Cigna ustekinumab SC Prior Auth Policy Update

Coverage Criteria for Ustekinumab Subcutaneous Products

Crohn's Disease

Crohn's Disease — Approve for the duration noted if the patient meets ONE of the following (A or B):

Crohn's disease - initial or established: A) Initial Therapy: Approve for 6 months if ALL of the following are met: (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 therapy with ustekinumab subcutaneous; AND (iii) the medication is prescribed by or in consultation with a gastroenterologist. OR B) Patient is Currently Receiving Ustekinumab Subcutaneous: Approve for 1 year if BOTH of the following are met: (i) patient has been established on the requested drug for at least 6 months; AND (ii) patient meets at least ONE of the following: (a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include fecal markers such as fecal calprotectin or lactoferrin, serum markers such as C-reactive protein, imaging, endoscopic assessment, or reduced corticosteroid dose); OR (b) compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or blood in stool).see text

Patients with <6 months of prior therapy or restarting therapy are reviewed under Initial Therapy.

Plaque Psoriasis

Plaque Psoriasis — Approve (45 mg syringe/vial) if patient meets ONE of the following (A or B):

Plaque psoriasis - initial or established: A) Initial Therapy: Approve for 3 months if ALL of the following are met: (i) patient is ≥ 6 years of age; AND (ii) patient meets ONE of: (a) patient has tried at least one traditional systemic agent for psoriasis for at least 3 months, unless intolerant (examples include methotrexate, cyclosporine, acitretin; a 3-month trial of PUVA may count); OR (b) according to the prescriber, the patient has a contraindication to methotrexate; AND (iii) the medication is prescribed by or in consultation with a dermatologist. Note: A 3-month trial or prior intolerance to a biologic (other than the requested biologic), Otezla/Otezla XR (apremilast), or Sotyktu (deucravacitinib) can substitute for the traditional systemic agent requirement; a biosimilar of the requested biologic does not count. OR B) Patient is Currently Receiving Ustekinumab Subcutaneous: Approve for 1 year if ALL of the following are met: (i) patient has been established on the requested drug for at least 3 months; AND (ii) patient experienced a beneficial clinical response (improvement from baseline in at least one of estimated body surface area, erythema, induration/thickness, and/or scale); AND (iii) compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, itching, and/or burning).see text

If 90 mg syringe is requested, approve per listed weight/established-therapy exceptions.

Psoriatic Arthritis

Psoriatic Arthritis — Approve (45 mg syringe/vial) if patient meets ONE of the following (A or B):

Psoriatic arthritis - initial or established: A) Initial Therapy: Approve for 6 months if BOTH of the following are met: (i) patient is > 6 years of age; AND (ii) the medication is prescribed by or in consultation with a rheumatologist or a dermatologist. OR B) Patient is Currently Receiving Ustekinumab Subcutaneous: Approve for 1 year if BOTH of the following are met: (i) patient has been established on the requested drug for at least 6 months; AND (ii) patient meets at least ONE of the following: (a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples of standardized measures include DAPSA, CPDAI, PsA DAS, MDA, PsAID-12, serum markers such as CRP/ESR, and enthesitis/dactylitis scores); OR (b) compared with baseline, patient experienced improvement in at least one symptom (e.g., less joint pain, morning stiffness, improved function, decreased soft tissue swelling).see text

Patients with <6 months of prior therapy or restarting therapy are reviewed under Initial Therapy.

Ulcerative Colitis

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

Ulcerative colitis - initial or established: A) Initial Therapy: Approve for 6 months if ALL of the following are met: (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 therapy with ustekinumab subcutaneous; AND (iii) the medication is prescribed by or in consultation with a gastroenterologist. OR B) Patient is Currently Receiving Ustekinumab Subcutaneous: Approve for 1 year if BOTH of the following are met: (i) patient has been established on the requested drug for at least 6 months; AND (ii) patient meets at least ONE of the following: (a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include fecal calprotectin, serum CRP, endoscopic assessment, or reduced corticosteroid dose); OR (b) compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or decreased rectal bleeding).see text

Patients with <6 months of prior therapy or restarting therapy are reviewed under Initial Therapy.

Unified coverage criteria and recent substantive edits

Policy applies the same coverage criteria to all ustekinumab subcutaneous products; includes indication-specific initial approval requirements and age thresholds added in revisions.

General: Same prior authorization criteria apply across all ustekinumab subcutaneous products (brands, biosimilars, unbranded).

Product list expanded in history; see HISTORY for specific additions.

Age requirements: For initial approvals: Crohn's disease and Ulcerative Colitis require patient ≥ 18 years; Psoriatic Arthritis requires patient ≥ 6 years.age

Added during selected revisions.

