Subject: Vizimpro 2770-A SGM P2021

Drug

VIZIMPRO  (dacomitinib)

Policy:

      I.  INDICATIONS

          The indications below including FDA-approved indications and compendial uses are
          considered a covered benefit provided that all the approval criteria are met and the member
          has no exclusions to the prescribed therapy.

          FDA-Approved Indication
          Vizimpro is indicated for the first-line treatment of patients with metastatic non-small cell
          lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon
          21 L858R substitution mutations as detected by an FDA-approved test.

          Compendial Uses
          NSCLC, recurrent, advanced or metastatic sensitizing EGFR mutation-positive

          All other indications are considered experimental/investigational and not medically necessary.

    II.  DOCUMENTATION
 
          Submission of the following information is necessary to initiate the prior authorization review:
          For NSCLC, EGFR mutation testing results.

   III. CRITERIA FOR INITIAL APPROVAL

          Non-small cell lung cancer (NSCLC)
          Authorization of 12 months may be granted for treatment of recurrent, advanced or
          metastatic NSCLC when the member has sensitizing EGFR mutation-positive disease as a
          single agent.

    IV. CONTINUATION OF THERAPY  

          Authorization of 12 months may be granted for continued treatment in members requesting
          reauthorization for an indication listed in Section III when there is no evidence of
          unacceptable toxicity while on the current regimen.

 

Place of Service:

Outpatient

The above policy is based on the following references:

V. REFERENCES

 

1. Vizimpro [package insert]. New York, NY: Pfizer, Inc.; December 2020.
2. The NCCN Drugs & Biologics Compendium 2021 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed March 1, 2021.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 27, 2021