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Neighborhood Health Plan RI Iclusig Coverage | OpenPayer

v1.0.11

OpenPayerPolicy UpdatesHematology/OncologyNeighborhood Health Plan RI Iclusig Coverage | Ope…

CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Iclusig (ponatinib) — Coverage Criteria

Policy governing prior authorization and coverage criteria for Iclusig (ponatinib) for Neighborhood Health Plan of Rhode Island members, including FDA-approved and specified compendial uses.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIclusig (ponatinib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of required testing (e.g., BCR-ABL1/T315I or FGFR1/ABL1 results) and evidence of prior kinase inhibitor use when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

T315Imutation referenced

≥2CP-CML prior therapies

≥4GIST prior therapies

Coverage Criteria for Iclusig (ponatinib)

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CML — Initial therapy / Indication-specific coverage

Covered when ANY of the following are met (and required documentation provided):

CML approval criteria: Member has T315I-positive CML (any phase) confirmed by testing

Authorization typically 12 months; cytogenetic and/or molecular confirmation of Ph chromosome or BCR-ABL gene required

CML approval criteria: Member has accelerated phase (AP) or blast phase (BP) CML for whom other kinase inhibitors are not indicated

Authorization typically 12 months; cytogenetic and/or molecular confirmation of Ph chromosome or BCR-ABL gene required

CML approval criteria: Member has chronic phase (CP) CML with resistance or intolerance to at least two prior kinase inhibitors>= 2 prior kinase inhibitors

Authorization typically 12 months; cytogenetic and/or molecular confirmation of Ph chromosome or BCR-ABL gene required

CML approval criteria: Member received hematopoietic stem cell transplant (HSCT) for CML

Authorization typically 12 months

Ph+ ALL — Initial therapy / Indication-specific coverage

Covered when ANY of the following are met (and required documentation provided):

Ph+ ALL approval criteria: Member has T315I-positive Ph+ ALL confirmed by testing

Authorization typically 12 months; cytogenetic and/or molecular confirmation of Ph chromosome or BCR-ABL gene required

Ph+ ALL approval criteria: Ph+ ALL for which other kinase inhibitors are not indicated

Authorization typically 12 months; cytogenetic and/or molecular confirmation of Ph chromosome or BCR-ABL gene required

Ph+ ALL approval criteria: Member received hematopoietic stem cell transplant (HSCT) for Ph+ ALL

Authorization typically 12 months

Myeloid/Lymphoid Neoplasms with Eosinophilia and GIST — Initial therapy / Indication-specific coverage

Covered when ALL of the following are met:

Myeloid/lymphoid neoplasms with eosinophilia: Disease with confirmed FGFR1 or ABL1 rearrangement in chronic phase or blast phase

Authorization typically 12 months; molecular confirmation of rearrangement required

GIST: Residual, unresectable, recurrent or metastatic GIST after progression on at least four FDA-approved therapies (e.g., imatinib, sunitinib, regorafenib, ripretinib)>= 4 prior FDA-approved GIST therapies

Authorization typically 12 months

Continuation/Duration criteria

Covered for continuation when ALL of the following are met:

Continuation criteria: No evidence of unacceptable toxicity and no disease progression while on the current regimen

Authorization of 12 months may be granted

Continuation criteria: Patient meets disease-specific confirmation criteria: for CML/Ph+ ALL — cytogenetic and/or molecular confirmation of Ph chromosome or BCR-ABL gene; for myeloid/lymphoid neoplasms — prior confirmation of FGFR1 or ABL1 rearrangement; OR patient has received HSCT for the indicated disease

Authorization of 12 months may be granted

All indications other than the listed FDA-approved indications and the specified compendial uses are considered experimental/investigational and are not medically necessary. Requests for Iclusig (ponatinib) for diagnoses or uses not included in the INDICATIONS or Compendial Uses sections should be denied as not medically necessary.

Use of Iclusig for any indication not specified in the 'INDICATIONS' section — including uses that are not listed under the FDA-approved indications or the specified compendial uses — is considered not medically necessary. Prior authorization will not be approved for such off‑label or unlisted indications.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization and authorization duration

Authorization of up to 12 months may be granted when approval criteria are met for the specified indications below. Prior authorization is required before initiation (except where continuation/renewal rules apply) and for continuation of therapy when applicable. Continued therapy may be authorized for 12 months when there is no evidence of unacceptable toxicity or disease progression while on the current regimen and the member meets the confirmed-diagnosis or post–hematopoietic stem cell transplant criteria listed for each indication.

