CurrentCignaPolicy IP0714

Nemluvio (nemolizumab) — Coverage Criteria

Cigna coverage policy for Nemluvio (nemolizumab) subcutaneous injection for treatment of moderate-to-severe atopic dermatitis in patients ≥12 years and prurigo nodularis in adults, describing medical necessity criteria and coverage conditions for insured members under Cigna-administered plans.

Policy Summary

PayerCigna

PolicyNemluvio (nemolizumab) — Coverage Criteria

Policy CodePolicy IP0714

Change TypeNew policy

Effective Date

Next Review Date

Key ActionSubmit prior authorization showing the patient meets medical necessity criteria including age, prior topical therapy trials/response, and specialty prescriber requirement.

SourceLink

POLICY UPDATE CHANGES

New policy established for Nemluvio (nemolizumab) with indications, medical necessity criteria, and exclusions.

2FDA-approved indications listed

4 monthsInitial approval duration

1 yearRenewal approval duration

≥12; ≥18Minimum ages (AD; PN)

≥20PN nodular lesion requirement

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Medical Necessity and Coverage Criteria

inv-01: Atopic Dermatitis - FDA-Approved Indication

Nemluvio is covered when ONE of the following is met:

Atopic Dermatitis (overall): Patient meets either Initial Therapy (A) or Currently Receiving (B) criteria

Initial Therapy (A)

Age: Patient is >= 12 years of age>=12 years
Body surface area: Atopic dermatitis involvement estimated to be >= 10% of the body surface area per prescriber>=10% BSA
Topical corticosteroid trial: Patient has tried at least one medium-, medium-high, high-, or super-high-potency prescription topical corticosteroid applied daily for >= 28 consecutive days with inadequate efficacy as determined by the prescriber>=28 days
Prescriber must attest inadequate efficacy
Topical therapy concurrent or discontinued: Either Nemluvio will be used in combination with a topical corticosteroid and/or a topical calcineurin inhibitor OR the patient’s topical therapy has been discontinued because atopic dermatitis has sufficiently improved with Nemluvio
Prescriber specialty: Medication prescribed by or in consultation with an allergist, immunologist, or dermatologist
Preferred product criteria met for the product(s) as listed in the applicable Individual and Family Plans table
See product table

Currently Receiving (B)

Prior treatment duration: Patient has already received at least 4 months of therapy with Nemluvio>=4 months
A patient with <4 months or restarting should be considered under Initial Therapy criteria
Clinical response: Patient has experienced a beneficial clinical response as determined by the prescriber (examples include improvements in erythema, lesions, pruritus, decreased BSA, or reduced need for other therapies)
Examples provided in policy

inv-02: Prurigo Nodularis - FDA-Approved Indication

Nemluvio is covered when ONE of the following is met:

Prurigo Nodularis (overall): Patient meets either Initial Therapy (A) or Currently Receiving (B) criteria

Initial Therapy (A)

Age: Patient is >= 18 years of age>=18 years
Nodular lesions: Patient has >= 20 identifiable nodular lesions total on both arms and/or both legs and/or trunk>=20 nodular lesions
Consistent with trial enrollment criteria

Concurrent use of Nemluvio with certain other systemic therapies is expressly excluded. Specifically, Nemluvio used concurrently with another monoclonal antibody therapy is considered not covered because the efficacy and safety of such combinations have not been established. The policy lists examples of monoclonal antibodies (e.g., Adbry, Cinqair, Dupixent, Ebglyss, Fasenra, Nucala, Teszpire, and Xolair) to clarify this exclusion. Additionally, concurrent use with Janus kinase (JAK) inhibitors, oral or topical, is not recommended and is included among conditions not covered. Providers should therefore not request combination therapy authorizations for Nemluvio with these agents unless subsequent evidence or policy updates indicate otherwise.

