Subject: erlotinib-Tarceva 1664-A SGM P2023

Drug

TARCEVA  (erlotinib)

erlotinib

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.

          A.  FDA-Approved Indications
               1.  Non-Small Cell Lung Cancer (NSCLC)
                    Tarceva is indicated for the treatment of patients with
                    metastatic non-small cell lung cancer (NSCLC) whose
                    tumors have epidermal growth factor receptor (EGFR)
                    exon 19 deletions or exon 21 (L858R) substitution
                    mutations as detected by an FDA-approved test receiving
                    first-line, maintenance, or second or greater line
                    treatment after progression following at least one prior
                    chemotherapy regimen.

               Limitations of use:
                    a.  Safety and efficacy of Tarceva have not been
                         established in patients with NSCLC whose tumors
                         have other EGFR mutations.
                    b.  Tarceva is not recommended for use in combination
                         with platinum-based chemotherapy.

               2.  Pancreatic cancer
                    Tarceva in combination with gemcitabine is indicated for
                    the first-line treatment of patients with locally advanced,
                    unresectable or metastatic pancreatic cancer.

          B.  Compendial Uses
               1.  NSCLC, recurrent, advanced or metastatic sensitizing
                    EGFR mutation-positive
               2.  Recurrent bone cancer – recurrent chordoma
               3.  Renal cell carcinoma, relapsed or stage IV disease with
                    non-clear cell histology
               4.  Brain metastases from EGFR sensitizing mutation-positive
                    NSCLC
               5.  Recurrent pancreatic cancer

          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: EGFR mutation testing results
          (where applicable).


  III.  CRITERIA FOR INITIAL APPROVAL

          A.  Non-small cell lung cancer (NSCLC)
               Authorization of 12 months may be granted for treatment of
               recurrent, advanced or metastatic NSCLC (including brain
               metastases from NSCLC) when the member has sensitizing
               EGFR mutation-positive disease as a single agent or in
               combination with ramucirumab or bevacizumab.

          B.  Pancreatic cancer
               Authorization of 12 months may be granted for treatment of
               locally advanced, unresectable, recurrent or metastatic
               pancreatic cancer in combination with gemcitabine.

          C.  Renal cell carcinoma (RCC)
               Authorization of 12 months may be granted for treatment of
               relapsed or stage IV renal cell carcinoma with non-clear cell
               histology as a single agent or in combination with
               bevacizumab.

          D.  Chordoma
               Authorization of 12 months may be granted for treatment of
               recurrent chordoma as a single agent.


   IV.  CONTINUATION OF THERAPY

          A.  Non-small cell lung cancer (NSCLC)
               Authorization of 12 months may be granted for continued
               treatment in members requesting reauthorization for EGFR
               positive NSCLC when either of the following criteria are met:
               1.  There is no evidence of unacceptable toxicity or disease
                    progression while on the current regimen.
               2.  Disease is T790M negative and there is no evidence of
                    unacceptable toxicity.

          B.  All other indications
               Authorization of 12 months may be granted for continued
               treatment in members requesting reauthorization for all
               other indications listed in Section III when there is no
               evidence of unacceptable toxicity or disease progression
               while on the current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Tarceva [package insert]. South San Francisco, CA: Genentech USA, Inc.; October 2016.
2. Erlotinib [package insert]. Pennington, NJ: Zydus Pharmaceuticals USA, Inc.; April 2020.
3. The NCCN Drugs & Biologics Compendium © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed March 4, 2023.

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 18, 2023