CurrentMass General Brigham Health PlanPolicy N/A

Vizimpro (dacomitinib) — Coverage Criteria for EGFR‑mutant NSCLC

This policy governs prior authorization, quantity limits, and coverage criteria for Vizimpro (dacomitinib) for Mass General Brigham Health Plan members, primarily for pharmacy benefit use for treatment of EGFR mutation–positive metastatic NSCLC.

Policy Summary

PayerMass General Brigham Health Plan

PolicyVizimpro (dacomitinib) — Coverage Criteria for EGFR‑mutant NSCLC

Policy CodePolicy N/A

Change TypeAdministrative classification change

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionSubmit EGFR mutation testing results showing a sensitizing EGFR mutation and request prior authorization for single‑agent therapy.

SourceLink

POLICY UPDATE CHANGES

Policy was switched from SGM to Custom and made effective 01/01/2024.

12 monthsapproval duration

first-lineFDA line

exon19/exon21required mutations

allowedreauthorization

Coverage Criteria for Vizimpro (dacomitinib)

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inv-01: Initial Therapy

Authorization may be granted when ALL of the following are met:

Initial authorization criteria: Submission of EGFR mutation testing results demonstrating a sensitizing EGFR mutation (e.g., exon 19 deletion or exon 21 L858R).

Test results should document a sensitizing EGFR mutation as specified in the FDA indication.

Initial authorization criteria: Treatment is prescribed as a single agent for sensitizing EGFR mutation–positive disease.

Therapy must be single‑agent dacomitinib in accordance with the FDA‑approved first‑line indication.

inv-02: Continuation of Therapy

Authorization may be granted for members new to the plan already receiving therapy or for continuation when ALL of the following are met:

Members new to plan on therapy: Members new to the plan who are currently receiving the requested medication may be authorized (excluding products obtained as samples or via manufacturer patient assistance programs).

Documentation of current therapy is required; excludes samples and PAP supplies.

Continuation/reauthorization criteria: Either: 1) No evidence of unacceptable toxicity or disease progression while on the current regimen; OR 2) Disease is T790M negative and there is no evidence of unacceptable toxicity.

Either condition is sufficient for continuation/reauthorization.

All indications other than metastatic non-small cell lung cancer (NSCLC) with a sensitizing EGFR mutation are considered experimental/investigational and not medically necessary.

Use of Vizimpro (dacomitinib) for diagnoses other than NSCLC with a documented sensitizing EGFR mutation is not medically necessary and may be denied.

Initial Therapy

inv-11: Initial Therapy

Initial authorization criteria reflect FDA-approved indication.

Initial authorization: Documented EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R) detected by an appropriate test.

Aligns with the FDA‑approved first‑line indication for metastatic NSCLC.

Initial authorization: Therapy prescribed as single‑agent dacomitinib for metastatic NSCLC with a sensitizing EGFR mutation.

Therapy must match the single‑agent use in the FDA label.

Continuation / Reauthorization Criteria

inv-12: Continuation of Therapy

Continuation/reauthorization rules:

Continuation criteria: No evidence of unacceptable toxicity or disease progression while on the current regimen.

If met, authorization for continued therapy may be granted.

Continuation criteria: Disease is T790M negative and there is no evidence of unacceptable toxicity.

If met, authorization for continued therapy may be granted.

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vizimpro (dacomitinib) under the pharmacy benefit. Approvals may be granted for members new to the plan who are currently receiving therapy with the requested medication (excludes samples and manufacturer patient assistance program supply).

Pharmacy benefit: Prior authorization required
Approvals may be granted for members new to the plan who are currently receiving therapy

Step Therapy

No step therapy requirement is specified in this policy.

Documentation Required

Required Documentation

Submit EGFR mutation testing results demonstrating a sensitizing EGFR mutation (exon 19 deletion or exon 21 L858R). Documentation must show use as a single agent for treatment of recurrent, advanced, or metastatic non–small cell lung cancer (NSCLC) with a sensitizing EGFR mutation.

Required: EGFR mutation testing results (sensitizing mutation such as exon 19 deletion or exon 21 L858R)
Indication: NSCLC, recurrent/advanced/metastatic with sensitizing EGFR mutation
Regimen: Single-agent use

Denial Risk

Non‑covered Indications

Use for indications other than NSCLC with a sensitizing EGFR mutation is considered experimental/investigational and not medically necessary.

Background

Dacomitinib (Vizimpro) is indicated for treatment of NSCLC that is sensitizing EGFR mutation–positive. It is an oral irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor intended for use in patients with EGFR mutation–positive disease; uses outside of this population are considered experimental/investigational and not medically necessary.