CurrentCignaPolicy IP0646

Inflammatory Conditions - Zymfentra Prior Authorization Policy

Prior authorization policy for Zymfentra (subcutaneous infliximab-dyyb) as maintenance therapy for adults with Crohn's disease or ulcerative colitis who have initiated therapy with an infliximab IV product; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Zymfentra Prior Authorization Policy

Policy CodePolicy IP0646

Change TypeNew policy and subsequent revisions (material changes to UC initial therapy options)

Effective Date

Next Review Date

Key ActionObtain prior authorization for Zymfentra (J1748); initial approvals are for 6 months and established patients on infliximab ≥6 months may be approved for 1 year with documented benefit.

SourceLink

POLICY UPDATE CHANGES

New policy created for Zymfentra prior authorization.

Ulcerative colitis initial therapy options were modified (options removed).

Policy title updated and 'Policy Statement' section added.

2FDA‑approved indications covered (CD, UC)

120 mgRecommended SC dose

J1748HCPCS code

6 mo

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Coverage Criteria for Zymfentra

Crohn's Disease

Approve when ONE of the following is met

Crohn's Disease approval pathways

A) Initial Therapy (approve for 6 months)
- Patient is ≥ 18 years of age;
- Per prescriber, patient is currently receiving infliximab IV maintenance therapy or will receive induction dosing with an infliximab IV product within 3 months of initiating Zymfentra;
- Medication is prescribed by or in consultation with a gastroenterologist;
B) Patient Currently Receiving an Infliximab Product (approve for 1 year)
- Patient has been established on therapy for at least 6 months;
- AND patient meets at least one of the following:
  - 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 such as MRE or CTE, endoscopic assessment, and/or reduced dose of corticosteroids);
  - Compared with baseline (prior to initiating an infliximab product), patient experienced an improvement in at least one symptom such as decreased pain, fatigue, stool frequency, and/or blood in stool.

Ulcerative Colitis

Approve when ONE of the following is met

Ulcerative Colitis approval pathways

A) Initial Therapy (approve for 6 months)
- Patient is ≥ 18 years of age;
- Per prescriber, patient is currently receiving infliximab IV maintenance therapy or will receive induction dosing with an infliximab IV product within 3 months of initiating Zymfentra;
- Medication is prescribed by or in consultation with a gastroenterologist;
B) Patient Currently Receiving an Infliximab Product (approve for 1 year)
- Patient has been established on therapy for at least 6 months;

Zymfentra must not be used concurrently with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition. Concurrent administration in combination therapy is considered not medically necessary due to a potentially higher rate of adverse events and lack of controlled clinical data supporting additive efficacy. Conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine) are not excluded and may be used in combination when clinically appropriate.

Use of Zymfentra for any indication other than maintenance therapy for Crohn's disease or ulcerative colitis following an infliximab IV induction regimen is considered not medically necessary. Requests for Zymfentra outside these specified FDA‑approved maintenance settings will be denied.

Coding, Age, and Dosing

Considered Medically Necessary when criteria metHCPCSCovered

J1748

Injection, infliximab-dyyb (Zymfentra), 10 mg

inv-06: Age — patient is ≥ 18 years of age

Age requirementPatient is ≥ 18 years of age

Applies toAdults being considered for Zymfentra maintenance after infliximab IV induction or established infliximab therapy

Policy referencesFDA‑approved indications for Crohn's disease and ulcerative colitis require adult patients (see coverage criteria)

Provider Requirements, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Zymfentra (J1748). Initial approvals are provided for 6 months for patients meeting initial therapy criteria; established-therapy approvals are provided for 1 year for patients meeting continuation criteria. In cases where the approval is authorized in months, 1 month = 30 days.

Drug: J1748 (Injection, infliximab-dyyb / Zymfentra, 10 mg)
Initial approval duration: 6 months
Established therapy approval duration: 12 months (1 year)

Documentation Required

Specialist Involvement Required

Initial approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., gastroenterologist for Crohn's disease or ulcerative colitis).

Specialist: Gastroenterologist (for CD or UC) or appropriate specialist for the treated condition

Background on Zymfentra

Zymfentra (infliximab‑dyyb) is a subcutaneous formulation of infliximab, a tumor necrosis factor (TNF) inhibitor, indicated as maintenance therapy for moderately to severely active Crohn's disease and ulcerative colitis in adults who have received an infliximab IV induction regimen. Standard IV induction with an infliximab product is administered at Weeks 0, 2, and 6; responders may transition to subcutaneous Zymfentra for maintenance. The approved subcutaneous maintenance dose is 120 mg once every 2 weeks.

Key Definitions and Dosing

inv-14: Induction regimen — infliximab IV Weeks 0, 2, 6 prior to switching

Required induction regimenInfliximab IV administered at Weeks 0, 2, and 6 prior to switching to Zymfentra

Timing for switchConversion to Zymfentra may occur at Week 10 or at any scheduled infliximab IV infusion for responders

Indication contextInduction regimen applies for both Crohn's disease and ulcerative colitis maintenance use

inv-15: Maintenance dose (Zymfentra) — 120 mg subcutaneous every 2 weeks

Recommended maintenance doseZymfentra 120 mg subcutaneous every 2 weeks

FormulationSubcutaneous (SC) infliximab-dyyb (Zymfentra)

Documentation Required

Required Clinical Documentation

Required clinical documentation must be provided to support the request. For initial therapy, the prescriber must attest the patient is currently receiving infliximab IV maintenance therapy or will receive infliximab IV induction dosing within 3 months of initiating Zymfentra. For established therapy, documentation must show the patient has been on infliximab product therapy for at least 6 months and demonstrate clinical benefit by objective measures or symptom improvement.

Prescriber attestation that patient is currently receiving infliximab IV maintenance or will receive infliximab IV induction within 3 months when requesting initial therapy
For continuation (established) therapy: documentation of ≥ 6 months on infliximab product
Objective measures demonstrating benefit (examples): fecal markers (fecal lactoferrin, fecal calprotectin), serum markers (C-reactive protein), imaging (MRE, CTE), endoscopic assessment, and/or reduced corticosteroid dose
Alternative documentation: clinical improvement in symptoms (e.g., decreased pain, fatigue, stool frequency, blood in stool) compared with baseline prior to infliximab