CurrentHawaii Medical Service Association (HMSA)Policy N/A

Nemluvio (nemolizumab-ilto) Coverage Criteria

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This policy governs prior authorization and reauthorization for Nemluvio for adult prurigo nodularis and moderate-to-severe atopic dermatitis in members aged 12 years and older. It applies to HMSA QUEST members and requires clinical documentation, specialty prescribing or consultation, and satisfaction of indication-specific criteria.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyNemluvio (nemolizumab-ilto) Coverage Criteria

Policy CodePolicy N/A

Change TypeOriginal policy

Effective DateJuly 1, 2026

Next Review DateNot specified

Key ActionPrior authorization is required for Nemluvio; providers should use the fax form available on the HMSA medical policy website.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 monthsInitial atopic dermatitis authorization

6 monthsInitial prurigo nodularis authorization

12 monthsReauthorization period

10% BSA

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CurrentHawaii Medical Service Association (HMSA)Policy N/A

Nemluvio (nemolizumab-ilto) Coverage Criteria

Customize your policy alerts

Sign up for all Hawaii Medical Service Association (HMSA) policy alerts

Know when Hawaii Medical Service Association (HMSA) releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyNemluvio (nemolizumab-ilto) Coverage Criteria

Policy CodePolicy N/A

Change TypeOriginal policy

Effective DateJuly 1, 2026

Next Review DateNot specified

Key ActionPrior authorization is required for Nemluvio; providers should use the fax form available on the HMSA medical policy website.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 monthsInitial atopic dermatitis authorization

6 monthsInitial prurigo nodularis authorization

12 monthsReauthorization period

10% BSA

Atopic dermatitis disease extent threshold

20 lesionsMinimum prurigo nodularis lesion count

General Coverage Requirements

Initial Therapy — Atopic Dermatitis

Authorization of 4 months may be granted when <strong>one</strong> of the following pathways is met:

ONE of the following pathways

Previously treated with biologic or systemic targeted synthetic drug
- Member is 12 years of age or older.
- Member has previously received a biologic (e.g., Dupixent, Ebglyss) or systemic targeted synthetic drug (e.g., Rinvoq) indicated for moderate-to-severe atopic dermatitis in the past 180 days.
- The requested medication is prescribed in combination with a topical corticosteroid or topical calcineurin inhibitor, unless use of a topical corticosteroid and topical calcineurin inhibitor is not advisable for the member (e.g., due to contraindications or prior intolerances).
Treatment of moderate-to-severe atopic dermatitis
- Member is 12 years of age or older.
- Affected area
  - Affected body surface is greater than or equal to 10% body surface area.>= 10% body surface area
  - Crucial body areas are affected, including the hands, feet, face, neck, scalp, genitals/groin, or intertriginous areas.
- ONE of the following within the past 365 days
  - Inadequate treatment response to all of the following
    High-potency or super-high-potency topical corticosteroid used for 2 consecutive weeks (see Appendix).

Initial Therapy — Prurigo Nodularis

Authorization of 6 months may be granted when <strong>one</strong> of the following pathways is met:

ONE of the following pathways

Previously treated with biologic drug
- Member is 18 years of age or older.
- Member has previously received a biologic drug (e.g., Dupixent) indicated for prurigo nodularis in the past year.
Treatment of prurigo nodularis
- Member is 18 years of age or older.
- Member has pruritus lasting at least 6 weeks.>= 6 weeks

The member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

Clinical Thresholds and Treatment Durations

Atopic dermatitis disease extent

Required affected areaAt least 10% of body surface area

Alternative qualificationCrucial body areas may qualify even when affected body surface area is below 10%

AssessmentDocument the affected areas and body surface area when applicable

Topical corticosteroid trial

Required trial duration2 consecutive weeks

TherapyHigh-potency or super-high-potency topical corticosteroid

Response requirement

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Nemluvio (nemolizumab-ilto). Refer to the HMSA medical policy website for the fax form.

