CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tasigna (nilotinib) — coverage criteria

Defines accepted indications, contraindications, exclusions, coding, and prior authorization expectations for nilotinib (Tasigna) for members of Neighborhood Health Plan of Rhode Island (via Evolent utilization management). Applies to prescribing providers requesting authorization for Tasigna.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTasigna (nilotinib) — coverage criteria

Policy CodePolicy N/A

Change TypeClinical and operational revisions

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization through Evolent and document FDA labeling or recognized compendia/guidelines to support use.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced UM ONC_1199 Tasigna (nilotinib).

Updated indication section.

Updated maximum dosage form quantities in exclusion criteria.

Updated exclusion criteria and references.

2primary disease indications listed (ALL, CML)

5major exclusion items enumerated

J8999single billing code listed

Commercial/Exchange/Medicaidapplicable lines of business

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Coverage Criteria for Tasigna (nilotinib)

Acute Lymphoblastic Leukemia (ALL)

Covered when ANY of the following are met:

ALL indication: Member has Philadelphia chromosome positive or BCR-ABL positive B-cell acute lymphoblastic leukemia (ALL); nilotinib may be used as a single agent or in combination with chemotherapy for induction, consolidation, maintenance, or subsequent therapy.

based on document indications

Chronic Myeloid Leukemia (CML)

Covered when ANY of the following are met:

CML indication: Member has chronic myeloid leukemia (CML) that is Philadelphia chromosome or BCR-ABL positive; nilotinib may be used as a single agent as initial or subsequent therapy.

based on document indications

Coverage is excluded when the member’s disease is Philadelphia chromosome/BCR-ABL negative for either chronic myeloid leukemia (CML) or B‑cell acute lymphoblastic leukemia (ALL). Requests will also be denied when there is documented disease progression while the member was taking nilotinib (Tasigna).

Use is further excluded if the member’s BCR‑ABL1 kinase domain harbors any of the specified resistance mutations: T315I, Y253H, E255K/V, F359V/C/I, or G250E. Administrative dosing limits are also exclusionary: a single dose above 400 mg or monthly dispensing that exceeds the stated capsule maxima (240 of 50 mg, 112 of 150 mg, or 112 of 200 mg) will render the request not approvable.

Investigational or off‑label uses of nilotinib (Tasigna) that lack sufficient supporting evidence are considered not approvable. Sufficient evidence is defined by endorsement in FDA labeling, CMS‑recognized compendia, or acceptable peer‑reviewed literature; evidence must adequately represent the patient and regimen, use appropriate study design or sufficiently powered nonrandomized data, and report clinically meaningful outcomes.

Abstracts or meeting reports without a full published article do not provide adequate supportive clinical evidence and therefore do not satisfy the evidentiary requirements for coverage of off‑label or investigational indications.

Permitted Regimens and Settings

Regimen	Indication / Line of therapy	Coverage status
Nilotinib as a single agent or in combination with chemotherapy	Philadelphia chromosome–positive or BCR-ABL–positive B‑cell acute lymphoblastic leukemia (ALL); may be used for induction, consolidation, maintenance, or subsequent therapy	Covered

Regimen	Indication / Line of therapy	Coverage status
Nilotinib as a single agent	Chronic myeloid leukemia (CML) that is Philadelphia chromosome– or BCR-ABL–positive; may be used as initial or subsequent therapy	Covered

Line of Therapy

salvage

Salvage-line use: May be used as subsequent or salvage therapy for Philadelphia chromosome/BCR-ABL positive disease (e.g., ALL: subsequent therapy; CML: subsequent therapy).

document lists subsequent therapy as an acceptable line of use

first-line

First-line use: May be used as initial (first-line) therapy for Philadelphia chromosome/BCR-ABL positive chronic myeloid leukemia (CML).

document lists initial therapy as acceptable

Biomarker and Mutation Requirements

inv-17: BCR-ABL / Philadelphia chromosome — presence required/definition and related notes

RequirementPresence of the BCR-ABL fusion gene (Philadelphia chromosome/BCR-ABL positive) is required for coverage of nilotinib in ALL and CML.

Clinical implicationConfirms sensitivity to BCR-ABL tyrosine kinase inhibitors; nilotinib may be used in Ph+ B-cell ALL as single agent or with chemotherapy and in Ph+ CML as single agent.

Exclusion if absentUse is excluded when the member is Philadelphia chromosome or BCR-ABL negative (not approvable).

inv-18: BCR-ABL1 kinase domain mutations — list of relevant mutations (T315I, Y253H, E255K/V, F359V/C/I, G250E)

Key mutations (exclusion)T315I; Y253H; E255K/V; F359V/C/I; G250E — presence of any listed BCR-ABL1 kinase domain mutation excludes use of nilotinib.

Policy action

Billing and Coding

Drug HCPCS CodeHCPCS

J8999

nilotinib

inv-06: Maximum monthly capsule quantities by strength (240 x 50 mg; 112 x 150 mg; 112 x 200 mg)

50 mg capsulesMaximum 240 capsules per month.

150 mg capsulesMaximum 112 capsules per month.

200 mg capsulesMaximum 112 capsules per month.

inv-07: Single dose limit (400 mg)

Single dose maximum400 mg per dose — doses exceeding this limit are excluded and will lead to denial.

Policy consequenceRequests with dosing above the single dose limit of 400 mg are not approvable.

Related limits

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tasigna (nilotinib) and is processed by Evolent on behalf of Neighborhood Health Plan of Rhode Island. All medication requests from network ordering providers must be submitted to Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Requests must meet the policy criteria and exclusion limits listed in this section.
Include supporting documentation per policy (FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature).
Coding: J8999 - nilotinib.

Note

Continuation Exemption Conditions

Continuation (renewal) requests may be approved without full re-review when all of the following are true: the 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 from an active authorization; and no additional medications are being added to the continuation request. If any condition is not met, a full authorization review is required.

Background

Nilotinib (Tasigna) is a BCR‑ABL tyrosine kinase inhibitor indicated for treatment of Philadelphia chromosome/BCR‑ABL positive chronic myeloid leukemia and Ph+ B‑cell acute lymphoblastic leukemia. Because nilotinib is associated with a risk of QT interval prolongation and related cardiac events, monitoring of ECGs and electrolytes is required and use should be avoided in patients with predisposing conditions or interacting drugs; dosing administration also requires adherence to fasting windows per product labeling.

Definitions and Safety Notes

inv-13: Definition of Philadelphia chromosome / BCR-ABL positive

DefinitionPhiladelphia chromosome/BCR-ABL positive: presence of the BCR-ABL fusion gene resulting from the Philadelphia chromosome translocation; required for coverage in ALL and CML.

Clinical relevanceConfers sensitivity to BCR-ABL tyrosine kinase inhibitors such as nilotinib; defines eligible patient population in policy.

Exclusion if absentIf Philadelphia chromosome/BCR-ABL is negative, nilotinib use is excluded per policy.

inv-14: QT prolongation risk — monitoring requirements (ECG, electrolytes) and timing

QT monitoring scheduleObtain ECGs to monitor the QTc at baseline, at 7 days after initiation, periodically thereafter, and following any dose adjustments.

Electrolyte monitoring

Revision History

June 2025revisionLatest

Converted to new Evolent guideline template replacing UM ONC_1199 Tasigna (nilotinib); updated indication section, maximum dosage form quantities in exclusion criteria, exclusion criteria, and references.

June 2024revision

Updated NCH verbiage to Evolent.