ModifiedCignaPolicy N/A

Inflammatory Conditions - Zymfentra Prior Authorization Policy · Zymfentra (infliximab-dyyb subcutaneous injection - Celltrion)

Prior authorization policy for Zymfentra (infliximab-dyyb SC) covering FDA-approved indications Crohn's disease and ulcerative colitis, including initial and continuation criteria, duration of approvals, specialist prescribing requirement, and exclusions (not medically necessary uses). Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Zymfentra Prior Authorization Policy · Zymfentra (infliximab-dyyb subcutaneous injection - Celltrion)

Policy CodePolicy N/A

Change TypeSelected revisions (07/23/2025) and content changes (12/04/2024)

Effective Date

Next Review Date

Key ActionSubmit prior authorization requests documenting that patients meet the applicable initial or continuation criteria and specialist prescribing/consultation; include documentation of infliximab IV induction or established therapy and clinical response as required.

POLICY UPDATE CHANGES

Selected revision 07/23/2025 recorded (review date).

12/04/2024 revision removed certain initial therapy options for ulcerative colitis (removed trial of one systemic therapy and pouchitis-related options).

Selected revision changed wording in Conditions Not Covered to specify 'Concurrent Use with a Biologic or with a Targeted Synthetic Oral Small Molecule Drug'.

2Covered Indications (FDA)

6Initial Therapy Approval (months)

Coverage Summary & Indications

Zymfentra (infliximab-dyyb SC) is covered with criteria for FDA‑approved maintenance treatment of moderately to severely active Crohn's disease and ulcerative colitis in adults who have received an infliximab IV induction regimen. Therapy typically begins with an infliximab IV induction at Weeks 0, 2, and 6, and patients may switch to Zymfentra at Week 10 or at a scheduled IV infusion in responders. Coverage requires prior authorization and that the prescriber documents receipt of or planned infliximab IV induction or that the patient is established on infliximab IV therapy per the policy criteria.

Covered Indications - Crohn's Disease

Approve for Crohn's disease when ONE of the following (A or B) is met:

ANY of the following

A) Initial Therapy (approve 6 months)
- Patient is ≥ 18 years of age
- According to the prescriber, the patient is currently receiving infliximab intravenous maintenance therapy or will receive induction dosing with an infliximab intravenous product within 3 months of initiating therapy with Zymfentra
- Requirement (one of a-d)
  - Patient has tried or is currently taking systemic corticosteroids, or corticosteroids are contraindicated in this patient
    Examples of corticosteroids are prednisone and methylprednisolone
  - Patient has tried one conventional systemic therapy for Crohn's disease
    Examples include azathioprine, 6-mercaptopurine, or methotrexate; a trial of mesalamine does not count
  - Patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas
  - Patient had ileocolonic resection (to reduce the chance of Crohn's disease recurrence)
- The medication is prescribed by or in consultation with a gastroenterologist
B) Patient is Currently Receiving an Infliximab Product (approve 1 year)
- Patient has been established on therapy for at least 6 months≥ 6 months
  A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy
- At least one of
  - When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating the requested product)
  - Compared with baseline (prior to initiating an infliximab product), patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or blood in stool)

Covered Indications - Ulcerative Colitis

Approve for ulcerative colitis when ONE of the following (A or B) is met:

ANY of the following

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

Prior Authorization, Documentation & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for Zymfentra. Requests must document that the patient meets the applicable initial or continuation criteria and that the medication is prescribed by or in consultation with a specialist (e.g., gastroenterologist).

Documentation Required

Documentation of induction or response

For initiation, document receipt of or planned infliximab IV induction dosing within 3 months of starting Zymfentra. For continuation, document the patient has been established on infliximab therapy ≥6 months and has either objective evidence of clinical response (examples: fecal markers, CRP, imaging, endoscopy, or reduced steroid dose) or symptomatic improvement compared with baseline.

Codes Referenced

Drugs referencedmixed

Zymfentra	infliximab-dyyb subcutaneous injection (Celltrion) - policy subject
Infliximab IV products	Remicade and biosimilars - required induction/established therapy comparator

Clinical Context

Zymfentra is a subcutaneous TNF inhibitor indicated as maintenance treatment for moderately to severely active Crohn's disease and ulcerative colitis in adults who have received three induction doses with an infliximab IV product. Therapy is typically initiated with infliximab IV induction at Weeks 0, 2, and 6, and switching to Zymfentra may occur at Week 10 or at any scheduled infliximab IV infusion for patients with a clinical response or remission.

Policy Thresholds and Approval Durations

Established on infliximab therapy duration≥ 6 months

Initial therapy approval duration6 months

Established patient approval duration1 year

Evidence & Guidance

Evidence sources include the Prescribing information: Zymfentra prescribing information, Celltrion, May 2025, and guideline support from the American College of Gastroenterology (ACG) and American Gastroenterological Association (AGA) clinical practice guidelines for Crohn's disease and ulcerative colitis (2021–2025).

Policy Definitions

Definitions: Month = 30 days for approval duration calculations; Established on therapy = patient has been receiving therapy for at least 6 months.

Policy Revision Timeline

07/23/2025revision_selectedLatest

Selected revision recorded (review date).

12/04/2024revision_removed_uc_initial_options

Revision removed certain initial therapy options for ulcerative colitis (removed trial of one systemic therapy and pouchitis-related options).

12/06/2023revision_clarified_conditions_not_covered

Wording in Conditions Not Covered changed to specify 'Concurrent Use with a Biologic or with a Targeted Synthetic Oral Small Molecule Drug'.