Subject: Opzelura PA with Limit 5018-C P04-2026

Drug

OPZELURA  (ruxolitinib)

Policy:

Indications

FDA-approved Indications

Atopic Dermatitis

Opzelura is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Nonsegmental Vitiligo

Opzelura is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Limitations of Use

Use of Opzelura in combination with therapeutic biologics, other Janus kinase (JAK) inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

Coverage Criteria

Atopic Dermatitis

Authorization may be granted when the requested drug is being prescribed for topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in a non-immunocompromised patient when ALL of the following criteria are met:

·        The requested drug is NOT being prescribed in combination with therapeutic biologics, other Janus kinase (JAK) inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine.

·        The request is for an adult or pediatric patient 2 years of age or older.

·        The patient meets ONE of the following:

§  The patient’s disease is NOT adequately controlled with other topical prescription therapies (e.g., medium or higher potency topical corticosteroid, topical calcineurin inhibitor).

§  Other topical prescription therapies are NOT advisable (e.g., medium or higher potency topical corticosteroid, topical calcineurin inhibitor).

·        The requested drug will NOT be applied to affected areas of greater than 20 percent body surface area (BSA).

·        If additional quantities are being requested, then the requested drug is being prescribed to treat a body surface area that requires more than 60 grams per 28 days.

Nonsegmental Vitiligo

Authorization may be granted when the requested drug is being prescribed for the topical treatment of nonsegmental vitiligo when ALL of the following criteria are met:

·        The requested drug is NOT being prescribed in combination with therapeutic biologics, other Janus kinase (JAK) inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine.

·        The request is for an adult or pediatric patient 12 years of age or older.

·        The requested drug will NOT be applied to affected areas of greater than 10 percent body surface area (BSA).

·        If additional quantities are being requested, then the requested drug is being prescribed to treat a body surface area that requires more than 60 grams per 28 days.

Continuation of Therapy

Atopic Dermatitis

Authorization may be granted when the requested drug is being prescribed for topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in a non-immunocompromised patient when ALL of the following criteria are met:

·        The requested drug is NOT being prescribed in combination with therapeutic biologics, other Janus kinase (JAK) inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine.

·        The request is for an adult or pediatric patient 2 years of age or older.

·        The patient has achieved or maintained a positive clinical response as evidenced by improvement [e.g., improvement in or resolution of any of the following signs and symptoms: erythema (redness), edema (swelling), xerosis (dry skin), erosions, excoriations (evidence of scratching), oozing and crusting, lichenification (epidermal thickening), OR pruritus (itching)].

·        The requested drug will NOT be applied to affected areas of greater than 20 percent body surface area (BSA).

·        If additional quantities are being requested, then the requested drug is being prescribed to treat a body surface area that requires more than 60 grams per 28 days.

Nonsegmental Vitiligo

Authorization may be granted when the requested drug is being prescribed for the topical treatment of nonsegmental vitiligo when ALL of the following criteria are met:

·        The requested drug is NOT being prescribed in combination with therapeutic biologics, other Janus kinase (JAK) inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine.

·        The request is for an adult or pediatric patient 12 years of age or older.

·        The patient has achieved or maintained a positive clinical response as evidenced by improvement (e.g., meaningful repigmentation).

·        The requested drug will NOT be applied to affected areas of greater than 10 percent body surface area (BSA).

·        If additional quantities are being requested, then the requested drug is being prescribed to treat a body surface area that requires more than 60 grams per 28 days.

Quantity Limits Apply

60 grams per 21 days or 180 grams per 63 days.

For larger body surface area (BSA) for Vitiligo: 180 grams per 21 days or 540 grams per 63 days.

For larger body surface area (BSA) for Atopic Dermatitis: Pediatric patients 2 to 11 years of age: 120 grams per 21 days or 360 grams per 63 days.

For larger body surface area (BSA) for Atopic Dermatitis: Patients 12 years of age and older: 240 grams per 21 days or 720 grams per 63 days.

The duration of 21 days is used for a 28-day fill period and 63 days is used for an 84-day fill period to allow time for refill processing.

The intent is for prescriptions of the requested drug to be filled one month at a time for new starts; there should be no 3-month supplies filled for new starts.

Duration of Approval (DOA)

·        5018-C:

§  Atopic Dermatitis: Initial therapy DOA: 3 months; Continuation of therapy DOA: 12 months

§  Nonsegmental Vitiligo: Initial therapy DOA: 7 months; Continuation of therapy DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Opzelura [package insert]. Wilmington, DE: Incyte Corporation; September 2025.

2.     Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2026. https://online.lexi.com. Accessed February 12, 2026.

3.     Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 02/12/2026).

4.     Eichenfield LF, Tom WL, et. al. Guidelines of care for the management of atopic dermatitis: Section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol 2014; 70:338-51.

5.     Eichenfield LF, Tom WL, et. al. Guidelines of care for the management of atopic dermatitis: Section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol 2014; 71:116-32.

6.     Papp K, Szepietowski JC, Kircik L, et. al. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies. J Am Acad Dermatol 2021;85:863-72.

7.     U.S. Department of Health & Human Services. Burn Triage and Treatment – Thermal Injuries. Chemical Hazards Emergency Medical Management. February 04, 2026. Available at: https://chemm.hhs.gov/burns.htm. Accessed February 13, 2026.

8.     Kubelis-López DE, Zapata-Salazar NA, et al. Updates and new medical treatments for vitiligo (Review). Exp Ther Med. 2021;22(2):797.

9.     Eleftheriadou V, Atkar R, et al. British Association of Dermatologists guidelines for the management of people with vitiligo 2021. The British Journal of Dermatology. 2021;186(1):18-29.

10.  U.S. Food & Drug Administration. FDA approves topical treatment addressing repigmentation in vitiligo in patients age 12 and older. July 19, 2022. Available at: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-topical-treatment-addressing-repigmentation-vitiligo-patients-aged-12-and-older. Accessed February 12, 2026.

11.    Felsten, LM, Alikhan A, Pretronic-Rosic V. Vitiligo: a comprehensive overview Part II: treatment options and approach to treatment. J Am Acad Dermatol 2011; 65 (3): 493-514.

12.   Sidbury RS, Alikhan A, Berovitch 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.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 20, 2026