CurrentCignaPolicy IP0714

Nemluvio (nemolizumab) subcutaneous injection — coverage and prior authorization criteria

Defines Cigna prior authorization and medical necessity criteria for Nemluvio (nemolizumab) subcutaneous injection for atopic dermatitis and prurigo nodularis in applicable members and prescribers.

Policy Summary

PayerCigna

PolicyNemluvio (nemolizumab) subcutaneous injection — coverage and prior authorization criteria

Policy CodePolicy IP0714

Change TypeNew policy with subsequent template and annual updates

Effective Dateas written

Next Review Date

Key ActionSubmit prior authorization; initial approvals: 4 months for new therapy and 1 year for patients currently receiving Nemluvio who have responded.

SourceLink

POLICY UPDATE CHANGES

New policy created for Nemluvio with coverage criteria and prior authorization requirements.

Policy template updated on 2025-11-15.

Annual revision on 2026-03-15 reported as no criteria changes.

4 monthsinitial approval (new)

1 yearapproval (ongoing)

≥12min age (AD)

≥18min age (PN)

≥20

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nodular lesions req'd

Coverage and Medical Necessity Criteria

inv-01: Atopic Dermatitis — Approve when ONE of the following (A or B) is met; initial vs continuation logic present

Approve for atopic dermatitis when ONE of the following (A or B) is met

Atopic Dermatitis - A or B

A) Initial Therapy criteria
- i. Patient is ≥ 12 years of age.
- ii. According to the prescriber, the patient has atopic dermatitis involvement estimated to be ≥ 10% of the body surface area.
- iii. Prior topical corticosteroid trial (all must be met)
  - a) Patient has tried at least one medium-, medium-high, high-, and/or super-high-potency prescription topical corticosteroid.
  - b) This topical corticosteroid was applied daily for at least 28 consecutive days.
  - c) Inadequate efficacy was demonstrated with this topical corticosteroid therapy, according to the prescriber.
- iv. Concomitant topical therapy or disease state
  - a) Medication is used in combination with a topical corticosteroid and/or topical calcineurin inhibitor for initial therapy.
  - b) Disease has sufficiently improved with Nemluvio and topical therapy has been discontinued (as applicable).
- v. Medication is prescribed by or in consultation with an allergist, immunologist, or dermatologist.
- vi. Preferred product criteria is met for the product(s) as listed for Individual and Family Plans (when applicable).
B) Currently Receiving Nemluvio
- i. Patient has already received at least 4 months of therapy with Nemluvio.
- ii. Patient has responded to therapy as determined by the prescriber (examples of response include improvements in erythema, induration/papulation/edema, excoriations, lichenification, reduced pruritus, decreased requirement for other therapies, or reduced body surface area).

inv-02: Prurigo Nodularis — Approve when ONE of the following (A or B) is met; nodular lesion count and duration requirements

Approve for prurigo nodularis when ONE of the following (A or B) is met

Prurigo Nodularis - A or B

A) Initial Therapy criteria
- i. Patient is ≥ 18 years of age.
- ii. There are ≥ 20 identifiable nodular lesions on the arms, legs, and/or trunk (per prescriber assessment).
- iii. Patient has experienced pruritus for ≥ 6 weeks.
- iv. Cause assessment
  - a) The prurigo nodularis is NOT medication-induced or secondary to a nondermatologic condition such as neuropathy or a psychiatric disease.

Concurrent use of Nemluvio (nemolizumab) with another monoclonal antibody therapy is considered not medically necessary. The efficacy and safety of Nemluvio in combination with other monoclonal antibody therapies have not been established.

Nemluvio is considered not medically necessary for any use outside the FDA‑approved indications. This includes using Nemluvio in combination with the monoclonal antibodies listed in the policy and with Janus kinase (JAK) inhibitors (oral or topical), as combination use with these agents is not recommended or supported by established safety and efficacy data.

Relevant Codes and Key Clinical Thresholds

Covered/Relevant Codesmixed

No codes listed

Atopic dermatitis BSA

Threshold>= 10% of body surface area as estimated by the prescriber

Supporting age criterionPatient is >= 12 years of age

Assessment methodExtent determined by prescriber estimate of BSA involvement

Prurigo nodularis lesion count

Lesion count requirement>= 20 identifiable nodular lesions

DistributionNodules distributed bilaterally on the legs, and/or both arms, and/or trunk (per trial enrollment)

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Nemluvio. Initial approvals: 4 months for new therapy; continuation approvals: 1 year for patients currently receiving Nemluvio. Because of the specialized skills required for evaluation and monitoring, initial approval requires Nemluvio to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., allergist, immunologist, or dermatologist).

Initial approval duration = 4 months (1 month = 30 days).
Continuation approval duration = 1 year for patients who have already received ≥ 4 months of Nemluvio and have demonstrated clinical benefit.
Claims submitted without a covered diagnosis/procedure code will be denied; prior authorization must be obtained before billing.

Step Therapy

Topical Therapy and Product-Preference Requirements

Topical therapy and product-preference requirements must be documented prior to approval for atopic dermatitis/prurigo nodularis indications. For initial therapy, prescribers must document prior topical corticosteroid use and details of those trials. For Individual and Family Plans, preferred product criteria require trial and inadequate efficacy or intolerance to Dupixent unless the patient is already started on Nemluvio.

