CurrentHawaii Medical Service Association (HMSA)Policy N/A

SKYRIZI (risankizumab-rzaa) Coverage and Prior Authorization

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This policy governs HMSA coverage and authorization of Skyrizi (risankizumab-rzaa) for adults with plaque psoriasis, psoriatic arthritis, Crohn's disease, or ulcerative colitis across HMO, PPO, and QUEST lines of business, with indication-specific clinical criteria and required precertification.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicySKYRIZI (risankizumab-rzaa) Coverage and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateDec 19, 2025

Last ReviewJun 1, 2025

Next Review DateN/A

Key ActionSubmit the HMSA precertification fax form for Skyrizi through the HMSA medical specialty drug policy website.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentHawaii Medical Service Association (HMSA)Policy N/A

SKYRIZI (risankizumab-rzaa) Coverage and Prior Authorization

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)

PolicySKYRIZI (risankizumab-rzaa) Coverage and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateDec 19, 2025

Last ReviewJun 1, 2025

Next Review DateN/A

Key ActionSubmit the HMSA precertification fax form for Skyrizi through the HMSA medical specialty drug policy website.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4FDA-approved covered indications

12 monthsInitial authorization period

12 monthsReauthorization period

RequiredPrecertification

4Prescriber specialties

Coverage Criteria

Initial therapy: plaque psoriasis

Covered for adults when either the prior advanced-therapy pathway or the disease-severity pathway is met.

Adult member with moderate-to-severe plaque psoriasis

Qualifying pathway
- Prior biologic or targeted synthetic therapy: Previously received a biologic or targeted synthetic drug indicated for moderate-to-severe plaque psoriasis
  Examples include Sotyktu and Otezla
- Disease severity or treatment pathway
  - Severity criterion: Crucial body areas are affected or at least 10% of body surface area (BSA) is affectedCrucial body areas or >=10% BSA
    Crucial areas include the hands, feet, face, neck, scalp, genitals/groin, and intertriginous areas
  - Lower BSA with additional criterion
    Treatment failure or intolerance: Inadequate response or intolerance to phototherapy or pharmacologic treatment with methotrexate, cyclosporine, or acitretin
    Examples of phototherapy include UVB and PUVA
    Clinical avoidance reason: There is a clinical reason to avoid pharmacologic treatment with methotrexate, cyclosporine, and acitretin
    See applicable Appendix examples

note":"Authorization is for 12 months"}

Initial therapy: psoriatic arthritis

Covered for adults with active psoriatic arthritis when either the prior advanced-therapy pathway or the disease-severity/conventional-therapy pathway is met.

note":"Authorization is for 12 months"}

Initial therapy: Crohn's disease

Covered when the adult member has the specified disease activity.

Crohn's disease initial therapy: Adult member has moderately to severely active Crohn's diseaseModerately to severely active

Authorization is for 12 months

Initial therapy: ulcerative colitis

Covered when the adult member has the specified disease activity.

Ulcerative colitis initial therapy: Adult member has moderately to severely active ulcerative colitisModerately to severely active

Authorization is for 12 months

Initial approval when no prior authorization exists

Members without previous authorization or precertification, including new members and members already receiving treatment without prior authorization, must meet the initial approval criteria.

Initial approval required: Meet the applicable initial approval criteria for the requested indication

Applies to all members without previous authorization or precertification

Continuation therapy: plaque psoriasis

Covered for 12 months when the member was previously authorized by HMSA/CVS and is benefiting from therapy.

Plaque psoriasis reauthorization: Previously authorized by HMSA/CVS and has low disease activity or improvement in signs and symptoms from baseline12-month authorization

Benefit may be shown by reduction in affected BSA or improvement in itching, redness, flaking, scaling, burning, cracking, or pain

Continuation therapy: psoriatic arthritis, Crohn's disease, and ulcerative colitis

Covered for 12 months when the member was previously authorized by HMSA/CVS and has remission, low disease activity, or improvement from baseline.

Psoriatic arthritis reauthorization: Previously authorized by HMSA/CVS and has low disease activity or improvement in signs and symptoms from baseline12-month authorization

Improvement may involve swollen joints, tender joints, dactylitis, enthesitis, skin or nail involvement, functional status, or C-reactive protein (CRP)

Crohn's disease reauthorization: Previously authorized by HMSA/CVS and has achieved or maintained remission, or has low disease activity or improvement from baseline12-month authorization

Possible measures include abdominal pain or tenderness, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance, or a disease activity score such as CDAI

Ulcerative colitis reauthorization:

Active tuberculosis is excluded. Before initiation, members who are naïve to biologic drugs or targeted synthetic drugs associated with increased TB risk must have a documented negative TB test, such as a tuberculosis skin test (TST) or interferon-release assay (IGRA), completed within 12 months. If screening is positive, additional testing must confirm that active disease is absent. For latent TB, treatment must begin before Skyrizi initiation.

