Asset Publisher
Biologic Immunomodulators Prior Authorization with Quantity Limit with Preferred Products Program Summary
Policy Number: PH-991002
This program applies to SourceRx formularies.
POLICY REVIEW CYCLE
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Effective Date |
Date of Origin |
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01-01-2025 |
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FDA LABELED INDICATIONS AND DOSAGE
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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)
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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 photo therapy |
Interleukin F17A 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 |
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 |
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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 |
Interleukin-23 Inhibitor |
86 |
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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:
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T-cell Costimulation Blocker |
10 |
|
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 |
|
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) Adult patients with moderately to severely active ulcerative colitis with inadequate response or intolerant to prior treatment or requiring continuous steroid therapy
|
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 and older with moderate to severe plaque psoriasis (PS) who are candidates for phototherapy for systemic therapy Treatment of patients 6 years 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-23 Inhibitor |
13 |
|
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 |
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 |
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 |
|
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 |
|
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
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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, with the additional use of disease-modifying antirheumatic drugs (DMARDs) in patients with peripheral arthritis. The American College of Rheumatology (ACR), Spondylitis Association of America (SAA), and Spondyloarthritis Research and Treatment Network (SPARTAN) recommend the following pharmacological treatment for AS:(17,47)
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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 includes patients with chronic back pain and features suggestive of spondyloarthritis (SpA), but do not meet the classification of AS. 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, with the additional use of DMARDs in patients with peripheral arthritis. The American College of Rheumatology (ACR), Spondylitis Association of America (SAA), and Spondyloarthritis Research and Treatment Network (SPARTAN) recommendation for nr-axSpA are the same as AS:(17,47)
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RHEUMATOID DISORDERS - Rheumatoid arthritis (RA) |
Rheumatoid arthritis (RA) is the most common inflammatory autoimmune arthritis in adults. The main goal of therapy is to achieve remission, but additional goals include decrease inflammation, relieve symptoms, prevent joint and organ damage, improve physical function/overall well-being, and reduce long term complications.(18,25) 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) American College of Rheumatology (ACR) guidelines list the following guiding principles in the treatment of RA:(18)
ACR guidelines are broken down by previous treatment and disease activity:(18)
Early use of DMARD, particularly MTX, is recommended as soon as possible following diagnosis of RA. Dosing of MTX for RA is once weekly dosing with starting doses at 7.5 mg or 15 mg once weekly.(26,27,28) MTX dose is increased as tolerated and as needed to control symptoms and signs of RA disease. The usual target dose is at least 15 mg weekly and the usual maximum dose is 25 mg weekly.(27,28) ACR defines optimal dosing for RA treatments as 1) dosing to achieve a therapeutic target derived from mutual patient-clinician consideration of patient priorities and 2) given for at least 3 months before therapy escalation or switching. For patients who are unable to take MTX, hydroxychloroquine, sulfasalazine, or leflunomide are other DMARD options. In patients resistant to initial MTX treatment, combination DMARD (e.g., MTX plus sulfasalazine or hydroxychloroquine or a TNF-inhibitor) is recommended.(18) For patients who are resistant to MTX after 3 months of treatment at optimal doses (usually 25 mg per week), it is recommended to either use DMARD triple therapy with MTX plus sulfasalazine and hydroxychloroquine or combination of MTX with TNF inhibitor. Triple therapy regimen has been found to be of similar clinical efficacy to MTX with biologics in several randomized trials, including in patients with high level of disease activity or with adverse prognostic features. The use of triple therapy has been shown to be highly cost-effective compared with combining a biologic with MTX, providing comparable or near comparable clinical benefit. The use of biologic with MTX combination is preferred when patients have high disease activity and clinical benefit from a more rapid response is needed and when patients who do not achieve satisfactory response within 3 months with non-biologic triple therapy following an inadequate response to MTX therapy.(18,28) |
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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 ACR 2019 guidelines recommend the following treatment approach for PJIA:(34,35)
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RHEUMATOID DISORDERS - Systemic Juvenile Idiopathic Arthritis (SJIA) |
