Zongertinib (Hernexeos) — Coverage Criteria for HER2‑mutant NSCLC
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Medical necessity and prior authorization criteria for zongertinib (Hernexeos) for adults with unresectable or metastatic nonsquamous NSCLC harboring HER2 (ERBB2) activating mutations; applies to Centene-affiliated health plans including Commercial, HIM, and Medicaid.
Removed requirement for prior systemic therapy in FDA approved indications and removed 'failure of a prior systemic therapy' requirement in initial approval criteria to reflect expanded indication per prescribing information.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met
Prescribed regimen must be FDA‑approved or recommended by NCCN.
Dosing Limits / Off-label Dosing Exception
Prescribed regimen must be FDA‑approved or recommended by NCCN.
Continuation Therapy
Covered when ALL of the following are met
Prescribed regimen must be FDA‑approved or recommended by NCCN.
Non–FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless there is sufficient documentation of efficacy and safety consistent with the referenced off‑label use policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53) or applicable evidence of coverage documents.
Coverage is not authorized for non‑FDA approved indications that lack adequate supporting documentation per the referenced off‑label use policies. Requests for off‑label use must meet the documentation standards outlined in CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid) to be considered.
Coding
| No codes listed |
Provider Actions / Requirements
Prior Authorization Required
Prior authorization is required before Hernexeos (Hernexeos) will be approved. The provider must document the diagnosis, oncologist involvement, member age, single‑agent use, presence of an activating HER2 (ERBB2) mutation, dosing that does not exceed policy limits (or justification per guidelines/literature), and that the prescribed regimen is FDA‑approved or recommended by NCCN. For initial and continued therapy requests, approval duration is 12 months.
- Prescribed by or in consultation with an oncologist
- Age ≥ 18 years
- Single‑agent use
- Activating HER2 (ERBB2) mutation documented
- Dose limits: <90 kg = 120 mg/day (2 tablets); ≥90 kg = 180 mg/day (3 tablets) unless higher dose supported by practice guidelines or peer‑reviewed literature
- Prescribed regimen must be FDA‑approved or recommended by NCCN
Non‑FDA Indications Risk
Requests for non‑FDA approved (off‑label) indications that are not addressed in this policy may be denied unless the provider submits sufficient documentation demonstrating efficacy and safety consistent with the payer's off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for HIX, CP.PMN.53 for Medicaid) or other applicable evidence of coverage documents.
- Non‑FDA indications require supporting evidence per relevant off‑label policies: CP.CPA.09, HIM.PA.154, CP.PMN.53
Required Documentation
Provider must submit documentation (such as office chart notes, recent pathology or molecular testing reports confirming HER2 (ERBB2) activating mutation, prior treatment history, weight for dosing, evidence of response for continuation requests, and any supporting literature if dosing exceeds policy limits) to support that the member meets all applicable criteria.
- Office chart notes and clinical history
- Pathology/molecular testing confirming HER2 (ERBB2) activating mutation
- Documentation of current therapy and response (for continuation)
- Member weight to determine dosing tier
- Supporting practice guidelines or peer‑reviewed literature if dose exceeds listed limits
Preferred Product Requirement
When applicable, the policy requires use of zongertinib for members prior to approving Hernexeos when zongertinib is available and not contraindicated. If zongertinib is contraindicated or clinically not tolerated, document the contraindication or adverse effects.
- Member must use zongertinib first if available unless contraindicated or clinically significant adverse effects
- If contraindicated/intolerant, provide documentation of the reason
Background
Zongertinib (Hernexeos) is a kinase inhibitor indicated under accelerated approval for adult patients with unresectable or metastatic nonsquamous non‑small cell lung cancer harboring HER2 (ERBB2) tyrosine kinase domain activating mutations. Continued approval is contingent on verification of clinical benefit in confirmatory trials; prescribing and coverage decisions for non‑FDA indications must follow the off‑label documentation requirements referenced in this policy.
Definitions
Initial Therapy Criteria
Initial Therapy
Covered when ALL of the following are met
Prescribed regimen must be FDA‑approved or recommended by NCCN. Approval duration: 12 months.
Continuation Criteria
Continued Therapy
Covered when ALL of the following are met
Prescribed regimen must be FDA‑approved or recommended by NCCN. Approval duration: 12 months.
Step Therapy / Product Preference
| Step | Requirement |
|---|---|
| {"text":"1","status":""}|{"text":"For Hernexeos requests, member must use zongertinib if available unless contraindicated or clinically significant adverse effects are experienced.","status":""} |
Quantity Limits
Site of Care
Site of care: office — standard PA/documentation rules apply
No specific site‑of‑care restrictions are listed; standard prior authorization and documentation requirements apply for office-administered requests.
- Follow normal prior authorization submission processes for office settings
- Ensure required clinical documentation accompanies the PA request
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