ModifiedNeighborhood Health Plan of Rhode IslandPolicy N/A

Tasigna (nilotinib)

Defines accepted indications, contraindications, exclusion criteria, continuation rules, coding, and applicable lines of business for coverage and utilization management of Tasigna (nilotinib) processed by Evolent for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTasigna (nilotinib)

Policy CodePolicy N/A

Change TypeTemplate conversionindication and exclusion updates

Effective Date

Next Review Date

Key ActionSupport drug use with FDA labeling, CMS-approved compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

SourceLink

POLICY UPDATE CHANGES

June 2025 summary from policy history: Converted to new Evolent guideline template; updated indication section; updated maximum dosage form quantities in exclusion criteria; updated exclusion criteria and references.

June 2024 summary from policy history: Updated NCH verbiage to Evolent.

2Primary Covered Indications (CML, ALL)

3Absolute Contraindications listed

3Monthly capsule maximum formulations listed

Coverage Summary

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Scope: This guideline defines accepted indications and utilization management for Tasigna (nilotinib). Primary covered indications include Chronic Myeloid Leukemia (CML) (Philadelphia chromosome or BCR-ABL positive) and Philadelphia chromosome or BCR-ABL positive B‑Cell Acute Lymphoblastic Leukemia (ALL). Evolent is responsible for processing all medication requests and enforcing prior authorization, documentation, and utilization limits; medications not authorized by Evolent may be deemed not approvable and not reimbursable. The policy stance is mixed — FDA‑approved uses are accepted, and selected off‑label uses may be allowed when supported by recognized compendia or acceptable peer‑reviewed literature.

Quick thresholds and limits

Single dose limit400 mg

Monthly capsule maximum — 50 mg240 capsules per month

Monthly capsule maximum — 150 mg112 capsules per month

Monthly capsule maximum — 200 mg112 capsules per month

Continuation Therapy Criteria

General Coverage Requirements / Continuation Requests

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

Continuation request exemption

No progression: The member has not experienced disease progression on the requested medication
Recent use: The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
No added medications: Additional medication(s) are not being added to the continuation request

Documentation Required

Monitoring and safety documentation

Document baseline and follow-up ECGs (baseline, day 7, periodically, and after dose adjustments). Monitor for hypokalemia and hypomagnesemia prior to and periodically during therapy and correct deficiencies before and during treatment.

Contraindications and Safety Warnings

Contraindications / Warnings

Tasigna is contraindicated and requires monitoring as follows:

Absolute contraindications: Contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome
QT monitoring: Obtain ECGs at baseline, at 7 days after initiation, periodically thereafter, and following any dose adjustments to monitor QTc; QT prolongation and sudden deaths have been reported
Electrolyte monitoring: Monitor for hypokalemia and hypomagnesemia prior to and periodically during therapy and correct deficiencies
Drug interactions: Avoid concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors
Fasting instructions: Avoid food 2 hours before and 1 hour after taking a Tasigna dose

Documentation Required

ECG and electrolyte monitoring requirements

Obtain ECGs to monitor QTc at baseline, at 7 days after initiation, periodically thereafter, and following any dose adjustments. Monitor potassium and magnesium prior to and periodically during therapy and correct any deficiencies. Avoid use in patients with hypokalemia, hypomagnesemia, or long QT syndrome and avoid concomitant QT-prolonging drugs and strong CYP3A4 inhibitors.

Exclusion Criteria / Not Covered Scenarios

Not covered when ANY of the following exclusion criteria apply:

Ph-negative disease: The member has Philadelphia chromosome or BCR-ABL negative CML or ALL
Progression on nilotinib: Member has disease progression while taking Tasigna (nilotinib)
Contraindicated mutations: Tasigna (nilotinib) is contraindicated for use in members with the following mutations
Specific mutations not listed in document
Single dose limit exceeded: Dosing exceeds single dose limit of Tasigna (nilotinib) 400 mg400 mg
Monthly capsule limits exceeded: Treatment exceeds the maximum limit of 240 (50 mg); 112 (150 mg); or 112 (200 mg) capsules per month240 (50 mg); 112 (150 mg); 112 (200 mg)
Investigational / insufficient evidence: Investigational use with an off-label indication that is not supported by CMS-recognized compendia or acceptable peer-reviewed literature
Evidence insufficiency considerations
- Clinical characteristics represented: Whether the clinical characteristics of the patient and the cancer are adequately represented in the published evidence
- Regimen represented: Whether the administered regimen is adequately represented in the published evidence
- Meaningful outcomes: Whether reported study outcomes represent clinically meaningful outcomes (e.g., ASCO: Hazard Ratio < 0.80 and survival benefit for OS and PFS at least 3 months)
- Appropriate design: Whether the experimental design is appropriate to address the investigative question
- Non-randomized trials with a significant number of subjects may be supportive

Denial Risk

Dose and quantity limits enforcement

Claims may be denied/excluded if dosing exceeds the single dose limit of 400 mg or if monthly capsule quantities exceed the specified formulation limits.

240 capsules per month — 50 mg formulation
112 capsules per month — 150 mg formulation
112 capsules per month — 200 mg formulation
Single dose maximum: 400 mg

Provider Actions / Prior Authorization

Prior Authorization

Evolent authorization required

Evolent is responsible for processing all medication requests. Medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Documentation Required

Support drug use with authoritative sources

Support requests for this drug with authoritative sources: FDA product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

J8999

Billing Rule

Dose and quantity limits enforcement

Claims may be excluded/denied if dosing exceeds the single dose limit of 400 mg or monthly capsule limits for the available formulations. See exclusions for exact limits.

Single dose maximum: 400 mg
Monthly maximums: 240 (50 mg); 112 (150 mg); 112 (200 mg)

Clinical Evidence and References

Evidence summary: Key clinical evidence cited includes the ENESTnd trial (Saglio G, et al., N Engl J Med. 2010) comparing nilotinib versus imatinib for newly diagnosed CML, and the Tasigna prescribing information (Novartis, 2024). Coverage of off‑label indications requires support from CMS‑recognized compendia, NCCN/ASCO guidelines, FDA labeling, or peer‑reviewed literature that meets CMS standards; investigational or off‑label uses lacking such support are excluded per the policy.

Background

Background: The guideline describes accepted indications for nilotinib including FDA‑approved uses and off‑label uses supported by recognized compendia or acceptable peer‑reviewed literature. Evolent processes medication requests for the plan, enforces prior authorization and utilization limits, and requires that use be supported by authoritative sources (FDA labeling, CMS compendia, NCCN/ASCO, or acceptable peer‑reviewed literature).

Definitions

Continuation request exemption — definitionContinuation requests for a not-approvable medication are exempt if: member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTasigna (nilotinib)

Policy CodePolicy N/A

Change TypeTemplate conversionindication and exclusion updates

Effective Date

Next Review Date

Key ActionSupport drug use with FDA labeling, CMS-approved compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

SourceLink

On This Page

OpenPayer

Tasigna (nilotinib)

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Contraindications and Safety Warnings

Exclusion Criteria / Not Covered Scenarios

Applicable Codes

Provider Actions / Prior Authorization

Clinical Evidence and References

Background

Revision History