Any use of Nemluvio outside the FDA‑approved indications and the specific medical necessity criteria outlined in this policy is considered experimental, investigational, or unproven and is therefore not covered. This includes, but is not limited to, combinations and indications not evaluated in the pivotal trials or not described in the criteria sets. Requests for off‑label uses should include supporting peer‑reviewed evidence; absent such evidence, coverage will be denied as not medically necessary.

Age Thresholds, Trial Durations, and Approval Durations

Named biologics referenced (context: concurrent use/exclusions, step therapy)mixed

Dupixent	dupilumab (listed as comparator/step therapy)
Adbry	tralokinumab (listed among monoclonal antibody therapies)
Cinqair	reslizumab (listed among monoclonal antibody therapies)
Ebglyss	lebrikizumab (listed among monoclonal antibody therapies)
Fasenra	benralizumab (listed among monoclonal antibody therapies)
Nucala	mepolizumab (listed among monoclonal antibody therapies)
Teszpire	tezepelumab (listed among monoclonal antibody therapies)
Xolair	omalizumab (listed among monoclonal antibody therapies)

inv-06: Initial approval durations

Initial approval (new patients)Approve for 4 months for initial therapy when all initial-therapy criteria are met.

Continuation approval (patients currently receiving)Approve for 1 year when patient has already received at least 4 months of Nemluvio and meets the continuing-therapy response criteria.

Restarting therapyPatients who have received < 4 months of therapy or who are restarting should be evaluated under initial therapy criteria (4-month approval).

inv-07: Atopic dermatitis age threshold

Minimum age>= 12 years of age

Indication contextApplies to atopic dermatitis indication for moderate-to-severe disease in combination with topical therapies when not adequately controlled with topical prescription therapies.

Prior Authorization, Documentation, and Exclusions — Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for both initiation and continuation of Nemluvio therapy. Prescribers must obtain PA before starting treatment and for renewals when applicable.

Affects Nemluvio (subcutaneous injection)
PA required for initial approval (see Initial Therapy criteria) and for continuation/renewal (see Currently Receiving criteria)

Step Therapy

Dupixent Step Requirement for Some Plans

For members on Individual and Family Plans, a step-therapy requirement applies: the patient must have tried Dupixent (dupilumab) and according to the prescriber experienced inadequate efficacy or significant intolerance prior to approval of Nemluvio, unless the patient has already been started on Nemluvio.

Step requirement applies only to Individual and Family Plans
Exception: prior authorization may be approved if patient is already receiving Nemluvio

Drug Definition and Trial Enrollment Criteria

inv-15: Nemluvio (nemolizumab)

Drug class and mechanismNemluvio (nemolizumab) — a subcutaneous interleukin-31 (IL-31) receptor antagonist.

FDA-approved indications (summary)Indicated for moderate-to-severe atopic dermatitis in patients >= 12 years (in combination with topical corticosteroids and/or calcineurin inhibitors when not adequately controlled with topical prescription therapies) and for prurigo nodularis in adults.

Key clinical trial contextEfficacy demonstrated in ARCADIA (atopic dermatitis, patients >=12 years) and OLYMPIA (prurigo nodularis, patients >=18 years) trials with primary endpoints at 16 weeks.

inv-16: Prurigo nodularis enrollment criteria (trials)

Trial lesion-count enrollmentTrials required >= 20 nodular lesions distributed bilaterally on the legs and/or both arms and/or trunk (OLYMPIA studies).

Policy Summary

PayerCigna

PolicyNemluvio (nemolizumab) — Coverage Criteria

Policy CodePolicy IP0714

Change TypeNew policy

Effective Date

Next Review Date

Key ActionSubmit prior authorization showing the patient meets medical necessity criteria including age, prior topical therapy trials/response, and specialty prescriber requirement.

