CurrentColorado Rocky Mountain Health PlansPolicy N/A

Nemluvio (nemolizumab-ilto) prior authorization

This policy governs prior authorization and reauthorization requirements for Nemluvio (nemolizumab-ilto) for Colorado Rocky Mountain Health Plans members, covering indications, combination therapy exclusions, and authorization durations.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyNemluvio (nemolizumab-ilto) prior authorization

Policy CodePolicy N/A

Change TypeNew prior authorization program

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation of diagnosis and, for reauthorization, evidence of positive clinical response.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program for Nemluvio (nemolizumab-ilto) established.

12 monthsauthorization duration

2covered indications

listedcombination exclusions

Coverage Criteria for Nemluvio (nemolizumab-ilto)

Initial Therapy — Atopic Dermatitis

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Atopic dermatitis initial: Diagnosis of moderate to severe atopic dermatitis.

Chunk 2

Atopic dermatitis initial: Will be used in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.

Chunk 3

Atopic dermatitis initial: Patient is not receiving Nemluvio in combination with a biologic immunomodulator (e.g., tralokinumab, dupilumab, lebrikizumab) or a Janus kinase inhibitor (e.g., upadacitinib, tofacitinib, topical ruxolitinib, abrocitinib) for treatment of the same indication.

Chunk 3

Reauthorization — Atopic Dermatitis

Covered when BOTH of the following are met for reauthorization of atopic dermatitis:

Atopic dermatitis reauthorization: Documentation of positive clinical response to Nemluvio therapy.

Chunk 4

Atopic dermatitis reauthorization: Patient is not receiving Nemluvio in combination with a biologic immunomodulator or a Janus kinase inhibitor for the same indication.

Chunk 3

Initial Therapy — Prurigo Nodularis

Covered when BOTH of the following are met for prurigo nodularis:

Prurigo nodularis initial: Diagnosis of prurigo nodularis.

Chunk 6

Prurigo nodularis initial: Patient is not receiving Nemluvio in combination with Dupixent (dupilumab) for treatment of the same indication.

Chunk 7

Reauthorization — Prurigo Nodularis

Covered when BOTH of the following are met for reauthorization of prurigo nodularis:

Prurigo nodularis reauthorization: Documentation of positive clinical response to Nemluvio therapy.

Chunk 8

Prurigo nodularis reauthorization: Patient is not receiving Nemluvio in combination with Dupixent (dupilumab) for treatment of the same indication.

Chunk 7

Nemluvio must not be used in combination with certain other systemic or biologic therapies for the same indication. For atopic dermatitis, coverage excludes concomitant use with specified biologic immunomodulators (for example, tralokinumab, dupilumab, lebrikizumab) and with Janus kinase (JAK) inhibitors (for example, upadacitinib, tofacitinib, topical ruxolitinib, abrocitinib) when treating the same condition. For prurigo nodularis, coverage excludes concomitant use of Nemluvio with Dupixent (dupilumab) for the same indication. Requests for therapy may be denied if documentation shows Nemluvio is being administered together with these excluded agents for the same treatment purpose.

Initial Authorization Requirements

Initial Therapy Requirements

Initial authorization requirements by indication

Atopic dermatitis initial: Diagnosis of moderate to severe atopic dermatitis; will be used in combination with topical corticosteroids and/or calcineurin inhibitors when disease is not adequately controlled with topical prescription therapies; patient must not be receiving Nemluvio concomitantly with specified biologic immunomodulators or Janus kinase inhibitors for the same indication.

Chunks 2-3

Prurigo nodularis initial: Diagnosis of prurigo nodularis; patient must not be receiving Nemluvio concomitantly with Dupixent (dupilumab) for the same indication.

Chunks 6-7

Reauthorization / Continuation Requirements

Reauthorization / Continuation

Reauthorization/continuation requirements

Continuation: Documentation of positive clinical response to Nemluvio therapy is required for reauthorization.

Chunks 4 and 8

Continuation: Patient must not be receiving Nemluvio in combination with excluded agents (for atopic dermatitis: specified biologic immunomodulators or Janus kinase inhibitors; for prurigo nodularis: Dupixent) for the same indication.

Chunks 3 and 7

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required for Nemluvio. Approval is contingent on meeting the diagnosis- and criteria-based requirements in the policy.

Prior authorization required for Nemluvio (nemolizumab-ilto).

Step Therapy

Step Therapy Requirement — Topicals

Nemluvio for atopic dermatitis must be used in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with prescription topical therapies.

Required combination with topical corticosteroids and/or calcineurin inhibitors for AD when prescription topicals are inadequate.

Documentation Required

Reauthorization Documentation

For reauthorization, documentation must show a positive clinical response to Nemluvio therapy. Provide clinical notes detailing improvement in signs and/or symptoms since initiation of therapy.

Documentation of positive clinical response required at each reauthorization review.

Denial Risk

Combination Therapy Exclusion

Requests may be denied if the patient is receiving Nemluvio in combination with specified biologic immunomodulators or JAK inhibitors for the same indication. Examples include biologics (e.g., tralokinumab, dupilumab, lebrikizumab) and JAK inhibitors (e.g., upadacitinib, tofacitinib, abrocitinib, topical ruxolitinib).

Do not combine Nemluvio with biologic immunomodulators or JAK inhibitors for the same indication; list not exhaustive.

Step	Requirement
1
Use in combination with topical corticosteroids and/or calcineurin inhibitors when topical prescription therapies are inadequate

Background and Indications

Nemluvio (nemolizumab-ilto) is an interleukin‑31 receptor antagonist indicated per the product labeling for adults with prurigo nodularis and for adults and patients aged ≥12 years with moderate to severe atopic dermatitis. In atopic dermatitis the product is intended for use in combination with topical corticosteroids and/or calcineurin inhibitors when disease is not adequately controlled with prescription topical therapies. The policy reflects these approved indications and the requirement that Nemluvio not be used concomitantly with specified biologic immunomodulators or JAK inhibitors (for atopic dermatitis) or with dupilumab (for prurigo nodularis) when treating the same indication.

Key Definitions

Nemluvio (nemolizumab-ilto) — key facts

Drug classInterleukin-31 receptor antagonist

Generic namenemolizumab-ilto

Brand nameNemluvio

Indications coveredPrurigo nodularis (adults); moderate to severe atopic dermatitis in adults and patients ≥12 years (used with topical corticosteroids and/or calcineurin inhibitors when topical prescription therapies are inadequate)

Age rangeAdults for prurigo nodularis; adults and pediatric patients ≥12 years for atopic dermatitis

Quantity / Supply Limits

Nemluvio (nemolizumab-ilto) — quantity and program limits

Supply limitationsSupply limitations may be in place.

Potential program exceptionsUnitedHealthcare may approve initial and reauthorization based solely on prior claim/medication history, diagnosis codes, and/or claim logic despite coverage criteria.

Other utilization controlsMedical necessity requirements may be applied.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyNemluvio (nemolizumab-ilto) prior authorization

Policy CodePolicy N/A

Change TypeNew prior authorization program

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation of diagnosis and, for reauthorization, evidence of positive clinical response.

SourceLink

On This Page

OpenPayer

Nemluvio (nemolizumab-ilto) prior authorization

Coverage Criteria for Nemluvio (nemolizumab-ilto)

Initial Authorization Requirements

Reauthorization / Continuation Requirements

Provider Actions and Documentation

Step Therapy / Concomitant Topical Requirements

Background and Indications

Key Definitions

Quantity / Supply Limits

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