Sevabertinib (Hyrnuo) coverage
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Defines clinical coverage, prior authorization criteria, and administration/dosing guidance for sevabertinib (Hyrnuo) for qualifying members across commercial, HIM, and Medicaid lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy — Non-Small Cell Lung Cancer
Covered when ALL of the following are met:
Approval duration: 12 months
Continuation Therapy — Non-Small Cell Lung Cancer
Covered when ALL of the following are met:
Approval duration: 12 months
Requests for indications that are not FDA‑approved and are not specifically addressed in this policy will not be authorized unless the provider submits 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 Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or unless coverage is supported by the member’s evidence of coverage. Prior authorization is required and approval hinges on submission of clinical documentation demonstrating the request meets all applicable criteria for initial or continued therapy.
Coverage determinations under this policy are subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract of insurance) and to applicable state and federal requirements and Health Plan administrative policies and procedures. Providers must follow those coverage documents and any applicable Health Plan administrative policies when requesting authorization; conflicts with state Medicaid provisions will be governed by the applicable state Medicaid manual.
Uses that are non‑FDA approved and not addressed by this policy are considered not authorized and may be denied unless the request includes sufficient documentation per the referenced off‑label use policies or the member’s evidence of coverage that justifies approval.
Coding and Dosing Limits
Provider Actions & Authorization
Policy serves as medical necessity guide for prior authorization
This clinical policy is intended to serve as a guide to medical necessity to assist in making coverage decisions and administering benefits; prior authorization requests must follow the Health Plan's established processes and the terms of the member's coverage documents.
- Policy guides medical necessity determinations used in authorization decisions.
- Prior authorization requirements follow Health Plan processes and member coverage terms.
Therapeutic alternatives (Appendix B) may be required
Therapeutic alternatives are listed in Appendix B and may be required or considered prior to approval depending on formulary status and plan requirements.
- See Appendix B for preferred alternative therapies and dosing examples.
- Alternatives may require their own prior authorization if not formulary.
No formal step therapy specified; prior systemic therapy required
No specific step therapy sequence is specified in this policy text; however, initial approval requires failure of a prior systemic therapy as described in the criteria (see Appendix B for examples).
- Policy does not define a formal step therapy algorithm.
- Initial approval criterion requires prior systemic therapy failure.
Required documentation to support authorization
Providers must submit clinical documentation such as office chart notes, laboratory results, and other pertinent clinical information to demonstrate the member meets all approval criteria.
- Office notes documenting diagnosis and oncologist involvement.
- Laboratory or pathology reports confirming HER2 (ERBB2) activating mutation.
- Records showing prior systemic therapy and treatment response or progression history.
Adhere to member coverage documents and Health Plan procedures
Providers must follow the member's coverage documents and applicable Health Plan administrative policies and procedures when requesting coverage; coverage decisions are administered in accordance with those documents.
- Adhere to evidence of coverage, certificate of coverage, policy, and contract of insurance terms.
- Follow any applicable Health Plan-level administrative policies and procedures when submitting requests.
Off‑label indications may be denied without supporting documentation
Requests for non‑FDA approved (off‑label) indications that are not addressed in this policy may be denied unless sufficient documentation is provided in accordance with the Health Plan's off‑label use policies or the member's evidence of coverage.
- Off‑label requests must include evidence of efficacy and safety per off‑label use policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53).
- Non‑FDA uses not supported by the policy or off‑label criteria are considered not authorized and may be denied.
Coverage subject to member coverage terms and regulatory requirements
Coverage decisions are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable state and federal requirements; conflicts with state Medicaid provisions take precedence and may affect authorization.
- Decisions are governed by the member's evidence of coverage and plan contract.
- Applicable state and federal requirements and Health Plan administrative policies apply and may override this policy where required.
Initial Therapy — Hyrnuo
Initial Therapy — Hyrnuo
Initial approval criteria for NSCLC
Approval duration: 12 months
Continuation Therapy — Hyrnuo
Continuation Therapy — Hyrnuo
Continuation therapy coverage conditions
Approval duration: 12 months
Step Therapy Requirements
| Step | Requirement | Details |
|---|---|---|
| 1 | Prior systemic therapy required | Failure of a prior systemic therapy is required for initial approval; see Appendix B for examples of prior systemic therapies (therapeutic alternatives). |
Site of Care
Site of care: oral tablet — no site restriction
Sevabertinib (Hyrnuo) is an oral tablet and the policy does not restrict site of care; dispensing for home use is allowed per the policy.
- Site of care is not restricted in policy text.
Definitions
Background
Sevabertinib (Hyrnuo) is an oral tyrosine kinase inhibitor developed for treatment of adult patients with locally advanced or metastatic nonsquamous non‑small cell lung cancer (NSCLC) harboring activating HER2 (ERBB2) tyrosine kinase domain mutations. The agent received accelerated approval for this indication in patients who have received prior systemic therapy; continued approval may depend on verification of clinical benefit from confirmatory trials. Sevabertinib is administered orally and dosing guidance in this policy reflects the approved regimen and quantity limits.
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