 MG |
15 MG |
SourceRx |
|
Rinvoq lq |
upadacitinib oral soln |
1 MG/ML |
SourceRx |
|
Selarsdi |
ustekinumab-aekn soln prefilled syringe |
90 MG/ML |
SourceRx |
|
Selarsdi |
ustekinumab-aekn soln prefilled syringe |
45 MG/0.5ML |
SourceRx |
|
Siliq |
Brodalumab Subcutaneous Soln Prefilled Syringe 210 MG/1.5ML |
210 MG/1.5ML |
SourceRx |
|
Simlandi |
adalimumab-ryvk prefilled syringe kit |
80 MG/0.8ML |
SourceRx |
|
Simlandi |
adalimumab-ryvk prefilled syringe kit |
20 MG/0.2ML |
SourceRx |
|
Simlandi 1-pen kit |
adalimumab-ryvk auto-injector kit |
80 MG/0.8ML |
SourceRx |
|
Simponi |
Golimumab Subcutaneous Soln Auto-injector 100 MG/ML |
100 MG/ML |
SourceRx |
|
Simponi |
Golimumab Subcutaneous Soln Auto-injector 50 MG/0.5ML |
50 MG/0.5ML |
SourceRx |
|
Simponi |
Golimumab Subcutaneous Soln Prefilled Syringe 100 MG/ML |
100 MG/ML |
SourceRx |
|
Simponi |
Golimumab Subcutaneous Soln Prefilled Syringe 50 MG/0.5ML |
50 MG/0.5ML |
SourceRx |
|
Skyrizi |
Risankizumab-rzaa Soln Prefilled Syringe |
150 MG/ML |
SourceRx |
|
Skyrizi |
Risankizumab-rzaa Subcutaneous Soln Cartridge |
180 MG/1.2ML |
SourceRx |
|
Skyrizi |
Risankizumab-rzaa Subcutaneous Soln Cartridge |
360 MG/2.4ML |
SourceRx |
|
Skyrizi pen |
Risankizumab-rzaa Soln Auto-injector |
150 MG/ML |
SourceRx |
|
Sotyktu |
Deucravacitinib Tab |
6 MG |
SourceRx |
|
Stelara ; Ustekinumab |
Ustekinumab Inj 45 MG/0.5ML |
45 MG/0.5ML |
SourceRx |
|
Stelara ; Ustekinumab |
Ustekinumab Soln Prefilled Syringe 45 MG/0.5ML |
45 MG/0.5ML |
SourceRx |
|
Stelara ; Ustekinumab |
Ustekinumab Soln Prefilled Syringe 90 MG/ML |
90 MG/ML |
SourceRx |
|
Steqeyma |
ustekinumab-stba soln prefilled syringe |
45 MG/0.5ML |
SourceRx |
|
Steqeyma |
ustekinumab-stba soln prefilled syringe |
90 MG/ML |
SourceRx |
|
Taltz |
Ixekizumab Subcutaneous Soln Auto-injector 80 MG/ML |
80 MG/ML |
SourceRx |
|
Taltz |
ixekizumab subcutaneous soln prefilled syringe |
40 MG/0.5ML |
SourceRx |
|
Taltz |
ixekizumab subcutaneous soln prefilled syringe |
20 MG/0.25ML |
SourceRx |
|
Taltz |
Ixekizumab Subcutaneous Soln Prefilled Syringe 80 MG/ML |
80 MG/ML |
SourceRx |
|
Tremfya |
guselkumab soln auto-injector |
200 MG/2ML |
SourceRx |
|
Tremfya |
guselkumab soln prefilled syringe |
200 MG/2ML |
SourceRx |
|
Tremfya |
Guselkumab Soln Prefilled Syringe 100 MG/ML |
100 MG/ML |
SourceRx |
|
Tremfya ; Tremfya pen |
Guselkumab Soln Pen-Injector 100 MG/ML |
100 MG/ML |
SourceRx |
|
Tremfya induction pack fo |
guselkumab soln auto-injector |
200 MG/2ML |
SourceRx |
|
Tyenne |
tocilizumab-aazg subcutaneous soln auto-inj |
162 MG/0.9ML |
SourceRx |
|
Tyenne |
tocilizumab-aazg subcutaneous soln pref syr |
162 MG/0.9ML |
SourceRx |
|
Velsipity |
etrasimod arginine tab |
2 MG |
SourceRx |
|
Wezlana |
ustekinumab-auub inj |
45 MG/0.5ML |
SourceRx |
|
Wezlana |
ustekinumab-auub soln prefilled syringe |
90 MG/ML |
SourceRx |
|
Wezlana |
ustekinumab-auub soln prefilled syringe |
45 MG/0.5ML |
SourceRx |
|
Xeljanz |
Tofacitinib Citrate Oral Soln |
1 MG/ML |
SourceRx |
|
Xeljanz |
Tofacitinib Citrate Tab 10 MG (Base Equivalent) |
10 MG |
SourceRx |
|
Xeljanz |
Tofacitinib Citrate Tab 5 MG (Base Equivalent) |
5 MG |
SourceRx |
|
Xeljanz xr |
Tofacitinib Citrate Tab ER 24HR 11 MG (Base Equivalent) |
11 MG |
SourceRx |
|
Xeljanz xr |
Tofacitinib Citrate Tab ER 24HR 22 MG (Base Equivalent) |
22 MG |
SourceRx |
|
Yesintek |
ustekinumab-kfce soln prefilled syringe |
90 MG/ML |
SourceRx |
|
Yesintek |
ustekinumab-kfce soln prefilled syringe |
45 MG/0.5ML |
SourceRx |
|
Yesintek |
ustekinumab-kfce subcutaneous soln |
45 MG/0.5ML |
SourceRx |
|
Yusimry |
adalimumab-aqvh soln pen-injector 40 mg/0.8ml |
40 MG/0.8ML |
SourceRx |
|
Zymfentra 1-pen |
infliximab-dyyb soln auto-injector kit |
120 MG/ML |
SourceRx |
|
Zymfentra 2-pen |
infliximab-dyyb soln auto-injector kit |
120 MG/ML |
SourceRx |
|
Zymfentra 2-syringe |
infliximab-dyyb soln prefilled syringe kit |
120 MG/ML |
SourceRx |
|
Rinvoq |
Upadacitinib Tab ER |
30 MG |
SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
|
Module |
Clinical Criteria for Approval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adalimumab and Adalimumab Biosimilars |
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use Length of Approval: 12 months for all indications EXCEPT:
NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
All other Target Agents |
Step Table
Note: For Xeljanz products (Xeljanz and Xeljanz XR) and Rinvoq products (Rinvoq and Rinvoq LQ), a trial of either or both dosage forms collectively counts as ONE product
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use Length of Approval: 12 months for all agents EXCEPT:
NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Ustekinumab and Ustekinumab Biosimilars |
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
|
Module |
Clinical Criteria for Approval |
|
QL with PA |
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use Length of Approval: up to 12 months Note: For agents that require a loading dose for a new start, approve the loading dose based on FDA labeling, followed by the maintenance dose for the remainder of the length of approval. **NOTE: Cosentyx loading doses for the diagnoses of AS, nr-axSpA, and PSA are NOT approvable. |
CONTRAINDICATION AGENTS
|
Contraindicated as Concomitant Therapy |
|
Agents NOT to be used Concomitantly Abrilada (adalimumab-afzb) |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
ALBP _ Commercial _ CS _ Biologic_Immunomodulators_PAQL _ProgSum_ 07-01-2025 _© Copyright Prime Therapeutics LLC. April 2025 All Rights Reserved