CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zymfentra (infliximab-dyyb) — Maintenance therapy for ulcerative colitis and Crohn's disease

Clinical coverage policy for use of Zymfentra as maintenance treatment in adults with moderately to severely active ulcerative colitis or Crohn's disease who have completed IV infliximab induction and meet specified criteria; applies to Medicaid, Commercial, and Medicare populations as indicated.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZymfentra (infliximab-dyyb) — Maintenance therapy for UC and CD

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2025

Next Review DateJul 1, 2025

Key ActionObtain prior authorization and document ≥10 weeks of IV infliximab induction with clinical remission and rationale for switching to subcutaneous maintenance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

120 mgmaintenance dose every 2 weeks

6 monthsauthorization period

2 pens/28dpharmacy quantity limit

J1748billing code

Adults ≥18minimum age

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Coverage Criteria for Zymfentra (infliximab-dyyb)

Initial Therapy (Adults)

Covered when ALL of the following are met:

Initial approval criteria: 1. Patient is at least 18 years of age; 2. Zymfentra is prescribed by, or in consultation with, a gastroenterology specialist; 3. Only one formulation of infliximab will be used (intravenous or subcutaneous); 4. Documentation that the patient has received at least 10 weeks of IV infliximab therapy (3 induction doses), is in clinical remission, and cannot continue receiving maintenance IV infliximab therapy due to intolerable side effects with medical rationale provided; 5. Patient has moderate to severe disease (e.g., Mayo Clinical Score 6-12 with Mayo Endoscopic Subscore 2 or 3 for UC, or CDAI ≥220 for CD); 6. No active infection, including clinically important localized infections; 7. Medication will not be administered concurrently with live vaccines; 8. Patient is not on concomitant treatment with another injectable biologic response modifier (including TNF inhibitors or IL-inhibitors) or specified oral non-biologic agents; 9. Dosing and frequency are within FDA guidelines; 10. Physician has assessed baseline disease severity using an objective measure/tool; 11. Medicare members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements.

Authorization duration: 6 months.

Continuation Therapy

Covered when ALL of the following are met:

Continuation criteria: 1. Patient continues to meet all initial approval criteria; 2. Patient is tolerating the medication; 3. Patient is receiving ongoing monitoring for presence of TB or other active infections; 4. For Crohn's disease: chart notes or medical record documentation supports achievement or maintenance of remission or a positive clinical response, demonstrated by low disease activity or improvement in signs and symptoms (e.g., number of liquid stools, abdominal pain, presence of abdominal mass, body weight, hematocrit, extra-intestinal complications, tapering/discontinuation of corticosteroids, use of anti-diarrheal drugs, mucosal improvement on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on CDAI or Harvey-Bradshaw Index); 5. For ulcerative colitis: chart notes or medical record documentation supports achievement or maintenance of remission or a positive clinical response, demonstrated by improvement in stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal improvement on endoscopy/CTE/MRE/intestinal ultrasound, tapering/discontinuation of corticosteroids, and/or improvement on UCEIS or Mayo Score.

Authorization duration: 6 months.

Covered Indications

Permitted indications: Maintenance treatment of moderately to severely active ulcerative colitis (UC) in adults following treatment with an infliximab product administered intravenously; Maintenance treatment of moderately to severely active Crohn's disease (CD) in adults following treatment with an infliximab product administered intravenously.

All other indications are considered experimental/investigational and not medically necessary.

Requests for Zymfentra for any indication other than the two maintenance uses listed below are considered experimental/investigational and are not medically necessary.

Coverage of Zymfentra is limited to maintenance treatment of moderately to severely active ulcerative colitis or Crohn's disease in adults following prior treatment with an infliximab product administered intravenously; use for other indications is not covered.

Coding and Billing

Billing codeHCPCS

J1748

Injection, infliximab-dyyb (zymfentra), 10 mg

NDC/GPI identifiers and quantity limitsNDC

72606-0025-01	ZYMFENTRA 1-PEN NDC
72606-0025-02	ZYMFENTRA 2-PEN NDC
72606-0025-10	ZYMFENTRA 2-SYRINGE NDC

Max units per dosing interval

Maximum billable units per dosing interval12 billable units = 120 mg every 2 weeks

Corresponding HCPCS unitJ1748 (Injection, infliximab-dyyb, 10 mg) — 12 units = 120 mg

Pharmacy quantity limit (context)Pharmacy quantity limit: 2 pens per 28 days (1-pen NDC = 120 mg)

Provider Requirements and Administrative Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Zymfentra. Approvals may be granted for up to 6 months; prior authorization must document required clinical information and rationale for the request.

