Cigna Tremfya Prior Auth Policy Update

Coverage Criteria

inv-01: Tremfya subcutaneous is medically necessary when ONE of the following FDA-approved indication groups is met (1, 2, 3, or 4):

Tremfya subcutaneous is medically necessary when ONE of the following FDA-approved indication groups is met (1, 2, 3, or 4):

1. Crohn's Disease

A) Initial Therapy (approve 6 months): Patient is > 18 years of age; AND patient meets ONE of: a) patient has tried or is currently taking corticosteroids, or corticosteroids are contraindicated; OR b) patient has tried one other 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; AND the medication is prescribed by or in consultation with a gastroenterologist.Approve 6 months
Mesalamine does not count as a systemic agent; biosimilars of the requested biologic do not count toward prior biologic trials.
B) Currently Receiving (approve 1 year): Patient has been established on therapy for at least 6 months; AND patient meets at least ONE of: a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: fecal markers such as fecal lactoferrin or fecal calprotectin, serum markers such as C-reactive protein, imaging studies, endoscopic assessment, and/or reduced corticosteroid dose); OR b) compared with baseline, patient experienced improvement in at least one symptom (eg decreased pain, fatigue, stool frequency, and/or blood in stool).Approve 1 year
Patients with <6 months of therapy or restarting are reviewed under Initial Therapy.

2. Plaque Psoriasis

A) Initial Therapy (approve 3 months): Patient is ≥ 18 years of age; AND patient meets ONE of: a) patient has tried at least one traditional systemic agent for psoriasis for at least 3 months (examples: methotrexate, cyclosporine, acitretin) or a 3-month trial of PUVA, unless intolerant; OR b) patient has a contraindication to methotrexate; AND the requested agent is prescribed by or in consultation with a dermatologist.Approve 3 months
Exception if patient has had a 3-month trial or intolerance to at least one biologic other than the requested drug; biosimilars do not count.
B) Currently Receiving (approve 1 year): Patient has been established on the requested drug for at least 3 months; AND patient experienced a beneficial clinical response from baseline in at least one objective skin measure (eg estimated body surface area, erythema, induration/thickness, and/or scale); AND compared with baseline patient experienced improvement in at least one symptom (eg decreased pain, itching, burning).Approve 1 year
Patients with <3 months of therapy or restarting are reviewed under Initial Therapy.

3. Psoriatic Arthritis

A) Initial Therapy (approve 6 months): Patient is > 18 years of age; AND the medication is prescribed by or in consultation with a rheumatologist or a dermatologist.Approve 6 months
B) Currently Receiving (approve 1 year): Patient has been established on the requested drug for at least 6 months; AND patient meets at least ONE of: a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument, MDA, PsAID-12, CRP, ESR); OR b) compared with baseline, patient experienced improvement in at least one symptom (eg less joint pain, morning stiffness, improved function, decreased swelling).Approve 1 year
Patients with <6 months of therapy or restarting are reviewed under Initial Therapy.

4. Ulcerative Colitis

A) Initial Therapy (approve 6 months): Patient is ≥ 18 years of age; AND according to the prescriber, the patient will receive three induction doses with Tremfya intravenous within 3 months of initiating therapy with Tremfya subcutaneous; AND the medication is prescribed by or in consultation with a gastroenterologist.Approve 6 months
B) Currently Receiving (approve 1 year): Patient has been established on the requested drug for at least 6 months; AND patient meets at least ONE of: a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: fecal calprotectin, CRP, endoscopic assessment, and/or reduced corticosteroid dose); OR b) compared with baseline, patient experienced improvement in at least one symptom (eg decreased pain, fatigue, stool frequency, decreased rectal bleeding).Approve 1 year
Patients with <6 months of therapy or restarting are reviewed under Initial Therapy.

Concurrent use of Tremfya with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is not medically necessary. The policy specifies that Tremfya subcutaneous should not be administered in combination with another biologic or a targeted synthetic oral small molecule drug used to treat inflammatory conditions due to increased risk of adverse events and a lack of controlled clinical data showing additive benefit. Conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine) may be used in combination with Tremfya and are not excluded by this policy.

Use of Tremfya subcutaneous for any indication not listed among the FDA-approved uses in this policy is considered not medically necessary. The policy explicitly states that Tremfya for any other use is not covered and that the list of excluded uses may be updated as new published data become available.

Coding

Covered CPT/HCPCS/ICD-10 codesmixed

No codes listed

Established therapy duration to qualify for continuation approval

Psoriasis (Plaque Psoriasis)Established on requested drug ≥ 3 months to qualify for continuation approval (approve for 1 year)

Crohn's DiseaseEstablished on therapy ≥ 6 months to qualify for continuation approval (approve for 1 year)

Psoriatic ArthritisEstablished on therapy ≥ 6 months to qualify for continuation approval (approve for 1 year)

Ulcerative ColitisEstablished on therapy ≥ 6 months to qualify for continuation approval (approve for 1 year)

Provider Actions & Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior authorization is required for benefit coverage of Tremfya. All approvals are issued for the durations noted in the policy (months counted as 30 days). Initial approval requires the medication to be prescribed by or in consultation with a specialist who treats the condition (for example, gastroenterologist for Crohn's/UC, dermatologist for psoriasis, rheumatologist or dermatologist for psoriatic arthritis).