Concurrent use is excluded. Skyrizi must not be used with another biologic drug or targeted synthetic drug for the same indication.

Coverage and Coding Details

Plaque psoriasis BSA thresholds

At least 10% BSACoverage pathway for moderate-to-severe plaque psoriasis when at least 10% of body surface area is affected.

At least 3% BSACoverage pathway when at least 3% of body surface area is affected and the member has inadequate response or intolerance to phototherapy or methotrexate, cyclosporine, or acitretin, or has a clinical reason to avoid those pharmacologic treatments.

Crucial body areasCoverage may apply when crucial areas are affected, including the hands, feet, face, neck, scalp, genitals or groin, and intertriginous areas.

Provider Requirements and Submission Guidance

Prior Authorization

Precertification Required

Precertification is required for Skyrizi. Submit the request using the fax form available on the HMSA medical specialty drug policy website.

Complete and submit the HMSA medical specialty drug precertification form.

Prior Authorization

Specialist Prescribing or Consultation

Skyrizi must be prescribed by, or prescribed in consultation with, a specialty associated with the indication.

Plaque psoriasis: dermatologist.
Psoriatic arthritis: dermatologist or rheumatologist.
Crohn's disease or ulcerative colitis: gastroenterologist.

Unsupported block type: billing_rule

Policy Background

Skyrizi (risankizumab-rzaa) is covered for adults with plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, or moderately to severely active ulcerative colitis. Coverage requires precertification and indication-specific clinical criteria; initial authorization is generally granted for 12 months.

Definitions and Clinical Measures

BSA

DefinitionBSA is the body surface area affected by plaque psoriasis.

Higher thresholdAt least 10% BSA affected is one policy criterion for moderate-to-severe plaque psoriasis.

Lower thresholdAt least 3% BSA affected may qualify when the applicable treatment failure, intolerance, or treatment-avoidance criterion is also met.

TST

TermTST means tuberculosis skin test.

Screening roleA TST may be used for tuberculosis screening before Skyrizi initiation.

Required timing

Initial Therapy Criteria

Plaque psoriasis — 12-month authorization criteria

Authorization of 12 months may be granted for qualifying adult members.

Adult member with moderate-to-severe plaque psoriasis

Qualifying plaque psoriasis pathway
- Prior advanced therapy: Previously received a biologic or targeted synthetic drug indicated for moderate-to-severe plaque psoriasis
- Disease severity or treatment pathway
  - Severity criterion: Crucial body areas are affected or at least 10% BSA is affectedCrucial body areas or >=10% BSA
  - Lower BSA with additional criterion

Continuation and Reauthorization

Reauthorization — 12-month continuation criteria

Authorization of 12 months may be granted to adult members previously authorized by HMSA/CVS who are benefiting from Skyrizi.

Previously authorized adult member: Adult member was previously authorized by HMSA/CVS

Condition-specific benefit

Plaque psoriasis benefit: Has low disease activity or improvement in signs and symptoms from baseline
Benefit may be shown by reduced affected BSA or improvement in itching, redness, flaking, scaling, burning, cracking, or pain
Psoriatic arthritis benefit: Has low disease activity or improvement from baseline in swollen joints, tender joints, dactylitis, enthesitis, skin or nail involvement, functional status, or CRP

Step Therapy Requirements

Step	Applies when	Requirement or exception
1	Moderate-to-severe plaque psoriasis with at least 3% affected BSA	Member must have an inadequate response or intolerance to phototherapy (such as UVB or PUVA), methotrexate, cyclosporine, or acitretin; a clinical reason to avoid methotrexate, cyclosporine, and acitretin may satisfy the requirement.
1	Moderate-to-severe plaque psoriasis	Previously received a biologic or targeted synthetic drug indicated for moderate-to-severe plaque psoriasis.

Step	Applies when	Requirement	Exception or alternative pathway
1	Mild-to-moderate active psoriatic arthritis	Inadequate response to methotrexate, leflunomide, or another conventional synthetic drug administered at an adequate dose and duration.	Intolerance or contraindication to applicable conventional synthetic therapy, or enthesitis, may satisfy the criterion.
1	Active psoriatic arthritis	Previously received a biologic or targeted synthetic drug indicated for active psoriatic arthritis.	Alternatively, the member may have severe disease.

