CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zymfentra (infliximab-dyyb) — Maintenance Treatment for Ulcerative Colitis and Crohn's Disease

Covers use of Zymfentra for maintenance treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults who have completed IV infliximab induction and meet criteria; applies to Neighborhood Health Plan of Rhode Island members under Medicaid, Commercial, and Medicare scopes as specified.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZymfentra (infliximab-dyyb) — Maintenance Treatment for Ulcerative Colitis and Crohn's Disease

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization demonstrating adult age, gastroenterology involvement, completion of IV infliximab induction (≥3 doses) and inability to continue IV maintenance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization period

120 mg q2wmaintenance dosing

2 / 28dpharmacy ql (1-pen)

J1748billing code

Coverage Criteria for Zymfentra (infliximab-dyyb)

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Initial Approval

Authorization of 6 months may be granted when ALL of the following are met:

Initial approval criteria

Age and prescriber: Patient is at least 18 years of age; Zymfentra must be prescribed by, or in consultation with, a specialist in gastroenterology.
Formulation and induction: Only one formulation of infliximab will be used (intravenous or subcutaneous); 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 with medical rationale provided.
Disease severity: Patient has moderate to severe disease (e.g., Mayo Clinical Score 6-12 with Mayo Endoscopic Subscore 2 or 3 for UC; Crohn's Disease Activity Index (CDAI) score ≥220 for CD).
Infection and vaccines: Patient does not have an active infection, including clinically important localized infections; the requested medication must not be administered concurrently with live vaccines.
Concomitant therapy exclusion: Patient is not on concomitant treatment with an injectable biologic response modifier (examples include TNF inhibitors such as adalimumab, etanercept, golimumab, etc., or IL-inhibitors such as secukinumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, bimekizumab, mirikizumab) or other oral non-biologic agents (examples include apremilast, tofacitinib, baricitinib, upadacitinib, etrasimod).
Dosing and assessment: Dosing and frequency are within FDA guidelines; physician has assessed baseline disease severity utilizing an objective measure/tool.

Continuation of Therapy

Authorization of 6 months may be granted when ALL of the following are met:

Continuation criteria

General continuation requirements: Patient meets all initial criteria; patient is tolerating the medication; patient is receiving ongoing monitoring for presence of TB or other active infections.
Evidence of response - Crohn's disease (A): Chart notes or medical record documentation support achievement or maintenance of remission or a positive clinical response to therapy as indicated by low disease activity or improvement in signs and symptoms compared to baseline (examples: number of liquid stools, abdominal pain severity, presence of abdominal mass, body weight vs IBW, hematocrit, extra‑intestinal complications, tapering/discontinuation of corticosteroids, use of anti‑diarrheal drugs, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on CDAI or Harvey‑Bradshaw Index).
Evidence of response - Ulcerative colitis (B): Chart notes or medical record documentation support achievement or maintenance of remission or a positive clinical response to therapy as indicated by improvement in stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, tapering/discontinuation of corticosteroids, and/or improvement on UCEIS or Mayo Score.

All uses of Zymfentra outside of the two listed maintenance indications are considered experimental/investigational and are not medically necessary.

Use of Zymfentra (infliximab-dyyb) for any indication other than maintenance treatment of moderately to severely active ulcerative colitis or Crohn’s disease following prior intravenous infliximab induction is not covered as it is considered not medically necessary.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit documentation demonstrating that the patient meets the initial-approval criteria (age ≥18, gastroenterology specialist involvement, completion of IV infliximab induction with response/remission evidence, disease severity, infection screening, dosing within FDA guidelines, and absence of prohibited concomitant therapies). Billing note: Zymfentra (J1748) should be billed per applicable medical or pharmacy benefit rules and quantity limits (see policy dosing/quantity limits).

Prior authorization required before initiation of therapy
Bill J1748 (infliximab-dyyb) per benefit-specific rules; follow quantity limits (e.g., 120 mg every 2 weeks; pharmacy quantity limits apply)

Denial Risk

Indication Restriction — Not Medically Necessary for Other Uses

Requests for uses other than maintenance treatment of moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) in adults following an IV infliximab induction are considered not medically necessary. All other indications are experimental/investigational and will be denied.

Documentation Required

Required Clinical Documentation

The medical record must include documentation of all of the following: patient age (≥18 years); that Zymfentra was prescribed by or in consultation with a gastroenterology specialist; documentation of completion of an IV infliximab induction regimen (5 mg/kg at Weeks 0, 2, and 6) with an infliximab product; documentation of clinical response or remission to the IV induction and rationale why IV maintenance cannot be continued (if applicable); baseline disease severity assessment (e.g., Mayo Score, CDAI) and objective monitoring data; evidence of ongoing infection screening (including TB) and absence of active infection; and the current medication list documenting no concurrent prohibited biologic or specified oral non-biologic agents.

Document IV infliximab induction: 5 mg/kg at Weeks 0, 2, and 6 (at least 10 weeks of IV therapy / 3 induction doses)
Include objective disease activity measures (Mayo Score, CDAI, CRP, fecal calprotectin, endoscopy findings, etc.)
Provide rationale if IV maintenance cannot be continued and evidence of clinical response/remission

Note

IV Induction Required Before SC Maintenance

All patients must complete an IV infliximab induction regimen (5 mg/kg at Weeks 0, 2, and 6) with an infliximab product (e.g., Inflectra, Avsola, Remicade) prior to initiating subcutaneous Zymfentra for maintenance. The first subcutaneous dose should replace the next scheduled IV infusion (maintenance dosing: 120 mg SC every 2 weeks starting at Week 10).

Definitions and Clinical Terms

IV induction

Required IV induction regimenIntravenous infliximab 5 mg/kg at Weeks 0, 2, and 6 (minimum of 3 induction doses over at least 10 weeks)

PurposeMust be completed prior to initiating Zymfentra subcutaneous maintenance

Switching to SCFirst subcutaneous dose is administered in place of the next scheduled IV infusion after completion of induction

Clinical response/remission documentation

Acceptable measuresDisease‑specific clinical scoring tools such as CDAI for Crohn's disease or Mayo Score/UCEIS for ulcerative colitis

Additional documentationImprovement in signs/symptoms (e.g., stool frequency, rectal bleeding, abdominal pain), biomarkers (CRP, fecal calprotectin), endoscopic appearance, imaging, weight, or corticosteroid tapering

Use for continuationChart notes or medical record must document achievement or maintenance of remission or positive clinical response compared to baseline

72606-0025-01	ZYMFENTRA 1-PEN NDC
72606-0025-02	ZYMFENTRA 2-PEN NDC
72606-0025-10	ZYMFENTRA 2-SYRINGE NDC
5250504020F530	ZYMFENTRA 1-PEN GPI
5250504020F530	ZYMFENTRA 2-PEN GPI
5250504020F830	ZYMFENTRA 2-SYRINGE GPI

OpenPayer

Zymfentra (infliximab-dyyb) — Maintenance Treatment for Ulcerative Colitis and Crohn's Disease

Coverage Criteria for Zymfentra (infliximab-dyyb)

Coding and Quantity Limits

Provider Actions, Authorization & Documentation

Background

Definitions and Clinical Terms