Systemic juvenile idiopathic arthritis (SJIA) is a subset of 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. Up to 40% of cases of SJIA are associated with macrophage activation syndrome (MAS), a secondary hemophagocytic syndrome that is a life-threatening complication requiring urgent recognition and treatment. MAS presents with fevers, high ferritin levels, cytopenias, elevated liver enzyme levels, low fibrinogen levels, and high triglyceride levels. As it may occur at any point during the disease course careful monitoring is necessary for children with or without MAS at presentation. Goals of therapy for SJIA includes 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.(19) SJIA is defined as:(19)
SJIA without MAS The American College of Rheumatology conditionally recommends IL-1 or IL-6 inhibitors and/or a brief trial of scheduled non-steroidal anti-inflammatories (NSAIDs) for initial treatment for SJIA without MAS. Studies suggest that a small proportion of patients with systemic JIA will respond to NSAIDs alone. If clinical response is not rapid and complete, rapid escalation of therapy is recommended. There is no consensus on the appropriate duration of initial use of NSAIDs before escalating therapy, as many prescribers prefer that the use of NSAIDs be avoided altogether for SJIA. Oral glucocorticoids are conditionally recommended against use in this population (the recommendation is conditional, as IL-1 or IL-6 inhibitors may not always be immediately available, and glucocorticoids may help control systemic and joint manifestations until IL-1 or IL-6 inhibitors can be started. Conventional synthetic disease modifying antirheumatic drugs (DMARDs) are strongly recommended against as initial therapy in this population. For subsequent therapy IL-1 and IL-6 inhibitors are strongly recommended over a single or combination of conventional synthetic DMARDs for inadequate response to intolerance of NSAIDs and/or glucocorticoids.(19) SJIA with MAS The American College of Rheumatology conditionally recommends IL-1 or IL-6 inhibitors over calcineurin inhibitors alone to achieve inactive disease and resolution of MAS. Glucocorticoids are conditionally recommended as part of initial treatment in patients with SJIA with MAS. Systemic glucocorticoids may be necessary for severely ill patients because they can have rapid onset of action. Longer-term glucocorticoids therapy in children is not appropriate because of its effects on bone health and growth.(19) |
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RHEUMATOID DISORDERS - Enthesitis Related Arthritis |
Juvenile idiopathic arthritis (JIA) is a group of heterogenous forms of arthritis characterized by onset before 16 years of age, involving one or more joints, and lasting 6 weeks or more. Enthesitis related arthritis (ERA) is one form of JIA in which patients have predominately enthesitis, enthesitis and arthritis, juvenile ankylosing spondylitis, or inflammatory bowel disease associated arthropathy. The International League Against Rheumatism as arthritis and enthesitis that lasts at least 6 weeks in a child less than 16 years OR arthritis or enthesitis with two of the following features: sacroiliac tenderness or inflammatory spinal pain, HLA-B27 positivity, onset of arthritis in a male patient older than 6 years, and family history of HLA-B27 associated disease. 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) The ACR 2019 guidelines recommend the following treatment approach for ERA:
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RHEUMATOID DISORDERS - Psoriatic Arthritis (PsA) |
Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disease associated with psoriasis, most commonly presenting with peripheral arthritis, dactylitis, enthesitis, and spondylitis. Treatment involves the use of a variety of interventions, including many agents used for the treatment of other inflammatory arthritis, particularly spondyloarthritis and RA, and other management strategies of the cutaneous manifestations of psoriasis.(29) The American Academy of Dermatology (AAD) recommends initiating MTX in most patients with moderate to severe PsA. After 12 to 16 weeks of MTX therapy with appropriate dose escalation, the AAD recommends adding or switching to a TNF inhibitor if there is minimal improvement on MTX monotherapy.(30) The American College of Rheumatology (ACR) and the National Psoriasis Foundation (NPF) guidelines for PsA recommend a treat-to-target approach in therapy, regardless of disease activity, and the following:(29)
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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 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, inflammatory disorder that affects hair follicles and sometimes nails. Initial presentation generally involves patches of hair loss on the scalp, but any hair-bearing skin may be involved. Short broken hairs, also known as exclamation point hairs, may be seen around the margins of the patches. The hair follicles in the growth phase prematurely transition to the non-proliferative involution and resting phases. This leads to hair shedding and inhibition of hair growth. The integrity of hair follicles are preserved, allowing for the potential regrowth of hair even in longstanding disease. Roughly 34-50% of patients will spontaneously recover within a year from symptom onset. AA often remits in patients with almost all patients experiencing multiple episodes of the disease, and roughly 14-50% of patients will progress to total scalp hair loss, known as alopecia totalis (AT), or total loss of scalp and body hair, known as alopecia universalis (AU). Severity at initial presentation is a strong predictor of long-term outcomes of the disease, with more severe disease progressing to AT or AU. Diagnosis is based off of clinical presentation and patient history. Other causes of alopecia need to be ruled out, and some patients may require a biopsy for diagnosis.(65,66) The management of AA involves counseling, and potentially antidepressants, due to the psychological effects associated with hair loss. Pharmacologic treatments are often temporary and do not alter the long-term course of the disease. Spontaneous remission rates also make it difficult to assess treatment efficacy, especially in patients with mild disease. Very potent topical corticosteroids have been used to treat patchy AA spots, but there is limited evidence to support long-term use. Intralesional corticosteroids are also an option for patchy AA spots and have shown more sustained hair growth. Systemic corticosteroids are generally reserved for patients with more extensive hair loss, but adverse effects tend to limit duration of use. Hair loss frequently recurs when these treatments are stopped. Conventional systemic immunomodulators and JAK inhibitors are often used for patients with disease that is refractory to corticosteroids and topical immunotherapy.(65,66) |
