CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vizimpro (dacomitinib) Policy

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVizimpro (dacomitinib) Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 30, 2024

Next Review Date

Key ActionAll medication requests must be processed by Evolent/UM; medications not authorized may be deemed not approvable and not reimbursable.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes in this policy update.

1Covered Indications (NSCLC with EGFR exon19 or L858R)

4Explicit Exclusion Criteria

3Committee Review Dates Listed

Coverage Summary

Defines coverage criteria, exclusions, and utilization management requirements for Vizimpro (dacomitinib), including FDA-approved and off-label uses supported by recognized compendia/guidelines, for processing medication requests by Evolent/UM. Vizimpro (dacomitinib) is covered with criteria; coverage is limited to uses consistent with FDA-approved labeling and select off‑label uses supported by CMS‑recognized compendia, NCCN, ASCO, or peer‑reviewed literature. Evolent processes medication requests and the final authorization decision is made by the Utilization Management (UM) Committee.

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Initial and Continuation Therapy Criteria

Initial / Continued Use for NSCLC

Vizimpro (dacomitinib) may be used when ALL of the following are met:

Indication: advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC)
EGFR mutation: Tumor harbors EGFR exon 19 deletion or L858R mutation in exon 21
Mutation test: Mutation detected by an FDA approved test
Monotherapy first-line: Used as monotherapy as first-line therapy

Continuation Requests Exemption

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

No disease progression: The member has not experienced disease progression on the requested medication
Prior use within last year: The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
No additional meds: Additional medication(s) are not being added to the continuation request

Provider Actions / Prior Authorization & Billing

Prior Authorization

Prior authorization required

Prior authorization is required and processed by Evolent Utilization Management for all Vizimpro (dacomitinib) requests. Providers must obtain authorization before dispensing; claims for medications not authorized by Evolent may be denied as not approvable and not reimbursable.

Documentation Required

Mutation test documentation required

Documentation of EGFR mutation testing is required. The request must include results showing EGFR exon 19 deletion or L858R mutation in exon 21 detected by an FDA‑approved test (or equivalent documentation from CMS‑recognized compendia/peer‑reviewed literature when applicable).

Denial Risk

Denial risk: prior osimertinib progression

Requests will be denied if the member has experienced disease progression on prior osimertinib (Tagrisso). Prior progression on osimertinib is an exclusion criterion and a basis for non‑coverage of Vizimpro.

Billing Rule

Dose and quantity limits enforced

Dose and quantity limits are enforced. Approvals will not exceed the single‑dose limit or monthly tablet maximums specified in the policy.

Single dose limit: 45 mg (requests exceeding a single dose of 45 mg will be denied).
Monthly tablet limits: maximum of 90 tablets per month for 15 mg strength, or a maximum of 30 tablets per month for 30 mg or 45 mg strengths.

Background

This policy defines accepted indications for Vizimpro (dacomitinib) including FDA-approved labeling and off-label uses supported by CMS‑recognized compendia, NCCN, ASCO, or peer‑reviewed literature. Evolent is responsible for processing medication requests from network providers, and final approval is by the Utilization Management Committee; medications not authorized by Evolent may be deemed not approvable and not reimbursable.