mhn Skyrizi (risankizumab) Coverage Update

Coverage Criteria

Initial Therapy — Plaque Psoriasis

Initial Approval — Plaque Psoriasis (must meet ALL):

Plaque Psoriasis Initial: Diagnosis of moderate-to-severe plaque psoriasis (PsO) as evidenced by either: (a) ≥ 3% total body surface area (BSA) involvement, or (b) involvement of hands, feet, scalp, face, or genital area; prescribed by or in consultation with a dermatologist or rheumatologist; age ≥ 18 years; prior therapy requirements met as below; no combination use with biological DMARDs or Janus kinase inhibitors; dosing does not exceed 150 mg at Weeks 0 and 4, then every 12 weeks thereafter.

Prior trials: failure of a ≥3 consecutive month trial of methotrexate (unless intolerant/contraindicated) AND failure of additional conventional options (cyclosporine or acitretin or phototherapy as specified) plus failure of a ≥3 month trial of one adalimumab product or history of failure of two TNF blockers; failure of Taltz (≥3 months) and failure of one ustekinumab product (≥3 months) are also required unless contraindicated or intolerant. Prior authorization may be required for listed comparators.

Initial Therapy — Psoriatic Arthritis

Initial Approval — Psoriatic Arthritis (must meet ALL):

Psoriatic Arthritis Initial: Diagnosis of psoriatic arthritis (PsA); prescribed by or in consultation with a dermatologist or rheumatologist; age ≥ 18 years; failure of ALL of the following (each used ≥3 consecutive months unless contraindicated or intolerant): (a) one adalimumab product (unless member has history of failure of two TNF blockers), (b) Otezla/Otezla XR, (c) Taltz, (d) one ustekinumab product, and (e) if not responsive/intolerant to TNF blockers then Xeljanz/Xeljanz XR unless cardiovascular risk precludes use; no combination use with biological DMARDs or JAK inhibitors; dose does not exceed 150 mg at Weeks 0 and 4, then every 12 weeks thereafter.

Each required agent trial typically ≥3 months unless contraindicated; prior authorization may be required for listed comparators.

Initial Therapy — Crohn's Disease

Initial Approval — Crohn's Disease (must meet ALL):

Crohn's Disease Initial

Crohn's Dosing: Induction: 600 mg IV at Weeks 0, 4, and 8; Maintenance: 360 mg SC at Week 12 and every 8 weeks thereafter (SC maintenance options include 180 mg or 360 mg per section V); if request is for vials or cartridges, quantity limited to one single-dose vial or one pre-filled cartridge per dose.
IV induction doses administered in infusion setting; quantity limits apply to vial/cartridge requests only.

Initial Therapy — Ulcerative Colitis

Initial Approval — Ulcerative Colitis (must meet ALL):

Ulcerative Colitis Initial: Diagnosis of moderately to severely active ulcerative colitis (UC); prescribed by or in consultation with a gastroenterologist; age ≥ 18 years; disease severity documentation and prior therapy requirements met; no combination use with biological DMARDs or JAK inhibitors; induction and maintenance dosing as specified.

Disease activity: documentation of Mayo Score ≥6 OR modified Mayo Score ≥5 OR Mayo Endoscopic Score ≥2 is required to define moderate-to-severe UC. Prior therapy: failure of an 8-week trial of systemic corticosteroids (unless contraindicated or previously failed a biologic for UC) AND failure of one adalimumab product or one ustekinumab product used ≥3 months unless contraindicated. Dosing: Induction 1,200 mg IV at Weeks 0, 4, and 8; Maintenance 360 mg SC at Week 12 and every 8 weeks thereafter. If request is for cartridges, quantity limited to one pre-filled cartridge per dose. Prior authorization may be required for listed comparators.

Continuation — Continued Therapy

Continued Therapy (all indications):

Continued Therapy: Member meets one of: (a) currently receiving medication via Centene benefit or previously met initial approval criteria, or (b) currently receiving medication and enrolled in continuity of care provisions; member is responding positively to therapy; no combination use with biological DMARDs or JAK inhibitors; dose increases do not exceed indication-specific maximums.