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DERMATOLOGICAL DISORDERS - Psoriasis (PS) |
Psoriasis (PS) is a chronic inflammatory skin condition that is often associated with systemic manifestations, especially arthritis. Diagnosis is usually clinical, based on the presence of typical erythematous scaly patches, papules, and plaques that are often pruritic and sometimes painful. Treatment goals for psoriasis include improvement of skin, nail, and joint lesions plus enhanced quality of life.(20) The American Academy of Family Physicians (AAFP) categorizes psoriasis severity into mild to moderate (less than 5% of body surface area [BSA]) and moderate to severe (5% or more of BSA). The AAFP psoriasis treatment guidelines recommend basing treatment on disease severity:(20)
The American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) categorize psoriasis severity as limited or 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 occurs in select locations (e.g., hands, feet, scalp, face, or genital area) or when it causes intractable pruritus.(31) The AAD psoriasis treatment guidelines recommend the following*:(30,31,33,88)
* Strength of recommendation and descriptions
Biologics are routinely used when one or more traditional systemic agents fail to produce adequate response, but are considered first line in patients with moderate to severe psoriasis with concomitant severe PsA. Primary failure is defined as initial nonresponse to treatment. Primary failure to a TNF-α inhibitor does not preclude successful response to a different TNF-α inhibitor. Failure of another biologic therapy does not preclude successful response to ustekinumab.(88) The National Psoriasis Foundation (NPF) medical board recommend a treat-to-target approach to therapy for psoriasis that include the following:(32)
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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 weeks 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. The American College of Gastroenterology (ACG) recommends a treat-to-target approach and recommend 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 for the management of mild to moderate UC(38):
The American Gastroenterology Association (AGA) published recommendations for the management of moderate to severe UC(48):
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OTHER DISORDERS - Uveitis |
Uveitis is characterized by inflammation of the uvea, which is the middle portion of the eye; the anterior portion of the uvea includes the iris and ciliary body, and the posterior portion of the uvea is known as the choroid.(39) Treatment of non-infectious uveitis depends on the location of inflammation. Anterior uveitis is generally treated with topical glucocorticoids, such as prednisolone ophthalmic drops.(22,39) Uveitis that is primarily posterior to the lens is generally not responsive to topical medication, although some experts are increasingly using difluprednate.(22) Oral corticosteroids continue to be the mainstay of treatment for noninfectious intermediate, posterior, and pan uveitis. Intraocular and periocular injections of triamcinolone or glucocorticoids are also options, although patients may decline the injections. Systemic treatment is generally reserved for resistant inflammation and may be indicated in patients with glaucoma who cannot be treated with local injection. If remission has been achieved for 6 to 12 months with systemic glucocorticoids, the maintenance dose may be gradually discontinued.(22,42) The American Academy of Ophthalmology recommends the use of immunosuppressive agents, such as methotrexate, azathioprine, mycophenolate, cyclosporine, and tacrolimus, for patients that are intolerant and/or resistant to systemic corticosteroids. TNF-inhibitors, such as adalimumab, are recommended if the patient is inadequately controlled by corticosteroids and non-corticosteroid systemic immunomodulatory therapies.(22,42) |
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OTHER DISORDERS - Giant Cell Arteritis (GCA) |
Giant cell arteritis (GCA) is a blood vessel disease that commonly occurs with polymyalgia rheumatica. It is a type of vasculitis involving mostly the arteries of the scalp and head, especially the arteries over the temples. Eyesight can be affected if GCA spreads to the blood vessels that supply the eye. Treatment should begin as soon as possible to prevent loss of vision.(23) The American College of Rheumatology/Vasculitis Foundation guidelines recommend High-dose systemic glucocorticoids as the mainstay of therapy for GCA. The guidelines provide the following recommendations for the medical 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 syndrome is caused by a gain of function mutation in the NLRP3 gene leading to over secretion of fever causing cytokine IL-1B. The CAPS spectrum includes mild, moderate, and severe phenotypes. The mild phenotype is called familial cold autoinflammatory syndrome (FCAS), the moderate phenotype is also known as Muckle-Wells syndrome (MWS), 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 recognize that all but a few patients with CAPS have detectable systemic inflammation and use unique CPS-specific clinical features along the whole disease spectrum to achieve reasonable specificity and sensitivity to aid clinicians in making the CAPS diagnosis. These diagnostic criteria do not include genetic confirmation, and therefore can be applied in places where genetic testing is not available. The diagnostic criteria for CAPS are as follows:(24)
