Effective Date

Date of Origin 

07-01-2025            

04-01-2025

Nemluvio®

(nemolizumab-ilto)

Subcutaneous injection

Treatment of adults with prurigo nodularis

Treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies

1

Prurigo Nodularis (PN)

Prurigo nodularis (PN) is a skin disorder that is defined by the presence of chronic pruritus and multiple elevated, firm, and nodular lesions. PN is more common in older adults but can occur in children. The underlying cause of PN is unknown, but it appears neural and immunologic processes both play a role in its development. The nodules form in a subset of patients that have chronic pruritus, with the nodules forming in areas with continuous scratching over prolonged periods of time. There is significant disease burden associated with PN including sleep disruption, anxiety, and depression. The nodules are typically firm, dome-shaped, and itchy and range in size from millimeters to several centimeters. The nodules can range in color from flesh tones to brown/black and can range in number from a few to hundreds. The pruritus associated with PN can range from sporadic to continuous, and generally the underlying cause is unknown. There are a number of conditions, both dermatologic and other diseases, that are associated with PN, such as atopic dermatitis, kidney disease, diabetes, and HIV.(2)

The diagnosis of PN is generally one of exclusion. The American Academy of Dermatology (AAD) indicates that the diagnostic workup should include a clinical examination with a complete review of systems and assessment of PN severity, which should include both disease burden (e.g., quality of life, sleep disturbances) and pruritus intensity. The AAD notes three core features associated with PN:(2)

• Presence of firm, nodular lesions
• Pruritus that lasts for at least 6 weeks
• History and/or signs of repeated scratching, picking, or rubbing

Management requires a multifaceted approach with a focus on reducing pruritus, interrupting the itch-scratch cycle, and healing lesions.(2) General measures that should be used at baseline include gentle skin care, moisturizers, and antipruritic emollients.(2,3) Treatment may need to address both the neural and immunologic components of pruritus based on patient signs and symptoms, and often involves the use of topical and systemic therapies.(4) Most therapies for PN have not been adequately studied, and their evidence for use is based on small clinical trials, observational studies, and case reports.(2)

Topical therapies are the initial treatment for limited disease. Topical corticosteroids (TCS) target the immunologic component of PN.(2) The International Forum for the Study of Itch (IFSI) 2020 guideline on chronic prurigo including prurigo nodularis strongly recommends moderate to very potent topical corticosteroids on lesional skin.(3) Intralesional corticosteroids may be directly injected into thicker lesions where required, but use should be limited to patients with less than 10 lesions. Topical calcineurin inhibitors and topical calcipotriol have also been used in patients who failed TCS therapy and a prolonged course of a topical immunomodulator is desired. Topical capsaicin, which targets the neural component of PN, has limited clinical evidence and tends to have short term efficacy.(2)

Systemic therapies are used for widespread disease or disease refractory to topical therapy.(2,4) Phototherapy is reasonably tolerated and addresses both the immunologic and neural components of PN.(2) However, phototherapy combined with topical therapy will not be adequate for most patients, and the majority will require supplemental systemic therapy.(4) Oral immunosuppressants, such as methotrexate and cyclosporine, have shown to reduce pruritus and heal lesions per limited data available. Methotrexate is generally preferred due to its more favorable side effect profile in comparison to cyclosporine, and cyclosporine should only be considered in more severe cases.(2,4) Other systemic therapies that have shown to be less efficacious and treat the neural component of PN include thalidomide, gabapentin, pregabalin, antidepressants, aprepitant, and naltrexone.(2) Since PN is a nonhistaminergic condition, antihistamines are unlikely to be effective and are not recommended.(2,4)

Biologic agents are the first therapies to gain approval from the US Food and Drug Administration (FDA) for the treatment of PN. These immunomodulating drugs are believed to target molecules expressed by specific cell types that release a variety of itching mediators that directly or indirectly stimulate receptors on nerve endings in the skin. Biologic agents disrupt this cycle and have been proven to alleviate both pruritus and PN lesions.(4)

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.(7)

Goals of treatment are to reduce symptoms (pruritus and dermatitis), prevent exacerbations, and minimize therapeutics risks.(8) 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).(8,9) 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.(10)

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:(10)

• Topical corticosteroids (TCS)
• Calcineurin inhibitors (TCIs) (e.g., tacrolimus, pimecrolimus)
• Topical PDE-4 inhibitors (e.g., crisaborole) [mild to moderate AD]
• Topical JAK inhibitors (e.g., ruxolitinib) [mild to moderate AD]

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.(10)

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.(10) Prescribing information for pimecrolimus cream and tacrolimus ointment indicate evaluation after 6 weeks if symptoms of AD do not improve for adults and pediatrics.(11,12). 