Authorization duration: up to 6 months
Prior authorization required

Step Therapy

Step Therapy Exception for Medicare Members

Medicare members who have received the requested medication within the prior 365 days are exempt from step therapy requirements.

Medicare step therapy exception: prior receipt within 365 days exempts member

Background

Zymfentra (infliximab-dyyb) subcutaneous was studied and is indicated as a maintenance treatment option in adults with moderately to severely active ulcerative colitis or Crohn's disease who have completed induction with an intravenously administered infliximab product; the policy limits use to this post‑IV infliximab maintenance context.

Definitions and Clinical Endpoints

Clinical remission (UC)

Clinical remission (LIBERTY-UC definition)Decrease from baseline in modified Mayo score of ≥2 points and ≥30% plus a decrease in rectal bleeding score (RBS) of ≥1 point or absolute RBS of 0 or 1 at week 10 after induction; used as trial definition for eligibility and endpoint

Policy measurement requirementPolicy requires objective disease severity assessment (e.g., Mayo Score) at baseline and documentation of response or remission for coverage decisions

Dosing contextPatients in LIBERTY-UC received three IV induction doses at Weeks 0, 2, and 6 prior to assessment and randomization to 120 mg SC every 2 weeks

Clinical remission (CD)

Clinical remission (LIBERTY-CD definition)Absolute Crohn's Disease Activity Index (CDAI) score of <150 points at the trial endpoint

Policy assessment requirement

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZymfentra (infliximab-dyyb) — Maintenance therapy for UC and CD

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2025

Next Review DateJul 1, 2025

Key ActionObtain prior authorization and document ≥10 weeks of IV infliximab induction with clinical remission and rationale for switching to subcutaneous maintenance.

SourceLink

On This Page

Documentation Required

Prior IV Infliximab Induction and Rationale

Documentation of prior IV infliximab induction and clinical rationale for switching to subcutaneous infliximab (Zymfentra) is required. The request must show the patient completed at least 10 weeks of IV infliximab induction (minimum 3 induction doses), the patient achieved clinical remission on IV infliximab, and there is a medical rationale why continued IV maintenance infliximab is not possible (for example, intolerable side effects) with supporting clinical details.

Minimum prior IV infliximab induction: ≥10 weeks (at least 3 induction doses)
Documented clinical remission on IV infliximab
Reason patient cannot continue IV maintenance infliximab (medical rationale and supporting details required)

Documentation Required

Monitoring and Response Documentation

Continuation of therapy requires chart notes or medical record documentation demonstrating maintenance of remission or a positive clinical response. Documentation should reference objective measures and/or clinical signs of improvement from baseline.

For Crohn's disease: documentation of remission or response (e.g., reduced liquid stools, less abdominal pain, improved CDAI or Harvey-Bradshaw Index, improved imaging/endoscopy findings, reduced corticosteroid use)
For ulcerative colitis: documentation of remission or response (e.g., improved stool frequency, reduced rectal bleeding, lower CRP or fecal calprotectin, improved endoscopy findings, improved Mayo or UCEIS scores, reduced corticosteroid use)

Denial Risk

Specialist Prescriber, Indication Restrictions, and Concurrent Therapy

Prescriptions must be written by, or in consultation with, a gastroenterology specialist. Requests for indications other than maintenance treatment of moderately to severely active UC or CD following IV infliximab induction are considered not medically necessary/experimental. Concurrent use with other injectable biologic response modifiers or specified oral non-biologic agents is not permitted; if concurrent therapy is claimed, detailed documentation explaining clinical justification is required.

Specialist prescriber: gastroenterology or documented gastroenterology consultation required
Indication restrictions: other indications considered experimental/investigational and not medically necessary
Concurrent therapy prohibition: no concurrent use with other injectable biologics (e.g., adalimumab, ustekinumab, etc.) or specified oral non-biologic agents (e.g., tofacitinib); medical justification required if asserted

Policy requires use of objective measures for Crohn's disease assessment (e.g., CDAI or Harvey‑Bradshaw Index) to document achievement or maintenance of remission

Trial induction and dosing contextAll subjects completed three IV infliximab induction doses (Weeks 0, 2, and 6) prior to assessment and randomized to 120 mg SC every 2 weeks