ModifiedNeighborhood Health Plan of Rhode IslandPolicy N/A

Tasigna

Defines accepted indications, contraindications, exclusions, dosing limits, coding, and prior-authorization/continuation rules for Tasigna (nilotinib) across applicable lines of business (Commercial, Exchange/Marketplace, Medicaid). Applies to initial and continuation medication requests processed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTasigna

Policy CodePolicy N/A

Change TypeTemplate conversion and clinical/exclusion updates

Effective Date

Next Review Date

Key ActionAll medication requests for Tasigna must be processed and authorized by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1199 Tasigna guideline; indication section and maximum dosage form quantities in exclusion criteria updated.

Updated organization name verbiage from NCH to Evolent.

2Covered Indications (ALL, CML)

6Excluded BCR-ABL1 mutations listed

3Monthly capsule quantity limits (50/150/200 mg)

Coverage Summary

Covered with criteria: Tasigna (nilotinib) is covered when used for Philadelphia chromosome/BCR‑ABL positive Chronic Myeloid Leukemia (CML) or B‑cell Acute Lymphoblastic Leukemia (ALL) per the policy's accepted indications; applies to Commercial, Exchange/Marketplace, and Medicaid and is processed by Evolent. Coverage requires supporting evidence from FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Accepted Indications / Medical Necessity

Tasigna (nilotinib) is covered when ALL of the following are met:

Indication (ONE of)
- Member has Philadelphia chromosome positive or BCR-ABL positive B-Cell Acute Lymphoblastic Leukemia (ALL); Tasigna may be used as a single agent or in combination with chemotherapy as induction, consolidation, maintenance, or subsequent therapy.
- Member has Chronic Myeloid Leukemia (CML) (Philadelphia chromosome or BCR-ABL positive); Tasigna may be used as a single agent as initial or subsequent therapy.
Use is supported by one of: FDA approved product labeling, CMS‑recognized compendia, NCCN, ASCO clinical guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Continuation Therapy Criteria

Continuation Therapy

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

Member has not experienced disease progression on the requested medication.
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
Additional medication(s) are not being added to the continuation request.

Contraindications, Exclusions and Safety Warnings

Contraindications / Warnings (Exclusionary conditions)

Tasigna is contraindicated / excluded when ANY of the following apply:

Patient has hypokalemia, hypomagnesemia, or long QT syndrome.
Member has Philadelphia chromosome or BCR-ABL negative CML or ALL.
Member has disease progression while taking Tasigna (nilotinib).
Member has BCR-ABL1 mutations T315I, Y253H, E255K/V, F359V/C/I, or G250E (nilotinib is contraindicated for use).
Dosing exceeds single dose limit of 400 mg.<= 400 mg
Treatment exceeds the maximum monthly limits: 240 capsules of 50 mg OR 112 capsules of 150 mg OR 112 capsules of 200 mg per month.<= 240 x 50 mg; <= 112 x 150 mg; <= 112 x 200 mg per month
Investigational use for an off-label indication that lacks sufficient evidence or is not generally accepted by the medical community (insufficient evidence defined by absence of CMS compendia support or acceptable peer-reviewed literature per policy).

Monitoring / Safety Requirements

Required monitoring and safety precautions (must be followed):

Obtain ECGs to monitor QTc at baseline, at 7 days after initiation, periodically thereafter, and after any dose adjustments.
Monitor for hypokalemia and hypomagnesemia prior to and periodically during therapy and correct deficiencies before administration.
Avoid concomitant drugs known to prolong QT interval and strong CYP3A4 inhibitors.
Advise patient to avoid food 2 hours before and 1 hour after taking a Tasigna dose.

Provider Actions & Prior Authorization

Prior Authorization

Authorization required and processed by Evolent

All medication requests for Tasigna must be processed and authorized by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

J8999

Documentation Required

Support with accepted evidence sources

Provider must support use with FDA labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements. Documentation should demonstrate applicability of the cited evidence to the patient’s clinical characteristics and the requested regimen.

Denial Risk

Denial for excluded mutations or progression

Claims may be denied if the member has any of the listed excluded BCR‑ABL1 mutations or has disease progression while on nilotinib.

T315I
Y253H
E255K/V
F359V/C/I
G250E

Billing Rule

Dose and quantity limits enforced

Claims exceeding the single-dose limit or maximum monthly capsule quantities are excluded and may be denied.

Single dose limit: <= 400 mg
Maximum monthly quantity - 50 mg capsules: <= 240 capsules/month
Maximum monthly quantity - 150 mg capsules: <= 112 capsules/month
Maximum monthly quantity - 200 mg capsules: <= 112 capsules/month
Affected code: J8999

Clinical Evidence & References

ENESTndKey randomized trial — Nilotinib vs imatinib (N Engl J Med 2010)

Tasigna PI 2024Prescribing information — Novartis Tasigna prescribing information 2024

Evidence sources: Key evidence cited includes randomized trials such as ENESTnd (Nilotinib vs imatinib), the Tasigna prescribing information (Novartis 2024), and clinical compendia (Clinical Pharmacology, Micromedex, NCCN, AHFS). Use must be supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or peer‑reviewed literature that meets the CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Background

Background: Tasigna (nilotinib) is a tyrosine kinase inhibitor with FDA‑approved indications for Philadelphia chromosome/BCR‑ABL positive Chronic Myeloid Leukemia (CML) and for Philadelphia chromosome/BCR‑ABL positive B‑cell Acute Lymphoblastic Leukemia (ALL). Per policy, use must be supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

Dose & Quantity Limits

Single dose limit<= 400 mg

Maximum monthly quantity - 50 mg capsules<= 240 capsules/month

Maximum monthly quantity - 150 mg capsules<= 112 capsules/month

Maximum monthly quantity - 200 mg capsules<= 112 capsules/month

Definitions

Definitions: Continuation request exemption — a continuation request for a medication that would otherwise be not approvable may be allowed if the member has not experienced disease progression on the medication, the medication was used within the last year without a lapse of more than 30 days of active authorization, and no additional medications are being added to the continuation request.

Revision History

June 2025material_changeLatest

Converted to new Evolent guideline template; replaced prior UM ONC_1199 Tasigna guideline; updated indication section; updated maximum dosage form quantities in exclusion criteria; updated exclusion criteria; updated references.

June 2024administrative_update

Updated organization verbiage from NCH to Evolent.