Cigna ustekinumab SC Prior Auth Policy Update

Coverage and Exclusion Criteria

inv-01: Crohn's Disease

Approve for the duration noted if the patient meets ONE of the following (A or B):

Crohn's Disease A or B: A) Initial Therapy: Approve for 6 months if ALL: i. Patient is > 18 years of age; AND ii. According to the prescriber, the patient will receive a single induction dose with ustekinumab intravenous within 2 months of initiating ustekinumab subcutaneous; AND iii. Patient meets ONE of: a) patient has tried or is currently taking corticosteroids, or corticosteroids are contraindicated; OR b) patient has tried one conventional systemic therapy for Crohn's disease (examples: azathioprine, 6-mercaptopurine, methotrexate); OR c) patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas; OR d) patient had ileocolonic resection to reduce chance of Crohn's disease recurrence; AND iv. Medication is prescribed by or in consultation with a gastroenterologist. B) Patient is Currently Receiving Ustekinumab Subcutaneous: Approve for 1 year if BOTH: i. Patient has been established on the requested drug for at least 6 months; AND ii. Patient meets at least ONE of: a) when assessed by at least one objective measure the patient experienced a beneficial clinical response from baseline (examples: fecal markers, serum markers, imaging studies, endoscopic assessment, and/or reduced corticosteroid dose); OR b) compared with baseline the patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or blood in stool).

Examples of objective measures: fecal markers (fecal lactoferrin, fecal calprotectin), serum markers (CRP), imaging (MRE, CT enterography), endoscopy, or reduced steroid dose.

inv-02: Plaque Psoriasis

Patient meets ONE of the following (A or B):

Plaque Psoriasis A or B: A) Initial Therapy: Approve for 3 months if ALL: i. Patient is ≥ 6 years of age; AND ii. Patient meets ONE: a) patient has tried at least one traditional systemic agent for psoriasis for at least 3 months unless intolerant (examples: methotrexate, cyclosporine, acitretin; a 3-month trial of PUVA counts); OR b) patient has a contraindication to methotrexate as determined by the prescriber; AND iii. Medication is prescribed by or in consultation with a dermatologist. B) Patient is Currently Receiving Ustekinumab Subcutaneous: Approve for 1 year if ALL: i. Patient has been established on the requested drug for at least 3 months; AND ii. Patient experienced a beneficial clinical response, defined as improvement from baseline in at least one of estimated body surface area, erythema, induration/thickness, and/or scale; AND iii. Compared with baseline the patient experienced an improvement in at least one symptom (e.g., decreased itching, pain, burning).

If 90 mg syringe is requested, approve if patient weighs >100 kg OR is currently receiving the 90 mg syringe OR had inadequate efficacy after ≥3 months on the 45 mg syringe.

inv-03: Psoriatic Arthritis

Approve (45 mg) if the patient meets ONE of the following (A or B):

Psoriatic Arthritis A or B: A) Initial Therapy: Approve for 6 months if BOTH: i. Patient is > 6 years of age; AND ii. Medication is prescribed by or in consultation with a rheumatologist or a dermatologist. B) Patient is Currently Receiving Ustekinumab Subcutaneous: Approve for 1 year if BOTH: i. Patient has been established on the requested drug for at least 6 months; AND ii. Patient meets at least ONE of: a) when assessed by at least one objective measure the patient experienced a beneficial clinical response from baseline (examples: DAPSA, CPDAI, PsA DAS, MDA, PsAID-12, or serum markers); OR b) compared with baseline the patient experienced an improvement in at least one symptom (e.g., less joint pain, decreased morning stiffness, improved function or activities of daily living).

If 90 mg syringe is requested, approve if patient has moderate‑to‑severe plaque psoriasis and weighs >100 kg OR is currently receiving 90 mg OR had inadequate efficacy after ≥3 months on 45 mg.

inv-04: Ulcerative Colitis

Approve for the duration noted if the patient meets ONE of the following (A or B):

Ulcerative Colitis A or B: A) Initial Therapy: Approve for 6 months if ALL: i. Patient is > 18 years of age; AND ii. According to the prescriber, the patient will receive a single induction dose with ustekinumab intravenous within 2 months of initiating ustekinumab subcutaneous; AND iii. Medication is prescribed by or in consultation with a gastroenterologist. B) Patient is Currently Receiving Ustekinumab Subcutaneous: Approve for 1 year if BOTH: i. Patient has been established on the requested drug for at least 6 months; AND ii. Patient meets at least ONE of: a) when assessed by at least one objective measure the patient experienced a beneficial clinical response from baseline (examples: fecal calprotectin, CRP, endoscopy, and/or reduced corticosteroid dose); OR b) compared with baseline the patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, decreased rectal bleeding).

