CurrentMolina HealthcarePolicy C29923-A

Leqselvi (deuruxolitinib) coverage for severe alopecia areata

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This policy governs prior authorization and coverage requirements for oral Leqselvi (deuruxolitinib) in adults with severe alopecia areata, including clinical severity, prior treatment, safety screening, and specialist documentation requirements.

Policy Summary

PayerMolina Healthcare

PolicyLeqselvi (deuruxolitinib) coverage for severe alopecia areata

Policy CodePolicy C29923-A

Change TypeNo material change

Effective DateDecember 17, 2025

Next Review DateOctober 1, 2026

Key ActionSubmit prior authorization documentation showing severe alopecia areata, required prior treatment, safety screening, and prescriber or dermatologist involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

50%+Initial scalp hair-loss threshold

SALT ≤20Continuation response threshold

6 monthsInitial authorization

12 monthsContinuation authorization

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CurrentMolina HealthcarePolicy C29923-A

Leqselvi (deuruxolitinib) coverage for severe alopecia areata

Customize your policy alerts

Sign up for Molina Healthcare Policy C29923-A alerts

Get alerted when Policy C29923-A changes without checking for updates manually.

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Policy Summary

PayerMolina Healthcare

PolicyLeqselvi (deuruxolitinib) coverage for severe alopecia areata

Policy CodePolicy C29923-A

Change TypeNo material change

Effective DateDecember 17, 2025

Next Review DateOctober 1, 2026

Key ActionSubmit prior authorization documentation showing severe alopecia areata, required prior treatment, safety screening, and prescriber or dermatologist involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

50%+Initial scalp hair-loss threshold

SALT ≤20Continuation response threshold

6 monthsInitial authorization

12 monthsContinuation authorization

Policy-specified dose

Coverage Criteria

Initial Therapy

Initial therapy is covered when all of the following are met.

Initial therapy criteria

Diagnosis and disease duration
- Member has a documented diagnosis of severe alopecia areata.
- The current episode has lasted 6 months or longer with no spontaneous regrowth at any point during those 6 months.6 months or longer
Disease severity: Hair loss encompasses 50% or more of the scalp.SALT score 50 or higher
Prior treatment history
- Member has had an inadequate response to topical immunotherapy for 6 months.6 months
- Member has experienced serious side effects from topical immunotherapy.
- Topical immunotherapy is contraindicated for the member.
- Member has received oral corticosteroids for 6 weeks.6 weeks
Contraindication screening: The prescriber attests, or the clinical reviewer has found, that the member does not have any unaddressed FDA-labeled contraindications to Leqselvi.
Contraindications include CYP2C9 poor metabolizer status and use with moderate or strong CYP2C9 inhibitors. Live vaccines should be avoided during or immediately before treatment.
Infection screening: The member does not have an active or latent untreated infection, including clinically important localized infection.
Examples include hepatitis B and tuberculosis.
Prohibited concomitant therapy screening: The member is not receiving, and will not use Leqselvi in combination with, a TNF inhibitor, biologic response modifier or other biologic DMARD, Janus kinase inhibitor, or phosphodiesterase 4 inhibitor.
Examples include apremilast, tofacitinib, and upadacitinib. Verification may include prescriber attestation, medication fill history, or submitted documentation.

Continuation Therapy

Continuation therapy is covered when all of the following are met.

Continuation therapy criteria

Adherence
- Adherence to therapy is at least 85%.At least 85%
  Verified by the prescriber or member medication fill history.
- Adherence is less than 85% because surgery or treatment of an infection caused temporary discontinuation.Less than 85% permitted only for temporary discontinuation
Tolerability and toxicity: There is no evidence of intolerable adverse effects or drug toxicity.

Coverage for hair-loss or cosmetic indications is subject to the member’s state and line-of-business benefit provisions. Verify the applicable benefit explanation before determining coverage.

