Subject: Retevmo 3874-A SGM P2023
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. Adult patients with locally advanced or metastatic non-
small cell lung cancer (NSCLC) with a rearranged during
transfection (RET) gene fusion
2. Adult and pediatric patients 12 years of age and older
with advanced or metastatic medullary thyroid cancer
(MTC) with a RET mutation who require systemic therapy.
3. Adult and pediatric patients 12 years of age and older
with advanced or metastatic thyroid cancer with a RET
gene fusion who require systemic therapy and who are
radioactive iodine-refractory (if radioactive iodine is
appropriate).
4. Adult patients with locally advanced or metastatic solid
tumors with a RET gene fusion that have progressed on
or following prior systemic treatment or who have no
satisfactory alternative treatment options.
B. Compendial Uses
1. Recurrent, advanced or metastatic NSCLC with RET
rearrangement-positive tumors
2. Brain metastases from RET fusion positive NSCLC
3. Histiocytic Neoplasms with RET gene fusion:
a. Erdheim-Chester Disease (ECD)
b. Langerhans Cell Histiocytosis (LCH)
c. Rosai-Dorfman Disease
4. Occult primary cancer with RET gene fusion
5. Solid tumors with RET-gene fusion for recurrent,
persistent, progressive, unresectable disease
6. Thyroid cancer with RET gene fusion:
a. Locoregional or metastatic anaplastic thyroid
carcinoma
b. Unresectable or recurrent medullary thyroid cancer
c. Progressive/symptomatic thyroid 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: Documentation of the presence of
a RET gene fusion or specific RET gene mutation in tumor
specimens or plasma (where applicable).
III. CRITERIA FOR INITIAL APPROVAL
A. Non-Small Cell Lung Cancer
Authorization of 12 months may be granted as a single agent
for treatment of recurrent, advanced, or metastatic non-
small cell lung cancer (including brain metastases from
NSCLC) when the tumors have a RET gene fusion.
B. Thyroid Cancer
Authorization of 12 months may be granted for treatment of
thyroid cancer with a RET gene mutation when any of the
following criteria are met:
1. Member has locoregional or metastatic anaplastic thyroid
cancer and the requested medication will be used as a
single agent
2. Member has unresectable, recurrent, advanced, or
metastatic medullary thyroid cancer
3. Member has progressive/symptomatic, advanced, or
metastatic follicular, Hürthle cell, or papillary thyroid
carcinoma that is not amenable to radioactive iodine
therapy
C. Solid Tumors
Authorization of 12 months may be granted for treatment of
solid tumors when all of the following criteria are met:
1. The disease is recurrent, persistent, progressive,
unresectable, advanced or metastatic
2. The tumor has a RET gene fusion
3. Member has not responded to preoperative therapy, has
progressed on or following prior systemic treatment, or
has no satisfactory alternative treatment options
4. The medication will be used as a single agent for the
following solid tumors:
a. Epithelial ovarian cancer, fallopian tube cancer,
primary peritoneal cancer
b. Pancreatic adenocarcinoma
c. Cervical cancer
d. Small bowel adenocarcinoma
e. Colorectal cancer, including appendiceal
adenocarcinoma and anal adenocarcinoma
f. Hepatocellular carcinoma
g. Hepatobiliary carcinoma, including intrahepatic and
extrahepatic cholangiocarcinoma and gallbladder
cancer
h. Breast cancer
i. Salivary gland tumors
j. Esophageal and esophagogastric junction cancers
k. Gastric cancer
l. Soft tissue sarcoma of the extremity/body wall,
head/neck, retroperitoneal/intra-abdominal sarcoma
D. Histiocytic Neoplasms
Authorization of 12 months may be granted for the treatment
of any of the following histiocytic neoplasm subtypes as a
single agent in members with a RET gene fusion:
1. Symptomatic or relapsed/refractory Erdheim-Chester
Disease (ECD)
2. Symptomatic or relapsed/refractory Rosai-Dorfman
Disease
3. Langerhans Cell Histiocytosis (LCH)
E. Occult Primary Cancer
Authorization of 12 months may be granted for treatment of
occult primary cancer with a RET gene fusion that has
progressed on or following systemic treatment, or who have
no satisfactory alternative treatment options, when used 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 or disease progression while on the current
regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Retevmo [package insert]. Indianapolis, IN: Lilly USA, LLC; September 2022.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed March 13, 2023.
- Morgenstern D, Mascarenhas L, Campbell M, et al. Oral selpercatinib in pediatric patients with advanced RET-altered solid or primary CNS tumors: preliminary results from the phase 1/2 LIBRETTO-121 trial. J Clin Oncol. 2021;39(suppl 15):10009
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