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:(9)

• Monoclonal antibodies (biologics) (e.g., dupilumab, tralokinumab)
• JAK inhibitors (e.g., upadacitinib, abrocitinib, baricitinib)

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.(9)

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:(13)

One of the following:

• Affected BSA greater than or equal to 10%
• Investigator Global Assessment (IGA) greater than or equal to 3
• Eczema Area and Severity Index (EASI) greater than or equal to 16

OR

One of the following:

• Affected BSA greater than or equal to 10%
• Involvement of body sites that are difficult to treat with prolonged topical corticosteroid therapy (e.g., hands, feet, face, neck, scalp, genitals/groin, skin folds)
• Severe itch that has been unresponsive to topical therapies

Efficacy

Atopic Dermatitis
Two randomized, double-blind, placebo-controlled trials (ARCADIA 1 [NCT03985943] and ARCADIA 2 [NCT03989349]) enrolled a total of 1728 subjects 12 years of age and older with moderate-to-severe atopic dermatitis not adequately controlled by topical treatments. Disease severity was defined by an Investigator’s Global Assessment (IGA) score of 3 (moderate) and 4 (severe) in the overall assessment of atopic dermatitis, an Eczema Area and Severity Index (EASI) score of greater than or equal to 16, a minimum body surface area (BSA) involvement of greater than or equal to 10%, and a Peak Pruritus Numeric Rating Scale (PP-NRS) score of greater than or equal to 4. Seventy (70)% of subjects had a baseline IGA score of 3 (moderate AD), and 30% of subjects had a baseline IGA score of 4 (severe AD). The baseline mean EASI score was 27.5 and the baseline mean weekly average PP-NRS was 7.1. Overall, 63% of subjects received other previous systemic treatments for AD.(1)

Subjects in the Nemluvio group received initial subcutaneous injections of Nemluvio 60 mg, followed by 30 mg injections every 4 weeks until Week 16. Concomitant low and/or medium potency topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) were administered for at least 14 days prior to baseline and continued during the trial. Based on disease activity, these concomitant therapies could be tapered and/or discontinued at investigator discretion.(1)

Both ARCADIA 1 and ARCADIA 2 assessed the co-primary endpoints of:(1)

• Proportion of subjects with an IGA success (defined as an IGA of 0 [clear] or 1 [almost clear] and a greater than or equal to 2-point reduction from baseline) at Week 16
• Proportion of subjects with EASI-75 (greater than or equal to 75% improvement in EASI from baseline) at Week 16

The efficacy results for ARCADIA 1 and ARCADIA 2 evaluating the initial treatment period with Nemluvio over 16 weeks are presented in the table below.(1)

After 16 weeks, subjects achieving either EASI-75 or IGA success continued into the trial maintenance period for another 32 weeks to evaluate the maintenance of response achieved at Week 16. Nemluvio responders were re-randomized to either Nemluvio 30 mg every 4 weeks, Nemluvio 30 mg every 8 weeks, or placebo every 4 weeks (all groups continued background TCS/TCI). Subjects randomized to placebo in the initial treatment period who achieved the same clinical response at Week 16 continued to receive placebo every 4 weeks.(1)

