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Zoryve (roflumilast) Prior Authorization Program Summary
Policy Number: PH-91194
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
04-01-2023 |
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Zoryve® (roflumilast) Cream |
Cream 0.3%: Treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older Cream 0.15%: Topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older |
|
1 |
Zoryve® (roflumilast) Foam |
Treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older |
|
7 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
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.(2) 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:(2)
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.(4) The AAD psoriasis treatment guidelines recommend the following:(3,6)
The National Psoriasis Foundation (NPF) medical board recommend a treat-to-target approach to therapy for psoriasis that include the following:(5)
|
Seborrheic dermatitis (SD) |
Seborrheic dermatitis (SD) is a common skin condition in infants, adolescents, and adults. The characteristic symptoms of scaling, erythema, and itching occur most often on the scalp, face, chest, back, axilla, and groin. SD is a clinical diagnosis based on the location and appearance of the lesions. Although some environmental triggers (e.g., low temperature and humidity in winter) are likely to promote its development, several other factors including fungal colonization by Malassezia spp, sebaceous gland activity, as well as immunosuppression, endocrine, neurologic and iatrogenic factors have been postulated.(8,9) Treatment of SD is aimed at modulating sebum production, reducing skin colonization by Malassezia spp and controlling inflammation. In mild-to moderate SD forms, topical antifungals and/or topical corticosteroids are first-line therapy. Topical calcineurin inhibitors are effective, well tolerated second-line treatments. In Severe and/or resistant cases the off-label use of some topical and systemic drugs, as well as physical treatment with ultraviolet blue (UVB) phototherapy may be considered. Topical treatments include:(8,9)
Systemic antifungals (terbinafine, itraconazole) are mainly indicated in acute and/or severe and/or resistant SD forms.(8) |
Efficacy |
Plaque psoriasis Two multicenter, randomized, double-blind, vehicle-controlled trials (DERMIS-1 [NCT04211363] and DERMIS-2 [NCT04211389]) enrolled a total of 881 subjects with mild to severe plaque psoriasis and an affected BSA of 2% to 20%. At baseline, 16% of subjects had an Investigator’s Global Assessment (IGA) score of 2 (mild), 76% had an IGA score of 3 (moderate), and 8% had an IGA score of 4 (severe). One hundred seventy-nine (20%) subjects had an intertriginous IGA (I-IGA) score of 2 or higher (mild) at baseline, and 678 (77%) subjects had a baseline Worst Itch-Numeric Rating Score (WI-NRS) score of 4 or higher on a scale of 0 to 10.(1) Subjects were randomized 2:1 to receive Zoryve or vehicle applied once daily for 8 weeks. The primary endpoint was the proportion of subjects who achieved IGA treatment success at week 8. Success was defined as a score of “Clear” (0) or “Almost Clear” (1), plus a 2-grade improvement from baseline. Secondary endpoints included the proportion of subjects that achieved I-IGA success at week 8 and WI-NRS success sequentially at weeks 8, 4, and 2. WI-NRS success was defined as a reduction of at least 4 points from baseline in subjects with a baseline WI-NRS score of at least 4.(1) Patients treated with Zoryve achieved greater IGA success at week 8 compared to patients treated with vehicle (41.5% vs 5.8% [difference of 39.7% for DERMIS-1], 36.7% vs 7.1% [difference of 29.5% for DERMIS-2]. Among subjects with an I-IGA score of at least 2 (mild) at baseline (approximately 22% of subjects in DERMIS-1 and 19% in DERMIS-2), there was a higher percentage of subjects who achieved I-IGA success at week 8 in the group who received Zoryve compared to the group who received vehicle (DERMIS-1: 71.5% vs. 13.8%; DERMIS-2: 67.5% vs. 17.4%). Secondary endpoints were not statistically significant.(1) Seborrheic dermatitis Two randomized double-blind, vehicle-controlled trials (STRATUM [NCT04973228]) and Trial 203 [NCT04091646] enrolled patients with seborrheic dermatitis involving the scalp, face, and/or body with an Investigator Global Assessment (IGA) of moderate or severe (IGA of 4 or 3 on a 5 point scale from 0 to 4). The primary endpoint in both studies was the proportion of patients who achieved IGA treatment success at Week 8. Success was defined as a score of "Clear" (0) or "Almost Clear" (1), plus a 2-grade improvement from baseline. IGA was achieved in 79.5% and 71.1% of patients in STRATUM and Trial 203 respectively, with a 95% confidence interval in both trials.(7) |
Safety |
Zoryve is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).(1,7) |
REFERENCES
Number |
Reference |
1 |
Zoryve cream prescribing information. Arcutis Biotherapeutics, Inc. July 2024. |
2 |
Weigle, Nancy, M.D., et al. Psoriasis. American Academy of Family Physicians. May 2013. 87 (9): 626-633. |
3 |
Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. J Am Acad Dermatol. 2011;65(1):137–174. |
4 |
Menter, Alan et al. (2019). Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. Journal of the American Academy of Dermatology. doi: https://doi.org/10.1016/j.jaad.2018.11.057. |
5 |
Armstrong AW, Siegel MP, Bagel J, et al. From the medical board of the National Psoriasis Foundation: treatment targets for plaque psoriasis. Journal of the American Academy of Dermatology. 2017;76(2):290-298. doi: 10.1016/j.jaad.2016.10.017. |
6 |
Menter A, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. Journal of the American Academy of Dermatology. 2008; 58:826–850. doi: 10.1016/j.jaad.2008.02.039. |
7 |
Zoryve foam prescribing information. Arcutis Biotherapeutics, Inc. December 2023. |
8 |
Dall'Oglio F, Nasca MR, Gerbino C, Micali G. An Overview of the Diagnosis and Management of Seborrheic Dermatitis. Clin Cosmet Investig Dermatol. 2022 Aug 6;15:1537-1548. doi: 10.2147/CCID.S284671. PMID: 35967915; PMCID: PMC9365318. |
9 |
Clark GW, Pope SM, Jaboori K. Diagnosis and Treatment of Seborrheic Dermatitis. Am Fam Physician. 2015;91(3):185-190. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Zoryve |
roflumilast cream |
0.15 % |
M ; N ; O ; Y |
N |
|
|
Zoryve |
roflumilast cream |
0.3 % |
M ; N ; O ; Y |
N |
|
|
Zoryve |
roflumilast foam |
0.3 % |
M ; N ; O ; Y |
N |
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Zoryve |
roflumilast cream |
0.15 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zoryve |
roflumilast cream |
0.3 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zoryve |
roflumilast foam |
0.3 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: diagnosis of plaque psoriasis 12 months, diagnosis of seborrheic dermatitis 8 weeks, All other FDA approved indications 12 months *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months |
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 _ Zoryve_roflumilast__PA _ProgSum_ 10-01-2024 _
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