Dose limits for increases: PsO/PsA — 150 mg every 12 weeks; CD/UC — 360 mg every 8 weeks (if cartridges requested, 1 pre-filled cartridge every 8 weeks). Approval duration for continued therapy: 12 months.

Indication-specific dosing and coverage

Covered when dosing and disease documentation meet indication-specific criteria and any step or bypass rules are satisfied.

PsO/PsA dosing: Psoriasis and psoriatic arthritis dosing: 150 mg subcutaneous (SC) at Week 0 and Week 4, then every 12 weeks thereafter (maximum 150 mg every 12 weeks).

See Section V dosing details.

Crohn's disease dosing: Induction — 600 mg IV at Weeks 0, 4, and 8; Maintenance — 180 mg or 360 mg SC at Week 12 and every 8 weeks thereafter (IV 600 mg per dose; SC maintenance 360 mg every 8 weeks).

Quantity limits apply for vial/cartridge formulations (one single-dose vial or pre-filled cartridge per dose when requested).

Ulcerative colitis dosing: Induction — 1,200 mg IV at Weeks 0, 4, and 8; Maintenance — 180 mg or 360 mg SC at Week 12 and every 8 weeks thereafter (IV 1,200 mg per dose; SC maintenance 360 mg every 8 weeks).

Moderate-to-severe UC may be defined by modified Mayo Score ≥5 or Mayo Endoscopic Score >2 per updated criteria; quantity limits apply to cartridges where specified.

Coverage criteria and updates

Policy includes indication-specific coverage criteria with added options and step/bypass rules.

Ulcerative Colitis initial criteria: Added option to use modified Mayo Score ≥5 OR Mayo Endoscopic Score >2 to define moderate-to-severe UC; removal of automatic redirection to preferred adalimumab products due to guideline recommendations; revised redirection to Zeposia with bypass allowance when member has prior biologic failure.modified Mayo Score >=5 or Mayo Endoscopic Score >2

See Appendix F for supplemental information on modified Mayo Score.

Biosimilar and bypass requirements: For PsO, PsA, CD, and UC, requirement added to use one preferred ustekinumab (Stelara) biosimilar (examples: Otulfi, Pyzchiva, Selarsdi, Yesintek, Steqeyma) where applicable; allows bypass of conventional therapy requirements if member has failed a biologic agent, preventing step-back from biologic to conventional therapy.

Preferred biosimilar step requirement applies per SDC updates.

Quantity and approval updates: Quantity limits apply to vial/cartridge requests only; new 180 mg/1.2 mL single-dose prefilled syringe/cartridge form added; extended initial approval durations to 12 months for chronic conditions.

Non‑FDA‑approved indications are not addressed by this policy unless the request is supported by the off‑label use policy (CP.PMN.53) or other evidence of coverage documentation. Requests that propose combination therapy with other biological DMARDs, Janus kinase inhibitors, or other potent immunosuppressants listed in the policy are not authorized because of additive immunosuppression and elevated risk of neutropenia and serious infections.

Asthma is an explicit diagnosis for which coverage of risankizumab‑rzaa is not authorized. A randomized phase 2a trial demonstrated no benefit in severe asthma and showed a shorter time to first asthma worsening and a higher annualized rate of asthma worsening with risankizumab compared with placebo; therefore use for asthma is not covered.

Per the 2Q 2025 review, the policy removed automatic redirection to preferred adalimumab products for ulcerative colitis because adalimumab is not recommended due to low efficacy per the 2024 AGA guidelines; the policy now revises redirection to alternative agents (for example, Zeposia) with stated bypass allowances when prior biologic failure has occurred.

Use of risankizumab‑rzaa for severe asthma is not supported by the available evidence and is listed as not covered. The phase 2a trial cited in the policy found no clinical benefit and identified worse asthma outcomes with risankizumab versus placebo.

The policy no longer redirects ulcerative colitis requests to preferred adalimumab products because guideline review concluded adalimumab has low efficacy for UC; instead the policy specifies alternative step options and allows bypass to other agents when a history of biologic failure exists.