Leqselvi should not be used in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

Uses of Leqselvi other than the policy-supported treatment of severe alopecia areata in adults are considered experimental or investigational and are handled under Molina’s Off-Label policy.

Leqselvi is contraindicated in members who are CYP2C9 poor metabolizers or who use moderate or strong CYP2C9 inhibitors. Live vaccines should be avoided during and immediately before treatment with deuruxolitinib.

Leqselvi is not recommended for patients who are lactating or who have severe renal impairment or severe hepatic impairment.

Coding and Clinical Thresholds

HCPCSHCPCS

1	DESCRIPTION

Initial scalp hair-loss severity

Scalp hair loss50% or more of the scalp

SALT thresholdSALT score of 50 or higher

SALT severity rangeA score of 50 falls within the severe range (50-94)

Continuation treatment response

Required responseSALT score of 20 or less

SALT interpretationA SALT score of 20 equates to 20% scalp hair loss, or 80% scalp hair coverage

Documentation

Provider Requirements and Decision Risks

Prior Authorization

Prescriber, Age, Dose, and Administration Requirements

Prior authorization requires documentation that the member is an eligible adult with severe alopecia areata and that the requested product meets the prescriber, dose, route, benefit, and administration requirements.

Prescribed by or in consultation with a board-certified dermatologist; submit consultation notes with the initial request and each reauthorization request.
Member must be 18 years of age or older.
Dose: 8 mg twice daily; route: oral.
Recommended coverage is under the pharmacy benefit for patient self-administration.

Prior Authorization

Authorization Duration

Authorization is limited to the specified approval periods.

Initial authorization: 6 months.
Continuation authorization: 12 months.

Clinical Background

Alopecia areata is a chronic, relapsing autoimmune disorder that causes nonscarring hair loss, commonly involving the scalp and face. Limited disease may undergo unpredictable spontaneous remission, whereas moderate to severe disease is more likely to follow a chronic course with little or no remission. Extensive disease is commonly treated initially with topical immunotherapy or other corticosteroid-based approaches.

Definitions

SALT score

Full nameSeverity of Alopecia Tool

PurposeA standardized tool to quantify hair loss on the scalp

Initial coverage thresholdSALT score of 50 or higher

Persistent current episode

DefinitionA current episode lasting at least 6 months

Spontaneous regrowthNo spontaneous regrowth at any point during those 6 months

Policy applicationThis persistence requirement applies to initial therapy

Leqselvi Initial Therapy

Leqselvi initial therapy requires all policy criteria.

Leqselvi initial therapy criteria

Diagnosis and disease duration
- Member has a documented diagnosis of severe alopecia areata.
- The current episode has lasted 6 months or longer with no spontaneous regrowth at any point during those 6 months.6 months or longer
Scalp hair-loss severity: Hair loss encompasses 50% or more of the scalp.SALT score 50 or higher

Leqselvi Continuation

Leqselvi continuation therapy requires all listed criteria.

Leqselvi continuation criteria

Adherence
- Adherence to therapy is at least 85%.At least 85%
  Verified by the prescriber or member medication fill history.
- Adherence is less than 85% because surgery or treatment of an infection caused temporary discontinuation.Less than 85% permitted only for temporary discontinuation
Tolerability: There is no evidence of intolerable adverse effects or drug toxicity.

Step Therapy

Step	Required prior therapy	Duration or qualifying outcome
1	Topical immunotherapy	Inadequate response for 6 months, serious side effects, or contraindication
1	Oral corticosteroids	Treatment for 6 weeks

Quantity Limits

Leqselvi dosage

DrugLeqselvi (deuruxolitinib)

Policy-specified dose8 mg twice daily

RouteOral

Site of Care

Billing Rule

Use pharmacy benefit and patient self-administration

Oral Leqselvi is recommended for pharmacy benefit coverage and patient self-administration at home.

Route: oral.
Coverage setting: pharmacy benefit.
Administration: patient self-administered.

