CurrentHawaii Medical Service Association (HMSA)Policy N/A

Nemluvio (nemolizumab-ilto) Coverage Criteria

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This policy governs HMSA prior authorization and coverage criteria for Nemluvio for adult prurigo nodularis and moderate-to-severe atopic dermatitis in members age 12 and older. It applies to HMO and PPO members and requires documentation, qualifying prior therapy or clinical circumstances, and specialty prescribing.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyNemluvio (nemolizumab-ilto) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2026

Next Review DateN/A

Key ActionSubmit the required prior authorization fax form available on the HMSA medical policy website.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Covered indications

4 moInitial atopic dermatitis

6 moInitial prurigo nodularis

12 moReauthorization

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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 TypeNo material change

Effective DateJul 1, 2026

Next Review DateN/A

Key ActionSubmit the required prior authorization fax form available on the HMSA medical policy website.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Covered indications

4 moInitial atopic dermatitis

6 moInitial prurigo nodularis

12 moReauthorization

Coverage Criteria

Atopic dermatitis initial therapy: biologic or targeted synthetic drug pathway

Authorization of 4 months may be granted when all stated requirements are met.

Atopic dermatitis initial pathway: prior biologic or targeted synthetic drug: Member is age 12 years or older, has moderate-to-severe atopic dermatitis, had an inadequate response or intolerance to at least one biologic (for example, Adbry, Dupixent, or Ebglyss) or systemic targeted synthetic drug (for example, Cibinqo or Rinvoq) in the past 180 days, and will use Nemluvio in combination with a low- to medium-potency topical corticosteroid or topical calcineurin inhibitor unless those treatments are not advisable.Age 12 years or older; prior therapy within past 180 days

Authorization period is 4 months.

Atopic dermatitis initial therapy: topical-treatment pathway

Authorization of 4 months may be granted when all of the following criteria are met.

Atopic dermatitis initial pathway: topical therapy criteria

Qualifying topical-treatment alternative: Member has had an inadequate treatment response to two of the following within the past 180 days: high-potency or super-high-potency topical corticosteroid, topical calcineurin inhibitor, topical JAK inhibitor, or topical PDE-4 inhibitor; OR use of all four listed topical options is not advisable due to contraindications, prior intolerances, or potency not appropriate for the member's age.Two therapies within past 180 days, or all listed therapies not advisable
The policy contains two alternative routes: inadequate response to two therapies, or inability to use the listed therapies.

Prurigo nodularis initial therapy: prior biologic pathway

Authorization of 6 months may be granted for members age 18 years or older.

Prurigo nodularis initial pathway: prior biologic: Member is age 18 years or older and previously received a biologic drug indicated for prurigo nodularis, such as Dupixent, within the past year.Age 18 years or older; prior indicated biologic within past year

Authorization period is 6 months.

Prurigo nodularis initial therapy: clinical and prior-treatment pathway

Authorization of 6 months may be granted when all of the following criteria are met.

Prurigo nodularis initial clinical criteria

Qualifying prior-treatment alternative: Member has had an inadequate response to one of the following: medium- to super-high-potency topical corticosteroid, topical calcineurin inhibitor, phototherapy such as UVB or PUVA, methotrexate, or cyclosporine; OR member has had intolerance or a clinical reason to avoid the specified topical corticosteroid and topical calcineurin inhibitor options and the specified methotrexate and cyclosporine options.Inadequate response to one qualifying therapy, or qualifying intolerance/clinical reason to avoid alternatives
The policy contains inadequate-response and intolerance/avoidance routes.

Initial approval when no prior authorization exists

Members without previous authorizations or precertifications, including members currently receiving treatment without prior authorization, must meet the initial-approval criteria.

No previous authorization: Member meets the applicable initial-therapy criteria in the policy coverage criteria section.Applicable initial criteria

Applies to new members and members receiving treatment without prior authorization.

Atopic dermatitis continuation therapy

Authorization of 12 months may be granted for members previously authorized by HMSA/CVS.

Atopic dermatitis reauthorization: Member is age 12 years or older, was previously authorized by HMSA/CVS, and achieved or maintains a positive clinical response since starting Nemluvio, evidenced by low disease activity such as clear or almost clear skin, or improvement in signs and symptoms such as redness, itching, or oozing/crusting.Age 12 years or older; positive clinical response

Authorization period is 12 months.

Prurigo nodularis continuation therapy

Authorization of 12 months may be granted for members previously authorized by HMSA/CVS.

Prurigo nodularis reauthorization: Member is age 18 years or older, was previously authorized by HMSA/CVS, and achieved or maintains a positive clinical response since starting Nemluvio, evidenced by low disease activity such as clear or almost clear skin, or by reduced pruritus intensity and improvement in the extent and severity of nodular lesions.Age 18 years or older; positive clinical response

Authorization period is 12 months.

Nemluvio must not be used concomitantly with another biologic drug or targeted synthetic drug for the same indication.

Services not covered under this Medical Policy will generally be determined not medically necessary under Hawaii law, subject to applicable member contract language. If the treating physician disagrees with HMSA/CVS’s medical-necessity determination, the physician may request reconsideration with supporting documentation.

Clinical Thresholds and Look-Back Periods

Atopic dermatitis prior-therapy look-back

Look-back periodPast 180 days

Atopic dermatitis pathwayInadequate response or intolerance to at least one biologic or systemic targeted synthetic drug, or inadequate response to two qualifying topical therapies, within the past 180 days

Qualifying topical therapiesHigh-potency or super-high-potency topical corticosteroid, topical calcineurin inhibitor, topical JAK inhibitor, or topical PDE-4 inhibitor

Atopic dermatitis affected body surface area

Minimum affected areaAt least 10% of body surface area

Alternative disease extentCrucial body-area involvement may qualify instead of the 10% body-surface-area threshold

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers should submit the HMSA medical policy fax form available through the HMSA medical policy website.

Use the HMSA medical policy website to access the required fax form.

Billing Rule

Specialist Prescriber Required

Nemluvio must be prescribed by, or prescribed in consultation with, a dermatologist or allergist/immunologist.

Document the qualifying prescriber specialty or specialist consultation.

Policy Background

Nemluvio (nemolizumab-ilto) is covered for adult prurigo nodularis and for moderate-to-severe atopic dermatitis in adults and pediatric members age 12 years and older. Atopic dermatitis treatment is used with topical corticosteroids and/or calcineurin inhibitors when disease is not adequately controlled with topical prescription therapies.

Clinical Definitions

Qualifying atopic dermatitis disease extent

Body-surface-area thresholdAffected body surface area is at least 10%

Crucial body-area alternativeCrucial body areas may be affected instead of meeting the 10% threshold

Examples of crucial areasHands, feet, face, neck, scalp, genitals/groin, or intertriginous areas

Prurigo nodularis clinical features

Pruritus durationAt least 6 weeks

Scratching history or signsRepeated itch-scratch cycle, including scratching, picking, or rubbing

Lesion count

Initial Authorization

Atopic dermatitis initial authorization — 4-month authorization period

Authorization of 4 months may be granted when all stated requirements are met.

Atopic dermatitis initial authorization: Member is age 12 years or older with moderate-to-severe atopic dermatitis, has had inadequate response or intolerance to at least one biologic or systemic targeted synthetic drug in the past 180 days, and uses Nemluvio with a low- to medium-potency topical corticosteroid or topical calcineurin inhibitor unless those therapies are not advisable.Age >=12; prior qualifying therapy in past 180 days

Examples include Adbry, Dupixent, Ebglyss, Cibinqo, and Rinvoq. Authorization period is 4 months.

Atopic dermatitis topical-treatment authorization — 4-month period and all required criteria

Authorization of 4 months may be granted when all of the following criteria are met.

Atopic dermatitis topical-treatment authorization: Member is age 12 years or older with moderate-to-severe atopic dermatitis, has affected body surface area of at least 10% or crucial body-area involvement, qualifies through the specified topical treatment-response or avoidance pathway, and uses Nemluvio with a low- to medium-potency topical corticosteroid or topical calcineurin inhibitor unless those therapies are not advisable.

Reauthorization

Atopic dermatitis reauthorization — 12-month continuation criteria

Authorization of 12 months may be granted for atopic dermatitis continuation.

Atopic dermatitis reauthorization: Member is age 12 years or older, was previously authorized by HMSA/CVS, and achieves or maintains a positive clinical response to Nemluvio, shown by low disease activity or improvement in atopic dermatitis signs and symptoms.Age >=12; positive clinical response

Low disease activity includes clear or almost clear skin. Authorization period is 12 months.

Prurigo nodularis reauthorization — 12-month continuation criteria

Authorization of 12 months may be granted for prurigo nodularis continuation.

Prurigo nodularis reauthorization: Member is age 18 years or older, was previously authorized by HMSA/CVS, and achieves or maintains a positive clinical response to Nemluvio, shown by low disease activity or reduction in pruritus intensity with improvement in nodular lesions.

