CurrentCignaPolicy N/A

Oncology - Vizimpro Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for Vizimpro (dacomitinib) for treatment of non-small cell lung cancer in covered members.

Policy Summary

PayerCigna

PolicyOncology - Vizimpro Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document age (≥18), advanced/metastatic NSCLC, and a sensitizing EGFR mutation detected by an approved test.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearapproval duration

12/11/2024policy review

No criteria changesannual revision

Coverage Criteria for Vizimpro (dacomitinib)

Initial therapy (FDA-approved)

Covered when ALL of the following are met for the FDA‑approved indication:

FDA-Approved Indication criteria

Age: Patient is ≥ 18 years of age>= 18 years
Disease stage: Patient has advanced or metastatic disease
Biomarker: Patient has sensitizing EGFR mutation-positive non-small cell lung cancer as detected by an approved test (examples include exon 19 deletions, exon 21 L858R, L861Q, G719X, S768I)
Mutation must be detected by an FDA-approved test

Policy Summary

PayerCigna

PolicyOncology - Vizimpro Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document age (≥18), advanced/metastatic NSCLC, and a sensitizing EGFR mutation detected by an approved test.

SourceLink

On This Page

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Regimen	Indication / Line of therapy	Coverage status	Dosing / Formulation	Approval duration
Vizimpro (dacomitinib) tablets
First-line treatment of metastatic non-small cell lung cancer with sensitizing EGFR mutations (FDA: exon 19 deletion or exon 21 L858R; NCCN also lists certain other sensitizing mutations such as L861Q, G719X, S768I)
Covered with criteria
Oral dacomitinib tablets (manufacturer: Pfizer); dosing per product labeling
Approve for 1 year if all coverage criteria are met

Provider Actions & Authorization Requirements

Prior Authorization

Prior Authorization Recommended

Prior authorization recommended. Approvals provided for 1 year for patients meeting criteria (age ≥ 18, advanced/metastatic disease, and sensitizing EGFR mutation–positive NSCLC detected by an approved test).

Approval duration: 1 year
Affected product: Vizimpro (dacomitinib tablets)

Note

Provider Action

Provider must submit documentation to support the request as noted below.

Documentation Required

Required Clinical Documentation

Documentation must support patient age (≥ 18 years), disease stage (advanced or metastatic non–small cell lung cancer), and presence of a sensitizing EGFR mutation detected by an FDA-approved or otherwise approved test. Examples of sensitizing EGFR mutations include exon 19 deletions, exon 21 (L858R) substitution, L861Q, G719X, and S768I.

Denial Risk

Non‑approved Indications

Use of Vizimpro (dacomitinib) for any indication other than the specified FDA‑approved indication for sensitizing EGFR mutation–positive advanced/metastatic NSCLC is considered experimental, investigational, or unproven.

Definitions

Sensitizing EGFR mutations — definition and examples

DefinitionEGFR mutations that confer sensitivity to EGFR tyrosine kinase inhibitors (TKIs).

Common examplesExon 19 deletions and exon 21 L858R substitution mutations are the most common sensitizing EGFR mutations.

Less common sensitizing mutationsL861Q, G719X, and S768I are less common mutations that also confer sensitivity to EGFR TKIs.

Clinical relevancePatients with sensitizing EGFR mutations have significantly better responses to EGFR TKIs compared with those without these mutations.

Regulatory contextVizimpro (dacomitinib) is indicated for first-line treatment of metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA‑approved test.

Biomarker Requirements

EGFR sensitizing mutations — required examples and testing

Required mutation examplesExon 19 deletions; exon 21 L858R substitution; L861Q; G719X; S768I.

Detection requirementThe sensitizing EGFR mutation must be detected by an FDA‑approved (approved) test.

Coverage implicationPresence of a sensitizing EGFR mutation detected by an approved test is required for approval of Vizimpro for the FDA‑approved indication.

Guideline supportNCCN recommends testing for sensitizing EGFR mutations in metastatic NSCLC and lists Vizimpro as first‑line or recommended therapy for these mutations.

Background

Vizimpro (dacomitinib) is an oral EGFR tyrosine kinase inhibitor (TKI) indicated for the first‑line treatment of metastatic non‑small cell lung cancer (NSCLC) in patients whose tumors harbor sensitizing EGFR mutations such as exon 19 deletions or exon 21 L858R substitutions. Clinical guidance (NCCN) recommends testing for sensitizing EGFR mutations in metastatic NSCLC and includes Vizimpro as a first‑line option in appropriate mutation contexts.

Per the policy, prior authorization is recommended and approvals for the FDA‑approved indication are provided for 1 year when criteria are met, including patient age ≥ 18 years, advanced or metastatic disease, and a sensitizing EGFR mutation detected by an approved test.

OpenPayer