Prurigo Nodularis
Two randomized, double-blind, placebo-controlled trials (OLYMPIA 1 [NCT04501666] and OLYMPIA 2 [NCT04501679]) enrolled a total of 560 adult subjects with prurigo nodularis (PN). OLYMPIA 1 and OLYMPIA 2 assessed the effect of Nemluvio on the signs and symptoms of PN, targeting improvement in skin lesions and pruritus over 16 weeks. In OLYMPIA 1, subjects were extended up to 24 weeks of treatment. Disease severity was defined using an IGA in the overall assessment of prurigo nodularis nodules on a severity scale of 0 to 4. The IGA is a 5-category scale, including “0 = clear”, “1 = almost clear”, “2 = mild”, “3 = moderate” or “4 = severe” indicating the investigator’s overall assessment of the pruriginous nodules. The PP-NRS score is a weekly average of daily PP-NRS scores on an 11-point scale from 0-10 that assesses the maximal intensity of pruritus in the last 24 hours with 0 being no itch and 10 being worst itch imaginable.(1)

Subjects enrolled in these two trials had an IGA score greater than or equal to 3, severe pruritus as defined by a weekly average of the PP-NRS score of greater than or equal to 7 on a scale of 0 to 10, and greater than or equal to 20 nodular lesions. Fifty-eight (58)% of subjects had a baseline IGA score of 3 (moderate PN), and 42% of subjects had a baseline IGA of 4 (severe PN). The baseline weekly average PP-NRS score was a mean of 8.5. Thirty-two (32)% of subjects had a history of atopy.(1) In the OLYMPIA 2 trial, 78.5% of subjects had previously used topical corticosteroids for the treatment of PN.(5) In both trials, patients were prohibited from using other therapies for PN such as topical corticosteroids, topical calcineurin inhibitors, or systemic immunomodulators, unless they were required as a rescue medication at the discretion of the investigator.(5,6)

Subjects weighing less than 90 kg in the Nemluvio group received subcutaneous injections of Nemluvio 60 mg at Week 0, followed by 30 mg injections every 4 weeks. Subjects weighing 90 kg or more in the Nemluvio group received subcutaneous injections of Nemluvio 60 mg at Week 0 and every 4 weeks.(1)

Efficacy was assessed with the proportion of subjects with an improvement of greater than or equal to 4 from baseline in PP-NRS, the proportion of subjects with an IGA of 0 (Clear) or 1 (Almost Clear) and a greater than or equal to 2-point improvement from baseline, the proportion of subjects who achieved a response in both PP-NRS and IGA per the criteria described above, and the proportion of subjects with PP-NRS less than 2.(1)

In both OLYMPIA 1 and OLYMPIA 2, statistically significant improvements in itch and PN skin lesions were observed at Week 16, with some subjects achieving this as early as Week 4. Examination of weight, age, gender, race, history of atopy, and prior treatment did not identify meaningful differences in response to Nemluvio among these subgroups at Week 16.(1,5,6)

Safety

Nemluvio is contraindicated in patients who have known hypersensitivity to nemolizumab-ilto or to any of the excipients of the product.(1)

1

Nemluvio prescribing information. Galderma Laboratories. December 2024.

2

Elmariah S, Kim B, Berger T, et al. Practical approaches for diagnosis and management of prurigo nodularis: United States expert panel consensus. J Am Acad Dermatol. 2021; 84:747-760.

3

Ständer S, Pereira MP, Berger TG, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi:10.1097/itx.0000000000000042

4

Yook HJ, Lee JH. Prurigo nodularis: Pathogenesis and the horizon of potential therapeutics. International Journal of Molecular Sciences. 2024;25(10):1-26. doi:10.3390/ijms25105164

5

Kwatra S, Yosipovitch G, Legat F, et al. Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. New England Journal of Medicine. 2023;389(17):1579-1589. doi:10.1056/nejmoa2301333

6

Stander S, Yosipovitch G, Legat F, et al. Nemolizumab monotherapy improves itch and skin lesions in patients with moderate-to-severe prurigo nodularis: Results from a global phase 3 trial (OLYMPIA 1). European Academy of Dermatology and Venereology; 2023. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.eadv/abstracts_congress2023/39434.pdf

7

Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of Care for the Management of Atopic Dermatitis: Section 1. Diagnosis and Assessment of Atopic Dermatitis. J Am Acad Dermatol. 2014 Feb;70(2):338-51.

8

Sidbury R, Tom WL, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014 Dec;71(6):1218-33.

9

Davis DM, Drucker AM, Alikhan A, et al. Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies. Journal of the American Academy of Dermatology. 2024;90(2):e43-e56. doi:10.1016/j.jaad.2023.08.102

10

Sidbury R, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol. 2023;89(1):e1-e20.

