Subject: erlotinib 1664-A SGM P2024
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)
Erlotinib 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 erlotinib have not been established in patients with NSCLC
whose tumors have other EGFR mutations.
b. Erlotinib is not recommended for use in combination with platinum-based
chemotherapy.
2. Pancreatic cancer
Erlotinib 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:
- Erlotinib [package insert]. Pennington, NJ: Zydus Pharmaceuticals USA, Inc.; October 2023.
- The NCCN Drugs & Biologics Compendium © 2024 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed March 4, 2024.
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, 2024