Policy Summary

PayerMolina Healthcare

PolicyLeqselvi (deuruxolitinib) coverage for severe alopecia areata

Policy CodePolicy C29923-A

Change TypeNo material change

Effective DateDecember 17, 2025

Next Review DateOctober 1, 2026

Key ActionSubmit prior authorization documentation showing severe alopecia areata, required prior treatment, safety screening, and prescriber or dermatologist involvement.

SourceLink

On This Page

Infection monitoring: The prescriber attests to ongoing monitoring for development of infection according to the FDA label.

Examples include tuberculosis and hepatitis B reactivation monitoring.

Clinical response: The member has achieved a SALT score of 20 or less.SALT score 20 or less

Documentation required.

Achievement of the SALT score must be documented for continuation therapy

Current episode duration

Minimum duration6 months or longer

Regrowth requirementNo spontaneous regrowth at any point within the 6 months

Coverage phaseApplies to initial therapy

Oral corticosteroid prior therapy

Treatment durationOral corticosteroids for 6 weeks

Coverage phaseRequired for initial coverage when this prior-treatment pathway applies

Prior-treatment alternativesThe policy also recognizes inadequate response, serious side effects, or contraindication to topical immunotherapy

Adherence

Minimum adherenceAt least 85% of the time

Temporary-discontinuation exceptionAdherence below 85% may qualify when surgery or treatment of an infection causes temporary discontinuation

VerificationVerified by the prescriber or member medication fill history

Absolute lymphocyte count

ThresholdAbsolute lymphocyte count below 500 cells/mm3

Before treatmentLeqselvi treatment is not recommended at this threshold

During treatmentTherapy should be interrupted and may be resumed upon resolution

Absolute neutrophil count

ThresholdAbsolute neutrophil count below 1,000 cells/mm3

Before treatmentLeqselvi treatment is not recommended at this threshold

During treatmentTherapy should be interrupted and may be resumed upon resolution

Hemoglobin

ThresholdHemoglobin below 8 g/dL

Before treatmentLeqselvi treatment is not recommended at this threshold

During treatmentTherapy should be interrupted and may be resumed upon resolution

SALT severity categories

No hair loss0

Limited1-20

Moderate21-49

Severe50-94

Very severe95-100

Step Therapy

Prior Therapy Documentation Required

Before initial coverage, document an inadequate response for 6 months, serious side effects, or a contraindication to topical immunotherapy, or an inadequate response to oral corticosteroids used for 6 weeks.

Document the prior therapy, duration, response, adverse effects, or contraindication.

Documentation Required

Clinical Records and Supporting Information

Submit clinical records and supporting information sufficient for Molina to determine medical necessity, benefit eligibility, and whether the requested use is non-investigational.

Diagnosis: severe alopecia areata.
Provide patient records, relevant test results, and provider credentials when requested.
For weight-, body-surface-area-, or other member-specific dosing, submit the applicable measurement.
Molina may request additional case-specific information and applies updated FDA-label information when applicable.

Documentation Required

Initial Disease Severity Requirements

Initial coverage requires documentation of severe alopecia areata, a persistent current episode, and substantial scalp hair loss.

Current episode has lasted at least 6 months with no spontaneous regrowth at any point during that period.
Hair loss encompasses at least 50% of the scalp, documented by a SALT score of 50 or higher.
Document the diagnosis and disease-severity assessment.

Documentation Required

Safety and Concomitant Therapy Documentation

The prescriber must address safety risks and verify that the requested therapy is not being used with prohibited concomitant treatments.

Attest that FDA-labeled contraindications have been addressed and that the member does not have an active or latent untreated infection, including tuberculosis or hepatitis B.
Do not use concurrently with a TNF inhibitor, biologic response modifier, other biologic DMARD, JAK inhibitor, or phosphodiesterase 4 inhibitor such as apremilast, tofacitinib, or upadacitinib.
Verification may use prescriber attestation, medication fill history, or submitted clinical documentation.

