Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Nemluvio SGM 6592-A P2026
Drug
NEMLUVIO(nemolizumab-ilto)
Policy:
Indications
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-approved Indications1
Treatment of adults with prurigo nodularis (PN).
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.
All other indications are considered experimental/investigational and not medically necessary.
Documentation
Submission of the following information is necessary to initiate the prior authorization review:
Atopic Dermatitis
Initial requests
Chart notes or medical record documentation showing affected area(s) and body surface area (where applicable).
Chart notes, medical record documentation, or claims history supporting previous medications tried, including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Prurigo Nodularis (PN)
Initial requests
Chart notes or medical record documentation of symptoms (e.g., pruritus, nodular lesions).
Chart notes, medical record documentation, or claims history supporting previous therapies tried, including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.
Continuation requests
Chart notes or medical record documentation supporting positive clinical response.
Prescriber Specialties
This medication must be prescribed by or in consultation with a dermatologist or allergist/immunologist.
Coverage Criteria
Atopic Dermatitis1,2,8-11
Authorization of 4 months may be granted for members 12 years of age or older who have previously received a biologic (e.g., Adbry, Dupixent, Ebglyss) or systemic targeted synthetic drug (e.g., Cibinqo, Rinvoq) indicated for moderate-to-severe atopic dermatitis in the past 12 months. The requested medication must be prescribed in combination with a topical corticosteroid or topical calcineurin inhibitor, unless the use of a topical corticosteroid and topical calcineurin inhibitor are not advisable for the member (e.g., due to contraindications, prior intolerances).
Authorization of 4 months may be granted for treatment of moderate-to-severe atopic dermatitis in members 12 years of age or older when all of the following criteria are met:
Affected body surface is greater than or equal to 10% body surface area OR crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected.
Member meets either of the following:
Member has had an inadequate treatment response with one of the following in the past 12 months:
A medium potency to super-high potency topical corticosteroid (see Appendix A)
A topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus)
A topical Janus kinase (JAK) inhibitor (g., Opzelura)
A topical phosphodiesterase-4 (PDE-4) inhibitor (e.g., Eucrisa, Zoryve)
A topical aryl hydrocarbon receptor agonist (g., Vtama)
The use of medium potency to super-high potency topical corticosteroid, topical calcineurin inhibitor, topical JAK inhibitor, topical PDE-4 inhibitor, and topical aryl hydrocarbon receptor agonist are not advisable for the member (e.g., due to contraindications, prior intolerances)
Member is prescribed the requested medication in combination with a topical corticosteroid or topical calcineurin inhibitor, unless the use of a topical corticosteroid and topical calcineurin inhibitor are not advisable for the member (e.g., due to contraindications, prior intolerances).
Prurigo Nodularis (PN)1,3-5
Authorization of 6 months may be granted for members 18 years of age or older who have previously received a biologic drug (e.g., Dupixent) indicated for prurigo nodularis in the past 12 months.
Authorization of 6 months may be granted for treatment of prurigo nodularis in members 18 years of age or older when all of the following criteria are met:
Member has pruritus lasting at least 6 weeks.
Member has history or signs of repeated itch-scratch cycle (e.g., scratching, picking, or rubbing).
Member has a minimum of 20 nodular lesions.
Member meets either of the following:
Member has had an inadequate response to one of the following:
A medium to super-high potency topical corticosteroid (see Appendix A)
A topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus)
Phototherapy (e.g., UVB, PUVA)
Pharmacologic treatment with methotrexate or cyclosporine
Member has had an intolerance or a clinical reason to avoid all of the following:
Medium to super-high potency topical corticosteroids (see Appendix A)
Topical calcineurin inhibitors
Phototherapy
Pharmacologic treatment with methotrexate and cyclosporine (see Appendix B)
Continuation of Therapy
Atopic Dermatitis1,8
Authorization of 12 months may be granted for members 12 years of age or older (including new members) who are using the requested medication for moderate-to-severe atopic dermatitis and who achieve or maintain a positive clinical response as evidenced by low disease activity (i.e., clear or almost clear skin), or improvement in signs and symptoms of atopic dermatitis (e.g., redness, itching, oozing/crusting).
Prurigo Nodularis (PN)3-5
Authorization of 12 months may be granted for members 18 years of age or older (including new members) who are using the requested medication for prurigo nodularis and who achieve or maintain a positive clinical response as evidenced by either of the following:
Low disease activity (i.e., clear or almost clear skin)
Reduction in pruritis intensity and improvement in extent and severity of nodular lesions
Other
Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.
Appendix
Appendix A: Table. Relative Potency of Select Topical Corticosteroid Products2
Hydrocortisone (base, greater than or equal to 2%)
Cream, Ointment, Lotion, Solution
2.5%
VII. Least potent (group 7)
Hydrocortisone (base, greater than or equal to 2%)
Cream, Gel, Lotion
2%
VII. Least potent (group 7)
Hydrocortisone (base, less than 2%)
Cream, Ointment, Liquid, Lotion, Solution
1%
VII. Least potent (group 7)
Hydrocortisone (base, less than 2%)
Cream, Ointment
0.5%
VII. Least potent (group 7)
Hydrocortisone acetate
Cream
2.5%
VII. Least potent (group 7)
Hydrocortisone acetate
Lotion
2%
VII. Least potent (group 7)
Hydrocortisone acetate
Cream, Ointment
1%
Appendix B: Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate or Cyclosporine5,6
Clinical diagnosis of alcohol use disorder, alcoholic liver disease or other chronic liver disease
Drug interaction
Risk of treatment-related toxicity
Pregnancy or currently planning pregnancy
Breastfeeding
Significant comorbidity prohibits use of systemic agents (e.g., liver or kidney disease, blood dyscrasias, uncontrolled hypertension)
Hypersensitivity
History of intolerance or adverse event
Place of Service:
Outpatient
The above policy is based on the following references:
Nemluvio [package insert]. Dallas, TX: Galderma Laboratories, L.P.; June 2025.
Comparison of Representative Topical Corticosteroid Preparations (Classified According to the United States System). Drug Facts and Comparisons. Facts and Comparisons. UpToDate Inc. https://fco.factsandcomparisons.com. Accessed November 7, 2025.
Ständer HF, Elmariah S, Zeidler C, Spellman M, Ständer S. Diagnostic and treatment algorithm for chronic nodular prurigo. J Am Acad Dermatol. 2020;82(2):460-468.
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(3):747-760.
Ständer S, Pereira MP, Berger T, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 202;5(4):p e42.
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;70:338-351.
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.
Davis DMR, Drucker AM, Alikhan A, et al. Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies. J Am Acad Dermatol. 2024 Feb;90(2):e43-e56.
Davis DMR, Frazer-Green L, Alikhan A, et al. Focused update: Guidelines of care for the management of atopic dermatitis in adults. J Am Acad Dermatol. 2025;93(3):745.e1-745.e7.
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.
