CurrentBlue Cross Blue Shield - IowaPolicy 05.05.62

Nemluvio (nemolizumab) — Coverage Criteria for Prurigo Nodularis and Atopic Dermatitis

Defines prior authorization, coverage criteria, dosing limits, and documentation requirements for Nemluvio (nemolizumab) for prurigo nodularis and moderate-to-severe atopic dermatitis for applicable Blue Cross Blue Shield - Iowa members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyNemluvio (nemolizumab) — Coverage Criteria for Prurigo Nodularis and Atopic Dermatitis

Policy CodePolicy 05.05.62

Change TypeNo material change

Effective DateOct 7, 2025

Next Review Date

Key ActionPrior authorization is required and providers must document prior therapies, clinical response, or clinical reasons to avoid preferred products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsPN initial auth (adults)

4 monthsAD initial auth (≥12 yrs)

12 monthsContinuation auth

2 pens/28dQty limits (30 mg pen)

30/60 mgFDA dosing options

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Coverage Criteria

Initial Therapy - Prurigo Nodularis

Covered when ALL of the following are met

PN Initial Approval

Duration and clinical pattern: Member has pruritus lasting at least 6 weeks and history or signs of repeated itch-scratch cycle (e.g., scratching, picking, or rubbing)6 weeks
Lesion burden: Member has a minimum of 20 nodular lesions>=20 lesions
Prior therapies: Member has had inadequate response to, intolerable adverse event with, or contraindication to preferred product Dupixent OR has had inadequate response to one of the following: medium to super-high potency topical corticosteroid, topical calcineurin inhibitor, phototherapy (UVB/PUVA), or systemic methotrexate or cyclosporine
See Appendix A for topical potency groups; Appendix B for systemic agent details

Initial Therapy - Moderate-to-Severe Atopic Dermatitis

Covered when ALL of the following are met

AD Initial Approval

Severity: Affected body surface area >=10% OR involvement of crucial body areas (e.g., hands)>=10% BSA
Preferred product step: Member has had inadequate response to, intolerable adverse event with, or contraindication to at least two preferred products (Dupixent, Ebglyss, Rinvoq); alternatively member currently receiving a non-preferred with positive outcome or has clinical reasons to avoid preferred products
Topical therapy trial or contraindication: Member had inadequate response to a medium potency to super-high potency topical corticosteroid or topical calcineurin inhibitor within the past 180 days OR topical calcineurin inhibitor, topical JAK inhibitor, or topical PDE-4 inhibitor are not advisable for the member
Member will not use Nemluvio concomitantly with other biologics or JAK inhibitors and will not exceed the maximum FDA‑approved dose for this indication.

Members must not use Nemluvio (nemolizumab) at the same time as any other biologic drug or targeted synthetic drug for the same indication. This concomitant use is prohibited under the policy to avoid overlapping immunomodulatory therapy and to ensure appropriateness of therapy selection.

Systemic agents (including oral immunosuppressants and other systemic dermatologic therapies) are contraindicated or may be excluded when clinical conditions increase risk of harm. Such conditions include a documented clinical diagnosis of alcohol use disorder, alcoholic liver disease or other chronic liver disease, known drug interactions that preclude safe use, increased risk of treatment-related toxicity, pregnancy or plans for pregnancy, breastfeeding, significant comorbidities that prohibit systemic agents (for example, liver or kidney disease, blood dyscrasias, uncontrolled hypertension), hypersensitivity, or a history of intolerance or adverse events to the systemic therapy.

Nemluvio is considered not medically necessary for members who do not meet the specific coverage criteria outlined in this policy. Members receiving samples or manufacturer patient assistance must meet the same initial approval requirements as other members.

Coding and Quantity Limits

Drug product detailsmixed

Nemluvio (nemolizumab-ilto) 30 mg/0.49 mL pre-filled pen

Formulation and strength as listed for quantity limits and dosing

Procedures and billing codes (section header)mixed

No codes listed

Affected body surface area (AD) — key thresholds

BSA threshold>= 10% body surface area OR involvement of crucial body areas (e.g., hands)

Age groupMembers 12 years of age and older (for atopic dermatitis criteria)

Documentation timeframePrior topical/systemic therapy trial documented within past 180 days when required

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required; initial approval criteria differ by indication and require meeting the health plan's preferred drug step requirements. For this program, Dupixent, Ebglyss, and Rinvoq are the preferred products and the criteria will generally require use of two of the health plan's preferred products before use of non-preferred products unless there is a documented clinical reason to avoid all preferred products, the member is already benefiting from a non-preferred product, or only one preferred product exists for the indication.

