CurrentmhnPolicy CP.PCH.59

Clinical Policy: Nemolizumab-ilto (Nemluvio)

Defines medical necessity criteria, prior authorization requirements, dosing limits, approval durations, continued therapy criteria, exclusions and related administrative guidance for Nemolizumab-ilto (Nemluvio) for commercial and HIM lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Nemolizumab-ilto (Nemluvio)

Policy CodePolicy CP.PCH.59

Change TypeRevised / Clarified

Effective DateDec 1, 2025

Next Review Date

Key ActionProvider must submit office chart notes, lab results, or other clinical information supporting that member has met all approval criteria (including NRS score, lesion count, prior therapy trials, prescriber specialty).

SourceLink

POLICY UPDATE CHANGES

Policy adapted from CP.PHAR.703 with revisions adding redirection to preferred agents Dupixent or Rinvoq for atopic dermatitis initial approval criteria.

Illinois HIM requests are exempt from certain step therapy requirements per IL HB 5395 effective 2026-01-01.

2FDA Approved Indications

>=7Itch severity threshold (NRS)

>=20Nodule count threshold

12m / 6mApproval durations (HIM / Commercial)

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coverage_stance: covered_with_criteria for Nemluvio (nemolizumab‑ilto) per policy. FDA‑approved indications: adults with prurigo nodularis (PN) and adults and pediatric patients ≥12 years with moderate‑to‑severe atopic dermatitis (AD) in combination with topical therapies (FDA approvals referenced). High‑level required prior therapy failures: for PN, documentation of failure of a ≥2‑week medium to very high potency topical corticosteroid and failure of ≥3 consecutive months of Dupixent (dupilumab) unless contraindicated (Illinois HIM requests exempt from the Dupixent step per IL HB 5395); for AD, inadequate response to two different formulary medium to very high potency topical corticosteroids (each ≥2 weeks) and one topical calcineurin inhibitor (≥4 weeks), plus failure of Dupixent or Rinvoq for > consecutive 4 months unless contraindicated (Illinois HIM exempt). Dosing by weight/indication: for PN, <90 kg: 60 mg once then 30 mg every 4 weeks; ≥90 kg: 60 mg once then 60 mg every 4 weeks. For AD: loading dose 60 mg once, maintenance 30 mg every 4 weeks (with option after 16 weeks to extend to 30 mg every 8 weeks for responders). Approval durations: HIM 12 months / Commercial 6 months (or to renewal date). scope_summary: defines medical necessity criteria, prior authorization and step therapy requirements (with Illinois HIM exceptions), dosing limits, continued therapy response documentation, exclusions for non‑FDA uses, and administrative guidance for Nemluvio coverage.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Requests for Nemluvio require prior authorization. Requests must document failure of the required topical and/or systemic therapies per the criteria and confirm Nemluvio is not being used concurrently with another biologic immunomodulator or a JAK inhibitor. Note that topical calcineurin inhibitors may also require prior authorization. Relevant billing codes: J3590, C9399.

Must demonstrate failure of required topical/systemic therapies per the policy
Nemluvio must not be prescribed concurrently with another biologic immunomodulator or a JAK inhibitor
Topical calcineurin inhibitors may require prior authorization
Affected codes: J3590, C9399

Documentation Required

Submit supporting documentation

Submit supporting documentation with the prior authorization request. Required documentation includes office chart notes or other clinical information, laboratory results where applicable, the patient's itch NRS score and lesion count (for PN), documentation of prior therapy trials, and the prescriber's specialty to demonstrate criteria are met.

Office chart notes or other clinical information
Lab results (if applicable)
Numeric Rating Scale (PP‑NRS / WI‑NRS) score
Nodular lesion count (for prurigo nodularis)
Documentation of prior therapy trials
Prescriber specialty (e.g., dermatologist, allergist as required)

Step Therapy

Step therapy requirement (where applicable)

Step therapy applies where specified in the initial approval criteria. For prurigo nodularis, failure of ≥3 consecutive months of Dupixent (dupilumab) is required prior to Nemluvio (Illinois HIM requests are exempt per IL HB 5395 effective 2026-01-01). For atopic dermatitis, failure of Dupixent or Rinvoq used for > consecutive 4 months is required prior to Nemluvio (Illinois HIM requests are exempt per IL HB 5395 effective 2026-01-01).

