Subject: Lonsurf 1896-A SGM P2022a
|
LONSURF
(trifluridine and tipiracil)
|
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. Lonsurf is indicated for the treatment of adult patients
with metastatic colorectal cancer previously treated with
fluoropyrimidine-, oxaliplatin- and irinotecan-based
chemotherapy, an anti-VEGF biological therapy, and if
RAS wild-type, an anti-EGFR therapy.
2. Lonsurf is indicated for the treatment of adult patients
with metastatic gastric or gastroesophageal junction
adenocarcinoma previously treated with at least two
prior lines of chemotherapy that included a
fluoropyrimidine, a platinum, either a taxane or
irinotecan, and if appropriate, HER2/neu-targeted
therapy.
B. Compendial Uses
1. Advanced or metastatic colon cancer
2. Advanced or metastatic rectal cancer
3. Esophageal and esophagogastric junction cancers
4. Gastric cancer
All other indications are considered experimental/investigational
and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Colorectal Cancer (CRC)
Authorization of 12 months may be granted for treatment of
advanced or metastatic colorectal cancer, including
appendiceal adenocarcinoma and anal adenocarcinoma,
when the member has progressed on previous treatment
with all the following regimens unless the member has a
contraindication or intolerance:
1. Fluoropyrimidine-, oxaliplatin- and irinotecan-based
chemotherapy; AND
2. An anti-vascular endothelial growth factor (VEGF)
therapy; AND
3. If RAS wild type, an anti-epidermal growth factor receptor
(EGFR) therapy, such as Erbitux (cetuximab) or Vectibix
(panitumumab), for rectal cancer, appendiceal
adenocarcinoma, anal adenocarcinoma, or left-sided
colon cancer.
B. Gastric or Gastroesophageal Junction Adenocarcinoma
Authorization of 12 months may be granted for treatment of
unresectable locally advanced, recurrent, or metastatic
gastric or gastroesophageal junction adenocarcinoma when
the member has been previously treated with at least two
prior lines of chemotherapy.
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication listed in Section II 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:
- Lonsurf [package insert]. Princeton, NJ: Taiho Oncology, Inc.; December 2019.
- The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed July 8, 2022.
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Anal Carcinoma. Version 1.2022. Accessed July 12, 2022. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Colon Cancer. Version 1.2022. Accessed September 12, 2022. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf
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.
December 29, 2022
