CurrentColorado Rocky Mountain Health PlansPolicy N/A

Step therapy and prior authorization for Tasigna (nilotinib)

Defines prior authorization and step therapy requirements for coverage of Tasigna (nilotinib), primarily for treatment of Philadelphia chromosome–positive chronic myelogenous/myeloid leukemia (Ph+ CML), and applies to UnitedHealthcare Pharmacy benefit members (state-specific mandates supersede where applicable).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy and prior authorization for Tasigna (nilotinib)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document a trial or physician consideration of imatinib (or attestation that imatinib is unsuitable) to support coverage for Tasigna.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

age <19auto-approve under 19

imatinib trialstep therapy requirement

2025 P 3082-10program id

Coverage Criteria for Tasigna (nilotinib)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage criteria

Covered when the following criteria are met for each group

Patients less than 19 years: Patient is less than 19 years of age

Authorization will be issued for 12 months

Ph+ CML initial or continuation: Diagnosis of Philadelphia chromosome-positive chronic myelogenous / myeloid leukemia (Ph+ CML) AND one of the following: (1) patient is not a suitable candidate for imatinib as attested by physician; OR (2) patient is currently on Tasigna therapy AND patient has not received a manufacturer supplied sample at no cost in the prescriber office or assistance from a Novartis-sponsored financial assistance program to establish current use

Authorization will be issued for 12 months

Other Indications: Tasigna will be approved for other indications per program rules, state mandates, or applicable compendia

Authorization will be issued for 12 months

Some states have specific mandates that may require coverage for off-label medication uses or direct reliance on particular compendium references. Where a state mandate or federal regulatory requirement applies, it supersedes this policy and any conflicting language in the benefit document.

For members under the age of 19 years, prescriptions for Tasigna will automatically process without a coverage review, per the program rules.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tasigna (nilotinib) for members with Philadelphia chromosome–positive chronic myelogenous/myeloid leukemia (Ph+ CML). For members under 19 years of age, requests are auto-processed and authorization will be issued for 12 months.

Authorization duration: 12 months for members <19 years
Applies to Tasigna for Ph+ CML

Step Therapy

Step Therapy Requirement and Failure to Meet Conditions

A step-therapy requirement applies: coverage for Tasigna for Ph+ CML requires either a documented trial of imatinib or physician documentation that the patient is not a suitable candidate for imatinib. If the step-therapy criteria are not met or not documented, coverage will be denied until documentation is provided supporting an exception or prior trial.

Required trial or physician consideration of imatinib before Tasigna coverage
If step therapy not documented/met → coverage denial or requirement to provide documentation of exception

Documentation Required

Required Documentation for Exceptions

Physician attestation or documentation is required to support exceptions to step therapy (e.g., attestation that the patient is not a suitable candidate for imatinib). Documentation options include confirmation that the patient is currently on Tasigna therapy and that the patient did not receive a manufacturer-supplied sample or Novartis financial assistance to establish current use.

Physician attestation that imatinib is unsuitable
Documentation that patient is currently on Tasigna
Documentation that no manufacturer sample or Novartis assistance was used to establish current Tasigna use

Initial Therapy Criteria

Initial therapy

Initial therapy criteria for Ph+ CML

Initial approval for Ph+ CML: Diagnosis of Philadelphia chromosome-positive chronic myelogenous / myeloid leukemia (Ph+ CML) AND (physician attestation that the patient is not a suitable candidate for imatinib OR documentation of a trial or consideration of imatinib)

Authorization 12 months

Continuation Therapy Criteria

Continuation therapy

Rules for members already on Tasigna

Current Tasigna users: Patient is currently on Tasigna therapy AND patient has not received a manufacturer supplied sample at no cost in the prescriber office or any form of assistance from a Novartis-sponsored financial assistance program (e.g., sample card redeemable at a pharmacy) as a means to establish current use

Meets criteria for approval/continuation; authorization will be issued for 12 months

Step Therapy Requirements

Step	Requirement	Coverage action
1	A trial of imatinib or physician consideration of imatinib is required before coverage of Tasigna for Philadelphia chromosome–positive chronic myelogenous / myeloid leukemia (Ph+ CML)	Covered with criteria: Tasigna approved when trial/consideration of imatinib is documented or physician attests patient is not a suitable candidate for imatinib
1.a	Diagnosis of Philadelphia chromosome–positive chronic myelogenous / myeloid leukemia (Ph+ CML)	Required for approval under the Ph+ CML criteria
1.b (physician attestation)	Physician attestation that the patient is not a suitable candidate for imatinib	If attested, Tasigna may be approved without prior imatinib trial
1.b (current user)	Patient is currently on Tasigna therapy AND patient has not received manufacturer supplied sample at no cost in prescriber office or assistance from a Novartis‑sponsored financial assistance program to establish current use	Meets criteria for continuation approval of Tasigna

Definitions

Ph+ CML definition — Philadelphia chromosome–positive chronic myelogenous/myeloid leukemia required for approval

TermPhiladelphia chromosome–positive chronic myelogenous / myeloid leukemia (Ph+ CML)

DefinitionDiagnosis of Philadelphia chromosome-positive chronic myelogenous / myeloid leukemia (Ph+ CML).

RelevanceRequired diagnosis for approval of Tasigna under the Ph+ CML coverage criteria.

Authorization noteWhen criteria are met, authorization will be issued for 12 months.

Background

Step therapy programs are used to encourage the use of lower-cost therapeutic alternatives when clinically appropriate. This program requires consideration or a trial of imatinib before approving Tasigna (nilotinib) for Philadelphia chromosome–positive chronic myelogenous/myeloid leukemia (Ph+ CML), unless a clinical justification is documented or the member meets current-user conditions.

When Tasigna is subject to the step therapy requirement, the provider must either document a trial or consideration of imatinib or provide a physician attestation that the patient is not a suitable candidate for imatinib. Members already on Tasigna who meet the program’s current-user documentation requirements may be eligible for continuation without meeting the imatinib trial.

Prior authorization is required for approval of Tasigna for Ph+ CML except for members under 19 years (who auto‑process). When approved, authorizations are issued for 12 months.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy and prior authorization for Tasigna (nilotinib)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document a trial or physician consideration of imatinib (or attestation that imatinib is unsuitable) to support coverage for Tasigna.

SourceLink

On This Page