11

Pimecrolimus cream prescribing information. Oceanside Pharmaceuticals. September 2020.

12

Tacrolimus ointment prescribing information. Glenmark Pharmaceuticals Inc., USA. August 2023.

13

Institute For Clinical and Economic Review (ICER). JAK Inhibitors and Monoclonal Antibodies for the Treatment of Atopic Dermatitis: Effectiveness and Value. Final Evidence Report. August 2021. Updated February 2023.

Nemluvio

nemolizumab-ilto for subcutaneous auto-injector

30 MG

M ; N ; O ; Y

N

Nemluvio

nemolizumab-ilto for subcutaneous auto-injector

30 MG

1

Pen

28

DAYS

Nemluvio

nemolizumab-ilto for subcutaneous auto-injector

30 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Nemluvio

nemolizumab-ilto for subcutaneous auto-injector

30 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

PA

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. ONE of the following:
   1. The requested agent is eligible for continuation of therapy AND ONE of the following:

1. 1. 1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR 
      2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
   2. BOTH of the following:
      1. ONE of the following:
         1. The patient has a diagnosis of prurigo nodularis (PN) and BOTH of the following:
            1. The patient has ALL of the following features associated with PN:
               1. Presence of greater than or equal to 20 firm, nodular lesions AND
               2. Pruritus that has lasted for at least 6 weeks AND
               3. History and/or signs of repeated scratching, picking, or rubbing AND
            2. ONE of the following:
               1. The patient has ONE of the following:
                  1. Has tried and had an inadequate response to ONE at least medium-potency topical corticosteroid used in the treatment of PN after at least a 2-week duration of therapy OR
                  2. Has an intolerance or hypersensitivity to ONE at least medium-potency topical corticosteroid used in the treatment of PN OR
               2. The patient has an FDA labeled contraindication to ALL medium-, high-, and super-potency topical corticosteroids used in the treatment of PN OR
         2. The patient has a diagnosis of moderate-to-severe atopic dermatitis (AD) AND ALL of the following:
            1. ONE of the following:
               1. The patient has at least 10% body surface area involvement OR
               2. The patient has involvement of body sites that are difficult to treat with prolonged topical corticosteroid therapy (e.g., hands, feet, face, neck, scalp, genitals/groin, skin folds) OR
               3. The patient has an Eczema Area and Severity Index (EASI) score greater than or equal to 16 OR
               4. The patient has an Investigator Global Assessment (IGA) score greater than or equal to 3 AND
            2. ONE of the following:
               1. BOTH of the following:
                  1. ONE of the following:
                     1. The patient has ONE of the following:
                        1. Has tried and had an inadequate response to ONE at least medium-potency topical corticosteroid used in the treatment of AD after at least a 4-week duration of therapy OR
                        2. Has an intolerance or hypersensitivity to ONE at least medium-potency topical corticosteroid used in the treatment of AD OR
                     2. The patient has an FDA labeled contraindication to ALL medium-, high-, and super-potency topical corticosteroids used in the treatment of AD OR
                  2. ONE of the following:
                     1. The patient has ONE of the following:
                        1. Has tried and had an inadequate response to ONE topical calcineurin inhibitor (e.g., Elidel/pimecrolimus, Protopic/tacrolimus) used in the treatment of AD after at least a 6-week duration of therapy OR
                        2. Has an intolerance or hypersensitivity to ONE topical calcineurin inhibitor used in the treatment of AD OR
                     2. The patient has an FDA labeled contraindication to ALL topical calcineurin inhibitors used in the treatment of AD OR
               2. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of AD AND
            3. The prescriber has documented the patient’s baseline (prior to therapy with the requested agent) pruritus and other symptom severity (e.g., erythema, edema, xerosis, erosions/excoriations, oozing and crusting, and/or lichenification) OR
         3. The patient has another FDA labeled indication for the requested agent and route of administration AND
      2. If the patient has an FDA labeled indication, then ONE of the following:
         1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
         2. There is support for using the requested agent for the patient’s age for the requested indication OR
   3. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
2. If the patient has a diagnosis of moderate-to-severe atopic dermatitis (AD), then BOTH of the following:
   1. The patient is currently treated with topical emollients and practicing good skin care AND
   2. The patient will continue the use of topical emollients and good skin care practices in combination with the requested agent AND
3. If the requested agent is Nemluvio for a diagnosis of atopic dermatitis, then BOTH of the following:
   1. ONE of the following:
      1. BOTH of the following:
         1. The patient is currently treated with at least a low-potency topical corticosteroid OR a topical calcineurin inhibitor (e.g., Elidel/pimecrolimus, Protopic/tacrolimus) AND
         2. The patient will continue topical corticosteroid OR topical calcineurin inhibitor therapy in combination with the requested agent OR
      2. The patient has been treated with the requested agent for at least 16 consecutive weeks AND BOTH of the following:
         1. The disease has sufficiently improved AND
         2. Based on disease activity, concurrent topical therapies (e.g., topical corticosteroid, topical calcineurin inhibitor) have been tapered and discontinued OR
      3. The patient has an intolerance, hypersensitivity, or FDA labeled contraindication to ALL topical corticosteroids AND topical calcineurin inhibitors AND
   2. ONE of the following:
      1. The patient is initiating therapy with the requested agent OR
      2. The patient has been treated with the requested agent for less than 16 consecutive weeks OR
      3. The patient has been treated with the requested agent for at least 16 consecutive weeks AND ONE of the following:
         1. The requested dose is 30 mg every 8 weeks OR
         2. The requested dose is 30 mg every 4 weeks AND ONE of the following:
            1. The patient has NOT achieved clear or almost clear skin OR
            2. There is support for continued therapy at the requested dose of 30 mg every 4 weeks AND
4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, dermatologist, immunologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
5. ONE of the following (please refer to “Agents NOT to be used Concomitantly” table): 
   1. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
   2. The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
      1. The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND
      2. There is support for the use of combination therapy (submitted copy of clinical trials, phase III studies, or guidelines required) AND
6. The patient does NOT have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use

