Neighborhood Health Plan Skyrizi Coverage & Prior Auth

Coverage and Clinical Criteria

Initial therapy — Plaque psoriasis

Authorization of 12 months may be granted for adult members for treatment of moderate to severe plaque psoriasis when ANY of the following are met:

Plaque psoriasis coverage criteria: Crucial body areas affected (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas).

Plaque psoriasis coverage criteria: At least 10% of body surface area (BSA) is affected.>= 10% BSA

Plaque psoriasis coverage criteria: At least 3% of body surface area (BSA) is affected AND either (1) inadequate response or intolerance to phototherapy (e.g., UVB, PUVA) or pharmacologic treatment with methotrexate, cyclosporine, or acitretin, OR (2) a documented clinical reason to avoid methotrexate, cyclosporine, and acitretin.>= 3% BSA

Includes prior therapy requirements or contraindications; see Appendix for examples of clinical reasons to avoid therapies.

Initial therapy — Psoriatic arthritis

Authorization of 12 months may be granted for adult members for treatment of active psoriatic arthritis when ANY of the following are met:

Psoriatic arthritis coverage criteria: Member has mild to moderate disease AND the member has had an inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD (e.g., sulfasalazine) administered at adequate dose and duration.clinical judgment

Prior conventional synthetic therapy required unless intolerance/contraindication

Psoriatic arthritis coverage criteria: Member has mild to moderate disease AND has an intolerance or contraindication to methotrexate, leflunomide, or another conventional synthetic DMARD (e.g., sulfasalazine).clinical judgment

Document intolerance/contraindication (see Appendix)

Psoriatic arthritis coverage criteria: Member has mild to moderate disease AND has enthesitis.

Initial therapy — Crohn's disease

Authorization of 12 months may be granted for treatment of moderately to severely active Crohn's disease when the member meets indication-specific criteria and prior authorization requirements.

Crohn's disease coverage: Member is using the requested medication for moderately to severely active Crohn's disease.

Continuation requires documentation of remission or positive clinical response (see continuation criteria).

Initial therapy — Ulcerative colitis

Authorization of 12 months may be granted for treatment of moderately to severely active ulcerative colitis when the member meets indication-specific criteria and prior authorization requirements.

Ulcerative colitis coverage: Member is using the requested medication for moderately to severely active ulcerative colitis.

Continuation requires documentation of remission or positive clinical response (see continuation criteria).

Continuation therapy — Plaque psoriasis

Authorization of 12 months may be granted for members who achieve or maintain a positive clinical response.

Plaque psoriasis continuation: Demonstrated reduction in body surface area (BSA) affected from baseline.improvement from baseline

Documentation required in chart notes

Plaque psoriasis continuation: Improvement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, burning, cracking, pain).improvement from baseline

Documentation required in chart notes

Continuation therapy — Psoriatic arthritis

Authorization of 12 months may be granted for members who achieve or maintain a positive clinical response.

Psoriatic arthritis continuation: Improvement in number of swollen joints from baseline.improvement from baseline

Document in medical records

Psoriatic arthritis continuation: Improvement in number of tender joints from baseline.improvement from baseline

Document in medical records

Psoriatic arthritis continuation: Improvement in dactylitis or enthesitis from baseline.improvement from baseline

Document in medical records

Continuation therapy — Crohn's disease

Authorization of 12 months may be granted for members who achieve or maintain remission or a positive clinical response.

Crohn's disease continuation: Remission.remission or measurable improvement

Documented in chart notes, imaging, or scoring tools

Crohn's disease continuation: Improvement in abdominal pain/tenderness, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on a disease activity scoring tool (e.g., CDAI).remission or measurable improvement

Documented in chart notes, imaging, or scoring tools

Continuation therapy — Ulcerative colitis

Authorization of 12 months may be granted for members who achieve or maintain remission or a positive clinical response.

Ulcerative colitis continuation: Remission.remission or measurable improvement

Documented in chart notes, labs, or endoscopy/imaging

Ulcerative colitis continuation: Improvement in stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on a disease activity scoring tool (e.g., UCEIS, Mayo score).remission or measurable improvement

Documented in chart notes, labs, or endoscopy/imaging

General safety

Safety and concomitant therapy rules apply for all indications.

General safety criteria: Documented negative tuberculosis (TB) test (TST or IGRA) within 12 months for patients naïve to biologic or targeted synthetic drugs; if TB screening is positive, further testing must exclude active disease (e.g., chest x-ray) and latent TB must be treated prior to initiation. Do not administer the requested medication to members with active TB infection.TB testing within 12 months

Applies to all indications

General safety criteria: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

Applies to all indications

Ulcerative colitis — initial/continuation authorization

Covered when ALL of the following are met for ulcerative colitis:

Ulcerative colitis authorization: Member is using the requested medication for moderately to severely active ulcerative colitis AND achieves or maintains remission or a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms.

Evidence of improvement may include stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal appearance on imaging/endoscopy, or improvement on a disease activity scoring tool (e.g., UCEIS, Mayo score).

Universal safety requirements

Conditions required for all indications:

TB screening and concomitant therapy: Member has a documented negative TB test (TST or IGRA) within 12 months if naïve to biologic/targeted synthetic drugs; if TB screening is positive, further testing must exclude active disease and latent TB must be treated before initiation. Do not administer to members with active TB infection. Member may not use the requested medication concomitantly with any other biologic or targeted synthetic drug for the same indication.TB testing within 12 months

Do not administer to members with active TB infection.

All indications for risankizumab (Skyrizi) that are not listed among the FDA-approved or recognized compendial uses are considered experimental/investigational and not medically necessary and therefore are not covered under this policy.

Do not administer the requested medication to members with active tuberculosis infection. The policy requires evaluation and appropriate treatment for latent TB prior to initiation, and active disease must be excluded before therapy is given.

Use of Skyrizi for any indication other than the listed FDA-approved indications (moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis) or accepted compendial uses is not medically necessary and is not covered by this policy.

Concurrent use of Skyrizi with another biologic drug or a targeted synthetic drug for the same indication is not allowed. Requests that propose concomitant therapy with another biologic or targeted synthetic agent for the same condition may be denied.

Referenced Codes and Key Values

Referenced drugNDC

risankizumab-rzaa

Generic name for Skyrizi

Plaque psoriasis BSA — Coverage thresholds

Primary BSA threshold>= 10% of body surface area (BSA)

Secondary BSA threshold>= 3% of BSA with additional criteria

Additional criteria for >=3% BSAInadequate response or intolerance to phototherapy (e.g., UVB, PUVA) or methotrexate/cyclosporine/acitretin

Alternative criterion for >=3% BSAClinical reason to avoid methotrexate, cyclosporine, or acitretin (see Appendix)

Crucial body areas criterionInvolvement of hands, feet, face, neck, scalp, genitals/groin, or intertriginous areas qualifies regardless of BSA

TB screening interval

Provider Requirements, Documentation, and Denial Risks

Documentation Required

Required documentation

Submission of the following information is necessary to initiate the prior authorization review: chart notes or medical record documentation of affected area(s) and body surface area (BSA) affected (if applicable); chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy; if therapy is not advisable, documentation of clinical reason to avoid therapy. For continuation requests, submit chart notes or medical record documentation demonstrating decreased BSA and/or improvement in signs and symptoms, or other evidence of positive clinical response or remission (for Crohn's disease and ulcerative colitis: documentation of improvement in disease-specific measures such as stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, endoscopic appearance, or validated disease activity scores).

Initial requests: affected areas and BSA; prior medication history and responses or documented clinical reason to avoid prior therapies
Continuation requests: documentation of decreased BSA and/or improvement in signs and symptoms or other objective measures of response/remission (see indication-specific examples)
Crohn's disease/Ulcerative colitis continuation: improvement in specific clinical signs, laboratory markers, endoscopic or imaging findings, or validated activity scores

Background and Scope

Skyrizi (risankizumab-rzaa) is indicated for adults with moderate-to-severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease and ulcerative colitis. Coverage under this policy is conditional on meeting the disease-specific clinical criteria, safety requirements (including TB screening when applicable), and prior authorization requirements described elsewhere in the policy.

Key Terms and Clinical Definitions

Body surface area (BSA) — Definition and policy thresholds

DefinitionBody surface area (BSA) = percent of the patient's body surface affected by psoriasis

Coverage threshold (primary)>= 10% BSA qualifies for coverage

Coverage threshold (secondary)>= 3% BSA qualifies only with inadequate response/intolerance to phototherapy or methotrexate/cyclosporine/acitretin, or a clinical reason to avoid those therapies

TB screening — Acceptable tests and timing

Acceptable testsTuberculosis skin test (TST) or interferon-release assay (IGRA)

Timing requirementTest must be performed within 12 months prior to initiating therapy

OpenPayer

Skyrizi (risankizumab-rzaa) — coverage and prior authorization criteria

Coverage and Clinical Criteria

Referenced Codes and Key Values

Provider Requirements, Documentation, and Denial Risks

Background and Scope

Key Terms and Clinical Definitions