Initial Therapy Criteria

Initial therapy — Indication-specific

Indication-specific initial therapy criteria (must meet ALL items listed per indication):

Plaque Psoriasis Initial (summary): See plaque psoriasis initial criteria: diagnosis (≥3% BSA or involvement of special areas), prescriber specialty, age ≥18, sequential trials of conventional systemic agents and specified biologics (adalimumab product or history of two TNF failures, Taltz, ustekinumab), prohibition on combination use with bDMARDs/JAKi, dosing limit 150 mg at Weeks 0 and 4 then q12w.

Prior authorization may be required for comparators; approval duration: 12 months.

Psoriatic Arthritis Initial (summary): See PsA initial criteria: diagnosis, prescriber specialty, age ≥18, failure of all specified agents (one adalimumab product unless history of two TNF failures, Otezla/Otezla XR, Taltz, one ustekinumab product, and Xeljanz if applicable), prohibition on combination use, dosing limit 150 mg at Weeks 0 and 4 then q12w.

Each comparator trial typically ≥3 months; prior authorization may be required.

Crohn's Disease Initial (summary):

Continuation and Maintenance Criteria

Continuation — Continued Therapy

Continuation — Continued therapy requirements:

Continued Therapy Requirements: Member must be currently receiving the medication via the Centene benefit or have previously met initial approval criteria (or be covered under continuity of care); member must be demonstrating a positive clinical response to therapy; no combination use with biological DMARDs or JAK inhibitors; dose increases must not exceed indication-specific maxima.

Approval duration for continued therapy: 12 months. Dose limits for increases: PsO/PsA — 150 mg every 12 weeks; CD/UC — 360 mg every 8 weeks (if cartridges requested, 1 pre-filled cartridge every 8 weeks).

Maintenance therapy

Maintenance therapy — Continuation/maintenance dosing per indication:

Maintenance PsO/PsA: Maintenance dosing for plaque psoriasis and psoriatic arthritis: 150 mg SC every 12 weeks.

Dose increase requests must not exceed 150 mg every 12 weeks.

Step Therapy and Biosimilar Requirements

Indication	Required prior therapy (conventional agents)	Required prior biologic trials / preferred biosimilar step	Notes / Bypass rules
{"text":"Plaque Psoriasis (PsO)","status":""},{"text":"- Failure of ≥3 month trial of methotrexate (or documented intolerance/contraindication)\n- If MTX not used: failure of ≥3 month trial of cyclosporine or acitretin, or failure of phototherapy if other agents contraindicated","status":""},{"text":"- Failure of ≥3 month trial of one adalimumab product (preferred: Hadlima, Simlandi, Yusimry, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-fkjp) OR failure of Taltz (≥3 months) AND failure of one ustekinumab product (preferred Stelara biosimilars: Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, Steqeyma) as applicable. Use of one preferred Stelara biosimilar is required step option for PsO.","status":""},{"text":"- Bypass: If member has previously failed a biologic for PsO, conventional therapy step may be bypassed. Prior biologic history may also allow bypass of adalimumab/ustekinumab step per TNFi history. Prior authorization may be required for adalimumab, Taltz, and ustekinumab products.","status":""}

Indication	Preferred step-through requirement	Bypass allowance
{"text":"Psoriatic Arthritis (PsA)","status":""},{"text":"- Prior failure of ALL: one adalimumab product (preferred examples listed), Otezla, Taltz, and one ustekinumab product. For step requirement to biologics, use one preferred Stelara biosimilar as an option for step-through for PsA.","status":""},{"text":"- Bypass: If member has history of failure of two TNF blockers, TNFi steps may be bypassed; prior biologic failure or intolerance may also allow bypass.","status":""}
{"text":"Crohn's Disease (CD)","status":""},{"text":"- Failure of ≥3 month trial of an immunomodulator (azathioprine, 6-MP, or MTX) unless previously failed a biologic for CD or medically unable. Then failure of one adalimumab product (preferred examples) OR history of failure of two TNF blockers; use of one preferred Stelara biosimilar as step option for CD.","status":""},{"text":"- Bypass: Prior failure of a biologic for CD allows bypass of conventional therapies; history of two TNF blocker failures allows bypass of adalimumab step.","status":""}
{"text":"Ulcerative Colitis (UC)","status":""},{"text":"- Documentation of disease activity (Mayo score ≥6, modified Mayo ≥5, or Mayo Endoscopic Score ≥2). Failure of 8-week systemic corticosteroids trial, and failure of one adalimumab product OR one ustekinumab product (preferred examples). For UC, step-through may include preferred adalimumab product or preferred ustekinumab product; one preferred Stelara biosimilar is a required step option.","status":""},{"text":"- Bypass: If member previously failed a biologic for UC, conventional therapy steps may be bypassed. Prior authorization may be required for adalimumab and ustekinumab products.","status":""}

