CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Avmapki Fakzynja Co-pack (avutometinib and defactinib) coverage criteria

Defines accepted indications, prior authorization/coverage guidance, exclusions, dosing limits, and coding for the Avmapki Fakzynja Co-pack (avutometinib and defactinib) in the treatment of cancer (specialty: Hematology/Oncology). Applies to network ordering providers submitting medication requests to Evolent on behalf of Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAvmapki Fakzynja Co-pack (avutometinib and defactinib) coverage criteria

Policy CodePolicy N/A

Change TypeNew policy

Effective DateJune 2025

Next Review DateN/A

Key ActionSubmit medication requests to Evolent with supporting evidence per FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature and document continuation criteria when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Primary covered indication (KRAS‑mutated recurrent LGSOC)

2Per‑month maximum product limits (capsules/tablets)

1HCPCS drug code listed

Medical Necessity Criteria

Continuation therapy exemption

Continuation requests for a not‑approvable medication are exempt from this guideline when ALL of the following are met:

ALL of the following

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
No additional medication(s) are being added to the continuation request

Exclusion criteria — contraindications to approval

Treatment is excluded when ANY of the following are present:

ANY of the following

KRAS wild‑type low‑grade serous ovarian cancer
Disease progression while taking Avmapki Fakzynja Co-pack (avutometinib and defactinib)
Concurrent use with other anticancer therapies
Dosing exceeds single dose limit of Avmapki (avutometinib) 3.2 mg and Fakzynja (defactinib) 200 mg
Treatment exceeds the monthly maximum limit of 24 Avmapki (avutometinib) capsules (0.8 mg each) and 42 Fakzynja (defactinib) tablets (200 mg each)
Investigational use for off‑label indications lacking sufficient evidence or not accepted by the medical community (see document for evidence standards and examples)

Prior Authorization, Documentation, and Denial Conditions

Prior Authorization

Prior authorization required and Evolent adjudication

All medication requests for Avmapki Fakzynja Co-pack (avutometinib and defactinib) must be processed by Evolent and supported by FDA product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS standards per the Medicare Benefit Policy Manual Chapter 15.

J8999

Documentation Required

Clinical evidence/documentation requirements

For off‑label or investigational requests, submit supporting clinical evidence that adequately represents the patient and regimen, reports clinically meaningful outcomes, and uses appropriate study design as described in the guideline. Continuation requests must document absence of disease progression and that the medication was used within the last year without a lapse of more than 30 days of active authorization.

Denial Risk

Denial conditions

Requests will be excluded/denied when any exclusion criteria are met, including KRAS wild‑type disease, disease progression on therapy, concurrent anticancer therapy, dosing or monthly supply limits exceeded, or investigational/off‑label use lacking sufficient evidence.

J8999

Clinical Background and Evidence Base

Avmapki Fakzynja Co-pack (avutometinib and defactinib) is indicated for the treatment of adult patients with KRAS‑mutated recurrent low‑grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. The indication and accepted use are supported by clinical trial data from the ENGOT‑ov60/GOG‑3052/RAMP 201 study and by the product prescribing information, which are cited as the primary evidence sources and standards for adjudication.

Key Definitions

Definitions

Sufficient evidenceEvidence supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or peer‑reviewed literature that meets CMS standards, including appropriate patient and regimen representation, clinically meaningful outcomes, and appropriate study design.

Continuation request exemptionA continuation request for a not‑approvable medication may be processed if 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 of active authorization, and no additional medications are being added to the continuation request.