CurrentMass General Brigham Health PlanPolicy N/A

Danziten (nilotinib) tablet — Prior Authorization Coverage Criteria

Policy governing prior authorization and pharmacy benefit coverage for Danziten (nilotinib) tablets for adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) under Mass General Brigham Health Plan (Commercial/Exchange).

Policy Summary

PayerMass General Brigham Health Plan

PolicyDanziten (nilotinib) tablet — Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document age, Ph+ CML diagnosis, disease phase/risk, prior therapy history including trial and failure/intolerance/contraindication to imatinib and to nilotinib capsule (or rationale why capsule cannot be used).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial and reauthorization approval duration

≥18Minimum age for coverage

4/dayQuantity limit

SpecialtySpecialty designation

Commercial/Exchange

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Coverage Criteria for Danziten (nilotinib) Tablets

Initial Authorization Criteria

Authorization may be granted when ONE of the following pathways is met:

Pathway A - Continuation for recent plan entrants: Member is new to the plan within the past 90 days AND is currently receiving treatment with the requested medication (excludes supply obtained as samples or via manufacturer's patient assistance programs).

Continuity of care pathway

Pathway B - New authorization criteria

Age and diagnosis: Member is 18 years of age or older AND has a diagnosis of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML).
Disease status: Either disease is in accelerated phase OR (disease is in chronic phase AND either disease is intermediate or high risk OR disease is low-risk with trial and failure, contraindication, or intolerance to imatinib).
Reflects risk‑stratified sequencing
Nilotinib capsule trial or rationale: Member has had a trial and failure, intolerance, or contraindication to nilotinib capsule OR the provider submits a clinical rationale why the member cannot administer nilotinib capsule.
Tablet formulation requires prior trial or justification

Continuation of Therapy

Reauthorization

Reauthorization criteria: Member has had a positive response to therapy and does not show evidence of disease progression or toxicity.

Reauthorization approvals granted for 12 months if met

Authorization is excluded for members who are not new to the plan within the past 90 days unless they meet the policy's clinical criteria. The policy allows a continuity exception only for members who are new to the plan within the past 90 days and currently receiving the requested medication; supplies obtained as samples or via a manufacturer's patient assistance program do not qualify for this exception.

This policy applies specifically to Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML). Use of Danziten (nilotinib) tablets for diagnoses other than Ph+ CML is not supported by this policy; authorization requires documentation of the Ph+ CML diagnosis and the disease status defined in the coverage criteria.

Regimen / Indication	Coverage status
Nilotinib (Danziten) tablet for treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase
Nilotinib (Danziten) tablet for treatment of chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant of prior therapy that included imatinib

Coding, Age, and Quantity Limits

Coding (not specified)mixed

N/A	No specific CPT/HCPCS/ICD-10/NDC codes listed in document

inv-06: Age

Age requirementMember must be 18 years of age or older.

Reference policy clauseAuthorization criteria list explicitly states 'Member is 18 years of age or older.'

ApplicabilityApplies to initial authorizations and new therapy evaluations per coverage criteria.

inv-07: Quantity Limit

Daily quantity limit4 tablets per day for Danziten (nilotinib) tablet.

Policy sectionListed under Limitations as the quantity limitation for Danziten tablet.

Prior Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Danziten (nilotinib) tablets under the pharmacy benefit for Commercial/Exchange members.

Applies to Commercial/Exchange members under the pharmacy benefit
Medication designated specialty — must be filled at a contracted specialty pharmacy

Step Therapy

Step/Sequence Requirements

A trial, failure, intolerance, or contraindication to imatinib is required for approval when the member has low-risk chronic phase disease; other sequencing rules apply for intermediate/high risk or accelerated phase disease per criteria.

For chronic phase, low-risk disease: trial and failure, intolerance, or contraindication to imatinib required
For chronic phase, intermediate or high risk: imatinib trial requirement not required

Line of Therapy Specifications

first-line | subsequent

Indication contexts: Indicated for newly diagnosed Ph+ CML in chronic phase AND for chronic phase and accelerated phase Ph+ CML resistant to or intolerant of prior therapy that included imatinib.

Reflects FDA label and guideline‑based contexts for first‑line and subsequent use

Definitions

inv-13: Ph+ CML

DefinitionPhiladelphia chromosome positive chronic myeloid leukemia (Ph+ CML) includes disease presentations in chronic phase (CP) and accelerated phase (AP).

Indications referencedPolicy and prescribing information reference use for newly diagnosed Ph+ CML in chronic phase and for CP/AP Ph+ CML resistant to or intolerant of prior therapy including imatinib.

Coverage scopePolicy coverage and clinical criteria are specific to Ph+ CML (CP and AP); use for other diagnoses is not supported by this policy.

Covered Regimens and Indications

Indication	Key coverage requirements
Treatment of newly diagnosed Ph+ CML in chronic phase
Member is >= 18 years of age; diagnosis of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML); disease in chronic phase AND disease is intermediate or high risk OR disease is low-risk with trial and failure, contraindication, or intolerance to imatinib; member has had trial and failure, intolerance, or contraindication to nilotinib capsule or provider supplies clinical rationale why capsule cannot be administered
Treatment of CP or AP Ph+ CML resistant to or intolerant of prior therapy that included imatinib
Member is >= 18 years of age; diagnosis of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML); disease is in accelerated phase OR (chronic phase with the criteria above); member has had trial and failure, intolerance, or contraindication to nilotinib capsule or provider supplies clinical rationale why capsule cannot be administered

Background

Nilotinib is a kinase inhibitor indicated for adults with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase and for chronic phase or accelerated phase Ph+ CML that is resistant to or intolerant of prior therapy including imatinib. The policy evaluates disease phase (chronic vs accelerated), risk status for chronic phase, and prior treatment history when determining medical necessity for the tablet formulation.

Revision History

2025-02-12policy_reviewLatest

Policy created and reviewed at the February Pharmacy & Therapeutics (P&T) committee; effective date set to 2025-05-01.

2025-05-01effective_date

Policy effective date for Danziten (nilotinib) tablet coverage and prior authorization requirements under the Commercial/Exchange pharmacy benefit.