Documentation Required

Continuation Response and Safety Documentation

For continuation authorization, document clinical response, adherence, tolerability, toxicity, and ongoing infection monitoring.

Adherence is at least 85%, verified by the prescriber or medication fill history; lower adherence may be accepted when temporary discontinuation was required for surgery or infection treatment.
Prescriber attests that there are no intolerable adverse effects or drug toxicity.
Prescriber attests to ongoing monitoring for infection, including tuberculosis and hepatitis B reactivation, according to the FDA label.
Document achievement of a SALT score of 20 or less.

Documentation Required

Dermatology Consultation Notes

When Leqselvi is prescribed in consultation with a dermatologist, include the dermatologist’s consultation documentation with both the initial request and reauthorization requests.

Consultation notes are required for each applicable request.

Prior Authorization

Baseline CBC and Hematologic Restrictions

Obtain a complete blood count before treatment. Leqselvi is not recommended below specified hematologic thresholds and must be interrupted if those abnormalities occur until they resolve.

Do not recommend treatment when ALC is <500 cells/mm3, ANC is <1,000 cells/mm3, or hemoglobin is <8 g/dL.
Interrupt therapy for ALC <500 cells/mm3, ANC <1,000 cells/mm3, or hemoglobin <8 g/dL; treatment may resume after resolution.

Prior Authorization

Tuberculosis Screening and Treatment

Screen for latent tuberculosis before and during therapy, and treat latent TB before Leqselvi is started.

Interrupt treatment when a serious infection, including TB, is present until the infection is controlled.
Document screening and treatment of latent TB as clinically appropriate.

Note

Laboratory and Abdominal-Pain Monitoring

Monitor lipids, hemoglobin, neutrophils, and lymphocytes during therapy. Patients with new-onset abdominal pain require prompt evaluation for possible gastrointestinal perforation.

Monitor for lipid elevations, anemia, neutropenia, and lymphopenia.
Evaluate new-onset abdominal pain promptly.

Denial Risk

Benefit Exclusion or Unmet Clinical Criteria

Coverage may be denied when hair loss or cosmetic indications are excluded under the member’s state or line of business benefit, or when the requested use does not meet the policy’s medical-necessity criteria.

First review the applicable state and line of business Explanation of Benefits to determine whether hair-loss or cosmetic indications are covered.
Denial may result when required benefit eligibility, diagnosis, severity, prior-therapy, or other clinical criteria are unmet.

Denial Risk

Insufficient Disease Severity or Treatment History

Initial coverage may be denied when disease severity or treatment history is insufficiently documented.

Current episode is less than 6 months or spontaneous regrowth occurred during the 6-month period.
Scalp hair loss is below 50% or the SALT score is below 50.
Required prior therapy was not tried for the specified duration, was effective, or lacks documentation of inadequate response, serious side effects, or contraindication.

Denial Risk

Contraindication, Infection, or Prohibited Combination

Deny or do not authorize treatment when a contraindication, untreated infection, or prohibited combination is present or has not been adequately addressed in the submitted documentation.

CYP2C9 poor metabolizer status or concurrent use of a moderate or strong CYP2C9 inhibitor.
Active or latent untreated infection, including tuberculosis or hepatitis B.
Concurrent treatment with a TNF inhibitor, biologic DMARD or other biologic response modifier, JAK inhibitor, or phosphodiesterase 4 inhibitor.
Live vaccines should be avoided during or immediately before treatment.

Denial Risk

Failure to Meet Continuation Response Requirements

Continuation coverage may be denied when the member does not demonstrate the required response or the request lacks required continuation documentation.

Failure to document a SALT score of 20 or less.
Failure to meet the adherence standard without an accepted temporary interruption for surgery or infection treatment.
Intolerable adverse effects, drug toxicity, or absence of required infection monitoring.

