CurrentUnitedHealthcarePolicy 2025 P 1482-1

Avmapki Fakzynja Co-Pack (avutometinib; defactinib) prior authorization

Defines UnitedHealthcare prior authorization and reauthorization criteria for Avmapki Fakzynja Co-Pack for treatment of KRAS‑mutated recurrent low‑grade serous ovarian cancer, including pediatric automatic processing rules and references to state/federal mandates.

Policy Summary

PayerUnitedHealthcare

PolicyAvmapki Fakzynja Co-Pack (avutometinib; defactinib) prior authorization

Policy CodePolicy 2025 P 1482-1

Change TypeNew prior authorization program

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for adult members showing diagnosis of KRAS‑mutated recurrent LGSOC with prior systemic therapy to obtain approval for 12 months.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program for Avmapki Fakzynja Co-Pack (avutometinib; defactinib) was created.

2025-10-01effective date

7/2025P&T approval

12 monthsauthorization period

KRAS‑mutated LGSOCapproved indication

Coverage Criteria

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Initial Authorization

Covered when ALL of the following are met

Initial Authorization for adults

Diagnosis of recurrent low-grade serous ovarian cancer (LGSOC)
Molecular marker: Tumor is KRAS-mutated
Prior therapy: Patient has received prior systemic therapy

Reauthorization

Reauthorization covered when the following is met

Reauthorization: Patient does not show evidence of progressive disease while on Avmapki Fakzynja Co-Pack therapy

Authorization issued for 12 months

Patients less than 19 years of age

Approval rule for members under 19

Pediatric automatic approval: Patient is less than 19 years of age

Authorization issued for 12 months and will process without coverage review

Coverage is subject to applicable state and federal mandates and to recognized compendia. Where a state mandate or federal requirement applies, or where a compendium referenced by the member’s benefit plan requires coverage, that mandate or compendium supersedes the provisions of this policy.

Coverage under this policy is also subject to the member’s specific benefit plan terms and any state or federal mandates. Some states mandate benefit coverage for off‑label use or require use of particular compendia; when such mandates apply they take precedence over this policy.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for adult members (age 19 and older). Providers must submit documentation supporting the diagnosis and criteria listed in the coverage section when requesting initial authorization or reauthorization.

Prior authorization required for members ≥ 19 years
Key documentation: diagnosis of recurrent low-grade serous ovarian cancer (LGSOC), tumor KRAS mutation status, and evidence of prior systemic therapy for initial requests
Reauthorization: documentation showing no evidence of disease progression while on therapy

Note

Pediatric Automatic Processing

Prescriptions for members under 19 years will automatically process without a coverage review. When automatic processing applies, the authorization will be issued for 12 months.

Automatic processing for members < 19 years
Issued authorization period: 12 months

Step Therapy

No step therapy requirements are specified for Avmapki Fakzynja Co-Pack in this program.

Documentation Required

Supporting Documentation and Automated Approval

UnitedHealthcare may use prior claim or medication history, ICD-10 diagnosis codes, and automated claim-logic rules to approve initial requests or reauthorizations without full clinical documentation. Supply limits may also be applied; check benefit-specific limits when submitting requests.

Automated approval may use prior claims/medication history and diagnosis codes (ICD-10)
Claim-logic rules can drive approvals and reapprovals depending on program/therapeutic class
Supply limits may be enforced per member benefit

Denial Risk

Denial Risks from Benefit or Mandate Conflicts

Coverage may be affected by state-specific mandates, federal requirements, or the member's individual benefit plan. Where state mandates require coverage for off-label uses or alternative compendia, those mandates supersede the program criteria. Verify member-specific benefits and applicable mandates before authorization.

State mandates for off-label use or alternative compendia may supersede program language
Federal requirements and the member’s signed benefit plan can affect coverage decisions
Confirm member-specific benefit details to reduce risk of denial

Background

Avmapki Fakzynja Co‑Pack combines two kinase inhibitors, avutometinib and defactinib, and is indicated for adult patients with KRAS‑mutated recurrent low‑grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. Approval was granted under accelerated approval based on tumor response rate and duration of response; continued approval may depend on confirmatory trials. For members under 19 years of age, prescriptions will automatically process without a coverage review and authorized for 12 months per the pediatric processing rule.

Step	Requirement
1	No step therapy specified in this document.

Policy Summary

PayerUnitedHealthcare

PolicyAvmapki Fakzynja Co-Pack (avutometinib; defactinib) prior authorization

Policy CodePolicy 2025 P 1482-1

Change TypeNew prior authorization program

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for adult members showing diagnosis of KRAS‑mutated recurrent LGSOC with prior systemic therapy to obtain approval for 12 months.

SourceLink

On This Page

OpenPayer

Avmapki Fakzynja Co-Pack (avutometinib; defactinib) prior authorization

Coverage Criteria

Initial Therapy

Reauthorization / Continuation Therapy

Provider Actions and Requirements

Background

Definitions

Step Therapy

Quantity Limits

Site of Care