CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vizimpro (dacomitinib) — Coverage Criteria

Defines coverage, authorization, and clinical criteria for Vizimpro (dacomitinib) for treatment of cancer (primarily NSCLC) for Neighborhood Health Plan of Rhode Island members; applies to UM reviewers and prescribing providers submitting medication requests to Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVizimpro (dacomitinib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 30, 2024

Next Review DateN/A

Key ActionSubmit prior authorization for Vizimpro; continuation requests are exempt if no progression, use within last year without >30‑day lapse, and no additional medications are added.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

first-line NSCLCprimary covered indication

max 45 mgsingle-dose dosing limit

max 90/30 tabsmonthly quantity limit

allowed if no progressioncontinuation request rule

Coverage Criteria for Vizimpro (dacomitinib)

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Initial (first-line) therapy for EGFR-mutated NSCLC

Covered when ALL of the following are met

First-line NSCLC with EGFR mutation: Patient has advanced/recurrent/metastatic non-small cell lung cancer with EGFR exon 19 deletion OR L858R mutation in exon 21 as detected by an FDA-approved test

Based on FDA-approved indication for dacomitinib (Vizimpro).

Monotherapy: Dacomitinib (Vizimpro) is prescribed as monotherapy for first-line treatment (no concurrent systemic therapy)

Concurrent systemic therapy is an exclusion per policy.

Supportive evidence: Use is supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per CMS criteria

See documentation requirements in policy.

Continuation therapy

Continuation requests are exempt from the policy when ALL of the following are met

No disease progression: Member has not experienced disease progression on the requested medication

Continuation allowed only if no progression.

Recent prior authorization: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization

Prevents gaps in ongoing therapy.

No additional meds: No additional medication(s) are being added to the continuation request

Adds restriction to qualify for continuation exemption.

The policy excludes requests that involve concurrent use with other systemic therapy. Dacomitinib (Vizimpro) is intended as monotherapy for the covered first‑line indication and combination systemic regimens are not permitted under this policy. Additionally, investigational or off‑label uses that lack sufficient supporting evidence or are not generally accepted by the medical community are not covered. The policy defines insufficient evidence as lacking representation of the patient/cancer characteristics in published evidence, inadequate regimen representation, absence of clinically meaningful outcomes (for example, an ASCO‑recommended Hazard Ratio < 0.80 or at least a 3‑month survival benefit for OS/PFS), inappropriate experimental design, or reliance on uncontrolled case reports or meeting abstracts without full peer‑reviewed publication. Finally, dosing and quantity limits are enforced: a single dose that exceeds 45 mg is excluded, and treatment that exceeds the monthly tablet maximums is excluded (more than 90 tablets of 15 mg OR more than 30 tablets of 30 mg/45 mg per month).

Use of Vizimpro (dacomitinib) is explicitly excluded following documented disease progression on prior osimertinib (Tagrisso). Requests for treatment after progression on osimertinib should be denied per this policy.

Initial Therapy — First-line Use

Initial therapy

Covered as monotherapy for first-line treatment when criteria met

Mutation requirement: EGFR exon 19 deletion OR L858R mutation in exon 21 detected by an FDA-approved test

Meets the labeled indication for first-line dacomitinib (Vizimpro).

Monotherapy indication: Dacomitinib is prescribed as monotherapy (not combined with other systemic anticancer agents)

Concurrent systemic therapy is listed as an exclusion in the policy.

Continuation Therapy Criteria and Exemptions

Continuation therapy exemption

Continuation requests are exempt from the policy when ALL of the following are met

No progression: Member has not experienced disease progression on the requested medication

Continuation exemption requires absence of disease progression.

Recent use and authorization: Medication was used within the last year without a lapse of more than 30 days of an active authorization

Ensures continuity of prior-approved therapy.

No additional meds: No additional medications are being added to the continuation request

Addition of medications disqualifies the continuation exemption.

Coding and Quantity Limits

Drug codes referencedNDC

NDC	Referenced as affected billing code type for drugs

inv-06: Single-dose limit — ≤ 45 mg per single dose

Single-dose maximum≤ 45 mg per single dose

RelevanceExceeding this single-dose limit is listed as an exclusion and may trigger denial of coverage

Enforcement contextApplies to all Vizimpro (dacomitinib) dosing requests under this policy

inv-07: Monthly tablet limit — ≤ 90 tablets of 15 mg OR ≤ 30 tablets of 30 mg/45 mg per month

Monthly tablet limit (15 mg)≤ 90 tablets of 15 mg per month

Monthly tablet limit (30 mg/45 mg)≤ 30 tablets of 30 mg OR 45 mg per month

Policy consequenceTreatment exceeding these monthly limits is listed as an exclusion and may result in denial

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vizimpro (dacomitinib). Continuation requests are exempt from prior authorization requirements when all of the following are true: the member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request.

Prior authorization required for new starts
Continuation requests exempt if member meets all three criteria (no progression, prior use within last year without >30-day lapse, no additional meds added)

Documentation Required

Supporting Documentation Required

Provider must supply supporting documentation for the requested use of Vizimpro. Acceptable sources include FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS criteria for sufficiency of evidence.

FDA labeling
CMS-recognized compendia
NCCN or ASCO clinical guidelines
Peer-reviewed literature that meets CMS Medicare Benefit Manual Chapter 15 requirements

Denial Risk

Triggers for Denial

Requests may be denied for the following reasons. Review authorizations carefully to ensure none of these exclusion conditions apply before submission.

Disease progression on prior treatment with Tagrisso (osimertinib)
Concurrent use with other systemic therapy
Dosing exceeds single dose limit of 45 mg
Treatment exceeds monthly maximum limits: 90 tablets of 15 mg, or 30 tablets of 30 mg/45 mg per month
Investigational or off-label use lacking sufficient evidence (not supported by CMS compendia or acceptable peer-reviewed literature). Insufficient evidence considerations include inadequate patient/ cancer representation, regimen representation, lack of clinically meaningful outcomes (e.g., OS/PFS benefit <3 months or HR ≥0.80), poor experimental design, reliance on uncontrolled case reports or meeting abstracts without full peer-reviewed articles

Note

Provider-action placeholder: ensure prior authorization is requested when required and include all supporting documentation from accepted sources. For continuation requests meeting the exemption criteria, include documentation demonstrating prior authorization continuity and absence of disease progression.

When submitting a continuation request eligible for exemption, include evidence of prior authorization history within last year and documentation that member has not progressed on therapy
For new requests, attach FDA labeling, compendia/guideline citations, or qualifying peer-reviewed literature