Nemluvio (nemolizumab) initial approval for prurigo nodularis requires inadequate response, intolerance, or contraindication to Dupixent (dupilumab).
Nemluvio initial approval for atopic dermatitis requires inadequate response, intolerance, or contraindication to at least two preferred products (Dupixent, Ebglyss, Rinvoq).

Documentation Required

Documentation Required for Initial and Continuation Requests

Initial and continuation prior authorization requests must include supporting clinical documentation from the medical record.

Background

Prurigo nodularis (PN) and moderate-to-severe atopic dermatitis are chronic dermatologic conditions marked by persistent, often severe pruritus and skin lesions that can be refractory to topical and systemic treatments. Nemolizumab (Nemluvio) is indicated for adults with PN and for patients age 12 years and older with moderate-to-severe atopic dermatitis as an adjunct when topical therapies are inadequate; use should follow the policy’s required prior authorization steps and documentation standards.

Definitions and Indications

Indications

Prurigo nodularis indicationNemluvio (nemolizumab) is indicated for the treatment of adult patients with prurigo nodularis (PN)

Atopic dermatitis indicationNemluvio is indicated for 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 disease is not adequately controlled with topical prescription therapies

Combination therapy noteFor atopic dermatitis, use is as an adjunct to topical corticosteroids and/or calcineurin inhibitors

Topical corticosteroid potency groups

Potency group rangeGroups I (highest) through VII (least potent)

Examples - high potency (Group II)Diflorasone diacetate, Fluocinonide, Fluticasone propionate, Mometasone furoate, Triamcinolone acetonide

Revision History

2025-10-07Policy effective dateLatest

Policy became effective on 2025-10-07 with coverage criteria, prior authorization requirements, quantity limits, and continuation rules for Nemluvio (nemolizumab).

2025-10-07Last review

Policy last reviewed on 2025-10-07 confirming criteria for initial and continuation therapy for prurigo nodularis and moderate-to-severe atopic dermatitis, including authorization periods (6 months PN; 4 months AD) and 12-month continuation authorizations when response achieved.

2025-10-07

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyNemluvio (nemolizumab) — Coverage Criteria for Prurigo Nodularis and Atopic Dermatitis

Policy CodePolicy 05.05.62

Change TypeNo material change

Effective DateOct 7, 2025

Next Review Date

Key ActionPrior authorization is required and providers must document prior therapies, clinical response, or clinical reasons to avoid preferred products.

SourceLink

On This Page

Initial requests: chart notes or medical record documentation of symptoms (e.g., pruritus, nodular lesions for prurigo nodularis), affected areas and body surface area when applicable, and documentation or claims history of prerequisite therapies including dosage, duration, and response. If a prerequisite therapy is not advisable, include documentation of the clinical reason to avoid it.
Continuation requests: chart notes or medical record documentation supporting a positive clinical response to therapy (e.g., improvement in signs or symptoms, low disease activity).
Members receiving samples or manufacturer patient assistance program supplies must meet the criteria for initial approval.

Billing Rule

Procedures and Billing Codes — Provider Reporting

Providers must report services using appropriate coding when submitting claims or authorization requests.

Report services using relevant CPT codes, HCPCS (Alpha Numeric Level II) codes, revenue codes, and ICD diagnostic codes as applicable.
Ensure correct coding for dermatology procedures and systemic agent administration to support medical necessity and billing.

Denial Risk

Denial Risk — Medical Necessity and Contraindications

Nemluvio is considered not medically necessary for members who do not meet the criteria set forth in this policy. Use of systemic agents may be contraindicated in certain clinical scenarios and could lead to denial if present.

Contraindications or reasons to avoid systemic agents that should be documented include: alcohol use disorder, alcoholic liver disease or other chronic liver disease, pregnancy or planning pregnancy, breastfeeding, significant comorbidities (e.g., severe liver or kidney disease, blood dyscrasias, uncontrolled hypertension), known hypersensitivity, history of intolerance or adverse events, relevant drug interactions, or excessive risk of treatment-related toxicity.
If the member does not meet the policy criteria, Nemluvio requests should be denied as not medically necessary.

Examples - mid to lower potency (Groups IV–V)Betamethasone dipropionate, Clocortolone pivalate, Betamethasone valerate, Desonide, Fluocinolone acetonide

Examples - least potent (Group VII)Hydrocortisone (various strengths and dosage forms such as cream, ointment, lotion)

Coding and quantity limits published

Quantity limits for Nemluvio (nemolizumab-ilto) documented (initiation and maintenance pen limits) and procedure/billing guidance included.

2025-10-07Exclusions and contraindications clarified

Policy explicitly states Nemluvio must not be used concomitantly with other biologics or targeted synthetic drugs for the same indication and lists contraindications for systemic agents (eg, alcohol use disorder, chronic liver disease, pregnancy, breastfeeding, significant comorbidity).