Modifiedculinary health fundPolicy N/A

Inflammatory Conditions - Tremfya Subcutaneous Prior Authorization Policy

Defines prior authorization criteria, approval durations, and coverage limitations for Tremfya (guselkumab SC) for inflammatory conditions (Crohn's disease, plaque psoriasis, psoriatic arthritis, ulcerative colitis) for prescription benefit coverage; affects prescribers, pharmacies, and plan reviewers.

Policy Summary

Payerculinary health fund

PolicyInflammatory Conditions - Tremfya Subcutaneous Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial clinical updates (added UCrevised Crohn's and plaque psoriasis criteria)

Effective DateN/A

Next Review DateSep 24, 2025

Key ActionProvider must document specialist prescribing/consultation and objective or symptomatic improvement for continuation requests.

SourceLink

POLICY UPDATE CHANGES

Ulcerative colitis was added as a condition of approval to the policy.

For plaque psoriasis current therapy, the timeframe for established on therapy was changed to 3 months (from 90 days).

For Crohn's disease initial therapy, certain prior requirements (systemic corticosteroids, conventional systemic therapy, fistulas, ileocolonic resection) were removed.

4FDA-approved conditions

3m / 6m / 1yApproval durations

Concurrent biologic useNot recommended

Yes

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Coverage Criteria for Tremfya (guselkumab)

Crohn's Disease

Covered for Crohn's disease when ONE of the following is met

Crohn's disease - initial or continuation: A) Initial Therapy: Approve for 6 months if ALL: (i) patient is ≥ 18 years of age; AND (ii) the medication is prescribed by or in consultation with a gastroenterologist; OR B) Patient is Currently Receiving Tremfya (Continuation): Approve for 1 year if ALL: (i) patient has been established on therapy 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 include fecal markers such as fecal calprotectin or fecal lactoferrin, serum markers such as C-reactive protein, imaging, endoscopic assessment, or reduced corticosteroid dose); OR (b) compared with baseline the patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or blood in stool).see text

A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy.

Plaque Psoriasis

Covered for plaque psoriasis when ONE of the following is met

Plaque psoriasis - initial or continuation: A) Initial Therapy: Approve for 3 months if ALL: (i) patient meets ONE of: (a) patient is ≥ 6 to < 17 years of age AND weighs ≥ 40 kg; OR (b) patient is ≥ 18 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: methotrexate, cyclosporine, acitretin; a 3-month PUVA trial counts); OR (b) exception applies because patient has already had a 3-month trial or intolerance to at least one biologic (other than the requested medication), Otezla/Otezla XR, or Sotyktu; AND (iii) the medication is prescribed by or in consultation with a dermatologist. Note: A biosimilar of the requested biologic does not count toward the exception; a patient who has tried a biologic, Otezla/Otezla XR, or Sotyktu is not required to step back to a traditional systemic agent. Prescriber-determined contraindication to methotrexate is accepted. OR B) Patient is Currently Receiving Tremfya (Continuation): 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 improvement in at least one symptom (e.g., decreased pain, itching, and/or burning).see text

An exception to the trial-of-traditional-systemic-agent requirement may be made for prior biologic, Otezla/Otezla XR, or Sotyktu use or intolerance; prescriber-determined contraindication to methotrexate accepted.

Psoriatic Arthritis

Covered for psoriatic arthritis when ONE of the following is met

Psoriatic arthritis - initial or continuation: A) Initial Therapy: Approve for 6 months if ALL: (i) patient meets ONE of: (a) patient is ≥ 6 to < 17 years of age AND weighs ≥ 40 kg; OR (b) patient is ≥ 18 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 Tremfya (Continuation): Approve for 1 year if ALL: (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 of objective measures include DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC enthesitis score, Leeds Dactylitis Instrument Score, MDA, PsAID-12, and serum markers such as CRP/ESR); OR (b) compared with baseline the patient experienced improvement in at least one symptom (e.g., less joint pain, morning stiffness, fatigue, improved function or activities of daily living, decreased soft tissue swelling).see text

A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy.

