ModifiedCignaPolicy N/A

Iclusig (ponatinib) prior authorization

Policy Summary

PayerCigna

PolicyIclusig (ponatinib) prior authorization

Policy CodePolicy N/A

Change TypeMaterial updates to indications and prior-TKI requirements

Effective Date

Next Review Date

Key ActionObtain prior authorization and document prior TKI therapy or relevant mutation status (e.g., T315I, ABL1, FGFR1, Philadelphia chromosome, BCR::ABL1) as required.

POLICY UPDATE CHANGES

Chronic Myeloid Leukemia (CML) criteria were added for patients with accelerated-phase or blast-phase CML and no other tyrosine kinase inhibitor is indicated.

Gastrointestinal Stromal Tumor (GIST) was added as a new condition of approval in 'Other Uses With Supportive Evidence'.

Acute Lymphoblastic Leukemia (ALL) criteria expanded to include use in combination with chemotherapy as an approval option.

Age and prior TKI trial requirements were changed in earlier revisions (history shows changes between ≥15 and ≥18 and trial counts from two to one).

4Approved Indications/Uses Listed

1 yrTypical Approval Duration

>=18

Coverage Summary

Prior authorization policy for Iclusig (ponatinib tablets) for prescription benefit coverage under Cigna plans, specifying medical necessity criteria for FDA-approved indications and other uses with supportive evidence including Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), gastrointestinal stromal tumor (GIST), and myeloid/lymphoid neoplasms with eosinophilia.

This medication is covered with criteria and approvals are typically provided for 1 year. The policy’s statistical summary indicates a minimum age for most indications of ≥18 years.

Key facts

Approved Indications/Uses Listed4

Typical Approval Duration1 year

Minimum Age (most indications)>=18

Medical Necessity Criteria (by indication)

Acute Lymphoblastic Leukemia (ALL) - FDA-Approved Indication

Approve for 1 year if the patient meets BOTH of the following (A, and B):

ALL of the following

A) Patient meets ONE of the following
- Patient has Philadelphia chromosome-positive acute lymphoblastic leukemia
- Patient has ABL-class translocation
B) Patient meets ONE of the following
- The medication will be used in combination with chemotherapy
- The acute lymphoblastic leukemia is T315I-positive
- Patient has tried at least one other tyrosine kinase inhibitor. Note: Examples include imatinib and dasatinib.

Gastrointestinal Stromal Tumor (GIST) - Other Use with Supportive Evidence

Approve for 1 year if the patient meets BOTH of the following (A and B):

ALL of the following

A) Patient is ≥ 18 years of age
B) Patient has tried each of the following
- i.: One of imatinib or Ayvakit (avapritinib tablets)
- ii.: One of sunitinib or dasatinib
- iii.: Stivarga (regorafenib tablets)
- iv.:

Myeloid/Lymphoid Neoplasms with Eosinophilia - Other Use with Supportive Evidence

Approve for 1 year if the patient meets BOTH of the following (A and B):

ALL of the following

A) Patient is ≥ 18 years of age
B) Patient meets ONE of the following
- The tumor has an ABL1 rearrangement
- The tumor has an FGFR1 rearrangement

Not Medically Necessary / Denials

Iclusig is considered not medically necessary for any other uses beyond the indications and other uses with supportive evidence listed in this policy; claims for unlisted indications will be denied.

Coding

DrugNDCCovered

No codes listed

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of Iclusig; approvals provided for the durations specified (typically 1 year per indication).

Documentation Required

Document prior TKI therapy or mutation status

Providers must document prior tyrosine kinase inhibitor use where required (e.g., 'tried at least one other TKI' or sequence of specific agents for GIST) and/or mutation status (T315I, ABL1, FGFR1, Philadelphia chromosome, BCR::ABL1) to meet criteria.

T315I
ABL1 rearrangement
FGFR1 rearrangement
Philadelphia chromosome

Background & Evidence

Iclusig (ponatinib) is a tyrosine kinase inhibitor (TKI) indicated for adults with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) — including newly diagnosed in combination with chemotherapy and T315I-positive disease — and chronic myeloid leukemia (CML) (chronic, accelerated, or blast phase, including T315I mutation and certain patients with resistance/intolerance to prior TKIs).

One ALL indication (newly diagnosed Ph+ ALL in combination with chemotherapy) is approved under accelerated approval based on MRD-negative complete remission (CR) at end of induction. NCCN guidelines support Iclusig use in the listed scenarios (ALL, CML, GIST, and myeloid/lymphoid neoplasms).

Source	Reference
FDA prescribing information
Iclusig tablets prescribing information, March 2024
NCCN guideline support
Multiple NCCN guideline versions cited (ALL, CML, GIST, Myeloid/Lymphoid Neoplasms)

T315I: A specific BCR-ABL1 kinase domain mutation conferring resistance to many TKIs; presence qualifies for Iclusig per policy.

Revision History

05/31/2023added

Chronic Myeloid Leukemia (CML) criteria were added for patients with accelerated-phase CML or blast-phase CML and no other tyrosine kinase inhibitor is indicated.

05/31/2023added

Gastrointestinal Stromal Tumor (GIST) was added as a new condition of approval in 'Other Uses With Supportive Evidence'.

03/27/2024revised

Acute Lymphoblastic Leukemia (ALL) criteria were revised to add an option allowing use in combination with chemotherapy (reflecting new FDA labeled accelerated approval for newly diagnosed Ph+ ALL in combination with chemotherapy).