CurrentMass General Brigham Health PlanPolicy N/A

Vizimpro (dacomitinib) prior authorization and coverage

Defines prior authorization, quantity/step therapy, specialty pharmacy routing, and coverage criteria for Vizimpro (dacomitinib) under the Mass General Brigham Health Plan pharmacy benefit for applicable members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyVizimpro (dacomitinib) prior authorization and coverage

Policy CodePolicy N/A

Change TypeAdministrative revision

Effective Date01/01/2024

Next Review DateN/A

Key ActionSubmit prior authorization with EGFR mutation test results to support approval for first-line treatment of metastatic EGFR-mutant NSCLC.

SourceLink

POLICY UPDATE CHANGES

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

12 moapproval duration per authorization

first-lineindication position

specialtymedication designation

Commercial/Exchangebenefit applicability

Coverage Criteria for Vizimpro (dacomitinib)

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Initial and continuation therapy

Covered when ALL of the following are met:

Initial coverage for Vizimpro: Diagnosis of metastatic non-small cell lung cancer (NSCLC) with a sensitizing EGFR mutation (exon 19 deletion or exon 21 L858R) as detected by an FDA-approved test.

Supports FDA-approved indication

Documentation: Submission of EGFR mutation testing results is provided to support the diagnosis.

Required for authorization

Member status: Member is either currently receiving Vizimpro at the time of plan enrollment (continuation) OR is a new start meeting the above criteria.

Continuation allowed if documentation provided; excludes supply obtained as samples or via manufacturer patient assistance programs

Reauthorization

Reauthorization covered when ANY of the following are met:

No unacceptable toxicity: There is no evidence of unacceptable toxicity while on the current regimen.

Reauthorization condition

No disease progression: There is no evidence of disease progression while on the current regimen.

Reauthorization condition

T790M testing: Disease is T790M negative AND there is no evidence of unacceptable toxicity.

Alternative reauthorization pathway noted in policy

All indications for Vizimpro (dacomitinib) beyond treatment of non‑small cell lung cancer (NSCLC) with sensitizing EGFR mutations are considered experimental/investigational and are not medically necessary.

Use of Vizimpro for any indication other than metastatic NSCLC with a sensitizing EGFR mutation is not medically necessary (considered experimental/investigational).

Initial Therapy

Initial therapy — Initial authorization for Vizimpro as single-agent therapy

Initial authorization for Vizimpro as single-agent therapy

FDA indication match: Diagnosis of metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations.

FDA-approved indication

Testing documentation: Submission of EGFR mutation testing results.

Required for approval

Continuation Therapy

Continuation therapy — members new to plan currently receiving treatment may be authorized

Continuation (members new to plan currently receiving treatment) may be authorized.

Continuation eligibility: Member is currently receiving Vizimpro at the time of plan enrollment and documentation is provided (excluding product obtained as samples or via manufacturer's patient assistance programs).

Continuation allowed

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. May be granted for members currently receiving treatment and for new authorizations when the criteria below are met.

Applies to Pharmacy and Medical benefits as specified by plan
Specialty medication — must be filled at contracted specialty pharmacy (see contact info)

Step Therapy

Step therapy header present in source; no explicit step agents are defined in policy. Confirm applicable step requirements with the plan prior to prescribing.

Documentation Required

Required Documentation

Submission of supporting documentation is required to support authorization decisions. Include EGFR mutation testing results for members with NSCLC.

EGFR mutation testing report required for initial and continuation requests
Include documentation of current regimen and treatment response for reauthorization requests

Denial Risk

Risk of Denial for Incomplete Documentation or New Starts

Requests for members who are new to the plan and not currently receiving the medication may be denied. Incomplete documentation (including missing EGFR testing) or evidence of disease progression or unacceptable toxicity may result in denial.

New-to-plan starts: authorization generally limited to members already receiving the medication (samples or manufacturer patient assistance program supplies excluded)
Reauthorization: denied if disease progression or unacceptable toxicity is documented

Definitions

inv-12: Sensitizing EGFR mutation-positive

DefinitionPresence of EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test

Clinical contextRequired for first-line treatment eligibility for metastatic NSCLC with Vizimpro

Documentation requiredSubmission of EGFR mutation testing results must be provided to support authorization

inv-13: T790M negative

DefinitionNegative for the EGFR T790M resistance mutation

Use in reauthorizationDisease documented as T790M negative may satisfy one reauthorization pathway when there is no evidence of unacceptable toxicity

DocumentationTest result documenting T790M negative status should be submitted for reauthorization consideration

Step	Requirement / Prior agent	Notes
Step Therapy listed in policy header	No specific prior agents, steps, or failure criteria are defined in the policy document	Policy includes 'Step Therapy' in the benefit header but the body provides no explicit step requirements — prior authorization requirements are handled via coverage criteria instead