Approvals follow initial vs continuation durations described in the FDA‑Approved Indications sections (e.g., initial therapy approvals typically 6 months; continuation approvals typically 1 year when continuation criteria met).
1 month = 30 days for authorizations.
Specialist prescriber requirement: initial approvals require prescription by or in consultation with a specialist appropriate for the treated condition.

Note

Appendix — Informational Only

Appendix lists example biologic and targeted therapies (mechanism, formulations, and common indications) but does not specify or replace prior authorization procedures or operational authorization triggers. The appendix is informational — it does not enumerate the steps to obtain prior authorization.

Background

Tremfya (guselkumab) is an interleukin-23 (IL-23) inhibitor. It is indicated for adult patients with Crohn's disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis, and both subcutaneous and intravenous formulations of guselkumab are referenced in the policy appendix. Specialty society guidelines recognize IL-23 blockers among advanced therapy options for moderate to severe inflammatory conditions; use of Tremfya requires prior authorization and indication-specific prescribing by an appropriate specialist (for example, gastroenterologist for Crohn's disease or ulcerative colitis, dermatologist for plaque psoriasis, or rheumatologist/dermatologist for psoriatic arthritis).

Definitions & Mechanism

Tremfya mechanism

Mechanism of actionInterleukin-23 (IL-23) blocker

Drug classIL-23 inhibitor / biologic therapy

Formulations referencedGuselkumab SC injection; guselkumab IV infusion (appendix)

Abbreviations

SCSubcutaneous

IVIntravenous

TNFTumor necrosis factor

Initial Therapy Criteria

inv-17: Indication-specific initial therapy criteria and approval durations.

Indication-specific initial therapy criteria and approval durations.

Crohn's Disease initial: Patient >18 years of age; AND ONE of: corticosteroid trial/current or corticosteroids contraindicated; OR trial of one conventional systemic therapy for Crohn's disease (eg azathioprine, 6-mercaptopurine, methotrexate); OR enterocutaneous or rectovaginal fistulas; OR prior ileocolonic resection; AND medication prescribed by or in consultation with a gastroenterologist.Approve 6 months

Mesalamine does not count as a systemic agent; exception if patient already tried at least one biologic other than requested drug; biosimilars do not count.

Plaque Psoriasis initial: Patient ≥18 years of age; AND ONE of: trial of at least one traditional systemic agent for ≥3 months (eg methotrexate, cyclosporine, acitretin) or 3-month PUVA trial unless intolerant; OR contraindication to methotrexate; AND requested agent prescribed by or in consultation with a dermatologist.Approve 3 months

Continuation Therapy Criteria

inv-18: Criteria for patients currently receiving Tremfya to qualify for renewal/continuation approval.

Criteria for patients currently receiving Tremfya to qualify for renewal/continuation approval.

Crohn's Disease continuation: Established on therapy ≥ 6 months AND experienced beneficial clinical response by objective measure or symptom improvement.Approve 1 year

Plaque Psoriasis continuation: Established on therapy ≥ 3 months AND objective skin improvement (eg BSA, erythema, induration/thickness, scale) AND symptom improvement.Approve 1 year

Psoriatic Arthritis continuation: Established on therapy ≥ 6 months AND objective disease activity improvement (examples: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument, MDA, PsAID-12, CRP, ESR) OR symptom improvement.

Step Therapy / Prior Treatment Requirements

Requirement	Details / Exceptions
Trials of specified prior therapies or corticosteroids when indicated	For Crohn's disease initial therapy: patient must have tried or currently be taking corticosteroids (examples: prednisone or methylprednisolone) or corticosteroids are contraindicated; OR tried one other conventional systemic therapy (examples: azathioprine, 6-mercaptopurine, methotrexate); OR have enterocutaneous or rectovaginal fistulas; OR had ileocolonic resection. An exception to these requirements may be made if the patient has already tried at least one biologic other than the requested medication. (Mesalamine does not count as a systemic agent.)
Prior biologic trials — biosimilars do not count	Across indications, a biosimilar of the requested biologic does not count toward required prior biologic trials; exceptions permit approval if the patient already tried at least one non-requested biologic. Refer to appendix for examples of biologics used for each condition.
Plaque psoriasis prior therapy requirement	For plaque psoriasis initial therapy: patient must have tried at least one traditional systemic agent for ≥ 3 months (examples: methotrexate, cyclosporine, acitretin) or PUVA for 3 months, unless intolerant; or have a contraindication to methotrexate. An exception to the requirement can be made if the patient has already had a 3‑month trial or intolerance to at least one biologic other than the requested drug. Biosimilars do not count.
Psoriatic arthritis and other indications	For psoriatic arthritis and other indications where specified, initial therapy requires the medication to be prescribed by or in consultation with the appropriate specialist; trials of conventional systemic therapy or corticosteroids are required when indicated, unless exceptions apply (prior biologic tried, contraindication, or specific clinical features).

Site of Care

Billing Rule

Dosage, frequency, duration, and site of care must be clinically appropriate and evidence-based

Dosage, frequency, duration of therapy, and site of care must be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based on disease severity, alternative treatments, and prior response to therapy.

Site of care and treatment parameters should be tailored to clinical context and supported by evidence when submitting requests or claims.

Biosimilar Considerations