PN: Failure of ≥3 months of Dupixent required (IL HIM exempt per IL HB 5395 effective 2026-01-01)
AD: Failure of Dupixent or Rinvoq for > consecutive 4 months required (IL HIM exempt per IL HB 5395 effective 2026-01-01)

Billing Rule

Dose limits enforced

Dose limits are enforced. Dosing must not exceed the specified loading and maintenance regimens by weight and indication; approvals may be denied for requests exceeding the listed maximums.

PN weight < 90 kg: 60 mg once, then 30 mg every 4 weeks (maintenance maximum)
PN weight ≥ 90 kg: 60 mg once, then 60 mg every 4 weeks (maintenance maximum)
AD: Loading dose 60 mg once; maintenance 30 mg every 4 weeks (maximum)

Documentation Required

Continued therapy - response documentation

For continued therapy/renewal, submit documentation showing the member is responding to therapy and that initial criteria were previously met or the member is enrolled in continuity-of-care as applicable. Clinical response examples include improvement in itching or skin pain, reduction in nodules, or reduction in scratching for atopic dermatitis.

Evidence of positive clinical response (e.g., improvement in itch or skin pain, fewer nodules, reduced scratching)
Documentation that initial approval criteria were previously met or that the member qualifies under continuity-of-care provisions

Clinical Evidence & References

Primary evidence source: Nemluvio Prescribing Information, Galderma, June 2025 (product label/PI). Key trials and evidence cited in the policy: Phase 3 trials including ARCADIA 1 and ARCADIA 2 for atopic dermatitis (Lancet 2024), OLYMPIA 2 (NEJM Phase 3 trial of nemolizumab in prurigo nodularis, NEJM 2023), and supporting clinical studies and validation research (clinicaltrials.gov NCT04501666; validation of PP‑NRS and WI‑NRS and related analyses). Note: metric_cards / numeric trial metrics are not included because the brief provides evidence labels and citations but does not include additional quantitative trial metrics beyond those references.

Background

Nemluvio (nemolizumab‑ilto) is an interleukin‑31 receptor antagonist with FDA approvals for: (1) treatment of adults with prurigo nodularis and (2) treatment of adults and pediatric patients ≥12 years with moderate‑to‑severe atopic dermatitis when used in combination with topical corticosteroids and/or topical calcineurin inhibitors. The policy summarizes required prior topical and systemic therapy failures (topical corticosteroids, topical calcineurin inhibitors, and biologic/JAK step therapy such as Dupixent or Rinvoq where applicable, with Illinois HIM exceptions) and specifies dosing regimens by weight and indication (PN and AD loading/maintenance schedules), as detailed in the prescribing information.

PP‑NRS / WI‑NRS: single‑item patient‑reported measures assessing worst itch in the prior 24 hours on a 0–10 scale (0 = no itch, 10 = worst imaginable itch) (Peak Pruritus NRS / Worst Itch‑NRS).

JAK: Janus kinase.

PN: Prurigo nodularis.

Revision History

08.20.25creation

Policy created per August SDC; adapted from CP.PHAR.703 with revisions adding redirection to preferred agents Dupixent or Rinvoq for atopic dermatitis initial approval criteria.

11.25P&T approvalLatest

P&T Approval Date 11.25; Policy created per August SDC Date 08.20.25.

11.25material_changeLatest

Material change: policy adapted from CP.PHAR.703 with added redirection to preferred agents Dupixent or Rinvoq for atopic dermatitis initial approval criteria (see creation entry).

2026-01-01clarificationLatest

Clarification: Illinois HIM requests are exempt from the Dupixent/Rinvoq step therapy requirements per IL HB 5395 effective 2026-01-01.

2025-12-01effective_date

Policy effective date 2025-12-01; includes dosing and approval duration specifications for prurigo nodularis and atopic dermatitis.

Policy Summary

Payermhn

PolicyClinical Policy: Nemolizumab-ilto (Nemluvio)

Policy CodePolicy CP.PCH.59

Change TypeRevised / Clarified

Effective DateDec 1, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Clinical Policy: Nemolizumab-ilto (Nemluvio)

Coverage Summary

Initial Therapy Criteria — Prurigo Nodularis

Initial Therapy Criteria — Atopic Dermatitis

Initial Therapy — Other Indications

Continuation Therapy Criteria — Prurigo Nodularis

Continuation Therapy Criteria — Atopic Dermatitis

Unapproved / Not Authorized Indications

Provider Actions & Authorization Requirements

Applicable Codes

Clinical Evidence & References

Background

Revision History

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals