CurrentBlue Cross Blue Shield - IowaPolicy 05.05.74

Danziten (nilotinib) for Philadelphia chromosome–positive chronic myeloid leukemia

This policy governs medical necessity determination and benefit coverage for Danziten (nilotinib) in adult patients with Ph+ chronic myeloid leukemia (CML) for payor members covered under Blue Cross Blue Shield - Iowa.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyDanziten (nilotinib) for Philadelphia chromosome–positive chronic myeloid leukemia

Policy CodePolicy 05.05.74

Change TypeMinor editorial — no material clinical changes

Effective DateFeb 28, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation confirming Ph chromosome or BCR:ABL and required mutation testing when initiating after resistance to prior TKI.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

112/28dquantity limit

FDA-listedcovered indications

BCR:ABL1 ≤10%continuation threshold

Coverage Criteria for Danziten (nilotinib)

Initial Therapy

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Initial approval options: Any of the following: 1) Member has not received prior therapy with a tyrosine kinase inhibitor (TKI) (e.g., bosutinib, dasatinib, imatinib, ponatinib); 2) Member experienced toxicity or intolerance to prior therapy with a TKI; 3) Member experienced resistance to therapy with a TKI and results of BCR:ABL1 mutation testing are available where applicable.

Documentation: cytogenetic and/or molecular testing confirming Ph chromosome or BCR:ABL required.

Continuation of Therapy

Authorization may be granted for continued treatment when ALL of the following are met:

Continuation criteria: BCR:ABL1 ≤ 10% AND no evidence of disease progression AND no unacceptable toxicity while on the current regimen.BCR:ABL1 ≤ 10%

Continued authorization requires ongoing clinical documentation of response and tolerability.

Indication	FDA‑Recommended Dosing	Quantity Limit (standard)
Newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia, chronic phase (Ph+ CML‑CP)
142 mg orally twice daily
112 capsules per 28 days
Resistant or intolerant Ph+ CML‑CP and Ph+ CML‑accelerated phase (CML‑AP)
190 mg orally twice daily
112 capsules per 28 days

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval for initial therapy will be granted when documentation confirms the presence of the Philadelphia (Ph) chromosome or BCR:ABL gene and the member meets one of the following initial criteria: no prior TKI therapy, intolerance/toxicity to prior TKI, or resistance to prior TKI (with mutation testing where applicable).

Prior authorization required for initial therapy
Initial approval requires one of: no prior TKI therapy; intolerance/toxicity to prior TKI; resistance to prior TKI (mutation testing required where applicable)

Documentation Required

Required Documentation

Required documentation must be submitted to initiate the authorization review. Include the results of cytogenetic and/or molecular testing confirming the Philadelphia chromosome or BCR:ABL gene for treatment of CML. If the request is for initiation of therapy after resistance to a prior TKI, include results of BCR:ABL1 mutation testing (e.g., T315I, Y253H, E255K/M/V, F359V/C/I) where applicable.

Cytogenetic and/or molecular testing results confirming Ph chromosome or BCR:ABL gene
BCR:ABL1 mutation testing results when therapy is being initiated for resistance to a prior TKI

Denial Risk

Denial Risk / Not Medically Necessary

Therapy is considered not medically necessary and may be denied when the member does not meet the specified initial approval criteria or concurrent exclusions. Members receiving samples or medication via manufacturer patient assistance programs must meet the same initial approval criteria to continue therapy.

Not medically necessary if member does not meet initial approval criteria
Members receiving samples or patient assistance must meet the same criteria to continue therapy

First-line and Second-line Use

first-line | second-line

Line-of-therapy context: Newly diagnosed Philadelphia chromosome–positive CML in chronic phase (first-line) OR chronic phase or accelerated phase Ph+ CML resistant or intolerant to prior imatinib therapy (subsequent lines).

Refer to FDA‑approved indications for specific phase and resistance/intolerance settings.

Biomarker and Mutation Testing Requirements

inv-15: BCR:ABL1 — Continuation threshold ≤ 10%

Continuation thresholdBCR:ABL1 ≤ 10%

Continuation requirementsAND no evidence of disease progression AND no unacceptable toxicity while on current regimen

UseThreshold applied when authorizing continued treatment of CML

inv-16: BCR:ABL1 mutation panel — required mutations

Required mutation panelT315I

Required mutation panelY253H

Required mutation panelE255K/V

Required mutation panelF359V/C/I

Key Definitions

inv-12: Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) — definition/label entry

DefinitionPhiladelphia chromosome–positive chronic myeloid leukemia (Ph+ CML)

Covered indicationsNewly diagnosed Ph+ CML in chronic phase and Ph+ CML (chronic or accelerated phase) resistant or intolerant to prior imatinib therapy

Diagnostic requirementDiagnosis confirmed by detection of the Ph chromosome or the BCR:ABL gene (cytogenetic and/or molecular testing)

inv-13: BCR:ABL1 mutation testing — key resistance mutations

Purpose of testingBCR:ABL1 mutation testing is required when initiating therapy after resistance to prior TKI

Key resistance mutations listedT315I, Y253H, E255K/V, F359V/C/I

DocumentationResults must be submitted as part of authorization review when resistance to prior TKI is reported

Background on Danziten (nilotinib)

Danziten (nilotinib) is a tyrosine kinase inhibitor indicated for adult patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase and for chronic or accelerated phase Ph+ CML that is resistant or intolerant to prior imatinib therapy. Molecular and cytogenetic testing to confirm the Philadelphia chromosome/BCR:ABL is required to establish the diagnosis and guide treatment decisions; when initiating therapy after reported resistance to a prior TKI, BCR:ABL1 mutation testing for key resistance mutations should be available to inform therapy selection.