CurrentUnitedHealthcarePolicy 2025 P 1043-15

Iclusig® (ponatinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Prior authorization/notification criteria for coverage of Iclusig (ponatinib) for UnitedHealthcare Commercial Plans, including indications across pediatric patients (<19), CML, Ph+ ALL, myeloid/lymphoid/mixed lineage neoplasms with eosinophilia (FGFR1 or ABL1 rearrangements), and gastrointestinal stromal tumor (GIST); includes initial authorization and reauthorization rules and mentions state mandates and automated approval processes.

Policy Summary

PayerUnitedHealthcare

PolicyIclusig® (ponatinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 1043-15

Change TypeAnnual review (non-material)

Effective Date02/01/2026

Next Review Date

Key ActionMembers must meet the specified criteria for initial authorization and reauthorization; authorization durations are 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Annual review updated CML criteria based on NCCN recommendations and updated background and references (11/2025).

Effective date set to 2/1/2026.

11/2024 update: background and references updated with no changes to coverage criteria.

6Primary covered indications listed

12Authorization duration (months)

YesPediatric auto-approval

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Coverage Summary

This policy covers Iclusig (ponatinib) with specific authorization criteria. Pediatric patients (<19 years) are processed automatically and eligible for approval for 12 months. Approved adult indications with defined criteria include chronic myelogenous/myeloid leukemia (CML) in chronic, accelerated, or blast phases (with criteria such as resistance or intolerance to ≥2 TKIs, no identifiable BCR::ABL1 mutations, or confirmed T315I mutation), Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL), myeloid/lymphoid/mixed lineage neoplasms with eosinophilia that have FGFR1 or ABL1 rearrangements, and gastrointestinal stromal tumor (GIST) meeting listed disease-state criteria (e.g., unresectable, recurrent/metastatic after progression on approved therapies). Authorization durations are generally 12 months. State mandates and member-specific benefit plans or compendium requirements may supersede these criteria.

Key facts

Authorization duration12 months

Coverage stancecovered_with_criteria

Effective date2026-02-01

Last review2025-11

Policy number2025 P 1043-15

Initial Therapy Criteria

Patients less than 19 years of age

Iclusig will be approved based on the following criterion:

ALL of the following

Patient is less than 19 years of age

Authorization will be issued for 12 months.

Chronic Myelogenous / Myeloid Leukemia (CML) - Initial Authorization

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

ALL of the following

Diagnosis of chronic myelogenous/myeloid leukemia (CML)
One of the following

Continuation (Reauthorization) Criteria

Chronic Myelogenous / Myeloid Leukemia (CML) - Reauthorization

Iclusig will be approved based on the following criterion:

ALL of the following

Patient does not show evidence of progressive disease while on Iclusig therapy

Authorization will be issued for 12 months.

Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) - Reauthorization

Iclusig will be approved based on the following criterion:

ALL of the following

Patient does not show evidence of progressive disease while on Iclusig therapy

Provider Actions

Prior Authorization

Prior authorization required

Members must meet the specified criteria for initial authorization and reauthorization. Prior authorization is required for Iclusig; when criteria are met an authorization will be issued for 12 months.

Documentation Required

Mutation and prior therapy documentation

For CML: documentation should include disease phase (chronic, accelerated, or blast), prior TKI therapies with evidence of resistance or intolerance to two or more TKIs (e.g., imatinib, dasatinib, nilotinib), confirmation of a T315I mutation when claimed, or documentation that no identifiable BCR::ABL1 mutations are present. For other indications: documentation of the diagnosis and relevant rearrangements (FGFR1 or ABL1) for myeloid/lymphoid/mixed lineage neoplasms with eosinophilia, and for GIST documentation of disease status including progression on approved therapies (e.g., imatinib, sunitinib, regorafenib, standard dose ripretinib) as applicable.

Applicable Codes

ICD-10 diagnosis references (examples mentioned)ICD-10

No codes listed

Clinical Evidence and Background

Iclusig (ponatinib) is described in the package insert (Iclusig [package insert], March 2024) and is recognized in the NCCN Drugs and Biologics Compendium (accessed 2025) for indications including CML (chronic phase, accelerated phase, blast phase), Ph+ ALL, myeloid/lymphoid/mixed lineage neoplasms with eosinophilia (FGFR1 or ABL1 rearrangements), and gastrointestinal stromal tumor (GIST). The policy incorporates NCCN recognition as a condition for authorization. P&T approvals span from 2/2013 through 11/2025 with an effective policy date of 2/1/2026; the most recent annual review updated CML criteria and background (11/2025). Primary references include the Iclusig package insert and the NCCN Compendium.

