CurrentNeighborhood Health Plan of Rhode IslandPolicy Reference number 2027-A

Sorafenib Nexavar 2027 A Sgm P2024

Defines clinical indications (FDA-approved and compendial), documentation required for prior authorization, criteria for initial approval by indication, continuation/reauthorization criteria, and authorization duration for sorafenib (Nexavar).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySorafenib Nexavar 2027 A Sgm P2024

Policy CodePolicy Reference number 2027-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit FLT3-ITD mutation or FLT3 rearrangement testing results where applicable to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes — policy remains current with existing criteria and coverage positions.

3FDA-approved indications listed

12Compendial/other indications listed

12 monthsTypical authorization duration

Coverage Summary & Indications

Documentation & Prior Authorization Requirements

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Prior Authorization

Prior authorization required

Prior authorization is required for sorafenib (Nexavar). When clinical criteria for the requested indication are met, initial and continuation approvals are typically granted for up to 12 months.

Documentation Required

FLT3 testing results required

Submit FLT3 testing results where applicable to initiate prior authorization review.

Provide FLT3‑ITD mutation testing results when relevant.
Provide FLT3 rearrangement testing results when relevant.

Documentation Required

Evidence of prior therapies for GIST

For GIST, document that the member has failed at least four FDA‑approved therapies to meet criteria for coverage.

Document failure of at least four FDA‑approved therapies.
Examples include: imatinib, sunitinib, regorafenib, ripretinib.

Documentation Required

Medullary thyroid carcinoma treatment history

For medullary thyroid carcinoma, document either intolerance/contraindication to FDA‑approved systemic therapies or disease progression on those therapies to meet coverage criteria.

Document intolerance or contraindication to FDA‑approved options (e.g., vandetanib [Caprelsa], cabozantinib [Cometriq]).
Or document disease progression while on FDA‑approved systemic therapy (e.g., vandetanib [Caprelsa], cabozantinib [Cometriq]).

Initial Therapy Criteria (by indication)

Criteria for Initial Approval — Acute Myeloid Leukemia (AML) with FLT3-ITD mutation

Authorization of 12 months may be granted for treatment of AML with FLT3-ITD mutation when any of the following criteria are met:

AML with FLT3-ITD mutation initial approval

Low-intensity induction/post-induction/consolidation: If member is without IDH1 mutation, for use in low-intensity treatment induction, post-induction therapy, or consolidation therapy in combination with azacitidine or decitabine.
Authorization of 12 months may be granted.
Relapsed/refractory disease: For use in relapsed/refractory disease in combination with azacitidine or decitabine.
Authorization of 12 months may be granted.
Maintenance after HSCT: For use in maintenance therapy after hematopoietic stem cell transplant (HSCT) as a single agent.
Authorization of 12 months may be granted.

Criteria for Initial Approval — Renal Cell Carcinoma

Authorization parameters

RCC initial approval: Treatment of advanced renal cell carcinoma.

Authorization of 12 months may be granted.

Criteria for Initial Approval — Papillary, Oncocytic/Hürthle, or Follicular Thyroid Carcinoma

Authorization parameters

Papillary/Oncocytic/Hürthle/Follicular thyroid carcinoma: Progressive and/or symptomatic papillary, oncocytic/Hürthle cell, or follicular thyroid carcinoma not amenable to radioactive iodine (RAI) therapy.

Authorization of 12 months may be granted.

Criteria for Initial Approval — Myeloid/Lymphoid Neoplasms with Eosinophilia

Authorization parameters

Myeloid/lymphoid neoplasms with eosinophilia initial approval: Myeloid and/or lymphoid neoplasms with eosinophilia and FLT3 rearrangement in the chronic phase or blast phase.

Authorization of 12 months may be granted.

Background & Policy Context

Background: The policy lists the covered FDA‑approved indications and multiple compendial uses for sorafenib (Nexavar). Prior authorization requires submission of relevant mutation testing results (e.g., FLT3‑ITD or FLT3 rearrangement) where applicable. The policy references the Nexavar/sorafenib package inserts and the NCCN Drugs & Biologics Compendium as primary references. Authorization is typically granted for up to 12 months when clinical criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySorafenib Nexavar 2027 A Sgm P2024

Policy CodePolicy Reference number 2027-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit FLT3-ITD mutation or FLT3 rearrangement testing results where applicable to initiate prior authorization review.

SourceLink

On This Page

OpenPayer

Sorafenib Nexavar 2027 A Sgm P2024

Coverage Summary & Indications

Documentation & Prior Authorization Requirements

Initial Therapy Criteria (by indication)

Continuation / Reauthorization Criteria

Not Medically Necessary / Exclusions

Applicable Codes

Clinical Evidence & References

Background & Policy Context

Revision History