Step Therapy

Atopic Dermatitis: Required Topical Therapy Trial

For atopic dermatitis, document an inadequate response within the past 365 days to each required topical therapy, or document why the therapies are not advisable for the member.

High-potency or super-high-potency topical corticosteroid for 2 consecutive weeks, including response.
Topical calcineurin inhibitor (tacrolimus) for 6 consecutive weeks, including response.
Topical Janus kinase (JAK) inhibitor (Opzelura) for 8 consecutive weeks, including response.
Topical aryl hydrocarbon receptor agonist (Vtama) for 8 consecutive weeks, including response.

Policy Background

Nemluvio is covered for adult prurigo nodularis and for moderate-to-severe atopic dermatitis in adults and children 12 years of age and older when topical prescription therapies do not adequately control the disease. Atopic dermatitis coverage requires use with a topical corticosteroid and/or topical calcineurin inhibitor unless those therapies are not advisable. Prurigo nodularis coverage focuses on persistent pruritus, an itch-scratch cycle, nodular lesion burden, and inadequate response or inability to use prior therapies.

Policy Definitions

Crucial body areas

HandsDefined as a crucial body area

FeetDefined as a crucial body area

FaceDefined as a crucial body area

NeckDefined as a crucial body area

ScalpDefined as a crucial body area

Genitals/groinDefined as a crucial body area

Intertriginous areasDefined as a crucial body area

Initial Authorization Pathways

Initial Atopic Dermatitis Therapy — 4-Month Authorization

A 4-month authorization may be granted through either the recent prior-therapy pathway or the standard moderate-to-severe atopic dermatitis pathway.

4-month atopic dermatitis authorization pathway

Recent prior biologic or systemic targeted synthetic drug pathway: Member is 12 years of age or older, received a biologic or systemic targeted synthetic drug indicated for moderate-to-severe atopic dermatitis within the past 180 days, and is prescribed Nemluvio in combination with a topical corticosteroid or topical calcineurin inhibitor, unless those therapies are not advisable.Age >= 12 years; prior treatment within 180 days; authorization period 4 months
Standard pathway
- Disease extent: Affected body surface is greater than or equal to 10% body surface area, or crucial body areas are affected.

Reauthorization

Reauthorization — 12-Month Continuation

Previously authorized members may receive a 12-month continuation authorization when they achieve or maintain a positive clinical response.

12-month reauthorization

Atopic dermatitis: Member is 12 years of age or older, was previously authorized by HMSA/CVS, and has low disease activity, such as clear or almost clear skin, or improvement in signs and symptoms of atopic dermatitis, such as redness, itching, or oozing/crusting.Age >= 12 years; authorization period 12 months
Prurigo nodularis: Member is 18 years of age or older, was previously authorized by HMSA/CVS, and has low disease activity, such as clear or almost clear skin, or reduced pruritus intensity with improvement in the extent and severity of nodular lesions.Age >= 18 years; authorization period 12 months

Indication-Specific Treatment Pathways

Step	Eligibility	Prior treatment	Additional requirement	Authorization period
1	Atopic dermatitis; member is 12 years of age or older	Biologic or systemic targeted synthetic drug indicated for moderate-to-severe atopic dermatitis received within the past 180 days	Nemluvio must be prescribed with a topical corticosteroid or topical calcineurin inhibitor, unless use of both is not advisable because of contraindications or prior intolerance	Covered for 4 months

Step	Eligibility	Prior treatment	Additional requirement	Authorization period
1	Prurigo nodularis; member is 18 years of age or older	Biologic drug indicated for prurigo nodularis received within the past year	Prior biologic treatment pathway for prurigo nodularis	Covered for 6 months

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyNemluvio (nemolizumab-ilto) Coverage Criteria

Policy CodePolicy N/A

Change TypeOriginal policy

Effective DateJuly 1, 2026

Next Review DateNot specified

Key ActionPrior authorization is required for Nemluvio; providers should use the fax form available on the HMSA medical policy website.

