CurrentNeighborhood Health Plan of Rhode IslandPolicy 3047-A

Skyrizi (risankizumab-rzaa) prior authorization and coverage criteria

Requirements for prior authorization, documentation, prescriber specialty, and medical necessity criteria for Skyrizi (risankizumab-rzaa) for FDA-approved indications (plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis) for members of Neighborhood Health Plan of Rhode Island as referenced in the CVS Caremark document.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySkyrizi (risankizumab-rzaa) prior authorization and coverage criteria

Policy CodePolicy 3047-A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionProvide documentation of clinical response or a negative TB test within 12 months when required to support prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period routinely granted

Within 12 monthsTB testing window for biologic-naive members

>=10% / >=3% with reasonPlaque psoriasis BSA threshold

1reference document number

Coverage Criteria for Risankizumab (Skyrizi)

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Indication-specific initial and continuation criteria

Authorization of 12 months may be granted when the indication-specific criteria below are met.

Covered indications: Member has one of the FDA-approved indications: moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, or moderately to severely active ulcerative colitis.

Plaque psoriasis initial authorization: Authorization may be granted when ANY of the following criteria is met: 1) At least 10% body surface area (BSA) is affected; OR 2) Member has had inadequate response or intolerance to phototherapy (e.g., UVB, PUVA) or pharmacologic treatment with methotrexate, cyclosporine, or acitretin; OR 3) At least 3% BSA is affected AND the member has a clinical reason to avoid methotrexate, cyclosporine, and acitretin (see Appendix).BSA thresholds: >=10% BSA, or >=3% BSA with clinical reason to avoid systemic agents

Psoriatic arthritis initial authorization: Authorization may be granted when ANY of the following is met: 1) Member with mild-to-moderate disease has had inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD administered at adequate dose and duration; OR 2) Member has intolerance or contraindication to methotrexate or leflunomide; OR 3) Member has enthesitis; OR 4) Member has severe disease.

Crohn's disease initial authorization: Authorization may be granted for treatment of moderately to severely active Crohn's disease.

Ulcerative colitis initial authorization: Authorization may be granted for treatment of moderately to severely active ulcerative colitis.

Plaque psoriasis continuation: Authorization of 12 months may be granted when the member achieves or maintains a positive clinical response as evidenced by reduction in BSA from baseline or improvement in signs and symptoms from baseline (eg, itching, redness, flaking, scaling, burning, cracking, pain).

Psoriatic arthritis continuation: Authorization of 12 months may be granted when the member achieves or maintains a positive clinical response as evidenced by improvement from baseline in any of: number of swollen joints, number of tender joints, dactylitis, enthesitis, skin and/or nail involvement, functional status, or C-reactive protein (CRP).

Crohn's disease continuation: Authorization of 12 months may be granted when the member achieves or maintains remission or a positive clinical response as evidenced by improvement from baseline in any of: abdominal pain or tenderness, diarrhea, body weight, abdominal mass, hematocrit, appearance of the mucosa on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on a disease activity scoring tool (e.g., CDAI).

Ulcerative colitis continuation: Authorization of 12 months may be granted when the member achieves or maintains remission or a positive clinical response as evidenced by improvement from baseline in any of: stool frequency, urgency of defecation, rectal bleeding, C-reactive protein (CRP), fecal calprotectin (FC), improvement on a disease activity scoring tool (e.g., UCEIS, Mayo), or appearance of the mucosa on endoscopy/CTE/MRE/intestinal ultrasound.

Ulcerative colitis — continuation authorization

Authorization of 12 months may be granted when ALL of the following are met:

Ulcerative colitis maintenance/continuation: Member is using the requested medication for moderately to severely active ulcerative colitis and achieves or maintains remission or a positive clinical response.12-month authorization

Positive clinical response evidenced by improvement from baseline in any of: stool frequency, urgency of defecation, rectal bleeding, C-reactive protein (CRP), fecal calprotectin (FC), improvement on a disease activity scoring tool (e.g., UCEIS, Mayo), or appearance of the mucosa on endoscopy/CTE/MRE/intestinal ultrasound.

All indications for risankizumab (Skyrizi) that are not listed as FDA-approved indications in this policy are considered experimental/investigational and not medically necessary and will not be authorized. The FDA-approved indications referenced in this policy include treatment of moderate-to-severe plaque psoriasis, moderately to severely active Crohn's disease, active psoriatic arthritis, and moderately to severely active ulcerative colitis.

The requested medication may not be used concomitantly with any other biologic or targeted synthetic drug for the same indication. Concurrent use with another biologic or targeted synthetic therapy for the same condition is not permitted and may result in denial of the request.

Do not administer the requested medication to members with active tuberculosis infection. A positive TB screen requires further evaluation (e.g., chest X‑ray) to exclude active disease; if active TB is present, the medication must not be started.

Use of risankizumab for any indication other than the specific FDA-approved indications listed in this policy (plaque psoriasis, Crohn's disease, psoriatic arthritis, ulcerative colitis) is considered experimental/investigational and not medically necessary and will not be approved.

Concomitant use of the requested medication with any other biologic or targeted synthetic drug for the same indication is not permitted. Requests for overlapping biologic or targeted synthetic therapies for the same condition will be declined.

Provider Requirements, Documentation, and Authorization

Prior Authorization

Prior authorization required and duration

Prior authorization of up to 12 months may be granted when the applicable indication-specific criteria are met. Authorization durations described below (for plaque psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and other indications) reflect common approval lengths when clinical criteria are satisfied.

Authorization duration: up to 12 months when criteria are met
Prior authorization required before drug initiation for covered indications

Denial Risk

Concomitant biologic therapy

Do not administer the requested medication concomitantly with any other biologic or targeted synthetic drug for the same indication. Concurrent use of two biologic or targeted synthetic agents for the same disease is not permitted and may result in denial of the request.

Concomitant biologic or targeted synthetic therapy for the same indication is not allowed
Requests documenting combination biologic therapy will be denied unless clear, evidence-based justification is provided (e.g., separate non-overlapping indications)

Documentation Required

Required documentation for initial and continuation requests

Initial requests: Provide chart notes or medical record documentation of affected area(s) and body surface area (BSA) affected (if applicable). Include chart notes, medical record documentation, or claims history supporting previous medications tried and responses to therapy. If an indicated prior therapy is not advisable, include documentation of the clinical reason to avoid that therapy (see examples below). Continuation requests: Provide chart notes or medical record documentation demonstrating clinical benefit compared with baseline (e.g., decreased BSA affected, improvement in signs and symptoms, or documented remission). For Crohn’s disease and ulcerative colitis, continuation requests must include documentation of positive clinical response or remission (examples below).

Initial request: documentation of affected area(s) and BSA, prior medications tried, and response to therapy
Continuation request: documentation of decreased BSA and/or symptomatic improvement or remission
For IBD (CD/UC): documentation of response (stool frequency, urgency, rectal bleeding, CRP, fecal calprotectin, endoscopic/radiographic improvement)

Documentation Required

Required clinical documentation

Required clinical documentation should demonstrate response or remission compared with baseline. Acceptable evidence includes improvements in clinical signs and symptoms and objective markers of disease activity from baseline, such as stool frequency, urgency of defecation, rectal bleeding, C-reactive protein (CRP), fecal calprotectin (FC), improvement on validated disease activity scoring tools (e.g., UCEIS, Mayo score), or improved appearance on endoscopy, CTE, MRE, or intestinal ultrasound.

Document baseline disease status and subsequent improvement on follow-up
For ulcerative colitis: acceptable measures include stool frequency, urgency, rectal bleeding, CRP, FC, UCEIS/Mayo score, and endoscopic or imaging evidence of mucosal improvement

Documentation Required

Supporting safety and documentation notes

If a member has not tried recommended non-biologic systemic therapies or phototherapy, provide documentation of clinical reasons to avoid those agents when requesting an exception. Examples of acceptable clinical reasons to avoid methotrexate, cyclosporine, acitretin, or leflunomide (or other conventional systemic agents) include: clinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease; risk of treatment-related toxicity; significant drug interactions; pregnancy or planning pregnancy; breastfeeding; significant comorbidity prohibiting use (e.g., severe liver or kidney disease, blood dyscrasias, uncontrolled hypertension); hypersensitivity; or history of intolerance or adverse event. Additionally, for TB screening: provide a documented negative TB test (TST or IGRA) within 12 months for biologic-naive members initiating therapy; if TB screening is positive, further testing (e.g., chest X‑ray) must confirm no active disease. Do not administer therapy to members with active TB; if latent TB is identified, TB treatment must be started prior to initiating the requested medication.

Document clinical rationale to avoid non-biologic systemic agents when step therapy is not followed
Provide negative TB test (TST or IGRA) within 12 months for biologic‑naive members initiating therapy
If TB screening positive, confirm no active TB (e.g., chest X‑ray) before starting therapy; treat latent TB prior to initiation
Do not administer medication to members with active TB

Definitions and Clinical Terms

Covered indications

Indications (FDA-approved)Moderate-to-severe plaque psoriasis (PsO)

Indications (FDA-approved)Moderately to severely active Crohn's disease (CD)

Indications (FDA-approved)Active psoriatic arthritis (PsA)

Indications (FDA-approved)Moderately to severely active ulcerative colitis (UC)

Clinical response/remission definition

DefinitionPositive clinical response or remission is demonstrated by improvement from baseline in any of: decreased stool frequency, decreased urgency of defecation, reduced rectal bleeding, decreased C-reactive protein (CRP), decreased fecal calprotectin (FC), improved disease activity score (e.g., UCEIS, Mayo), or improved mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound

PurposeUsed to support 12-month authorization for ulcerative colitis when member achieves or maintains remission or a positive clinical response

DocumentationChart notes or medical record documentation comparing current status to baseline are required to support continuation

TB screening definition

Negative TB test definitionA documented negative tuberculosis test (TST or IGRA) within 12 months prior to initiating therapy for persons naive to biologic or targeted synthetic drugs

If screening positiveFurther testing to confirm no active disease (e.g., chest X-ray) is required; do not administer therapy to members with active TB; if latent TB, start TB treatment prior to initiation

Accepted test typesTuberculosis skin test (TST) or interferon-release assay (IGRA)

OpenPayer

Skyrizi (risankizumab-rzaa) prior authorization and coverage criteria

Coverage Criteria for Risankizumab (Skyrizi)

Document References, Codes and Key Metrics

Provider Requirements, Documentation, and Authorization

Background and Drug Overview

Definitions and Clinical Terms