FCAS is characterized by episodes of rash, fever. and joint pain following generalized exposure to cold. Attacks usually occur 1-2 hours after exposure and last less than 24.(49) Patients experience urticaria, arthralgia, fever with chills, severe thirst, red-eyes, and headache after a general cold exposure, including air conditioning. In MWS, inflammation can occur spontaneously as well as from triggers, such as stress, cold, or exercise, with episodes lasting from one to three days. MWS shares the same characteristics as FCAS, but is also characterized by renal amyloidosis, sensorineural hearing loss, and conjunctivitis. Hearing loss, partial or complete, often develop by teenage years.(41) NOMID is a rare chronic inflammatory disease. NOMID is characterized by fever, urticarial rash, aseptic meningitis, deforming arthropathy, hearing loss, and intellectual disability. An urticaria-like rash develops within the first six weeks of life, and a characteristic bony overgrowth predominantly involving the knees develops in most affected children. Therapies are aimed at suppressing inflammation and have included high-dose corticosteroids, disease-modifying antirheumatic drugs, and biologic agent targeting tumor necrosis factor (TNF). Selective blockade of interleukin-1B is effective in the pathophysiology and organ-specific manifestations of NMOSD, in particular the CNS manifestations of the disease.(57) Treatment aims are to suppress systemic inflammation, to improve functionality, to prevent organ damage, and to increase patients' quality of life. To achieve these aims, cytokine targeting drugs are important and evidence-based treatment. Since IL-1 plays a central role in CAPS pathogenesis, the anti-IL1 treatments (anakinra, canakinumab, and rilonacept) are recommended for the whole CAPS spectrum.(24) |
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OTHER DISORDERS Deficiency of the IL-1 Receptor Antagonist (DIRA) |
Systemic autoinflammatory diseases (SAIDs) are a group of multisystem immunodysregulatory disorders caused primarily by the dysfunction of the innate immune system. Currently, SAIDs are comprised of a wide range of disorders with systemic and organ-specific inflammation in the absence of infections or autoimmunity. In a subset of genetically defined SAIDs, the pathogenesis is driven by increased release or signaling of the pro-inflammatory cytokine IL-1.(51) Patients with DIRA present with early-onset pustular rashes that can be triggered by mechanical stress (pathergy), with sterile osteomyelitis, and nail changes (onychomadesis). Although inflammatory markers are typically highly elevated, fever may be absent. Vertebral involvement can include odontoid osteomyelitis resulting in destruction and neck instability, vertebral block formation and gibbus-like spinal changes that need to be screened for by MRI or CT. The differential diagnosis for DIRA includes chronic recurrent multifocal osteomyelitis (CRMO), synovitis, acne, pustulosis, hyperostosis, osteitis (SAPHO) syndrome and pustular psoriasis. Genetic testing for monogenic defects with overlapping clinical features should include LPIN2, FGR, FBLIM1 for CRMO, CARD14 for CARD14-Mediated Psoriasis (CAMPS), IL36RN for Deficiency of IL-36 Receptor Antagonist (DITRA), AP1S3 for other pustular psoriasis and MEFV for Pyrin-Associated Autoinflammation with Neutrophilic Dermatosis (PAAND).(51) 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. In absence of a consensus definition of remission or minimal disease activity for these diseases, remission has been defined for clinical studies and clinical monitoring as an absence of clinical symptoms and normal inflammatory markers. Anakinra and rilonacept both block IL-1α and IL-1β and should be used for DIRA patients.(51) |
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OTHER DISORDERS- Systemic Sclerosis (Scleroderma)-Associated Interstitial Lung Disease (ILD) |
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 ILD is a common manifestation that tends to occur early in the course of systemic sclerosis.(52) The American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) collaborated on classification criteria for the diagnosis of systemic sclerosis, in which they note that systemic sclerosis-associated ILD is diagnosed when there is radiographic evidence of diffuse parenchymal lung disease in patients with systemic sclerosis. The ACR/EULAR criteria note that ILD is defined as pulmonary fibrosis seen on HRCT or chest radiography, most pronounced in the basilar portions of the lungs.(54) The American College of Rheumatology (ACR) published a treatment algorithm for systemic sclerosis and related conditions. The ACR recommends the following treatment options for ILD associated with systemic sclerosis:(53) Induction therapy:
Maintenance therapy:
Recent recommendations from the American College of Rheumatology suggest early first line treatment with tocilizumab based on the efficacy and safety from phase II and phase III clinical trials. MMF and CYC are alternative options, but do not have clinical trial data showing efficacy and safety for patients with subclinical ILD. Patients that have clinical evidence of skin and/or musculoskeletal manifestations and inactive disease, MMF, CYC, and nintedanib are the preferred first line options for patients with SSc-ILD. Patients with clinical evidence of skin and/or musculoskeletal manifestations and active disease, tocilizumab, MMF, and CYC are suggested as initial therapy. After treatment is initiated, patients should be followed up every 4 months until disease stabilization. Patients that achieve stabilization on first line therapy, should continue first line therapy for maintenance therapy.(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.
