Clinical Policy: Sunvozertinib (Zegfrovy)
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Defines medical necessity criteria and prior authorization requirements for sunvozertinib (Zegfrovy) for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations; applies to members covered by the payer's Commercial, HIM, and Medicaid lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prescribed regimen must be FDA-approved or recommended by NCCN.
Prescribed regimen must be FDA-approved or recommended by NCCN.
inv-02: Continuation Therapy — Covered when ALL of the following are met for continuation
Covered when ALL of the following are met for continuation:
Prescribed regimen must be FDA-approved or recommended by NCCN.
Non‑FDA approved indications that are not specifically addressed in this policy are not covered unless the provider submits sufficient documentation of efficacy and safety in accordance with the referenced off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or applicable evidence of coverage documents.
Use of sunvozertinib (Zegfrovy) for non‑FDA approved indications without adequate supporting evidence as required by the off‑label use policies is considered not authorized for coverage.
Coding and Dosing
| ICD-10: C34.* | Malignant neoplasm of bronchus and lung (NSCLC - used for member diagnosis coding) |
Provider Actions and Requirements
Prior authorization required
Prior authorization is required. Submit a prior authorization request with supporting documentation that the member meets all applicable initial or continued therapy criteria, including diagnosis of recurrent/advanced/metastatic NSCLC, EGFR exon 20 insertion mutation positivity, prior platinum‑based chemotherapy progression (where applicable), prescriber specialty, age ≥18 years, single‑agent use, and adherence to dosing constraints.
- Prior authorization must document that the prescribed regimen is FDA‑approved or recommended by NCCN.
- Dosing constraints: standard 200 mg/day (1 tablet/day) or up to 400 mg/day (2 tablets/day) only with prescriber attestation of inability to avoid CYP3A inducers or supported by guidelines/literature.
Therapeutic alternatives and step considerations
Therapeutic alternatives listed in Appendix B (e.g., platinum‑based chemotherapy, immune checkpoint inhibitors, taxanes) may be considered per formulary and step‑therapy rules; off‑label or alternative uses require evaluation under the payer's off‑label policies.
- Appendix B lists platinum‑based chemotherapy (cisplatin, carboplatin), immune checkpoint inhibitors (e.g., nivolumab ± ipilimumab), taxanes (paclitaxel, albumin‑bound paclitaxel), docetaxel ± gemcitabine, gemcitabine ± vinorelbine, and pemetrexed.
- Use for non‑FDA approved indications must follow off‑label policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53).
Required clinical documentation
Provider must submit clinical documentation (such as office notes, laboratory results, and other clinical information) that supports the member's diagnosis of recurrent/advanced/metastatic NSCLC, EGFR exon 20 insertion mutation status, prior therapies (including platinum‑based chemotherapy), current medication list, and any prescriber consultation notes.
- Include evidence of EGFR exon 20 insertion (testing results) and documentation of progression on or after platinum‑based chemotherapy when applicable.
- If requesting dose above standard limits, submit prescriber attestation or supporting guidelines/literature per dosing exception criteria.
Documentation and indication‑related denial risk
Requests lacking adequate documentation that the member meets approval criteria — including absence of diagnostic evidence, missing biomarker test results (EGFR exon 20 insertion), or no documentation of prior platinum‑based chemotherapy when required — may be denied.
- Non‑FDA indications without sufficient off‑label evidence per the referenced off‑label policies may be considered not authorized.
- Denials can result if prescriber fails to provide dosing justification or attestation when exceeding standard dosing constraints.
Background
Sunvozertinib (Zegfrovy) is an epidermal growth factor receptor (EGFR) kinase inhibitor indicated under accelerated approval for adults with locally advanced or metastatic non‑small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations after progression on platinum‑based chemotherapy. The approved NSCLC dosing regimen is 200 mg orally once daily, with a maximum of 400 mg/day in the setting of concomitant strong or moderate CYP3A inducers; tablets are available in 150 mg and 200 mg strengths. Continued approval may be contingent on confirmatory trials.
Definitions
Initial Therapy Criteria
inv-13: Initial Therapy — Initial authorization criteria for NSCLC
Initial authorization criteria for NSCLC:
Prescribed regimen must be FDA-approved or recommended by NCCN.
Continuation Criteria
inv-14: Continued Therapy — Criteria for continued coverage
Criteria for continued coverage:
Prescribed regimen must be FDA-approved or recommended by NCCN.
Step Therapy / Sequence of Care
| Step | Requirement / description | Alternative therapies (Appendix B) |
|---|---|---|
| 1 | ||
| Zegfrovy (sunvozertinib) is indicated as subsequent therapy for adults (≥18 years) with recurrent, advanced, or metastatic NSCLC positive for EGFR exon 20 insertion mutations after progression on platinum-based chemotherapy; must be prescribed by or in consultation with an oncologist, used as a single agent, and meet dosing constraints (standard 200 mg/day; see dosing exceptions). | ||
| platinum-based chemotherapy (e.g., cisplatin, carboplatin); immune checkpoint inhibitor regimens (e.g., nivolumab ± ipilimumab); taxanes (paclitaxel, albumin-bound paclitaxel, docetaxel ± gemcitabine); gemcitabine ± vinorelbine; pemetrexed |
Quantity Limits
Site of Care
No site‑of‑care restrictions — documentation required
No site‑of‑care restrictions are specified; however, providers must submit documentation to support that the member meets the coverage criteria regardless of setting.
- Ensure documentation demonstrating criteria are met is included with the request even when therapy will be administered at home.
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