CurrentUnitedHealthcarePolicy N/A

Nemluvio (nemolizumab-ilto) prior authorization and medical necessity criteria

Defines UnitedHealthcare pharmacy prior authorization and medical necessity requirements for Nemluvio (nemolizumab-ilto) for atopic dermatitis and prurigo nodularis, including initial and reauthorization criteria and prescriber requirements affecting beneficiaries covered under UnitedHealthcare plans.

Policy Summary

PayerUnitedHealthcare

PolicyNemluvio (nemolizumab-ilto) prior authorization and medical necessity criteria

Policy CodePolicy N/A

Change TypeNew policy (program created)

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document trials of required topical therapies or reasons for contraindication/intolerance.

SourceLink

POLICY UPDATE CHANGES

New UnitedHealthcare Pharmacy Clinical Pharmacy Program for Nemluvio (nemolizumab-ilto) with prior authorization criteria.

2indications covered

12 monthsauthorization duration (common)

30 mg q8wmaintenance dosing (if clear/almost clear)

≥12 yrsage (AD)

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Coverage and Medical Necessity Criteria

Initial authorization — Atopic dermatitis

Approved when ALL of the following are met

Atopic dermatitis initial criteria: (1) Diagnosis of moderate to severe atopic dermatitis; AND (2) History of failure, contraindication, or intolerance to two of the following topical therapy classes (document dates of trials and/or contraindications): topical corticosteroids, topical calcineurin inhibitors, Eucrisa (crisaborole); AND (3) Patient is not receiving Nemluvio in combination with the following for treatment of the same indication: a) a biologic immunomodulator (e.g., Adbry/tralokinumab, Dupixent/dupilumab, Ebglyss/lebrikizumab) OR b) a Janus kinase inhibitor (e.g., Rinvoq/upadacitinib, Xeljanz/tofacitinib) ; AND (4) Prescribed by one of the following: dermatologist, allergist, or immunologist.

Authorization details: see reauthorization for maintenance dosing rules.

Initial authorization — Prurigo nodularis

Approved when ALL of the following are met

Prurigo nodularis initial criteria: (1) Diagnosis of prurigo nodularis; AND (2) Patient has greater than or equal to 20 nodular lesions; AND (3) History of failure, contraindication, or intolerance to previous prurigo nodularis treatments (e.g., topical corticosteroids, topical calcineurin inhibitors, topical capsaicin); AND (4) Patient is not receiving Nemluvio in combination with Dupixent (dupilumab) for treatment of the same indication; AND (5) Prescribed by one of the following: dermatologist, allergist, or immunologist.nodules >=20

Authorization duration: 12 months.

Reauthorization — Atopic dermatitis and Prurigo nodularis

Approved when ALL of the following are met

Reauthorization criteria: (1) Documentation of positive clinical response to Nemluvio therapy; AND (2) Patient is not receiving Nemluvio in combination with the following for treatment of the same indication: a) a biologic immunomodulator (e.g., Adbry/tralokinumab, Dupixent/dupilumab, Ebglyss/lebrikizumab) OR b) a Janus kinase inhibitor (e.g., Rinvoq/upadacitinib, Xeljanz/tofacitinib, Opzelura/topical ruxolitinib, Cibinqo/abrocitinib); AND (3) Prescribed by one of the following: dermatologist, allergist, or immunologist; AND (4) Maintenance dosing: If patient has achieved clear or almost clear skin, authorize Nemluvio 30 mg every 8 weeks for 12 months; if patient has not achieved clear or almost clear skin, authorize Nemluvio 30 mg every 4 weeks for 6 months.

Authorization generally issued for 12 months; reauthorization contingent on clinical response.

Concurrent administration of Nemluvio with certain other systemic immunomodulators for the same indication is prohibited. Specifically, Nemluvio must not be used in combination with listed biologic immunomodulators (for example, tralokinumab, dupilumab, lebrikizumab) or with selected Janus kinase (JAK) inhibitors (for example, upadacitinib, tofacitinib) when treating the same condition. For prurigo nodularis the policy explicitly disallows concurrent use with Dupixent (dupilumab). Requests that propose combination therapy with these agents for the same indication do not meet the policy's coverage criteria and may be denied.

For atopic dermatitis, initial approval requires documentation of moderate to severe disease and a history of failure, contraindication, or intolerance to two topical therapy classes (examples include topical corticosteroids, topical calcineurin inhibitors, and/or Eucrisa/crisaborole). Providers must document dates of trials and/or reasons for intolerance or contraindication. For prurigo nodularis, initial approval requires a diagnosis with documentation of ≥ 20 nodular lesions and history of failure, contraindication, or intolerance to prior prurigo nodularis treatments (for example topical corticosteroids, topical calcineurin inhibitors, topical capsaicin); the record must include lesion counts and prior treatment details. All requests must be for therapy prescribed by a dermatologist, allergist, or immunologist. Use of Nemluvio without the required documentation of topical therapy trials or without the required lesion count (for prurigo nodularis) does not meet medical necessity criteria and may result in denial.

Initial Therapy Requirements by Indication

Initial therapy criteria

Initial authorization requirements by indication

Atopic dermatitis initial: Diagnosis of moderate to severe atopic dermatitis; failure, contraindication, or intolerance to two topical therapy classes (document dates of trials and/or contraindications): topical corticosteroids, topical calcineurin inhibitors, Eucrisa (crisaborole); patient is not receiving Nemluvio in combination with specified biologic immunomodulators or Janus kinase inhibitors for the same indication; prescribed by a dermatologist, allergist, or immunologist.

See topical therapy classes for examples of agents.