The Future 5 trial did not assess if there was 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.
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. 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. 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 is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients. Olumiant(9) Baricitinib has the following boxed warnings:
Baricitinib does not have any 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 does not have any 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. Stelara(13) Ustekinumab is contraindicated for use in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients. 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. Velsipity(85) Etrasimod is contraindicated in:
Xeljanz/Xeljanz XR(16) Tofacitinib has the following boxed warnings:
Tofacitinib does not have any 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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|
88 |
Elmets CA, 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. J Am Acad Dermatol Volume 84 Number 2:432-470. |
|
89 |
Zymfentra prescribing information. Celltrion Inc. October 2023. |
|
90 |
Simlandi prescribing information. Teva Pharmaceuticals USA, Inc. February 2024. |
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 |
|
|
|
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 |
|
|
|
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 |
|
|
|
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/0.1 ML ; 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 |
|
|
|
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 |
|
|
|
Hulio |
adalimumab-fkjp auto-injector kit ; adalimumab-fkjp prefilled syringe kit |
20 MG/0.4ML ; 40 MG/0.8ML |
M ; N ; O ; Y |
N |
|
|
|
Simlandi 1-pen kit ; Simlandi 2-pen kit |
adalimumab-ryvk auto-injector kit |
40 MG/0.4ML |
M ; N ; O ; Y |
N |
|
|
|
|
adalimumab-ryvk prefilled syringe kit |
40 MG/0.4ML |
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 |
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 |
guselkumab soln auto-injector |
100 MG/ML ; 200 MG/2ML |
M ; N ; O ; Y |
N |
|
|
|
Tremfya |
guselkumab soln prefilled syringe |
100 MG/ML ; 200 MG/2ML |
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 sol prefill syringe |
100 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Omvoh |
mirikizumab-mrkz subcutaneous soln auto-injector |
100 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Skyrizi ; Skyrizi pen |
risankizumab-rzaa sol prefilled syringe ; risankizumab-rzaa soln auto-injector ; risankizumab-rzaa soln prefilled syringe |
150 MG/ML ; 75 MG/0.83ML |
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 inj ; ustekinumab soln prefilled syringe |
45 MG/0.5ML ; 90 MG/ML |
M ; N ; O ; Y |
N |
|
|
|
Entyvio |
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 |
|
|
|||||||||
|
|
adalimumab-aqvh soln pen-injector |
|
2 |
Pens |
28 |
DAYS |
|
|
|
|
|
adalimumab-ryvk prefilled syringe kit |
40 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
|
Etanercept For Subcutaneous Inj 25 MG |
|
8 |
Vials |
28 |
DAYS |
|
|
|
|
|
Guselkumab Soln Pen-Injector 100 MG/ML |
|
1 |
Pen |
56 |
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 |
|
|
|
|
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 prefilled syr |
160 MG/ML |
2 |
Syringes |
56 |
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 |
|
|
|
|
Cyltezo |
adalimumab-adbm auto-injector kit |
40 MG/0.4ML |
2 |
Pens |
28 |
DAYS |
|
|
00597049550 ; 00597057550;82009014422 |
|
Cyltezo |
adalimumab-adbm auto-injector kit |
40 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
00597037597 ; 00597054522;82009014822 |
|
Cyltezo |
adalimumab-adbm prefilled syringe kit |
10 MG/0.2ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Cyltezo |
adalimumab-adbm prefilled syringe kit |
20 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Cyltezo |
adalimumab-adbm prefilled syringe kit |
40 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Cyltezo |
adalimumab-adbm prefilled syringe kit |
40 MG/0.8ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.4ML |
1 |
Kit |
180 |
DAYS |
|
|
00597049560 ; 00597057560; |
|
Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.4ML |
1 |
Kit |
180 |
DAYS |
|
|
00597049540 ; 00597057540; |
|
Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.8ML |
4 |
Pens |
180 |
DAYS |
|
|
00597037523 ; 00597054544; |
|
Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.8ML |
6 |
Pens |
180 |
DAYS |
|
|
00597037516 ; 00597054566; |
|
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 |
