Avutometinib; Defactinib (Avmapki Fakzynja Co-Pack) coverage criteria
Customize your policy alerts
Sign up for Health Net Policy CP.PHAR.731 alerts
Get alerted when Policy CP.PHAR.731 changes without checking for updates manually.
Monitor payer policy activity
Defines medical necessity criteria, prior authorization, and coverage parameters for the co-packaged combination of avutometinib and defactinib (Avmapki Fakzynja Co-Pack), primarily for KRAS‑mutated recurrent low-grade serous ovarian cancer; affects prescribers and payers reviewing initial and continuation requests.
Revised initial approval duration from 6 months to 12 months.
Added ICHRA line of business to applicable coverage.
Coverage Criteria
Continuation Therapy — Covered when ALL of the following are met for Continued Therapy (Ovarian Cancer).
Covered when ALL of the following are met for Continued Therapy (Ovarian Cancer):
Prescribed regimen must be FDA-approved or recommended by NCCN; Approval duration: 12 months
Other/Off-label — Other diagnoses/indications (alternative handling).
Other diagnoses/indications (alternative handling):
See referenced policies for coverage determinations
Requests for use of Avmapki Fakzynja Co-Pack for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for ICHRA/Marketplace, and CP.PMN.53 for Medicaid).
Use of the co‑pack for off‑label indications without adequate supporting evidence or without following the referenced off‑label use policies is not authorized (i.e., will be considered not covered). Providers seeking authorization for such uses must follow the applicable off‑label submission requirements and supply clinical documentation per those policies.
Initial Therapy Criteria
Continuation Therapy Criteria
Provider Actions / Requirements
Prior authorization required — demonstrate all initial approval criteria
Prior authorization is required. The request must demonstrate all Initial Approval criteria for ovarian cancer: diagnosis of low-grade serous ovarian cancer (LGSOC); prescribed by or in consultation with an oncologist; age ≥ 18 years; disease is recurrent; disease is positive for a KRAS mutation; the Avmapki Fakzynja co-pack is not prescribed concurrently with any other agents for LGSOC; the member has received prior systemic therapy (see Appendix B); the member will use avutometinib and defactinib if available unless contraindicated or intolerant; and the dose meets the policy limits or is supported by practice guidelines/peer‑reviewed literature. Approval duration for initial requests is 12 months.
- Diagnosis: LGSOC
- Oncologist involvement required
- Age ≥ 18 years
- Recurrent disease
- KRAS mutation positive
- No concurrent agents for LGSOC
- Prior systemic therapy received (see Appendix B)
- Use both agents unless contraindicated
- Dose ≤ Avmapki 6.4 mg/week and Fakzynja 400 mg/day for first 3 weeks of each 4-week cycle OR guideline-supported dosing
Step/sequence expectations — no concurrent agents; prior systemic therapy required
The policy requires the co-pack to be used without concurrent agents for LGSOC and that the member has received prior systemic therapy (see Appendix B for therapeutic alternatives); specific step failures are not enumerated beyond the prior systemic therapy requirement.
- Co-pack must not be prescribed concurrently with any other agents for LGSOC
- Member must have received prior systemic therapy (see Appendix B)
Required clinical documentation — submit office notes and test results
Provider must submit supporting clinical documentation such as office chart notes, laboratory results, or other clinical information to show the member meets all approval criteria.
- Include documentation confirming diagnosis, KRAS mutation status, prior systemic therapy, oncologist involvement, and dosing rationale or supporting literature if applicable
Documentation and indication mismatch — risk of denial if criteria not documented
Requests that do not include documentation showing the member meets all approval criteria (for example: LGSOC diagnosis, KRAS mutation positivity, prior systemic therapy) or that are for non‑covered indications without off‑label policy support may be denied.
- Missing evidence of required diagnosis, mutation status, or prior therapy risks denial
- Requests for non‑FDA‑approved indications without sufficient off‑label documentation per referenced off‑label policies may be not authorized
Coding and Product Availability
| NDC not specified | Co-packaged avumetinib 0.8 mg capsule and defactinib 200 mg tablet (product availability listed; no NDC provided in policy) |
Quantity and Dosing Limits
Step Therapy / Prior Systemic Therapy
| Step | Requirement |
|---|---|
| 1 | Member must have received prior systemic therapy (see Appendix B for therapeutic alternatives); specific number or regimen of prior therapies is not mandated. |
| 2 | Avmapki Fakzynja Co-Pack is not to be prescribed concurrently with any other agents for low‑grade serous ovarian cancer (LGSOC). |
| 3 | Use of the co‑pack must follow availability guidance: member should use avutometinib and defactinib, if available, unless contraindicated or intolerant. |
| 4 | Prescribed regimen must be FDA‑approved or recommended by NCCN; dosing limits in Appendix/criteria apply (see dose limits for first 3 weeks of each 4‑week cycle). |
Definitions
Background
Avmapki Fakzynja Co‑Pack combines two kinase inhibitors, avutometinib and defactinib. The combination is FDA‑approved under accelerated approval for adult patients with KRAS‑mutated recurrent low‑grade serous ovarian cancer (LGSOC) after prior systemic therapy; continued approval may depend on confirmatory trial data. For requests outside the FDA‑approved indication, see the off‑label use policies referenced in this policy.
Site of Care
Site of care — infusion center not specified
Site of care for administration is not specified in the policy.
- No requirement or restriction listed for use in an infusion center
Revision History
3Q 2026 annual review: revised initial approval duration from 6 months to 12 months and added ICHRA line of business; references reviewed and updated.
Policy created (initial version).
References reviewed and updated during 3Q 2026 review cycle (administrative update recorded).
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.