Ulcerative Colitis

Covered for ulcerative colitis when ONE of the following is met

Ulcerative colitis - initial or continuation: A) Initial Therapy: Approve for 6 months if ALL: (i) patient is ≥ 18 years of age; AND (ii) the medication is prescribed by or in consultation with a gastroenterologist. OR B) Patient is Currently Receiving Tremfya (Continuation): Approve for 1 year if ALL: (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 include fecal markers such as fecal calprotectin, serum markers such as C-reactive protein, endoscopic assessment, imaging, or reduced corticosteroid dose); OR (b) compared with baseline the patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or decreased rectal bleeding).see text

A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy.

Requests for concurrent administration of Tremfya with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition are not recommended for approval. This guidance reflects concern for a potentially higher rate of adverse events and a lack of controlled clinical data demonstrating additive efficacy when combining these agents. Conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) are not excluded from combination use with Tremfya.

Use of Tremfya outside the conditions and requirements listed in the Recommended Authorization Criteria is not recommended for approval. The criteria in this policy will be updated as new published data become available; approval decisions should follow the current indication-specific initial and continuation criteria.

The Appendix provides examples of therapeutic agents and their mechanisms of action for reference but is not an all-inclusive list. Prescribers and reviewers should consult the individual agents' prescribing information for complete FDA-approved indications and product-specific details.

Combination therapy with another biologic or a targeted synthetic oral small molecule for an inflammatory condition is discouraged and not recommended for approval. Requests for concurrent use may be denied due to limited supporting controlled data and potential increased adverse events.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Tremfya prior authorization requirement

Prior authorization is required for Tremfya (guselkumab) and initial approval generally requires the medication to be prescribed by or in consultation with a specialist in the condition being treated (e.g., gastroenterologist for Crohn's/UC, dermatologist for plaque psoriasis, rheumatologist or dermatologist for psoriatic arthritis).

Specialist prescribing/consultation required for initial approvals (condition-specific).
Approvals durations referenced in policy statement (months = 30 days).

Note

Prior authorization (reference only)

This appendix includes an examples/reference list of other biologics and targeted therapies for clinician reference only. The appendix itself does not change prior authorization requirements or substitute for the PA criteria in the main policy sections.

Appendix lists drugs/indications for reference; it does not enumerate PA requirements or steps.
Refer to the main Recommended Authorization Criteria for PA rules and required documentation.

Definitions and Objective Measures

Objective measures — examples

Fecal markersExamples: fecal calprotectin, fecal lactoferrin used to assess intestinal inflammation and response to therapy.

Serum markersExamples: C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) as indicators of systemic inflammation and treatment response.

ImagingExamples: magnetic resonance enterography (MRE) and CT enterography to evaluate bowel inflammation and complications.

EndoscopyExamples: colonoscopy with endoscopic assessment to document mucosal healing or disease activity.

Disease activity indicesExamples: DAPSA, CPDAI, PsA DAS, PsAID-12 for psoriatic arthritis; clinical indices for IBD may include objective scoring of endoscopic or symptomatic change.

Abbreviations

Background on Guselkumab (Tremfya)

Guselkumab (Tremfya) is an interleukin-23 (IL-23) inhibitor available in subcutaneous and intravenous formulations. It is approved for multiple inflammatory conditions including Crohn's disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis. Clinical guidance referenced in this policy supports IL-23 blockade as an advanced therapy option and recommends objective assessment of response when applicable.

Appendix: Reference Drugs, Mechanisms, and Codes

The Appendix lists therapeutic agents by example (including IL-17, IL-23, integrin antagonists, JAK/TYK2 inhibitors, S1P modulators, and PDE4 inhibitors) for provider reference only. This list is illustrative and not exhaustive; refer to each product's prescribing information for approved indications and formulation details.