Quantity and Dosing Limits

Skyrizi dosing limits

Policy basisApprovals may be subject to dosing limits for Skyrizi (risankizumab-rzaa).

FDA labelingDosing limits may be applied in accordance with FDA-approved labeling.

Additional referencesDosing limits may also follow accepted compendia or evidence-based practice guidelines.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicySKYRIZI (risankizumab-rzaa) Coverage and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateDec 19, 2025

Last ReviewJun 1, 2025

Next Review DateN/A

Key ActionSubmit the HMSA precertification fax form for Skyrizi through the HMSA medical specialty drug policy website.

SourceLink

On This Page

Previously authorized by HMSA/CVS and has achieved or maintained remission, or has low disease activity or improvement from baseline

12-month authorization

Possible measures include stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal appearance, or a disease activity score such as UCEIS or Mayo score

Prior Authorization

Provider Submission Required

The provider must submit a precertification request before treatment. HMSA review requires documentation supporting the indication and all applicable approval criteria.

Submit the required clinical information with the precertification request.

Step Therapy

Plaque Psoriasis Prior Therapy

For plaque psoriasis, authorization may be granted to an adult member who has previously received a biologic or targeted synthetic drug indicated for moderate to severe plaque psoriasis.

Examples include Sotyktu and Otezla.
Document the prior agent, treatment history, and outcome.

Step Therapy

Psoriatic Arthritis Conventional Therapy

For active psoriatic arthritis, mild to moderate disease generally requires prior treatment with methotrexate, leflunomide, or another conventional synthetic drug at an adequate dose and duration, unless an applicable exception is documented.

Document inadequate response, intolerance, or contraindication.
Another conventional synthetic drug may include sulfasalazine.
Enthesitis or severe disease is an alternative pathway for mild to moderate or severe disease criteria, respectively.

Step Therapy

Prior Biologic or Targeted Synthetic Therapy

An initial-treatment pathway is available for adults who have previously received a qualifying biologic or targeted synthetic drug for the applicable indication.

Plaque psoriasis: prior biologic or targeted synthetic drug for moderate to severe plaque psoriasis.
Psoriatic arthritis: prior biologic or targeted synthetic drug for active psoriatic arthritis.

Documentation Required

Clinical Diagnosis and Treatment History

Document the clinical diagnosis, adult status, disease activity, relevant treatment history, and response or intolerance supporting the requested indication.

Identify the indication: plaque psoriasis, psoriatic arthritis, Crohn's disease, or ulcerative colitis.
Document disease severity or activity and prior therapies, including inadequate response, intolerance, contraindication, or relevant treatment outcomes.
For Crohn's disease or ulcerative colitis, document moderately to severely active disease.

Documentation Required

Plaque Psoriasis Evidence

For plaque psoriasis, document the affected crucial body areas, the percentage of body surface area involved, prior treatment, and treatment response or intolerance.

Crucial areas may include the hands, feet, face, neck, scalp, genitals/groin, or intertriginous areas.
Alternatively, document at least 10% BSA, or at least 3% BSA with inadequate response or intolerance to phototherapy or methotrexate, cyclosporine, or acitretin.
If pharmacologic treatment was avoided, document the clinical reason.

Documentation Required

Psoriatic Arthritis Evidence

For psoriatic arthritis, document disease severity, conventional synthetic drug treatment, and the member's response, intolerance, or contraindication.

For mild to moderate disease, document inadequate response to an adequate dose and duration of methotrexate, leflunomide, or another conventional synthetic drug; alternatively document intolerance, contraindication, or enthesitis.
Document severe disease when that pathway is used.

Documentation Required

Continuation Response Documentation

For reauthorization, document that the member was previously authorized by HMSA/CVS and is benefiting from Skyrizi through low disease activity, remission, or improvement from baseline in objective or clinically described signs and symptoms.

Plaque psoriasis: reduction in affected BSA or improvement in itching, redness, flaking, scaling, burning, cracking, or pain.
Psoriatic arthritis: improvement in swollen or tender joints, dactylitis, enthesitis, skin/nail involvement, functional status, or CRP.
Crohn's disease and ulcerative colitis: document remission or improvement in applicable clinical, laboratory, endoscopic, imaging, or disease-activity measures.

Documentation Required

Tuberculosis Screening

For members who are naïve to biologic drugs or targeted synthetic drugs associated with increased TB risk, document a negative tuberculosis test within 12 months before initiation.