SourceLink

On This Page

Topical calcineurin inhibitor (tacrolimus) used for 6 consecutive weeks.

Topical JAK inhibitor (Opzelura) used for 8 consecutive weeks.

Topical aryl hydrocarbon receptor agonist (Vtama) used for 8 consecutive weeks.

Treatment is not advisable

Use of a high-potency or super-high-potency topical corticosteroid is not advisable for the member (e.g., due to contraindications, prior intolerances, potency not appropriate for the member's age, or inadequate response).
Use of a topical calcineurin inhibitor is not advisable for the member (e.g., due to contraindications, prior intolerances, potency not appropriate for the member's age, or inadequate response).
Use of a topical JAK inhibitor is not advisable for the member (e.g., due to contraindications, prior intolerances, potency not appropriate for the member's age, or inadequate response).
Use of a topical aryl hydrocarbon receptor agonist is not advisable for the member (e.g., due to contraindications, prior intolerances, potency not appropriate for the member's age, or inadequate response).

The requested medication is prescribed in combination with a low-potency to medium-potency topical corticosteroid (see Appendix A) or topical calcineurin inhibitor, unless use of a low-potency to medium-potency topical corticosteroid and topical calcineurin inhibitor is not advisable for the member (e.g., due to contraindications or prior intolerances).

Member has a history or signs of a repeated itch-scratch cycle (e.g., scratching, picking, or rubbing).

Member has a minimum of 20 nodular lesions.>= 20 nodular lesions

ONE of the following treatment-history pathways

Member has had an inadequate response to one of the following: a medium- to super-high-potency topical corticosteroid (see Appendix A); a topical calcineurin inhibitor; phototherapy (e.g., UVB, PUVA); or pharmacologic treatment with methotrexate or cyclosporine.
Clinical reason to avoid treatment
- Member has had an intolerance or clinical reason to avoid both a medium- to super-high-potency topical corticosteroid (see Appendix A) and a topical calcineurin inhibitor.
- Member has had an intolerance or clinical reason to avoid pharmacologic treatment with both methotrexate and cyclosporine (see Appendix B).

Inadequate treatment response, unless the therapy is not advisable

Topical calcineurin inhibitor trial

Required trial duration6 consecutive weeks

TherapyTopical calcineurin inhibitor, including tacrolimus

Response requirementInadequate treatment response, unless the therapy is not advisable

Topical JAK inhibitor trial

Required trial duration8 consecutive weeks

TherapyTopical JAK inhibitor, such as Opzelura

Response requirementInadequate treatment response, unless the therapy is not advisable

Topical aryl hydrocarbon receptor agonist trial

Required trial duration8 consecutive weeks

TherapyTopical aryl hydrocarbon receptor agonist, such as Vtama

Response requirementInadequate treatment response, unless the therapy is not advisable

Prurigo nodularis pruritus

Minimum pruritus durationAt least 6 weeks

Associated featureHistory or signs of a repeated itch-scratch cycle

ExamplesScratching, picking, or rubbing

Prurigo nodularis lesion burden

Minimum lesion count20 nodular lesions

ConditionPrurigo nodularis

Additional disease featurePruritus lasting at least 6 weeks with a history or signs of a repeated itch-scratch cycle

If a required therapy was not advisable, document the clinical reason, such as contraindication, prior intolerance, age-inappropriate potency, or inadequate response.

Step Therapy

Prurigo Nodularis: Required Prior Therapy

For prurigo nodularis, document an inadequate response to at least one required prior therapy, or document the applicable intolerance or clinical reason to avoid therapy.

A medium- to super-high-potency topical corticosteroid.
A topical calcineurin inhibitor.
Phototherapy, such as UVB or PUVA.
Pharmacologic treatment with methotrexate or cyclosporine.
Alternatively, document intolerance or a clinical reason to avoid the applicable topical therapies and pharmacologic treatments.