Plaque Psoriasis exceptions: A 3-month trial or prior intolerance to Otezla/Otezla XR (apremilast) or Sotyktu (deucravacitinib) can substitute for a trial of one traditional systemic agent; methotrexate contraindication is determined according to the prescriber.3 months

Use of ustekinumab subcutaneous products is considered not medically necessary for indications that are not listed as approved uses in this policy. Examples of such non-covered indications include conditions with insufficient evidence of efficacy such as ankylosing spondylitis. The policy lists specific ustekinumab subcutaneous products and states these are not medically necessary for any other use(s) beyond the covered indications; the list may not be all-inclusive and will be updated as new published data become available.

The policy expressly excludes concurrent administration of ustekinumab subcutaneous with another biologic agent or with a targeted synthetic oral small molecule drug for an inflammatory condition. Combination therapy of this type is not covered because of potential for increased adverse events and a lack of controlled clinical data demonstrating additive efficacy. Conventional synthetic disease-modifying antirheumatic drugs (for example, methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) are not included in this exclusion.

The Conditions Not Covered language was updated to clarify the prohibited combinations: the policy now specifies Concurrent Use with a Biologic or with a Targeted Synthetic Oral Small Molecule Drug. This change replaces prior wording that referred more generally to oral small molecule disease-modifying antirheumatic drugs and aligns the exclusion with the Appendix examples and recent revision history.

Ankylosing spondylitis is explicitly listed as not medically necessary due to insufficient evidence supporting ustekinumab for this condition. The policy also reiterates that combination therapy with other biologics or targeted synthetic oral small molecule drugs is not covered, reinforcing that such combinations are excluded across the listed ustekinumab subcutaneous products.

During recent revisions, certain prior-therapy options that previously qualified a patient for initial approval of ustekinumab subcutaneous in Ulcerative Colitis were removed. Examples of removed options include a prior requirement that the patient had tried one systemic therapy or specific pouchitis treatment pathways; these scenarios no longer satisfy the policy's initial-therapy approval criteria.

Initial Therapy Approval Conditions

Initial therapy

Initial therapy — indication-specific initial approval conditions (age limits, specialist involvement, induction dosing requirements)

Crohn's initial: Patient > 18 years AND planned IV induction within 2 months of SC initiation AND prescribed by or in consultation with a gastroenterologist.

Plaque psoriasis initial: Patient >= 6 years AND patient has tried >=1 traditional systemic agent for >=3 months unless intolerant OR has a prescriber-determined contraindication to methotrexate OR meets the noted exceptions (3-month trial or prior intolerance to a biologic other than the requested drug, apremilast, or deucravacitinib); AND medication prescribed by or in consultation with a dermatologist.

Psoriatic arthritis initial: Patient > 6 years AND medication prescribed by or in consultation with a rheumatologist or dermatologist.

Continuation and Established-on-Therapy Criteria

Continuation therapy

Continuation therapy — Criteria for patients currently receiving ustekinumab SC to receive continued approval

Continuation therapy general: Patient established on the requested drug for the indication-specific minimum duration (3 months for plaque psoriasis; 6 months for Crohn's disease, psoriatic arthritis, and ulcerative colitis) AND demonstrated benefit, defined as either: (a) improvement by at least one objective measure from baseline (examples vary by indication, e.g., fecal calprotectin, CRP, endoscopy for GI indications; BSA, erythema, induration, scale for psoriasis; standardized composite scores for PsA); OR (b) improvement in at least one symptom compared with baseline.

Continuation therapy — established-on-therapy conditions

Continuation therapy — continuation/established-on-therapy conditions (e.g., standardized 3 months established-on-therapy timeframe)

Established therapy timeframe: For patients currently receiving ustekinumab subcutaneous, the timeframe for being considered established on therapy is standardized to 3 months (replacing prior 90-day wording for plaque psoriasis); indication-specific established durations remain (3 or 6 months as specified).

Step Therapy Requirements

Requirement	Details
Step requirement
Patient must have tried at least one traditional systemic agent for plaque psoriasis for ≥3 months unless intolerant. Examples of traditional systemic agents include methotrexate, cyclosporine, or acitretin; a 3-month trial of PUVA also counts.
Exceptions to the traditional systemic agent trial
Exception allowed if the patient has had a 3-month trial of or prior intolerance to at least one biologic (other than the requested medication), Otezla/Otezla XR (apremilast), or Sotyktu (deucravacitinib). A biosimilar of the requested biologic does not count. A patient who already tried a biologic is not required to step back to a traditional systemic agent. Methotrexate contraindication is determined by the prescriber.