Authorization duration: up to 12 months for initial or continued therapy when criteria are met
Prior authorization required before initiation for listed indications
Continuation requests require documentation of no unacceptable toxicity or disease progression while on therapy

Denial Risk

Experimental / Investigational exclusions

All indications not explicitly listed in the policy (outside FDA‑approved indications and the compendial uses specified) are considered experimental and investigational and are not medically necessary. Requests for use of the medication for any unlisted indication will be denied as investigational.

Experimental/Investigational exclusion: any indication not listed among FDA‑approved or specified compendial uses is not covered
Examples of covered compendial uses include: follow‑up or maintenance post‑HSCT for CML/Ph+ ALL, GIST, and myeloid/lymphoid neoplasms with eosinophilia with FGFR1 or ABL1 rearrangements

Drug and Billing Codes

Drug referencedmixed

Iclusig (ponatinib)

Policy drug name referenced throughout document

Line of Therapy Requirements

second-line

Second-line / line-of-therapy note: Policy references use after failure, resistance, or intolerance to prior kinase inhibitors in CP-CML (≥2 prior agents), and use when other kinase inhibitors are not indicated for AP/BP CML and Ph+ ALL; for GIST, use is reserved after progression on ≥4 FDA-approved therapies

See disease-specific nodes for exact prior therapy requirements

Biomarker and Genetic Testing Requirements

inv-20: BCR-ABL1 (T315I) — biomarker requirement

BiomarkerBCR-ABL1 (T315I)

Required forRequired for coverage in T315I-positive CML and Ph+ ALL

DocumentationResults of BCR-ABL1 mutation testing for T315I must be provided for initiation of therapy

ReferencePolicy references FDA‑approved indication for T315I-positive CML (any phase) and T315I-positive Ph+ ALL

inv-21: FGFR1 or ABL1 rearrangement — biomarker requirement

BiomarkerFGFR1 or ABL1 rearrangement

Required forRequired for coverage in myeloid/lymphoid neoplasms with eosinophilia

Disease phaseCoverage applies in chronic phase or blast phase when rearrangement is confirmed

DocumentationResults of testing/analysis confirming FGFR1 or ABL1 rearrangement must be provided

Definitions and Key Terms

inv-17: T315I mutation — A BCR-ABL1 kinase domain mutation that confers resistance to many kinase inhibitors; testing for this mutation is required for specified ...

DefinitionA BCR-ABL1 kinase domain mutation that confers resistance to many kinase inhibitors

Clinical implicationPresence of T315I identifies patients eligible for ponatinib when other kinase inhibitors are not effective

Testing requirementResults of BCR-ABL1 mutation testing for T315I must be submitted to initiate prior authorization

Covered indicationsT315I-positive CML (CP, AP, BP) and T315I-positive Ph+ ALL

inv-18: Ph chromosome / BCR-ABL gene — Cytogenetic or molecular evidence of the Philadelphia chromosome or BCR-ABL fusion required to confirm CML or Ph+ ALL diagnosis for cover...

DefinitionCytogenetic or molecular evidence of the Philadelphia chromosome or BCR-ABL fusion

Required for diagnosisRequired to confirm CML or Ph+ ALL for coverage

Testing modalityCytogenetic and/or molecular testing for detection of the Ph chromosome or the BCR-ABL gene must be provided prior to initiation

Policy useDetection confirmed by testing is a prerequisite for authorization of ponatinib in CML and Ph+ ALL

Background on Ponatinib (Iclusig)

Ponatinib (Iclusig) is included in this policy for its FDA‑approved and selected compendial uses. Compendial uses listed in the policy include follow‑up or maintenance therapy after hematopoietic stem cell transplant (HSCT) for CML and Ph+ B‑ALL, gastrointestinal stromal tumor (GIST), and myeloid/lymphoid neoplasms with eosinophilia and FGFR1 or ABL1 rearrangements in chronic or blast phase. All other indications are treated as experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIclusig (ponatinib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of required testing (e.g., BCR-ABL1/T315I or FGFR1/ABL1 results) and evidence of prior kinase inhibitor use when applicable.

SourceLink

On This Page

Coverage Criteria for Iclusig (ponatinib)Provider Actions, Prior Authorization, and Documentation Drug and Billing Codes Line of Therapy Requirements Biomarker and Genetic Testing Requirements Definitions and Key Terms Background on Ponatinib (Iclusig)