Length of Approval: 6 months for atopic dermatitis (AD), prurigo nodularis (PN); 12 months for all other indications

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND
2. ONE of the following:
   1. The patient has a diagnosis of moderate-to-severe atopic dermatitis AND BOTH of the following:
      1. The patient has had a reduction or stabilization from baseline (prior to therapy with the requested agent) of ONE of the following:
         1. Affected body surface area OR
         2. Flares OR
         3. Pruritus, erythema, edema, xerosis, erosions/excoriations, oozing and crusting, and/or lichenification OR
         4. A decrease in the Eczema Area and Severity Index (EASI) score OR
         5. A decrease in the Investigator Global Assessment (IGA) score AND
      2. The patient will continue standard maintenance therapies (e.g., topical emollients, good skin care practices) in combination with the requested agent OR
   2. The patient has a diagnosis other than moderate-to-severe atopic dermatitis AND has had clinical benefit with the requested agent AND
3. If the requested agent is Nemluvio for a diagnosis of atopic dermatitis, then BOTH of the following:
   1. ONE of the following:
      1. The patient will continue topical corticosteroid OR topical calcineurin inhibitor therapy in combination with the requested agent OR
      2. The patient has been treated with the requested agent for at least 16 consecutive weeks AND BOTH of the following:
         1. The disease has sufficiently improved AND
         2. Based on disease activity, concurrent topical therapies (e.g., topical corticosteroid, topical calcineurin inhibitor) have been tapered and discontinued OR
      3. The patient has an intolerance, hypersensitivity, or FDA labeled contraindication to ALL topical corticosteroids AND topical calcineurin inhibitors AND
   2. ONE of the following:
      1. The patient is initiating therapy with the requested agent OR
      2. The patient has been treated with the requested agent for less than 16 consecutive weeks OR
      3. The patient has been treated with the requested agent for at least 16 consecutive weeks AND ONE of the following:
         1. The requested dose is 30 mg every 8 weeks OR
         2. The requested dose is 30 mg every 4 weeks AND ONE of the following:
            1. The patient has NOT achieved clear or almost clear skin OR
            2. There is support for continued therapy at the requested dose of 30 mg every 4 weeks AND
4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, dermatologist, immunologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
5. ONE of the following (please refer to “Agents NOT to be used Concomitantly” table): 
   1. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
   2. The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
      1. The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND
      2. There is support for use of combination therapy (submitted copy of clinical trials, phase III studies, or guidelines required) AND
6. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:

