CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zegfrovy (sunvozertinib)

Defines accepted indications, continuation criteria, exclusions, and coding for Zegfrovy (sunvozertinib) use in cancer treatment, primarily for adult NSCLC with EGFR exon 20 insertion mutations; applies to Commercial, Exchange/Marketplace, and Medicaid lines of business and is used by Evolent to process medication requests.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZegfrovy (sunvozertinib)

Policy CodePolicy N/A

Change TypeNew policy

Effective Date

Next Review Date

Key ActionEvolent must process and authorize all medication requests; requests require supporting evidence from FDA labeling, CMS‑approved compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature.

SourceLink

POLICY UPDATE CHANGES

New policy created (Policy history indicates New policy August 2025).

1Covered Indications

4Primary Exclusion Reasons Listed

3Lines of Business

Coverage Summary

Zegfrovy (sunvozertinib) is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Coverage stance: covered_with_criteria. Scope: defines accepted indications, continuation criteria, exclusions, and coding for Zegfrovy (sunvozertinib) use in cancer treatment and applies to Commercial, Exchange/Marketplace, and Medicaid lines of business for processing medication requests.

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Initial Therapy - NSCLC indication

Covered when ALL of the following are met:

Member is an adult
Diagnosis: locally advanced or metastatic non-small cell lung cancer (NSCLC)
Tumor has EGFR exon 20 insertion mutation as detected by an FDA-approved test
Disease has progressed on or after platinum-based chemotherapy
Supporting evidence: Use is supported by FDA approved product labeling, CMS‑approved compendia, NCCN or ASCO guidelines, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements
Required supporting evidence per policy

Continuation Therapy Criteria

Continuation Therapy

Continuation requests are exempt from Evolent policy if ALL of the following are met:

Member has not experienced disease progression on the requested medication
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorizationno lapse > 30 days within last year
No additional medication(s) are being added to the continuation request

Continuation allowanceNo lapse greater than 30 days within the last year

Exclusions / Not Medically Necessary

Exclusion / Not medically necessary criteria

Treatment is NOT approvable when ANY of the following are present:

Disease progression while taking Zegfrovy (sunvozertinib)
Concurrent use with other anticancer therapies
Dosing exceeds single dose limit of Zegfrovy (sunvozertinib) 200 mg200 mg
Maximum single dose
Treatment exceeds the maximum limit of 30 (150 mg) or 30 (200 mg) tablets/month30 (150 mg) or 30 (200 mg) tablets/month
Monthly quantity limits
Evidence insufficiency considerations
- Whether clinical characteristics of patient and cancer are adequately represented in published evidence
- Whether administered therapy regimen is adequately represented in published evidence
- Whether reported study outcomes represent clinically meaningful outcomes (ASCO definition e.g., Hazard Ratio < 0.80 and survival benefit for OS/PFS >= 3 months)HR < 0.80; OS/PFS >= 3 months
- Whether experimental design is appropriate to address the investigative question
- Non-randomized trials with significant subjects may support accepted uses

Maximum single dose200 mg

Maximum tablets per month30 (150 mg) or 30 (200 mg) tablets/month

Provider Actions

Prior Authorization

Prior authorization required and processed by Evolent

Evolent is responsible for processing all medication requests for Zegfrovy (sunvozertinib). Medication requests must be authorized by Evolent and medications not authorized by Evolent may be deemed not approvable and not reimbursable.

J8999

Documentation Required

Support therapy with appropriate evidence

Use must be supported by FDA approved product labeling, CMS‑approved compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

FDA approved product labeling
CMS‑approved compendia
NCCN or ASCO clinical guidelines
Acceptable peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15

Denial Risk

Denial risk for concurrent anticancer therapies or progression

Requests for Zegfrovy (sunvozertinib) will not be approved if there is disease progression while taking Zegfrovy or if the request is for concurrent use with other anticancer therapies.

J8999

Billing Rule

Dose and quantity limits enforced

Single-dose and monthly tablet limits are enforced. Claims exceeding the single dose limit of 200 mg or the monthly maximum limits of 30 (150 mg) or 30 (200 mg) tablets may be excluded.

J8999

Clinical Evidence & References

CoveredIndication: adult locally advanced/metastatic NSCLC with EGFR exon 20 insertion after platinum chemo (requires FDA‑approved test)

ContraNot approvable: disease progression on Zegfrovy or concurrent anticancer therapies

LimitsDosing limits: single dose ≤200 mg; monthly ≤30 (150 mg) or 30 (200 mg) tablets

ContReqContinuation exemption: no progression, used within last year without >30‑day lapse, and no added meds

Evidence supporting coverage: Pivotal study citation: WUKONG1B primary analysis (Doucet L et al., Annals of Oncology 2024); Prescribing information: Zegfrovy prescribing information, Dizal (Jiangsu) Pharmaceutical Co., Ltd., 2025. Coverage requires supporting evidence consistent with recognized compendia or peer‑reviewed literature (FDA labeling, CMS‑approved compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15).

Background & Definitions

Background: Zegfrovy (sunvozertinib) is authorized for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, after progression on platinum‑based chemotherapy. Continuation requests have specific continuity‑of‑therapy criteria: continuation requests are exempt from the policy if the member has not experienced disease progression on the medication, the medication was used within the last year without a lapse of more than 30 days of active authorization, and no additional medications are being added to the continuation request. Coverage requires supporting evidence consistent with recognized compendia or peer‑reviewed literature (FDA product labeling, CMS‑approved compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15). Applies to Commercial, Exchange/Marketplace, and Medicaid lines of business.

Term	Definition
Continuation request exemption
Continuation requests may be exempt from the Evolent policy if no progression, used within last year without >30-day lapse, and no added medications.
Sufficient evidence
Evidence supported by CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS standards; case reports and abstracts without full articles generally inadequate.