58406-455-04 |
|
|
|
Enbrel |
Etanercept Subcutaneous Soln Prefilled Syringe 25 MG/0.5ML |
25 MG/0.5ML |
4 |
Syringes |
28 |
DAYS |
|
|
|
|
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 |
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 |
|
|
|
|
Hulio |
adalimumab-fkjp auto-injector kit |
40 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Hulio |
adalimumab-fkjp prefilled syringe kit |
20 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Hulio |
adalimumab-fkjp prefilled syringe kit |
40 MG/0.8ML |
2 |
Syringes |
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/0.4ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Hyrimoz |
adalimumab-adaz soln auto-injector |
40 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Hyrimoz |
adalimumab-adaz soln prefilled syringe |
10 MG/0.1 ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Hyrimoz |
adalimumab-adaz soln prefilled syringe |
20 MG/0.2ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Hyrimoz |
adalimumab-adaz soln prefilled syringe |
40 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Hyrimoz |
adalimumab-adaz soln prefilled syringe |
40 MG/0.8ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Hyrimoz ; Hyrimoz sensoready pens |
adalimumab-adaz soln auto-injector |
80 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
61314045420 ; 83457010701 |
|
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 |
|
|
|
|
Idacio (2 pen) |
adalimumab-aacf auto-injector kit |
40 MG/0.8ML |
1 |
Kit |
28 |
DAYS |
|
|
65219055408 ; 65219061299 |
|
Idacio (2 syringe) |
adalimumab-aacf prefilled syringe kit |
40 MG/0.8ML |
1 |
Kit |
28 |
DAYS |
|
|
|
|
Idacio starter package fo |
adalimumab-aacf auto-injector kit |
40 MG/0.8ML |
1 |
Kit |
180 |
DAYS |
|
|
65219055428 ; 65219061269 |
|
Idacio starter package fo |
adalimumab-aacf auto-injector kit |
40 MG/0.8ML |
1 |
Kit |
180 |
DAYS |
|
|
65219055438 ; 65219061289 |
|
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 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 |
|
|
|
|
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 |
|
|
|
|
Siliq |
Brodalumab Subcutaneous Soln Prefilled Syringe 210 MG/1.5ML |
210 MG/1.5ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Simlandi 1-pen kit ; Simlandi 2-pen kit |
adalimumab-ryvk auto-injector kit |
40 MG/0.4ML |
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 Sol Prefilled Syringe 2 x 75 MG/0.83ML Kit |
75 MG/0.83ML |
1 |
Box |
84 |
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 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 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 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 |
|
|
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 |
|
|
|
|
Tremfya |
Guselkumab Soln Pen-Injector 100 MG/ML |
100 MG/ML |
1 |
Pen |
56 |
DAYS |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
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 |
|
|
|
|
Yuflyma 1-pen kit |
adalimumab-aaty auto-injector kit |
80 MG/0.8ML |
2 |
Pens |
28 |
DAYS |
|
|
72606002304 ; 72606004004 |
|
Yuflyma 1-pen kit ; Yuflyma 2-pen kit |
adalimumab-aaty auto-injector kit |
40 MG/0.4ML |
2 |
Pens |
28 |
DAYS |
|
|
|
|
Yuflyma 2-syringe kit |
adalimumab-aaty prefilled syringe kit |
20 MG/0.2ML |
2 |
Syringes |
28 |
DAYS |
|
|
|
|
Yuflyma 2-syringe kit |
adalimumab-aaty prefilled syringe kit |
40 MG/0.4ML |
2 |
Syringes |
28 |
DAYS |
1 kit/28 days, per RX claims |
|
|
|
Yuflyma cd/uc/hs starter |
adalimumab-aaty auto-injector kit |
80 MG/0.8ML |
1 |
Kit |
180 |
DAYS |
|
|
72606002307 |
|
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 |
|
|
|||||||
|
6629003000E525 |
Enbrel |
Etanercept Subcutaneous Soln Prefilled Syringe 25 MG/0.5ML |
25 MG/0.5ML |
58406-455-04 |
|
|
|
|
6627001503F830 |
Yuflyma 2-syringe kit |
adalimumab-aaty prefilled syringe kit |
40 MG/0.4ML |
1 kit/28 days, per RX claims |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
|
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
|
adalimumab-ryvk prefilled syringe kit |
40 MG/0.4ML |
SourceRx |
|
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 |
|
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 |
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 |
|
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 |
|
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 |
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 |
|
Hulio |
adalimumab-fkjp auto-injector kit ; adalimumab-fkjp prefilled syringe kit |
20 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 |
|
