ModifiedColorado Rocky Mountain Health PlansPolicy 2025 P 1458-2

Zymfentra (infliximab-dyyb) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Prior authorization and reauthorization criteria for Zymfentra (infliximab-dyyb) for treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults within UnitedHealthcare commercial plans; policy notes exclusion from coverage for most benefits and allows automated approvals based on claim history/diagnosis.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyZymfentra (infliximab-dyyb) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1458-2

Change TypeProgram added; annual review

Effective DateJan 17, 2026

Next Review Date2026-10

Key ActionSubmit prior authorization requests for Zymfentra and document positive clinical response for reauthorization; approvals are issued for 12 months and Zymfentra is excluded from coverage for the majority of benefits.

SourceLink

POLICY UPDATE CHANGES

New prior authorization/notification program created for Zymfentra.

Annual review updated combination examples and language with no change to clinical intent.

2Covered Indications (conditional)

12 moAuthorization Duration

excludedGeneral Coverage Status

Prior authorization and reauthorization criteria for Zymfentra (infliximab-dyyb) cover treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults within UnitedHealthcare commercial plans. Initial authorization requires a qualifying diagnosis (ulcerative colitis or Crohn's disease) and that the patient is not receiving Zymfentra in combination with a systemic targeted immunomodulator for the same indication. Reauthorization requires documentation of a positive clinical response to Zymfentra therapy and that the patient is not receiving Zymfentra in combination with a systemic targeted immunomodulator for the same indication. Approvals are issued for 12 months. The policy also notes that Zymfentra is excluded from coverage for the majority of benefits and that UnitedHealthcare may allow automated approvals based on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic.

Key policy facts

Covered indications (conditional)2 (moderately to severely active ulcerative colitis; moderately to severely active Crohn's disease)

Authorization duration12 months

General coverage statusExcluded from coverage for the majority of benefits

Effective date2026-01-17

Last review2025-10

Next review2026-10

Initial Therapy Criteria

Initial Authorization - Ulcerative Colitis

Zymfentra will be approved based on both of the following criteria:

ALL of the following

Diagnosis of moderately to severely active ulcerative colitis
Patient is not receiving Zymfentra in combination with a systemic targeted immunomodulator for treatment of the same indication
examples: adalimumab, Entyvio (vedolizumab), Omvoh (mirikizumab-mrkz), Rinvoq (upadacitinib), Simponi (golimumab), Skyrizi (risankizumab), Tremfya (guselkumab), Xeljanz/Xeljanz XR (tofacitinib), ustekinumab, Zeposia (ozanimod)

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Initial Authorization - Crohn's Disease

Zymfentra will be approved based on both of the following criteria:

ALL of the following

Diagnosis of moderately to severely active Crohn's disease
Patient is not receiving Zymfentra in combination with a systemic targeted immunomodulator for treatment of the same indication
examples: adalimumab, Cimzia (certolizumab), Entyvio (vedolizumab), Omvoh (mirikizumab-mrkz), Rinvoq (upadacitinib), Skyrizi (risankizumab), Tremfya (guselkumab), ustekinumab

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Continuation / Reauthorization Criteria

Reauthorization - Ulcerative Colitis

Zymfentra will be approved based on both of the following criteria:

ALL of the following

Documentation of positive clinical response to Zymfentra therapy
Patient is not receiving Zymfentra in combination with a systemic targeted immunomodulator for treatment of the same indication
examples: adalimumab, Entyvio (vedolizumab), Omvoh (mirikizumab-mrkz), Rinvoq (upadacitinib), Simponi (golimumab), Skyrizi (risankizumab), Tremfya (guselkumab), Xeljanz/Xeljanz XR (tofacitinib), ustekinumab, Zeposia (ozanimod)

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Reauthorization - Crohn's Disease

Zymfentra will be approved based on both of the following criteria:

ALL of the following

Documentation of positive clinical response to Zymfentra therapy
Patient is not receiving Zymfentra in combination with a systemic targeted immunomodulator for treatment of the same indication
examples: adalimumab, Cimzia (certolizumab), Entyvio (vedolizumab), Omvoh (mirikizumab-mrkz), Rinvoq (upadacitinib), Skyrizi (risankizumab), Tremfya (guselkumab), ustekinumab

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Provider Actions

Prior Authorization

Prior authorization required (program)

Zymfentra is managed under a prior authorization/notification program. When the program criteria are met, approvals are issued for 12 months. Note: Zymfentra is excluded from coverage for the majority of benefits; state mandates, federal requirements, and the member-specific benefit plan may also affect coverage.

Documentation Required

Document positive clinical response for reauthorization

For reauthorization, the provider must document a positive clinical response to Zymfentra therapy.

Billing Rule

Automated approval possible

UnitedHealthcare may approve initial requests and reauthorizations based solely on previous claim or medication history, diagnosis codes (ICD-10), and/or claim logic. Use of automated approval and reapproval processes varies by program and therapeutic class.

Background

Zymfentra (infliximab-dyyb) is a tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of moderately to severely active ulcerative colitis and Crohn's disease following prior treatment with an infliximab IV product. UnitedHealthcare implements a prior authorization/notification program for Zymfentra with approvals issued for 12 months, and the policy notes that Zymfentra is excluded from coverage for the majority of benefits.

Systemic targeted immunomodulator examples provided in the policy include: adalimumab, vedolizumab (Entyvio), mirikizumab-mrkz (Omvoh), upadacitinib (Rinvoq), golimumab (Simponi), risankizumab (Skyrizi), guselkumab (Tremfya), tofacitinib (Xeljanz/Xeljanz XR), ustekinumab, ozanimod (Zeposia), and certolizumab (Cimzia).

Revision History

10/2024program_creation

New prior authorization/notification program created for Zymfentra

10/2024P&T_approval

P&T approval for Zymfentra prior authorization/notification program

10/2025annual_reviewLatest

Annual review updated combination examples and language; no change to clinical intent.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyZymfentra (infliximab-dyyb) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1458-2

Change TypeProgram added; annual review

Effective DateJan 17, 2026

Next Review Date2026-10

SourceLink

On This Page

OpenPayer

Zymfentra (infliximab-dyyb) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Provider Actions

Applicable Codes

Clinical Evidence & References

Background

Revision History