CurrentCignaPolicy N/A

Oncology - Nilotinib Products Prior Authorization Policy

Defines prior authorization requirements and medical necessity criteria for prescription coverage of nilotinib products (Tasigna, Danziten, and other nilotinib formulations) for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology - Nilotinib Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClinical updates and operational additions

Effective Date

Next Review DateMar 26, 2025

Key ActionObtain prior authorization and document diagnosis, age, relevant mutation status, and prior therapies when required for nilotinib requests.

SourceLink

POLICY UPDATE CHANGES

Melanoma, Cutaneous was added as a new condition of approval under Other Uses With Supportive Evidence based on NCCN guideline recommendations.

Acute Lymphoblastic Leukemia age requirement changed from ≥18 years to ≥15 years and removal of requirement to trial another TKI.

Danziten (nilotinib tablets) was added to the policy as a new formulation and included in indications.

3nilotinib product brand/formulations listed

1 yearstandard approval duration for covered indications

≥15minimum age for Ph+ ALL approval

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Coverage and Medical Necessity Criteria

Chronic Myeloid Leukemia (FDA-approved)

Covered when ONE of the following is met:

CML approval options: Patient has Philadelphia chromosome-positive chronic myeloid leukemia.

Approve for 1 year.

CML approval options: Patient has BCR::ABL1-mutation positive chronic myeloid leukemia.

Approve for 1 year.

Other Uses with Supportive Evidence

Covered when the following indication-specific conditions are met:

Ph+ ALL: Patient is ≥ 15 years of age AND patient has Philadelphia chromosome-positive acute lymphoblastic leukemia.

Approve for 1 year.

GIST: Patient is ≥ 18 years of age AND patient has tried ALL of the following: (i) imatinib or avapritinib; AND (ii) sunitinib or dasatinib; AND (iii) regorafenib; AND (iv) ripretinib.

Approve for 1 year.

Melanoma, Cutaneous: Patient is ≥ 18 years of age AND patient has metastatic or unresectable disease AND patient has an activating KIT mutation AND patient has tried at least one systemic regimen (examples listed in policy).

Approve for 1 year.

Myeloid/Lymphoid Neoplasms with Eosinophilia: Patient is ≥ 18 years of age AND the tumor has an ABL1 rearrangement.

Approve for 1 year.

Pigmented Villonodular Synovitis/TGCT: Patient has tried pexidartinib (Turalio) or vimseltinib (Romvimza) OR prescriber documents that the patient cannot take those agents (e.g., elevated liver enzymes or concomitant hepatotoxic medications).

Approve for 1 year.

Nilotinib products (including Danziten™, generic nilotinib capsules, and Tasigna®) are considered not medically necessary for any uses other than those specifically listed in this policy.

Any indication or use that is not explicitly listed under the FDA-approved Indication or the Other Uses With Supportive Evidence sections of this policy will be considered not medically necessary and will be denied.

Product Coding and Approval Duration

Specified Products (no billing codes listed)NDC

Danziten™ (nilotinib tablets - Azurity)	NDCs not listed
Nilotinib (nilotinib d-tartrate capsules - Cipla)	NDCs not listed
Tasigna® (nilotinib hcl capsules - Novartis, generic)	NDCs not listed

Approval Duration

Standard approval duration for covered indicationsApprovals are provided for 1 year for covered and supported off‑label indications unless otherwise specified

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior authorization required for all nilotinib products

Prior authorization is required for prescription benefit coverage of Danziten (nilotinib tablets), generic nilotinib capsules, and Tasigna (nilotinib HCl capsules). Approvals are provided for 1 year when criteria are met.

Step Therapy

Step therapy required for selected indications

For certain indications (e.g., GIST and Pigmented Villonodular Synovitis/TGCT), members must have tried specified prior agents before nilotinib will be approved, or the prescriber must document inability to take those agents.

GIST: patient must have tried imatinib or avapritinib; sunitinib or dasatinib; regorafenib; and ripretinib.
Pigmented villonodular synovitis/TGCT: patient must have tried pexidartinib or vimseltinib, or prescriber must state patient cannot take those agents (e.g., elevated liver enzymes or concomitant hepatotoxic medications).

Background and Drug Information

Nilotinib is a tyrosine kinase inhibitor. Policy determinations and coverage are limited to the specific indications and conditions described in this document; requests for nilotinib for indications outside those specified here are not covered.

Definitions and Formulation Notes

Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) — definition/key value

DefinitionPhiladelphia chromosome–positive chronic myeloid leukemia (Ph+ CML): chronic myeloid leukemia positive for the Philadelphia chromosome, including BCR::ABL1–mutation–positive disease.

FDA‑approved settingsIncluded for newly diagnosed chronic phase and for chronic/accelerated phase in adults with resistance or intolerance to prior therapy (including imatinib); Tasigna has pediatric approvals as noted in prescribing information.

Age considerationsTasigna: approved in adults and pediatric patients ≥1 year (per prescribing information); Danziten: approved for adults only due to pediatric marketing exclusivity for Tasigna.

Formulation interchangeability / administration — Danziten and Tasigna dosing and administration differences

InterchangeabilityDanziten and Tasigna are not milligram‑for‑milligram substitutable; dosing differs between products.

Line of Therapy Recommendations

first-line

Line: Nilotinib is recommended by NCCN as preferred for newly diagnosed chronic phase Ph+ CML and is an option in other settings; for Ph+ ALL nilotinib (as a TKI) is recommended in combination with chemotherapy or corticosteroids for induction and may be used in consolidation, maintenance, or relapsed/refractory settings (NCCN categories 1 and 2A respectively).

Guideline-based line placement varies by disease and regimen; see NCCN.

Biomarker and Molecular Test Requirements

KIT activating mutation — requirement for specific indications

Required biomarkerAn activating KIT mutation is required for approval of nilotinib for cutaneous melanoma (metastatic or unresectable) under Other Uses with Supportive Evidence.

Age requirementPatient must be ≥18 years of age for melanoma, cutaneous indication.

Additional requirementPatient must have tried at least one systemic regimen (examples provided in policy) for metastatic/unresectable disease.

BCR::ABL1 mutation / Philadelphia chromosome — required biomarker for Ph+ indications

Required biomarkerPresence of the Philadelphia chromosome or BCR::ABL1 mutation is required for approvals in CML and Ph+ ALL indications.

CML criteria

Recommended Regimens and Therapeutic Context

Indication	Regimen / Guideline recommendation	NCCN category	Coverage stance
Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL)	TKIs (including nilotinib) in combination with chemotherapy or corticosteroids for induction, and as part of consolidation and maintenance per NCCN; TKIs also used in relapsed/refractory settings	Category 2A	Covered when regimen aligns with guideline-specified use and documentation requirements

Indication	Regimen / Guideline recommendation	NCCN category	Coverage stance
Newly diagnosed chronic phase Philadelphia chromosome–positive (Ph+) or BCR::ABL1-mutation positive chronic myeloid leukemia (CML)	Nilotinib recommended as a preferred primary treatment for newly diagnosed chronic phase patients (consider risk score); also an alternative after primary treatment and in other settings including post-HSCT	Category 1 (preferred primary treatment)	Covered when used as recommended by NCCN and documentation supports diagnosis