Examples of assessment for inflammatory response include fecal calprotectin, CRP, endoscopic assessment, and/or reduced corticosteroid dose.

inv-05: Conditions Not Covered

The policy explicitly lists conditions and situations for which ustekinumab subcutaneous is not covered.

Conditions Not Covered - Ankylosing Spondylitis: Ustekinumab subcutaneous is not covered for Ankylosing Spondylitis; available evidence (e.g., TOPAS proof‑of‑concept study) is insufficient to support coverage.

TOPAS was a small prospective open‑label study (n=20) with mixed efficacy domains.

Conditions Not Covered - Concomitant Therapy: Concurrent administration of ustekinumab subcutaneous with another biologic or with a targeted synthetic oral small molecule drug used for an inflammatory condition is not covered due to safety and limited evidence; conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) are permitted in combination.

Combination therapy is generally not recommended because of potentially higher adverse events and lack of controlled data.

The policy treats listed ustekinumab subcutaneous products as not medically necessary for any uses not specified in FDA‑approved indications. The document lists specific products and states that coverage will follow the specified FDA‑approved indications; other uses are excluded and the list may be updated as new published data become available. (See the policy's Conditions Not Covered section for the full product list.)

The policy prohibits concurrent administration of ustekinumab with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition. Combination therapy is discouraged because of potentially higher adverse-event rates and limited controlled data demonstrating additive benefit. The policy clarifies that this exclusion does not apply to concomitant use of conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine).

The policy explicitly lists clinical situations that are not covered: Ankylosing Spondylitis is identified as not covered due to insufficient evidence from small, open‑label studies, and concomitant use with another biologic or a targeted synthetic oral small molecule drug for inflammatory conditions is excluded because of safety and limited efficacy data. Conventional synthetic DMARD co‑therapy is still permitted.

Use of ustekinumab subcutaneous for Ankylosing Spondylitis is considered not covered. The policy summarizes available evidence (the TOPAS proof‑of‑concept study: a small, open‑label trial of 20 patients) and concludes that more data are needed to demonstrate efficacy across key disease domains; therefore requests for this indication may be denied.

Initial Therapy — Authorization Requirements

inv-24: Initial Therapy

Initial therapy approval durations and requirements vary by indication.

Initial Crohn's: Initial approval: 6 months. Requirements: patient >18 years; prescriber states single IV induction with ustekinumab within 2 months of initiating SC; meets one of steroid use/conventional systemic therapy/fistula/ileocolonic resection criteria; prescribed by or in consultation with a gastroenterologist.6 months

Examples of conventional systemic therapy include azathioprine, 6‑mercaptopurine, methotrexate.

Initial Plaque Psoriasis: Initial approval: 3 months. Requirements: patient ≥6 years; trial of at least one traditional systemic agent for ≥3 months unless intolerant (examples: methotrexate, cyclosporine, acitretin; 3‑month PUVA counts); or contraindication to methotrexate; prescribed by or in consultation with a dermatologist.3 months

90 mg syringe criteria: patient >100 kg OR currently receiving 90 mg OR inadequate efficacy after ≥3 months on 45 mg.

Continuation Therapy — Ongoing Treatment

inv-26: Continuation Therapy

Criteria for patients currently receiving ustekinumab subcutaneous.

Continuation criteria general: Generally approve for 1 year if the patient has been established on the requested drug for the specified minimum duration (≥3 months for plaque psoriasis; ≥6 months for Crohn's disease, psoriatic arthritis, and ulcerative colitis) AND demonstrates beneficial clinical response by objective measures or symptom improvement compared with baseline.duration varies by indication

Examples of objective measures: fecal markers, serum markers, imaging, endoscopy, DAPSA/other PsA indices, or reduced corticosteroid dose.

Step Therapy and Prior Treatment Requirements

Requirement	Details
Trial of conventional or traditional systemic agents	For several initial-therapy indications (e.g., Crohn's disease, plaque psoriasis, psoriatic arthritis), the policy requires a trial of at least one conventional systemic agent or one traditional systemic agent prior to approval unless the patient is intolerant or meets an exception (such as prior biologic use). Examples include azathioprine, 6-mercaptopurine, methotrexate for Crohn's disease and methotrexate, cyclosporine, or acitretin for psoriasis.
Corticosteroid trial or contraindication (Crohn's disease)	For Crohn's disease initial therapy, the patient must have tried or currently be taking corticosteroids, or have corticosteroids contraindicated, unless an exception applies (e.g., prior biologic other than the requested drug).
Prescriber specialty requirement	Initial therapy must be prescribed by or in consultation with a specialist appropriate to the indication (gastroenterologist for Crohn's disease and ulcerative colitis; dermatologist for plaque psoriasis; rheumatologist or dermatologist for psoriatic arthritis).
Exceptions to step requirement	An exception to the requirement for a trial of steroids or a conventional/traditional systemic agent can be made if the patient has previously received at least one biologic other than the requested drug; a biosimilar of the requested biologic does not count. A patient who has already received a biologic is not required to 'step back' to try another agent.