Evidence

P&T Approval Dates range2/2013 through 11/2025

Primary referenceIclusig [package insert], March 2024

CompendiumNCCN Drugs and Biologics Compendium (accessed 2025)

Definitions

TKI: Tyrosine kinase inhibitors — examples include imatinib mesylate, dasatinib, nilotinib.

Ph+ALL: Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL).

CML phases: Chronic Myelogenous Leukemia phases — chronic phase (CP), accelerated phase (AP), blast phase (BP).

Revision History

11/2024update

11/2024 update: background and references updated with no changes to coverage criteria.

11/2025annual_review

Annual review updated CML criteria and background (noted 11/2025).

2/1/2026effective_dateLatest

Effective date set to 2/1/2026.

Policy Summary

PayerUnitedHealthcare

PolicyIclusig® (ponatinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 1043-15

Change TypeAnnual review (non-material)

Effective Date02/01/2026

Next Review Date

Key ActionMembers must meet the specified criteria for initial authorization and reauthorization; authorization durations are 12 months when criteria are met.

SourceLink

On This Page

Both of the following
- Disease is in the chronic phase
- Patient with resistance or intolerance to two or more tyrosine kinase inhibitor (TKI) therapies (e.g., imatinib mesylate, Sprycel (dasatinib), or Tasigna (nilotinib))
Patient has no identifiable BCR::ABL1 mutations
Confirmed documentation of T315I mutation
Accelerated or blast phase criteria
- Disease is in the accelerated or blast phase
- No other kinase inhibitors are indicated

Authorization will be issued for 12 months.

Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) - Initial Authorization

Iclusig will be approved based on the following criterion:

ALL of the following

Diagnosis of Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL)

Authorization will be issued for 12 months.

Myeloid, Lymphoid, or Mixed Lineage Neoplasms with Eosinophilia - Initial Authorization

Iclusig will be approved based on both of the following:

ALL of the following

Diagnosis of lymphoid, myeloid, or mixed lineage neoplasms with eosinophilia
One of the following
- Patient has a FGFR1 rearrangement
- Patient has an ABL1 rearrangement

Authorization will be issued for 12 months.

Gastrointestinal Stromal Tumor (GIST) - Initial Authorization

Iclusig will be approved based on both of the following:

ALL of the following

Diagnosis of gastrointestinal stromal tumor (GIST)
Disease is one of the following
- Gross residual disease (R2 resection)
- Unresectable primary disease
- Tumor rupture
- Recurrent/metastatic disease after progression on approved therapies (e.g. imatinib, sunitinib, regorafenib, and standard dose ripretinib)

Authorization will be issued for 12 months.

NCCN Recommended Regimens

Authorization condition

The drug has been recognized for treatment of the cancer indication by The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Authorization will be issued for 12 months. State mandates and member-specific benefit plans may impact coverage.

Authorization will be issued for 12 months.

Myeloid, Lymphoid, or Mixed Lineage Neoplasms with Eosinophilia - Reauthorization

Iclusig will be approved based on the following criterion:

ALL of the following

Patient does not show evidence of progressive disease while on Iclusig therapy

Authorization will be issued for 12 months.

Gastrointestinal Stromal Tumor (GIST) - Reauthorization

Iclusig will be approved based on the following criterion:

ALL of the following

Patient does not show evidence of progressive disease while on Iclusig therapy

Authorization will be issued for 12 months.

Billing Rule

Pediatric auto-approval

For members under age 19, the prescription will automatically process without a coverage review; an authorization will still be issued for 12 months.

Denial Risk

Reauthorization denial risk

Reauthorization will be denied if there is evidence that the patient shows progressive disease while on Iclusig therapy; reauthorization requires documentation that the patient does not show evidence of progressive disease. Authorizations are issued for 12 months when criteria are met.

Note

State mandates and compendium use

State mandates for off-label coverage or required use of other compendia may supersede this policy. Member-specific benefit plans and federal requirements may also impact coverage decisions.

Billing Rule

Automated approvals

UnitedHealthcare may approve initial authorizations and reauthorizations based solely on previous claim or medication history, diagnosis codes (ICD-10), and/or claim logic using automated approval processes.