Required Prior Therapies

Step	Required prior therapy	Coverage requirement
1	At least one biologic (such as Adbry, Dupixent, or Ebglyss) or systemic targeted synthetic drug (such as Cibinqo or Rinvoq) for atopic dermatitis, used within the past 180 days	Inadequate response or intolerance to the prior therapy

Step	Required prior therapy	Coverage requirement
1	Two of the following within the past 180 days: high-potency or super-high-potency topical corticosteroid, topical calcineurin inhibitor, topical JAK inhibitor, or topical PDE-4 inhibitor	Inadequate response to both therapies; alternatively, all four therapies are not advisable because of contraindications, prior intolerances, or potency inappropriate for the member’s age

Step	Required prior therapy	Coverage requirement
1	One of the following: medium- to super-high-potency topical corticosteroid, topical calcineurin inhibitor, phototherapy such as UVB or PUVA, methotrexate, or cyclosporine	Inadequate response to one qualifying therapy; alternatively, documented intolerance or a clinical reason to avoid the specified topical therapies and methotrexate or cyclosporine

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyNemluvio (nemolizumab-ilto) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2026

Next Review DateN/A

Key ActionSubmit the required prior authorization fax form available on the HMSA medical policy website.

SourceLink

On This Page

Crucial body areasHands, feet, face, neck, scalp, genitals/groin, or intertriginous areas

Prurigo nodularis symptom duration

Minimum symptom durationPruritus lasting at least 6 weeks

Required behaviorHistory or signs of a repeated itch-scratch cycle

ExamplesRepeated scratching, picking, or rubbing

Prurigo nodularis lesion count

Minimum lesion countAt least 20 nodular lesions

Required symptomPruritus lasting at least 6 weeks

Required clinical featureHistory or signs of repeated scratching, picking, or rubbing

Prior prurigo nodularis biologic

Prior treatmentA biologic drug indicated for prurigo nodularis, such as Dupixent

Look-back periodReceived within the past year

Age requirementMember must be 18 years of age or older

Authorization periodAuthorization may be granted for 6 months

Note

Review Coverage Criteria

The requested medication must meet the applicable atopic dermatitis or prurigo nodularis coverage criteria before authorization can be approved.

Review the HMSA medical policy criteria and submit all required supporting information.

Step Therapy

Atopic Dermatitis Prior Therapy

For atopic dermatitis, document the member's age, disease severity, prior treatment response or intolerance, and required concurrent topical therapy or the clinical reason it is not advisable.

Member must be at least 12 years old.
Document moderate-to-severe atopic dermatitis.
Requested therapy must be used with a low- to medium-potency topical corticosteroid or topical calcineurin inhibitor unless those therapies are not advisable because of contraindications or prior intolerance.
Document the clinical reason when required topical therapy is not advisable.

Step Therapy

Prurigo Nodularis Prior Therapy

For prurigo nodularis, document the member's age and prior therapy history, including the required biologic or other treatments and the response, intolerance, or reason to avoid therapy.

Member must be at least 18 years old.
Document prior receipt of a biologic indicated for prurigo nodularis within the past year, when applicable.
Document inadequate response to a qualifying therapy, or intolerance/clinical reason to avoid the required treatment options.

Documentation Required

Atopic Dermatitis Initial Documentation

Initial atopic dermatitis requests require chart notes or medical records showing the affected areas and body surface area, as applicable.

Document affected body surface area of at least 10% or involvement of crucial areas such as the hands, feet, face, neck, scalp, genitals/groin, or intertriginous areas.
Include the member's age and documentation of moderate-to-severe disease.

Documentation Required

Atopic Dermatitis Treatment History

Document the atopic dermatitis treatment history and the response to previous therapies. If a qualifying therapy was not advisable, document the clinical reason.

Include dosage, duration, and response for prior topical calcineurin inhibitors, topical corticosteroids, topical JAK inhibitors, topical PDE-4 inhibitors, biologics, or targeted synthetic drugs.
For the applicable approval pathway, document inadequate response or intolerance to at least one biologic or systemic targeted synthetic drug within the past 180 days.
Also document inadequate response to two qualifying high- or super-high-potency topical therapies within the past 180 days, or why those therapies are not advisable.

Documentation Required

Atopic Dermatitis Continuation Documentation

Continuation requests for atopic dermatitis require documentation that the member achieved or maintains a positive clinical response since starting Nemluvio.

Document low disease activity, such as clear or almost clear skin.
Alternatively, document improvement in signs and symptoms such as redness, itching, or oozing/crusting.
For reauthorization, the member must have been previously authorized by HMSA/CVS.

Documentation Required

Prurigo Nodularis Initial Documentation

Initial prurigo nodularis requests require documentation of the characteristic symptoms and lesions.

