Colorado Rocky Mountain Health Plans Prior Auth | OpenPayer

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Colorado Rocky Mountain Health Plans Prior Auth | OpenPayer

Coverage Criteria for Xospata (gilteritinib)

Patients <19 years

Covered for patients less than 19 years of age when ALL of the following are met:

Age <19: Member is less than 19 years of ageage <19

Authorization will be issued for 12 months

AML — Initial Authorization

Initial authorization for Acute Myeloid Leukemia (AML) — Covered when ALL of the following are met:

AML initial criteria: (1) Diagnosis of acute myeloid leukemia (AML) AND (2) AML is FMS-like tyrosine kinase 3 (FLT3) mutation-positive AND (3) One of the specified clinical scenarios: (a) used as low-intensity treatment induction when not a candidate for intensive induction therapy; (b) follow-up after induction therapy with response to previous lower intensity therapy with the same regimen; (c) post-allogeneic hematopoietic cell transplantation and in remission; (d) disease is relapsed or refractory; (e) consolidation therapy as continuation of low-intensity regimen used for induction in patients with poor-risk AML.

Authorization will be issued for 12 months

AML — Reauthorization

Reauthorization for AML — Covered when ALL of the following are met:

AML reauthorization: Patient does not show evidence of progressive disease while on Xospata therapyno progressive disease

Authorization will be issued for 12 months

Myeloid/Lymphoid Neoplasms with Eosinophilia — Initial Authorization

Initial authorization for lymphoid/myeloid/mixed lineage neoplasms with eosinophilia — Covered when ALL of the following are met:

Myeloid/lymphoid neoplasms initial: (1) Diagnosis of lymphoid, myeloid, or mixed lineage neoplasms with eosinophilia AND (2) Presence of an FMS-like tyrosine kinase 3 (FLT3) rearrangement in chronic phase or blast phase.

Authorization will be issued for 12 months

Myeloid/Lymphoid Neoplasms — Reauthorization

Reauthorization for myeloid/lymphoid neoplasms with eosinophilia — Covered when ALL of the following are met:

Neoplasms reauthorization: Patient does not show evidence of progressive disease while on Xospata therapyno progressive disease

Authorization will be issued for 12 months

NCCN Recommended Regimens

NCCN recognition

NCCN recognized: Drug recognized by The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B.

May support coverage decisions

Some states have legal mandates that require coverage for certain off-label medication uses or reference specific compendia. Where a state mandate applies, it supersedes the language in this policy and the notification/prior authorization criteria.

Therapy is not eligible for reauthorization if the patient shows evidence of progressive disease while receiving Xospata. Reauthorization for approved indications is contingent on documentation that the patient is not experiencing disease progression while on therapy; when this criterion is met, authorization is issued for 12 months.

Initial authorization requests that do not meet the specified indication criteria — including the required FLT3 mutation or rearrangement status and the listed clinical scenarios for AML or myeloid/lymphoid neoplasms with eosinophilia — will not be approved for coverage.

Initial Therapy

Initial Therapy

Initial therapy coverage rules

AML or neoplasm diagnosis: Diagnosis of AML (FLT3 mutation-positive) OR diagnosis of lymphoid/myeloid/mixed lineage neoplasms with eosinophilia (with FLT3 rearrangement).

See specific clinical scenario sub-criteria for AML

Continuation / Consolidation Therapy

Continuation/Consolidation Therapy

Consolidation/continuation therapy

Consolidation: Use as consolidation therapy as continuation of low-intensity regimen used for induction in patients with poor-risk AML.

Coding and Age Threshold

No codes listedmixed

No codes listed

Age threshold — < 19 years: automatic processing

Automatic processing ageMembers under 19 years of age are eligible for automatic approval (authorization issued for 12 months)

Authorization durationApproved authorizations are issued for 12 months

Applicable benefitApplies to Xospata (gilteritinib) prior authorization program

Provider Actions, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization/notification is required for Xospata (gilteritinib) under program 2026 P 1274-8. Requests must meet the indication-specific criteria described in the Coverage Information and AML sections. Authorization for AML indications will be issued for up to 12 months.

Program: Prior Authorization/Notification (2026 P 1274-8)
Medication: Xospata (gilteritinib)
Authorization duration: up to 12 months for AML indications

Step Therapy

Step Therapy

Step therapy — No specific step therapy sequence is required in this policy. However, automated approval or reauthorization processes may use prior medication/claim history for approvals where applicable; check member-specific benefit design for any plan-level step edits or supply limits.

No explicit step sequence specified in policy document

Definitions

FLT3 mutation / rearrangement — Molecular alteration of the FMS-like tyrosine kinase 3 gene

DefinitionMolecular alteration of the FMS-like tyrosine kinase 3 (FLT3) gene, including internal tandem duplication (ITD) or tyrosine kinase domain (TKD) mutations, or rearrangements detectable by appropriate testing

Included alterationsFLT3 ITD and TKD mutations referenced for AML; FLT3 rearrangements referenced for myeloid/lymphoid neoplasms with eosinophilia

Testing requirementDetection by an appropriate/validated molecular test (e.g., FDA-approved test for FLT3 mutation) is implied by indication language

Background

Xospata (gilteritinib) is a kinase inhibitor used in the settings described by this policy for FLT3-altered disease. Coverage is defined for adult indications including relapsed or refractory acute myeloid leukemia with documented FLT3 mutation and for certain myeloid/lymphoid neoplasms with eosinophilia and FLT3 rearrangement. Authorization decisions follow the indication-specific clinical scenarios in which gilteritinib is considered appropriate (for example, targeted therapy in relapsed/refractory FLT3-mutated AML, maintenance after transplant, low-intensity induction, or consolidation following low-intensity induction).

Step Therapy

Step	Requirement
0
No explicit step therapy requirements listed in this policy document.

Quantity Limits

Xospata (gilteritinib) — Supply limits may be in place

Quantity limits noteSupply limits may be in place for Xospata (gilteritinib)

Automated approvalsProgram may use automated approval/re-approval processes based on previous claim/medication history, diagnosis codes, or claim logic

Program variabilityUse of automated approval and re-approval processes varies by program and/or therapeutic class

Site of Care

Note

No site-of-care restrictions

No site‑of‑care or infusion center restrictions are specified in this policy.

Revision History and Policy Changes

2026-02annual reviewLatest

Annual review completed with no changes to coverage criteria.

2025-02annual review

Added criteria for treatment of AML based on NCCN recommendations.

2023-02annual review

Updated treatment criteria for myeloid/lymphoid neoplasms per NCCN recommendations and added state mandate language.