1. The requested quantity (dose) does NOT exceed the program quantity limit OR  
2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
   1. The requested agent is Nemluvio for a diagnosis of prurigo nodularis AND ONE of the following:
      1. The patient weighs less than 90 kg AND BOTH of the following:
         1. The request is for an initial loading dose AND
         2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR
      2. The patient weighs 90 kg or greater AND the requested quantity (dose) does NOT exceed 60 mg every 4 weeks OR
   2. BOTH of the following:
      1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication OR
   3. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit

Length of Approval: up to 12 months

Note: If approving initial loading dose for Nemluvio for atopic dermatitis or prurigo nodularis, approve quantity for loading dose for 1 month per FDA labeling followed by maintenance dose for the remainder of the length of approval. Maintenance dosing begins 4 weeks after patient receives the loading dose.

Agents NOT to be used Concomitantly

Abrilada (adalimumab-afzb)
Actemra (tocilizumab)
Adalimumab
Adbry (tralokinumab-ldrm)
Amjevita (adalimumab-atto)
Arcalyst (rilonacept)
Avsola (infliximab-axxq)
Benlysta (belimumab)
Bimzelx (bimekizumab-bkzx)
Cibinqo (abrocitinib)
Cimzia (certolizumab)
Cinqair (reslizumab)
Cosentyx (secukinumab)
Cyltezo (adalimumab-adbm)
Dupixent (dupilumab)
Ebglyss (lebrikizumab-lbkz)
Enbrel (etanercept)
Entyvio (vedolizumab)
Fasenra (benralizumab)
Hadlima (adalimumab-bwwd)
Hulio (adalimumab-fkjp)
Humira (adalimumab)
Hyrimoz (adalimumab-adaz)
Idacio (adalimumab-aacf)
Ilaris (canakinumab)
Ilumya (tildrakizumab-asmn)
Imuldosa (ustekinumab-srlf)
Inflectra (infliximab-dyyb)
Infliximab
Kevzara (sarilumab)
Kineret (anakinra)
Leqselvi (deuruxolitinib)
Litfulo (ritlecitinib)
Nemluvio (nemolizumab-ilto)
Nucala (mepolizumab)
Olumiant (baricitinib)
Omvoh (mirikizumab-mrkz)
Opzelura (ruxolitinib)
Orencia (abatacept)
Otezla (apremilast)
Otulfi (ustekinumab-aauz)
Pyzchiva (ustekinumab-ttwe)
Remicade (infliximab)
Renflexis (infliximab-abda)
Riabni (rituximab-arrx)
Rinvoq (upadacitinib)
Rituxan (rituximab)
Rituxan Hycela (rituximab/hyaluronidase human)
Ruxience (rituximab-pvvr)
Saphnelo (anifrolumab-fnia)
Selarsdi (ustekinumab-aekn)
Siliq (brodalumab)
Simlandi (adalimumab-ryvk)
Simponi (golimumab)
Simponi ARIA (golimumab)
Skyrizi (risankizumab-rzaa)
Sotyktu (deucravacitinib) 
Spevigo (spesolimab-sbzo) subcutaneous injection
Stelara (ustekinumab)
Steqeyma (ustekinumab-stba)
Taltz (ixekizumab)
Tezspire (tezepelumab-ekko)
Tofidence (tocilizumab-bavi)
Tremfya (guselkumab)
Truxima (rituximab-abbs)
Tyenne (tocilizumab-aazg)
Tysabri (natalizumab)
Ustekinumab
Velsipity (etrasimod)
Wezlana (ustekinumab-auub)
Xeljanz (tofacitinib)
Xeljanz XR (tofacitinib extended release)
Xolair (omalizumab)
Yestinek (ustekinumab-kfce)
Yuflyma (adalimumab-aaty)
Yusimry (adalimumab-aqvh)
Zeposia (ozanimod)
Zymfentra (infliximab-dyyb)