Revision	Impact on Ulcerative Colitis Initial Therapy
Removal of single-systemic-therapy pathway	For Ulcerative Colitis initial therapy, the policy removed prior approval options that previously allowed approval after a single systemic therapy; these options are no longer included in the initial-therapy criteria.
Removal of certain pouchitis-related options	The policy's annual revision removed pouchitis-related approval options (e.g., prior trial of antibiotic, probiotic, corticosteroid enema, or mesalamine enema) from the Ulcerative Colitis initial-therapy pathways.
Current initial-therapy requirements retained	Ulcerative Colitis initial therapy continues to require that the patient be >18 years of age, that the prescriber states the patient will receive a single IV induction dose within 2 months of initiating subcutaneous therapy, and that the medication be prescribed by or in consultation with a gastroenterologist; initial approvals are for 6 months.

Provider Requirements and Billing Actions

Billing Rule

Coding and claims

Claims submitted for services that are not accompanied by covered diagnosis and/or procedure codes under the applicable coverage policy will be denied as not covered. When billing, providers must use the most appropriate codes as of the effective date of the submission. Reimbursement is not allowed for services billed for conditions or diagnoses that are not covered under this coverage policy.

Claims lacking covered diagnosis or procedure codes will be denied

Documentation Required

Documentation of age criteria

For initial approvals, age requirements are documented in the criteria for specific indications (for example: Crohn's disease — patient ≥ 18 years; psoriatic arthritis — patient ≥ 6 years). Review the indication-specific criteria and supporting notes for the applicable age requirement.

Dosing Thresholds and Codes

Weight thresholds for dosing

Adult weight cutoffs≤ 100 kg and > 100 kg used to determine 45 mg vs 90 mg adult SC dosing for plaque psoriasis and psoriatic arthritis

Pediatric weight categories (≥6 years)<60 kg, 60–100 kg, and >100 kg — dosing: 0.75 mg/kg (<60 kg), 45 mg (60–100 kg), 90 mg (>100 kg)

Crohn's disease dosing noteMaintenance after IV induction: 90 mg SC Q8W (weight not used to alter maintenance dose in Crohn's)

Ulcerative colitis dosing noteMaintenance after IV induction: 90 mg SC Q8W (initiation requires prior single IV induction)

Billing Rule

Stelara and biosimilars — same PA criteria apply

Stelara (ustekinumab) and listed biosimilar/substitutable ustekinumab products are included in the policy and are covered under the same prior authorization criteria and requirements.

Biosimilars and Product List

Note

Additional ustekinumab SC products added — subject to same criteria

Additional ustekinumab subcutaneous products (listed in the policy history and product list) were added to the policy and are subject to the same clinical criteria and prior authorization requirements as Stelara SC.

Recent additions include multiple branded, biosimilar, and unbranded ustekinumab SC products; confirmation of product name should be included in the request.

Definitions and Clinical Measures

IV induction

DefinitionAn IV induction regimen consists of a single intravenous ustekinumab dose followed by subcutaneous maintenance dosing; for Crohn's disease and ulcerative colitis maintenance begins 8 weeks after the IV induction dose.

Timing for SC maintenanceMaintenance SC dosing begins 8 weeks after the initial IV induction dose for Crohn's disease and ulcerative colitis.

Prescription requirementPrescriber must state patient will receive the single IV induction dose within 2 months of initiating SC for initial therapy approvals (per indication criteria).

ASAS40 (Assessment of SpondyloArthritis International Society 40% improvement)

ASAS40 meaningAssessment of SpondyloArthritis International Society 40% improvement criterion (ASAS40): primary endpoint used in TOPAS trial to define a 40% improvement in disease activity at Week 24.

Background

Ustekinumab subcutaneous is an interleukin‑12/23 inhibitor indicated for inflammatory conditions including Crohn's disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis. Dosing is weight‑ and indication‑dependent and, for some gastrointestinal indications, may require a single intravenous induction dose followed by subcutaneous maintenance. The policy lists multiple branded and biosimilar ustekinumab SC products and aligns coverage criteria and prior‑authorization requirements across these products.

Revision History and Policy Changes

2025-06-25product_addition

Ustekinumab-aekn (unbranded Selarsdi) and Imuldosa subcutaneous were added to the policy; the same criteria apply for all ustekinumab subcutaneous products.

2025-07-23policy_name_and_product_updatesLatest

Policy name changed to list Ustekinumab Subcutaneous Products more generally; multiple additional branded and unbranded ustekinumab subcutaneous products (e.g., Wezlana, Otulfi, Pyzchiva, Selarsdi, Steqeyma, Yesintek, Ustekinumab-ttwe, unbranded Stelara, Ustekinumab-aekn, Imuldosa) were added and are subject to the same criteria.

OpenPayer

Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with Dosing