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/0.1 ML ; 20 MG/0.2ML ; 40 MG/0.4ML ; 40 MG/0.8ML ; 80 MG/0.8ML ; 80 MG/0.8ML & 40MG/0.4ML |
SourceRx |
|
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 |
|
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 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 ; 50 MG/0.4ML ; 87.5 MG/0.7ML |
SourceRx |
|
Orencia clickject |
abatacept subcutaneous soln auto-injector |
125 MG/ML |
SourceRx |
|
Rinvoq ; Rinvoq lq |
upadacitinib oral soln ; upadacitinib tab er |
1 MG/ML ; 15 MG ; 30 MG ; 45 MG |
SourceRx |
|
Siliq |
brodalumab subcutaneous soln prefilled syringe |
210 MG/1.5ML |
SourceRx |
|
Simlandi 1-pen kit ; Simlandi 2-pen kit |
adalimumab-ryvk auto-injector kit |
40 MG/0.4ML |
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 sol prefilled syringe ; risankizumab-rzaa soln auto-injector ; risankizumab-rzaa soln prefilled syringe |
150 MG/ML ; 75 MG/0.83ML |
SourceRx |
|
Sotyktu |
deucravacitinib tab |
6 MG |
SourceRx |
|
Stelara |
ustekinumab inj ; ustekinumab 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 auto-injector |
100 MG/ML ; 200 MG/2ML |
SourceRx |
|
Tremfya |
guselkumab soln prefilled syringe |
100 MG/ML ; 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 |
|
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 |
|
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 |
|
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 |
|
|
adalimumab-aqvh soln pen-injector |
|
SourceRx |
|
|
adalimumab-ryvk prefilled syringe kit |
40 MG/0.4ML |
SourceRx |
|
|
Etanercept For Subcutaneous Inj 25 MG |
|
SourceRx |
|
|
Guselkumab Soln Pen-Injector 100 MG/ML |
|
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 |
|
Amjevita |
adalimumab-atto soln auto-injector |
80 MG/0.8ML |
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 prefilled syringe |
10 MG/0.2ML |
SourceRx |
|
Amjevita |
adalimumab-atto soln prefilled syringe |
40 MG/0.4ML |
SourceRx |
|
Amjevita |
adalimumab-atto soln prefilled syringe |
40 MG/0.8ML |
SourceRx |
|
Amjevita |
adalimumab-atto soln prefilled syringe |
20 MG/0.2ML |
SourceRx |
|
Amjevita |
adalimumab-atto soln prefilled syringe |
20 MG/0.4ML |
SourceRx |
|
Bimzelx |
bimekizumab-bkzx subcutaneous soln auto-injector |
160 MG/ML |
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 |
|
Cyltezo |
adalimumab-adbm auto-injector kit |
40 MG/0.4ML |
SourceRx |
|
Cyltezo |
adalimumab-adbm auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Cyltezo |
adalimumab-adbm prefilled syringe kit |
40 MG/0.4ML |
SourceRx |
|
Cyltezo |
adalimumab-adbm prefilled syringe kit |
40 MG/0.8ML |
SourceRx |
|
Cyltezo |
adalimumab-adbm prefilled syringe kit |
20 MG/0.4ML |
SourceRx |
|
Cyltezo |
adalimumab-adbm prefilled syringe kit |
10 MG/0.2ML |
SourceRx |
|
Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.4ML |
SourceRx |
|
Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.4ML |
SourceRx |
|
Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Cyltezo starter package f |
adalimumab-adbm auto-injector kit |
40 MG/0.8ML |
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 |
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/0.4ML |
SourceRx |
|
Hadlima pushtouch |
adalimumab-bwwd soln auto-injector |
40 MG/0.8ML |
SourceRx |
|
Hulio |
adalimumab-fkjp auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Hulio |
adalimumab-fkjp prefilled syringe kit |
20 MG/0.4ML |
SourceRx |
|
Hulio |
adalimumab-fkjp prefilled syringe kit |
40 MG/0.8ML |
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 |
80 MG/0.8ML |
SourceRx |
|
Humira pen-cd/uc/hs start |
adalimumab auto-injector kit |
40 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 auto-injector |
40 MG/0.4ML |
SourceRx |
|
Hyrimoz |
adalimumab-adaz soln prefilled syringe |
10 MG/0.1 ML |
SourceRx |
|
Hyrimoz |
adalimumab-adaz soln prefilled syringe |
20 MG/0.2ML |
SourceRx |
|
Hyrimoz |
adalimumab-adaz soln prefilled syringe |
40 MG/0.8ML |
SourceRx |
|
Hyrimoz |
adalimumab-adaz soln prefilled syringe |
40 MG/0.4ML |
SourceRx |
|
Hyrimoz ; Hyrimoz sensoready pens |
adalimumab-adaz soln auto-injector |
80 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 |
|
Idacio (2 pen) |
adalimumab-aacf auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Idacio (2 syringe) |
adalimumab-aacf prefilled syringe kit |
40 MG/0.8ML |
SourceRx |
|
Idacio starter package fo |
adalimumab-aacf auto-injector kit |
40 MG/0.8ML |
SourceRx |
|
Idacio starter package fo |
adalimumab-aacf auto-injector kit |
40 MG/0.8ML |
