Subject: Retevmo 3874-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. 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 2 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 2 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 and pediatric patients 2 years of age and older 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
7. Gallbladder cancer with RET gene fusion
8. Vaginal cancer with RET gene fusion
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,
oncocytic/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. If the member has one of the following solid tumors, the requested medication will be
used as a single agent:
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
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
m. Ampullary adenocarcinoma
n. Vaginal cancer
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.
F. Gallbladder Cancer
1. Authorization of 12 months may be granted for treatment of unresectable, resected gross
residual (R2) or metastatic gallbladder cancer with a RET gene fusion that has
progressed on or following systemic treatment, when used as a single agent.
2. Authorization of 12 months may be granted for the neoadjuvant treatment of resectable
locoregionally advanced gallbladder cancer with a RET gene fusion, 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; May 2024.
- The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed May 21, 2024.
- 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, 2024