Denial Risk

Insufficient or Inappropriate Documentation

Molina may request additional documentation and may deny reimbursement or take other appropriate action when submitted records do not support medical necessity, non-investigational use, benefit eligibility, or appropriate billing practice.

Documentation may include patient records, test results, and ordering or performing provider credentials.
Molina may act when documentation is insufficient, inconsistent with the initial determination, or reflects inappropriate or excessive billing.

Denial Risk

Experimental or Investigational Use

All other uses of Leqselvi are considered experimental or investigational and are subject to Molina’s Off-Label policy.

Coverage may be denied for uses outside the policy criteria or otherwise considered experimental or investigational.

Denial Risk

Contraindicated Drug Interactions and Vaccination

Do not authorize use in CYP2C9 poor metabolizers or with moderate or strong CYP2C9 inhibitors, and instruct patients to avoid live vaccines during or immediately before treatment.

An FDA-cleared or FDA-approved test for CYP2C9 variants to direct deuruxolitinib use is not currently available.
Address contraindicated drug interactions and vaccination restrictions in the submitted documentation.

Denial Risk

Infection or Hematologic Safety Concerns

Serious infections and hematologic abnormalities require interruption or may require denial until the safety concern is controlled or resolved.

Interrupt treatment for serious bacterial, fungal, viral, opportunistic, or tuberculosis infection until controlled.
Interrupt therapy for ALC <500 cells/mm3, ANC <1,000 cells/mm3, or hemoglobin <8 g/dL; resume only after resolution.
Latent TB must be treated before use.

Denial Risk

Clinical Populations Not Recommended for Treatment

Leqselvi is not recommended for certain clinical populations and should not be authorized without appropriate clinical justification and review.

Not recommended for patients who are lactating, have severe renal impairment, or have severe hepatic impairment.
Consider the boxed-warning risks of serious infection, mortality, malignancy, major adverse cardiovascular events, thrombosis, and gastrointestinal perforation.

Severity of Alopecia Tool (SALT)

MeasurementStandardized measure of scalp hair loss

Range0 (no scalp hair loss) to 100 (total scalp hair loss)

InterpretationA SALT score of 20 represents 20% scalp hair loss, or 80% scalp hair coverage

Treatment responseHair regrowth is reflected by a decrease in the SALT score

Alopecia areata

ConditionA chronic autoimmune skin disorder

Hair loss characteristicNonscarring hair loss

Common sitesUsually affects the scalp and face, but can affect hair on other parts of the body

Disease extentLimited disease is usually less than 20% of the scalp surface area; extensive disease may require systemic treatment when local therapies are unsuccessful or unsuitable

Required prior treatment

Member has had an inadequate response to topical immunotherapy for 6 months.6 months
Member has experienced serious side effects from topical immunotherapy.
Topical immunotherapy is contraindicated for the member.
Member has received oral corticosteroids for 6 weeks.6 weeks

FDA-labeled contraindications: The prescriber attests, or the clinical reviewer has found, that the member does not have any unaddressed FDA-labeled contraindications to Leqselvi.

Contraindications include CYP2C9 poor metabolizer status and use with moderate or strong CYP2C9 inhibitors. Live vaccines should be avoided during or immediately before treatment.

Infection status: The member does not have an active or latent untreated infection, including clinically important localized infection.

Examples include hepatitis B and tuberculosis.

Concomitant therapy: The member is not receiving, and will not use Leqselvi in combination with, a TNF inhibitor, biologic response modifier or other biologic DMARD, Janus kinase inhibitor, or phosphodiesterase 4 inhibitor.

Examples include apremilast, tofacitinib, and upadacitinib.

Infection monitoring: The prescriber attests to ongoing monitoring for development of infection according to the FDA label.

Examples include tuberculosis and hepatitis B reactivation monitoring.

Treatment response: The member has achieved a SALT score of 20 or less.SALT score 20 or less

Documentation required.