Context	Policy change / application
Scope of step/prior-therapy requirements
Policy includes step or prior-therapy requirements applied per indication; plaque psoriasis specifically requires the traditional systemic agent trial (with exceptions).
Ulcerative colitis initial therapy options removed
During recent revisions certain initial therapy approval options for ulcerative colitis were removed (examples: removing 'the patient has tried one systemic therapy' and specific pouchitis-related prior therapy options). Prior-therapy/step requirements remain indication-specific and documented per the applicable initial therapy criteria.

Provider Actions, Documentation, and Billing Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required for ustekinumab subcutaneous products. All approvals are provided for the durations specified in the policy; when expressed in months, 1 month = 30 days. Initial approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated.

Applies to all listed branded, biosimilar, and unbranded ustekinumab SC products

Step Therapy

Plaque Psoriasis Step Requirement

Initial approvals for plaque psoriasis require either a trial of at least one traditional systemic agent for ≥3 months (examples: methotrexate, cyclosporine, acitretin; a 3‑month trial of PUVA also counts) unless the patient is intolerant, OR documentation that the prescriber determines the patient has a contraindication to methotrexate. An exception to the step requirement is permitted if the patient has had a 3‑month trial of or prior intolerance to at least one biologic (other than the requested medication), apremilast (Otezla/Otezla XR), or deucravacitinib (Sotyktu). A biosimilar of the requested biologic does not satisfy the exception. Patients already treated with a biologic are not required to first try a traditional systemic agent.

Coding and Dosing Information

Coding informationmixed

NDC/CPT/HCPCS codes not listed

No explicit billing codes provided in this part of the document.

Weight thresholds for dosing — dosing weight categories (>100 kg; 60–100 kg; < 60 kg)

60–100 kgAdults or pediatric patients 60–100 kg: 45 mg SC at Week 0, Week 4, then every 12 weeks for plaque psoriasis and psoriatic arthritis.

< 60 kgPediatric patients ≥6 years weighing <60 kg: weight-based 0.75 mg/kg SC at Week 0, Week 4, then every 12 weeks for plaque psoriasis and psoriatic arthritis.

Product and Dosing Definitions

Maintenance dosing schedules vary by indication

Plaque psoriasis maintenanceAdults ≤100 kg: 45 mg SC at Week 0, Week 4, then Q12W; Adults >100 kg: 90 mg SC at Week 0, Week 4, then Q12W.

Psoriatic arthritis maintenanceAdults >100 kg with coexistent moderate-to-severe plaque psoriasis: 90 mg SC at Week 0, Week 4, then Q12W; all other adults: 45 mg SC at Week 0, Week 4, then Q12W.

Ustekinumab (IL-12/23 inhibitor) SC and IV formulations — product class and formulation notes

Drug classUstekinumab is an interleukin (IL)-12/23 inhibitor.

Administration routeSC injections are administered under physician supervision or by patient/caregiver; IV formulation is used for induction where specified.

Administration Setting

Note

Site of care: office or home SC administration

Doses are administered by subcutaneous injection either under physician supervision in the office or by the patient/caregiver at home; initial approvals require specialist oversight per the policy statement.

Biosimilar and Brand Product Coverage

Billing Rule

Listed ustekinumab SC products covered when criteria met

Several branded, biosimilar, and unbranded ustekinumab subcutaneous products are listed and are covered when policy criteria are met (examples include Stelara, Wezlana, Otulfi, Pyzchiva, Selarsdi, Steqeyma, Yesintek, Imuldosa, Starjemza, and multiple unbranded formulations).

Billing Rule

Same PA criteria for all ustekinumab SC formulations

All listed ustekinumab subcutaneous products — brand, biosimilar, and unbranded formulations — are subject to the same prior authorization criteria; there is no separate PA criteria set for individual ustekinumab products in this policy.

Background

Ustekinumab subcutaneous is an interleukin IL-12/23 inhibitor indicated for Crohn's disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis as described in this policy. Dosing is weight- and indication-dependent and may follow an IV induction dose for certain gastrointestinal indications; maintenance schedules vary by indication (for example, 90 mg SC every 8 weeks for Crohn's disease and ulcerative colitis, with different intervals and weight-based adjustments for plaque psoriasis and psoriatic arthritis). The policy history also documents that the prior authorization criteria and product list have been broadened to apply uniformly across multiple ustekinumab subcutaneous products.

OpenPayer

Ustekinumab Subcutaneous Products Prior Authorization Policy

Coverage Criteria for Ustekinumab Subcutaneous Products

Initial Therapy Approval Conditions

Continuation and Established-on-Therapy Criteria

Step Therapy Requirements

Provider Actions, Documentation, and Billing Notes

Coding and Dosing Information

Product and Dosing Definitions

Administration Setting

Biosimilar and Brand Product Coverage

Background