Member must be at least 18 years old.
Document pruritus lasting at least 6 weeks.
Document a history or signs of a repeated itch-scratch cycle, such as scratching, picking, or rubbing.
Document a minimum of 20 nodular lesions.

Documentation Required

Prurigo Nodularis Continuation Documentation

Continuation requests for prurigo nodularis require documentation that the member achieved or maintains a positive clinical response since starting Nemluvio.

Document low disease activity, such as clear or almost clear skin.
Alternatively, document reduced pruritus intensity and improvement in the extent and severity of nodular lesions.
For reauthorization, the member must have been previously authorized by HMSA/CVS.

Denial Risk

Atopic Dermatitis Denial Risks

Atopic dermatitis authorization may be denied when the member does not meet the required indication, age, severity, prior-treatment, or concurrent-therapy criteria.

Atopic dermatitis authorization requires age 12 or older and moderate-to-severe disease.
The affected body surface area must be at least 10% or crucial body areas must be affected.
Required biologic or systemic targeted synthetic drug and topical-treatment response or intolerance criteria must be met.
Required low- to medium-potency topical corticosteroid or topical calcineurin inhibitor combination therapy must be used unless not advisable.

Denial Risk

Prurigo Nodularis Denial Risks

Prurigo nodularis authorization may be denied when the member does not meet the required indication, age, disease-severity, or prior-treatment criteria.

Prurigo nodularis authorization requires age 18 or older.
Document pruritus for at least 6 weeks, a repeated itch-scratch cycle, and at least 20 nodular lesions.
Required prior biologic use or qualifying treatment response, intolerance, or clinical reason to avoid therapy must be documented.

Denial Risk

Documentation and Response Denial Risk

Requests may be denied when the submitted records do not establish the required clinical findings, treatment history, or positive response for continuation.

Insufficient documentation of affected areas, body surface area, symptoms, nodular lesions, dosage, duration, or treatment response may result in denial.
Continuation requests require evidence of a positive clinical response, including low disease activity or documented improvement in disease signs and symptoms.

Denial Risk

Prescriber and Concurrent-Therapy Restrictions

Requests may be denied if the prescriber specialty requirement or concurrent-therapy restriction is not met.

Nemluvio must be prescribed by or in consultation with a dermatologist or allergist/immunologist.
The member cannot use Nemluvio concomitantly with another biologic drug or targeted synthetic drug for the same indication.

Note

Reconsideration and Supporting Documentation

Providers should submit supporting documentation when a treating physician disagrees with HMSA/CVS's medical-necessity determination and may request reconsideration of the criteria's application to the case.

Include documentation supporting the requested treatment and the treating physician's clinical rationale.
Benefit determinations remain subject to the member's contract language; contract terms control if they conflict with the policy.

Denial Risk

Services Outside Policy Criteria

Services outside the policy criteria are generally not medically necessary under Hawaii law, although the policy does not direct providers' medical practice or prohibit other clinically appropriate treatment.

Coverage is subject to applicable member contract language.
A treating physician may request reconsideration with supporting documentation when disagreeing with the medical-necessity determination.

At least 20 nodular lesions

Age >=12; BSA >=10% or crucial body-area involvement

The topical pathway requires inadequate response to two listed topical therapies within the past 180 days or that all listed high-potency/topical alternatives are not advisable. Authorization period is 4 months.

Prurigo nodularis prior biologic authorization — 6-month authorization period

Authorization of 6 months may be granted for members age 18 years or older.

Prurigo nodularis prior biologic authorization: Member is age 18 years or older and previously received a biologic indicated for prurigo nodularis within the past year.Age >=18; prior indicated biologic within past year

Dupixent is provided as an example. Authorization period is 6 months.

Prurigo nodularis clinical authorization — 6-month period and all required criteria

Authorization of 6 months may be granted when all of the following criteria are met.

Prurigo nodularis clinical authorization: Member is age 18 years or older, has pruritus for at least 6 weeks, has repeated itch-scratch behavior, has at least 20 nodular lesions, and has either inadequate response to a qualifying topical, phototherapy, methotrexate, or cyclosporine treatment or documented intolerance or clinical reason to avoid the specified treatment alternatives.Age >=18; pruritus >=6 weeks; >=20 nodular lesions

Qualifying therapies include medium- to super-high-potency topical corticosteroids, topical calcineurin inhibitors, UVB, PUVA, methotrexate, and cyclosporine. Authorization period is 6 months.

Age >=18; positive clinical response

Low disease activity includes clear or almost clear skin. Authorization period is 12 months.