Requirement	Details	Operational note
{"text":"Preferred agent requirement","status":""},{"text":"- One preferred Stelara biosimilar (Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, Steqeyma) or a preferred adalimumab product may be required prior to risankizumab unless bypass applies based on prior biologic failures or contraindications.","status":""},{"text":"- Providers must supply documentation of trials (agent, dates, dose, outcome) and disease activity measures where applicable. Requests may be subject to denial if the health care provider does not provide sufficient documentation or if step therapy requirements are not met.","status":""}

Step Therapy

Preferred biosimilar step requirement — For PsO, PsA, CD, and UC require use of one preferred Stelara biosimilar as step option

For PsO, PsA, CD, and UC, one preferred Stelara biosimilar must be used as a step option prior to risankizumab unless bypass criteria apply (e.g., prior failure of biologics, documented contraindication/intolerance).

Preferred Stelara biosimilars: Otulfi, Pyzchiva (branded), Selarsdi, Yesintek, Steqeyma
Providers must document prior trials, disease activity (e.g., Mayo scores for UC), and reasons for any bypass

Quantity Limits and Dosage Forms

Skyrizi (vials/cartridges) — quantity limit

Quantity limitOne single-dose vial or one pre-filled cartridge per dose when request is for vials or cartridges.

Applies toVial or cartridge requests for Skyrizi (risankizumab-rzaa).

ContextQuantity limit specified in Crohn's disease and cartridge requests language in dosing sections.

Risankizumab-rzaa — vial/cartridge limit for Crohn's disease

Quantity limit (CD)Only one single‑dose vial or single‑dose prefilled cartridge allowed per dose when requesting vials/cartridges for Crohn's disease.

Formulations referencedSingle‑dose prefilled cartridges and single‑dose vials listed in product availability (e.g., 180 mg/1.2 mL cartridges; 600 mg/10 mL vial).

Coding and Billing

Referenced HCPCS/J-codesHCPCS

J2327	Injection, Risankizumab-rzaa, intravenous, 1 mg.
C9399	Unclassified drugs or biologicals.
J3590	Unclassified biologics

Section III.B HCPCS additionsHCPCS

C9399	Not otherwise classified HCPCS code (added to section III.B)
J3590	Not otherwise classified drug HCPCS code (added to section III.B)

Body Surface Area (BSA) requirement for PsO

BSA threshold>= 3% of total body surface area

Use in criteriaUsed as evidence of moderate‑to‑severe plaque psoriasis for initial approval.

Alternative evidenceInvolvement of hands, feet, scalp, face, or genital area also qualifies if BSA <3%.

Mayo Score thresholds for UC

Mayo Score thresholdsMayo Score >= 6, modified Mayo Score >= 5, or Mayo Endoscopic Score >= 2

PurposeUsed to document disease activity for initial Ulcerative Colitis approval.

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required; approval is granted when indication-specific criteria are met (diagnosis, prescriber specialty, age ≥18, required prior medication trials or contraindications, dosing limits).

Prior authorization may also be required for comparator agents such as adalimumab, Taltz, ustekinumab, Otezla, and Xeljanz as noted in the criteria.

Prior Authorization

Prior authorization requirements updated (UC, biosimilar steps, quantity limits)

Prior authorization criteria were updated to add the ulcerative colitis indication, require preferred biosimilar/agent step options, and include quantity limits for vial/cartridge requests for CD and UC.