Acceptable screening may include a tuberculosis skin test (TST) or interferon-gamma release assay (IGRA).

Documentation Required

Concomitant Therapy Review

Review concomitant therapy and confirm that Skyrizi will not be used with another biologic drug or targeted synthetic drug for the same indication.

Document the relevant medication list and discontinuation or nonuse of prohibited same-indication advanced therapy.

Prior Authorization

Precertification Fax Form

Use the precertification fax form provided on the HMSA medical specialty drug policy website when submitting the request.

Include the clinical documentation required for the applicable indication and approval pathway.

Denial Risk

Covered Indication and Criteria Required

Coverage is limited to an FDA-approved or compendial indication for which all applicable approval criteria are met and no exclusion applies.

Requests for an unapproved indication or requests that do not meet the applicable criteria may not be covered.

Prior Authorization

Prescriber Specialty Requirement

The prescriber must meet the specialty requirement or consult with the specialty associated with the indication.

Dermatologist: plaque psoriasis or psoriatic arthritis.
Rheumatologist: psoriatic arthritis.
Gastroenterologist: Crohn's disease or ulcerative colitis.

Denial Risk

Active or Untreated Tuberculosis

Do not administer Skyrizi to a member with active tuberculosis. A positive screening test requires further evaluation to confirm that active disease is absent; if latent TB is present, treatment must begin before Skyrizi initiation.

Perform confirmatory evaluation when screening is positive, such as a chest x-ray.
Do not initiate therapy until required treatment for latent TB has started.

Denial Risk

Concurrent Same-Indication Advanced Therapy

Skyrizi cannot be used concomitantly with another biologic drug or targeted synthetic drug for the same indication.

Review the member's current and planned advanced therapies before initiating or continuing treatment.

Denial Risk

Indication-Specific Criteria Not Met

Initial authorization may be denied when the indication-specific pathway is not met or when required documentation is absent.

Plaque psoriasis: document qualifying prior biologic or targeted synthetic therapy, or the required disease extent and prior-treatment/avoidance criteria.
Psoriatic arthritis: document qualifying prior biologic or targeted synthetic therapy, or the applicable conventional synthetic drug response/intolerance/contraindication, enthesitis, or severe-disease criteria.
Also satisfy specialty, TB, concomitant-therapy, dosing, and precertification requirements.

For members naïve to biologic drugs or targeted synthetic drugs associated with increased TB risk, a documented negative TST must be obtained within 12 months before initiating therapy.

IGRA

TermIGRA means interferon-release assay.

Screening roleAn IGRA may be used for tuberculosis screening before Skyrizi initiation.

Required timingFor members naïve to biologic drugs or targeted synthetic drugs associated with increased TB risk, a documented negative IGRA must be obtained within 12 months before initiating therapy.

CDAI

TermCDAI means Crohn's Disease Activity Index.

Clinical useCDAI is a disease activity scoring tool that may be used to document improvement in Crohn's disease from baseline.

Continuation contextImprovement on a disease activity scoring tool such as the CDAI may support reauthorization when the member is benefiting from Skyrizi therapy.

UCEIS

TermUCEIS means Ulcerative Colitis Endoscopic Index of Severity.

Clinical useUCEIS is a disease activity scoring tool that may be used to document improvement in ulcerative colitis from baseline.

Continuation contextImprovement on a disease activity scoring tool such as the UCEIS may support reauthorization when the member is benefiting from Skyrizi therapy.

Treatment failure or intolerance: Inadequate response or intolerance to phototherapy, methotrexate, cyclosporine, or acitretin
Clinical avoidance reason: Clinical reason to avoid methotrexate, cyclosporine, and acitretin

note":"12-month authorization"}

Psoriatic arthritis — 12-month authorization criteria

Authorization of 12 months may be granted for qualifying adult members.

note":"12-month authorization"}

Crohn's disease — 12-month authorization criteria

Authorization of 12 months may be granted.

Crohn's disease: Adult member has moderately to severely active Crohn's diseaseModerately to severely active

Ulcerative colitis — 12-month authorization criteria

Authorization of 12 months may be granted.

Ulcerative colitis: Adult member has moderately to severely active ulcerative colitisModerately to severely active

Crohn's disease benefit: Has achieved or maintained remission, or has low disease activity or improvement from baseline in abdominal symptoms, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance, or CDAI

Ulcerative colitis benefit: Has achieved or maintained remission, or has low disease activity or improvement from baseline in stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal appearance, UCEIS, or Mayo score