Documentation Required

Atopic Dermatitis: Initial Documentation

For an initial atopic dermatitis request, submit chart notes or medical record documentation showing the affected areas and body surface area, where applicable. Document previous medications tried, including dosage, duration, and response to therapy; if a therapy is not advisable, document the clinical reason to avoid it.

Previous therapy documentation may include topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, topical aryl hydrocarbon receptor agonists, or biologic/targeted synthetic drugs.

Documentation Required

Atopic Dermatitis: Continuation Documentation

For continuation requests for atopic dermatitis, submit chart notes or medical record documentation supporting a positive clinical response to Nemluvio.

Documentation Required

Prurigo Nodularis: Initial Documentation

For an initial prurigo nodularis request, submit chart notes or medical record documentation describing the member’s symptoms and nodular lesions. Document previous therapies tried and the response to each therapy; if a therapy is not advisable, document the clinical reason to avoid it.

Symptoms may include pruritus and nodular lesions.

Documentation Required

Prurigo Nodularis: Continuation Documentation

For continuation requests for prurigo nodularis, submit chart notes or medical record documentation supporting a positive clinical response to Nemluvio.

Denial Risk

Atopic Dermatitis: Criteria Not Met

Atopic dermatitis requests do not meet criteria when required member, severity, prior-treatment, or concomitant-therapy requirements are not satisfied.

The affected body surface area is less than 10% and no crucial body area is affected.
Within the past 365 days, the member has not had an inadequate response to all required topical therapies and the therapies are not all documented as medically inadvisable.
The member is prescribed Nemluvio without a low- to medium-potency topical corticosteroid or topical calcineurin inhibitor, unless both are documented as not advisable.
A required topical therapy is not appropriate for the member’s age, or is contraindicated or previously not tolerated, without the required supporting documentation.

Denial Risk

Prurigo Nodularis: Criteria Not Met

Prurigo nodularis requests do not meet criteria when the member does not satisfy the age, symptom, lesion, prior-treatment, or other coverage requirements.

The member is younger than 18 years, except that the policy also describes authorization for members 18 or older with a previously received indicated biologic in the past year.
Pruritus has not lasted at least 6 weeks, or there is no history or sign of a repeated itch-scratch cycle.
The member has fewer than 20 nodular lesions.
There is no inadequate response to a qualifying prior therapy and no documented intolerance or clinical reason to avoid the required therapies.
The applicable initial or continuation documentation and other policy requirements are not met.

Denial Risk

No Concomitant Biologic or Targeted Synthetic Therapy

The member cannot use Nemluvio concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

Prior Authorization

Initial Criteria Required

Members without previous authorization or precertification—including new members and members currently receiving treatment without prior authorization—must meet the criteria for initial approval in section D.

Specified topical therapy classes

High- or super-high-potency topical corticosteroidsSpecified topical therapy class

Topical calcineurin inhibitorsSpecified topical therapy class

Topical JAK inhibitorsSpecified topical therapy class

Topical aryl hydrocarbon receptor agonistsSpecified topical therapy class

>= 10% BSA or crucial body areas

Prior topical therapy within the past 365 days

Inadequate response to all specified topical therapies: Inadequate response to a high- or super-high-potency topical corticosteroid for 2 consecutive weeks, a topical calcineurin inhibitor for 6 consecutive weeks, a topical JAK inhibitor for 8 consecutive weeks, and a topical aryl hydrocarbon receptor agonist for 8 consecutive weeks.2, 6, 8, and 8 consecutive weeks, respectively
Specified topical therapies not advisable: Use of all specified topical therapies is not advisable because of contraindications, prior intolerances, potency inappropriate for the member's age, or inadequate response.

Required concomitant therapy: Nemluvio is prescribed in combination with a low- to medium-potency topical corticosteroid or topical calcineurin inhibitor, unless both are not advisable.Combination therapy required unless not advisable