SourceLink

On This Page

Pruritus duration: Patient has experienced pruritus for >= 6 weeks>=6 weeks

Cause of PN: Either prurigo nodularis is not medication-induced or secondary to a nondermatologic condition OR a secondary cause has been identified and adequately managed per prescriber

Patients with pruritus from other active conditions were excluded from pivotal trials

Topical corticosteroid trial: Patient has tried at least one high- or super-high-potency prescription topical corticosteroid applied daily for >= 14 consecutive days with inadequate efficacy as determined by the prescriber>=14 days

Prescriber must attest inadequate efficacy

Prescriber specialty: Medication prescribed by or in consultation with an allergist, immunologist, or dermatologist

Preferred product criteria met for the product(s) as listed in the applicable Individual and Family Plans table

See product table

Currently Receiving (B)

Prior treatment duration: Patient has already received at least 4 months of therapy with Nemluvio>=4 months
Clinical benefit: Beneficial response defined by reduced nodular lesion count OR decreased pruritus OR reduced nodular lesion size

Evidence sourcePivotal ARCADIA studies evaluated patients >= 12 years of age with endpoints at 16 weeks.

inv-08: Prurigo nodularis thresholds

Minimum age>= 18 years of age

Nodular lesion requirement>= 20 identifiable nodular lesions total on both arms and/or both legs and/or trunk (trial enrollment criterion).

Pruritus duration>= 6 weeks of pruritus

inv-09: Topical corticosteroid trial durations

Atopic dermatitis topical corticosteroid trial>= 28 consecutive days of daily use of at least one medium- to super-high–potency prescription topical corticosteroid with inadequate efficacy per prescriber.

Prurigo nodularis topical corticosteroid trial>= 14 consecutive days of daily use of at least one high- or super-high–potency prescription topical corticosteroid with inadequate efficacy per prescriber.

Prescriber attestationPrescriber must state that inadequate efficacy was demonstrated with the topical corticosteroid therapy.

Documentation Required

Required Clinical Documentation

Clinical documentation must include prescriber attestation of prior topical therapy trials and response, lesion counts or extent of body surface area involved, duration and severity of pruritus when applicable, and specialty of prescriber or documentation of consultation with an allergist, immunologist, or dermatologist.

Attest that patient tried ≥1 medium/medium‑high/high/super‑high potency topical corticosteroid applied daily ≥28 consecutive days with inadequate efficacy
Record BSA involvement (≥10% for atopic dermatitis) or nodular lesion counts/size for prurigo nodularis
For continuation: document ≥4 months prior Nemluvio therapy and beneficial clinical response (reduced lesion count, decreased pruritus, or reduced lesion size)

Denial Risk

Concurrent Therapy Exclusions

Concurrent use of Nemluvio with other monoclonal antibodies or with Janus kinase (JAK) inhibitors (oral or topical) is not recommended and is considered unproven/uncovered.

Concurrent monoclonal antibody therapies (examples: Adbry, Cinqair, Dupixent, Ebglyss, Fasenra, Nucala, Teszpire, Xolair)
Concurrent use with JAK inhibitors (examples: Cibinqo, Leqselvi, Rinvoq, Opzelura)

Excluded causes of pruritus

Patients with chronic pruritus caused by an active condition other than prurigo nodularis, neuropathic or psychogenic pruritus were excluded from trials.

Topical corticosteroid exposure in trialsAcross studies, 78.5% of patients had tried topical corticosteroid therapy prior to enrollment.

Study duration and endpointsOLYMPIA 1 included 24 weeks of randomized therapy and OLYMPIA 2 included 16 weeks; primary endpoints were evaluated at 16 weeks.

Nemluvio (nemolizumab) is a subcutaneous monoclonal antibody that acts as an interleukin‑31 (IL‑31) receptor antagonist. It is indicated for moderate‑to‑severe atopic dermatitis in patients aged ≥ 12 years (in combination with topical therapies) and for prurigo nodularis in adults. Clinical efficacy was demonstrated in the phase 3 ARCADIA trials for atopic dermatitis and the OLYMPIA trials for prurigo nodularis, with primary endpoints assessed at 16 weeks. Labeling and clinical trial designs support use of Nemluvio with topical corticosteroids and/or topical calcineurin inhibitors, with the option to taper topical therapy based on clinical response.