Key Clinical Definitions and Enrollment Criteria

Extent for atopic dermatitis

Extent definitionAtopic dermatitis involvement >= 10% BSA

Clinical trial contextARCADIA trials evaluated patients >= 12 years and allowed tapering/discontinuation of topical therapies based on disease activity

Use with topical therapyNemluvio indicated in combination with topical corticosteroids and/or topical calcineurin inhibitors per labeling

Prurigo nodularis enrollment criteria

Enrollment lesion-count and symptom criteria>= 20 identifiable nodular lesions on arms, legs, and/or trunk AND pruritus >= 6 weeks

Age requirementPatients >= 18 years for prurigo nodularis indication

Clinical Background

Nemluvio (nemolizumab) is an interleukin‑31 (IL‑31) receptor antagonist. It is FDA‑approved for treatment of moderate‑to‑severe atopic dermatitis in patients aged ≥ 12 years used in combination with topical corticosteroids and/or topical calcineurin inhibitors, and for treatment of prurigo nodularis in adults. Efficacy was evaluated in the ARCADIA trials for atopic dermatitis and the OLYMPIA trials for prurigo nodularis with primary endpoints assessed at 16 weeks.

Policy Changes and Revision Timeline

Policy Summary

PayerCigna

PolicyNemluvio (nemolizumab) subcutaneous injection — coverage and prior authorization criteria

Policy CodePolicy IP0714

Change TypeNew policy with subsequent template and annual updates

Effective Dateas written

Next Review Date

Key ActionSubmit prior authorization; initial approvals: 4 months for new therapy and 1 year for patients currently receiving Nemluvio who have responded.

SourceLink

On This Page

b) The patient has a secondary cause of prurigo nodularis that has been identified and adequately managed, according to the prescriber.

v. Prior topical corticosteroid trial (all must be met)

a) Patient has tried at least one high- or super-high-potency prescription topical corticosteroid.
b) This topical corticosteroid was applied daily for at least 14 consecutive days.
c) Inadequate efficacy was demonstrated with this topical corticosteroid therapy, according to the prescriber.

vi. Medication is prescribed by or in consultation with an allergist, immunologist, or dermatologist.

vii. Preferred product criteria is met for the product(s) as listed for Individual and Family Plans (when applicable).

B) Currently Receiving Nemluvio

i. Patient has already received at least 4 months of therapy with Nemluvio.
ii. Patient has experienced a beneficial clinical response, defined by ONE of: reduced nodular lesion count, decreased pruritus, or reduced nodular lesion size.

Prescriber must document the nodular lesion count on exam

Pruritus duration for prurigo nodularis

Duration of pruritus>= 6 weeks

Relevance to enrollmentRequired for initial therapy eligibility for prurigo nodularis

Exclusion noteChronic pruritus due to other active conditions (neuropathic or psychogenic) were excluded in trials

Initial therapy requires trial of at least one medium-, medium-high, high-, and/or super-high–potency prescription topical corticosteroid applied daily for ≥ 28 consecutive days.
For prurigo nodularis criteria, patient must have tried at least one high- or super-high–potency prescription topical corticosteroid applied daily for ≥ 14 consecutive days with inadequate efficacy.
Individual and Family Plans: patient must have tried and had inadequate efficacy or significant intolerance to Dupixent, OR the patient has already been started on Nemluvio.

Documentation Required

Required Clinical Documentation

Prescribers must provide required clinical documentation to support the request. Documentation should include patient age, extent of disease, prior topical therapy details, pruritus duration, and prescriber specialty/consultation.

Document patient age (must be ≥ 12 years for initial therapy).
Document estimated body surface area (BSA) involvement (≥ 10% for initial atopic dermatitis criteria).
Detail prior topical corticosteroid trials: agent(s), potency, duration of use (≥ 28 days for initial; ≥ 14 days for prurigo nodularis high‑potency trial), and reason for failure (inadequate efficacy or intolerance).
Document duration of pruritus (≥ 6 weeks where required) and that prurigo nodularis is not medication‑induced or secondary to a nondermatologic condition, or that a secondary cause was identified and adequately managed.
Document that the medication is prescribed by or in consultation with an allergist, immunologist, or dermatologist when required.
For continuation requests, document that the patient has received ≥ 4 months of Nemluvio and has experienced a beneficial clinical response (reduced lesion count, decreased pruritus, or reduced lesion size).

Billing Rule

Authorization and Coding Compliance

Claims and billing must comply with coverage and coding requirements. Services billed without covered diagnosis/procedure codes under this policy will be denied.

Use the most appropriate diagnosis and procedure codes as of the date of service; claims without covered codes per this policy will be denied.
Obtain prior authorization before submitting claims for Nemluvio to avoid denial.
Ensure documentation supporting the PA is available upon request to substantiate medical necessity.

Trial exclusionPatients with chronic pruritus from other active non-prurigo nodularis conditions (eg, neuropathic, psychogenic) were excluded