Prurigo nodularis initial: Diagnosis of prurigo nodularis; >= 20 nodular lesions; failure, contraindication, or intolerance to prior prurigo nodularis treatments (e.g., topical corticosteroids, topical calcineurin inhibitors, topical capsaicin); patient is not receiving Nemluvio in combination with Dupixent for the same indication; prescribed by a dermatologist, allergist, or immunologist.nodules >=20

Authorization duration: 12 months.

Reauthorization and Maintenance Dosing

Maintenance dosing

Reauthorization/maintenance dosing rules

Maintenance dosing based on response: If patient has achieved clear or almost clear skin: authorize Nemluvio 30 mg every 8 weeks for 12 months; If patient has not yet achieved clear or almost clear skin: authorize Nemluvio 30 mg every 4 weeks for 6 months.

Documentation of positive clinical response required for reauthorization; patient must meet concurrent therapy restrictions and prescriber requirements.

Coding and Clinical Thresholds

Nodular lesion count for prurigo nodularis

Nodular lesion countGreater than or equal to 20 nodular lesions

PurposeThreshold used to confirm diagnosis/severity for prurigo nodularis initial authorization

Documentation requirementProvider must document nodular lesion count in the medical record for prior authorization

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Nemluvio. Approval is contingent on meeting the indication‑specific clinical criteria described in the policy.

Prior authorization required for Nemluvio
Authorization will be issued for up to 12 months (state mandates and member benefit plan may affect coverage)

Documentation Required

Atopic Dermatitis — Provider Action

For atopic dermatitis requests, document a history of failure, contraindication, or intolerance to TWO different topical therapeutic classes. Include the dates of each trial and, if applicable, the reason for discontinuation (e.g., adverse event or documented contraindication).

Required: failure/contraindication/intolerance to two topical classes (examples below)
Topical corticosteroids (document specific agent and trial dates)
Topical calcineurin inhibitors (e.g., Elidel, Protopic)
Phosphodiesterase‑4 inhibitor (e.g., Eucrisa)

Documentation Required

Prurigo Nodularis — Documentation Guidance

For prurigo nodularis, document the diagnosis and clinical burden (number of nodules). The policy requires ≥20 nodular lesions. Also document prior treatments tried, dates of trials, and the reason they failed or were not tolerated (e.g., topical corticosteroids, topical calcineurin inhibitors, topical capsaicin).

Documented diagnosis of prurigo nodularis
Documented count: ≥20 nodular lesions
Documentation of prior prurigo nodularis treatments with trial dates and reasons for failure/intolerance

Denial Risk

Denial Conditions / Risk

Requests may be denied if required documentation or a covered diagnosis is missing, or if the member is receiving Nemluvio in combination with disallowed therapies for the same indication. Ensure all required trial dates, diagnoses, and prescriber specialty are included to avoid denial.

Missing documentation of prior trials or dates may result in denial
Denial risk if required diagnosis criterion (e.g., ≥20 nodules for prurigo nodularis; moderate to severe atopic dermatitis) is not met
Denial if Nemluvio is used concurrently with disallowed agents for the same indication (e.g., Dupixent or specified biologic immunomodulators or JAK inhibitors)
Prescriber must be a dermatologist, allergist, or immunologist

Step Therapy and Trial Requirements

Required Trial / Treatment	Documentation Required
Topical corticosteroids (e.g., mometasone furoate, fluocinolone acetonide, fluocinonide)	Documented trial with dates and/or documented contraindication or intolerance
Topical calcineurin inhibitors (e.g., pimecrolimus, tacrolimus)	Documented trial with dates and/or documented contraindication or intolerance
Crisaborole (Eucrisa)	Documented trial with dates and/or documented contraindication or intolerance
Prior prurigo nodularis treatments (e.g., topical corticosteroids, topical calcineurin inhibitors, topical capsaicin)	Documented trial with dates and/or documented contraindication or intolerance; for prurigo nodularis also document nodular lesion count (≥20)

Drug Definition and Key Terms

Nemluvio (nemolizumab-ilto) — drug definition and authorized ages

Drug classInterleukin-31 receptor antagonist

Indications (per label)Prurigo nodularis (adults); moderate to severe atopic dermatitis in adults and pediatric patients ≥12 years, in combination with topical corticosteroids and/or calcineurin inhibitors when not adequately controlled with topical prescription therapies

Age authorizationAdults for prurigo nodularis; adults and pediatric patients 12 years and older for atopic dermatitis

Typical combination therapyFor atopic dermatitis: used in combination with topical corticosteroids and/or topical calcineurin inhibitors per label

Background and Drug Information

Nemluvio (nemolizumab-ilto) is an interleukin-31 receptor antagonist indicated for the treatment of adults with prurigo nodularis and for adults and pediatric patients ≥ 12 years with moderate to severe atopic dermatitis in combination with topical therapies when disease is not adequately controlled with prescription topical therapies.

Site of Care and Program Notes

Note

Site-of-care: program-specific supply limits and approval methods

Supply limitations and utilization management processes may vary by program; UnitedHealthcare may approve based on prior claim/medication history, diagnosis codes, and claim logic, so approvals can be influenced by site-of-care program rules.

Approvals may be granted based on claim/medication history and diagnosis codes alone under some programs
Supply limitations may apply at infusion centers or other sites of care

Policy Summary

PayerUnitedHealthcare

PolicyNemluvio (nemolizumab-ilto) prior authorization and medical necessity criteria

Policy CodePolicy N/A

Change TypeNew policy (program created)

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document trials of required topical therapies or reasons for contraindication/intolerance.

SourceLink

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