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 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 |
|
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 |
|
Siliq |
Brodalumab Subcutaneous Soln Prefilled Syringe 210 MG/1.5ML |
210 MG/1.5ML |
SourceRx |
|
Simlandi 1-pen kit ; Simlandi 2-pen kit |
adalimumab-ryvk auto-injector kit |
40 MG/0.4ML |
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 Sol Prefilled Syringe 2 x 75 MG/0.83ML Kit |
75 MG/0.83ML |
SourceRx |
|
Skyrizi |
Risankizumab-rzaa Soln Prefilled Syringe |
150 MG/ML |
SourceRx |
|
Skyrizi |
Risankizumab-rzaa Subcutaneous Soln Cartridge |
360 MG/2.4ML |
SourceRx |
|
Skyrizi |
Risankizumab-rzaa Subcutaneous Soln Cartridge |
180 MG/1.2ML |
SourceRx |
|
Skyrizi pen |
Risankizumab-rzaa Soln Auto-injector |
150 MG/ML |
SourceRx |
|
Sotyktu |
Deucravacitinib Tab |
6 MG |
SourceRx |
|
Stelara |
Ustekinumab Inj 45 MG/0.5ML |
45 MG/0.5ML |
SourceRx |
|
Stelara |
Ustekinumab Soln Prefilled Syringe 45 MG/0.5ML |
45 MG/0.5ML |
SourceRx |
|
Stelara |
Ustekinumab Soln Prefilled Syringe 90 MG/ML |
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 Pen-Injector 100 MG/ML |
100 MG/ML |
SourceRx |
|
Tremfya |
guselkumab soln prefilled syringe |
200 MG/2ML |
SourceRx |
|
Tremfya |
Guselkumab Soln Prefilled Syringe 100 MG/ML |
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 |
|
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 |
|
Yuflyma 1-pen kit |
adalimumab-aaty auto-injector kit |
80 MG/0.8ML |
SourceRx |
|
Yuflyma 1-pen kit ; Yuflyma 2-pen kit |
adalimumab-aaty auto-injector kit |
40 MG/0.4ML |
SourceRx |
|
Yuflyma 2-syringe kit |
adalimumab-aaty prefilled syringe kit |
20 MG/0.2ML |
SourceRx |
|
Yuflyma 2-syringe kit |
adalimumab-aaty prefilled syringe kit |
40 MG/0.4ML |
SourceRx |
|
Yuflyma cd/uc/hs starter |
adalimumab-aaty auto-injector kit |
80 MG/0.8ML |
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 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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 Rinvoq for atopic dermatitis (AD), Siliq for plaque psoriasis (PS), Xeljanz and Xeljanz XR for induction therapy for UC, and the agents with indications that require loading doses for new starts. NOTE: For agents that require a loading dose for a new start, approve the loading dose based on FDA labeling AND the maintenance dose for the remainder of the length of approval. Rinvoq for AD may be approved for 6 months, Siliq for PS may be approved for 16 weeks, and Xeljanz and Xeljanz XR for UC may be approved for 16 weeks. **NOTE: Cosentyx for the diagnoses of AS, nr-axSpA, and PSA loading doses are not approvable. 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:
Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use Length of Approval: 12 months **NOTE: Cosentyx for the diagnoses of AS, nr-axSpA, and PSA loading doses are not approvable. NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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 agents EXCEPT adalimumab containing products for ulcerative colitis (UC), and the agents with indications that require loading doses for new starts. NOTE: For agents that require a loading dose for a new start, approve the loading dose based on FDA labeling AND the maintenance dose for the remainder of the length of approval. Adalimumab containing products for UC may be approved for 12 weeks. 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:
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. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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: Initial Approval with PA: 12 months for all agents EXCEPT adalimumab containing products for ulcerative colitis (UC), Rinvoq for atopic dermatitis (AD), Siliq for plaque psoriasis (PS), Xeljanz and Xeljanz XR for induction therapy for UC, and the agents with indications that require loading doses for new starts. NOTE: For agents that require a loading dose for a new start, approve the loading dose based on FDA labeling AND the maintenance dose for the remainder of the length of approval. Adalimumab containing products for UC may be approved for 12 weeks, Rinvoq for AD may be approved for 6 months, Siliq for PS may be approved for 16 weeks, and Xeljanz and Xeljanz XR for UC may be approved for 16 weeks. Renewal Approval with PA: 12 months **NOTE: Cosentyx for the diagnoses of AS, nr-axSpA, and PSA loading doses 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 _ CSReg _ Biologic_Immunomodulators_PAQL _ProgSum_ 01-01-2025 _ © Copyright Prime Therapeutics LLC. October 2024 All Rights Reserved