Quantity limits: if request is for vials/cartridges, limit of one single-dose vial or one pre-filled cartridge per dose (CD/UC as specified).
Preferred biosimilar/agent step requirements added for multiple indications.

Site of Care and Administration

Note

Administration site requirements for IV induction and SC dosing

IV induction doses must be administered via an infusion center (IV induction: 600 mg for CD; 1,200 mg for UC); subcutaneous doses may be administered in office or at home when appropriate.

IV dosing regimens per indication are defined in the dosing section and must be followed for induction.
SC maintenance doses can be given in outpatient settings or at home as applicable.

Note

Site-of-care notes and documentation implications

Site-of-care considerations may affect administration setting and documentation; follow infusion center or outpatient clinic protocols and document site of administration as applicable.

Induction IV doses should be scheduled at infusion centers; document the site on prior authorization and billing submissions.

Biosimilar and Preferred Agent Requirements

Billing Rule

Preferred Stelara biosimilar required in step pathways

For PsO, PsA, CD, and UC, the policy requires use of one preferred ustekinumab (Stelara) biosimilar (Otulfi, Pyzchiva, Selarsdi, Yesintek, Steqeyma) as a step option where specified.

Preferred Stelara biosimilar use is required in applicable step pathways prior to risankizumab unless bypass criteria are met.

Step Therapy

Use preferred Stelara biosimilar before risankizumab when specified

Preferred Stelara biosimilar must be used prior to risankizumab where the criteria specify stepping through a ustekinumab product; bypass may apply if the member has prior biologic failure per policy rules.

Examples of preferred ustekinumab biosimilars are listed in the policy and should be used unless bypass criteria apply.

Background

Risankizumab‑rzaa (Skyrizi) is an interleukin‑23 (IL‑23) inhibitor indicated for adult patients with moderate‑to‑severe plaque psoriasis, active psoriatic arthritis, and for moderately to severely active Crohn’s disease and ulcerative colitis. The product is available in intravenous formulations for induction dosing (used for CD and UC induction) and subcutaneous formulations including single‑dose prefilled syringes and cartridges in multiple strengths.

Definitions and Scoring Systems

Definition — plaque psoriasis (PsO)

TermPlaque psoriasis

ShorthandPsO

ContextUsed throughout policy to denote moderate‑to‑severe plaque psoriasis eligible for systemic therapy or phototherapy.

Definition — Crohn's disease (CD)

TermCrohn's disease

ShorthandCD

ContextUsed in indication‑specific criteria for induction and maintenance dosing.

Quantity and Dosing Notes

Induction therapy dosing summary and formulations

Induction dosing — summaryInduction regimens by indication: PsO/PsA: 150 mg SC at Week 0 and Week 4; CD: 600 mg IV at Weeks 0, 4, 8; UC: 1,200 mg IV at Weeks 0, 4, 8.

Documented dose strengths/formulationsAvailable presentations include IV single‑dose vial 600 mg/10 mL; SC single‑dose prefilled syringes 90 mg, 150 mg, 180 mg/1.2 mL; pens and cartridges (180 mg/1.2 mL, 360 mg/2.4 mL).

Maintenance dosing noteMaintenance SC options include 180 mg or 360 mg at Week 12 and every 8 weeks for CD/UC; PsO/PsA maintenance 150 mg every 12 weeks.

Risankizumab‑rzaa — single‑dose formulations and strengths

New single‑dose formulation180 mg/1.2 mL single‑dose prefilled syringe (newly added presentation).

Other SC strengths

Revision History

2025-07-23added_indication

Added newly approved Ulcerative Colitis indication to the coverage criteria.

2025-01-23revised_criteria

For UC initial criteria, added option for documentation of modified Mayo Score ≥ 5, removed redirection to preferred adalimumab products per 2024 AGA guidance, and revised redirection to Zeposia with a bypass allowance when member has prior biologic failure.

2024-01-22coding_added

Added HCPCS codes C9399 and J3590 to Section III.B and updated coding implications.

OpenPayer

Risankizumab-rzaa (Skyrizi) coverage