Subject: Jemperli 4705-A SGM P2021b
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JEMPERLI
(dostarlimab-gxly)
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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
Jemperli is indicated for the treatment of adult patients with
mismatch repair deficient (dMMR) recurrent or advanced:
1. Endometrial cancer (EC), as determined by an FDA-approved
test, that has progressed on or following prior treatment with a
platinum-containing regimen.
2. Solid tumors, as determined by an FDA-approved test, that have
progressed on or following prior treatment and who have no
satisfactory alternative treatment options.
B. Compendial Uses
1. Breast cancer
2. Colorectal cancer
3. Gastric cancer
4. Occult primary cancer
5. Ovarian cancer
a. Epithelial ovarian cancer
b. Fallopian tube cancer
c. Primary peritoneal cancer
d. Carcinosarcoma (malignant mixed Mullerian tumors)
e. Clear cell carcinoma
f. Mucinous carcinoma
g. Grade 1 endometrioid carcinoma
h. Low-grade serous carcinoma/ ovarian borderline epithelial
tumors (low malignant potential with invasive implants)
6. Endometrial Carcinoma
7. Small Bowel Adenocarcinoma
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 laboratory report confirming
microsatellite instability-high (MSI-H) or mismatch repair deficient
(dMMR) tumor status, where applicable.
III. EXCLUSIONS
Coverage will not be provided for members who have experienced
disease progression while on PD-1 or PD-L1 inhibitor therapy.
IV. CRITERIA FOR INITIAL APPROVAL
A. Endometrial cancer (EC)
Authorization of 6 months may be granted for treatment of
microsatellite instability-high (MSI-H) or mismatch repair deficient
(dMMR) recurrent or advanced endometrial cancer (EC) that has
progressed on or following prior treatment with a platinum-
containing regimen.
B. Solid Tumors
Authorization of 6 months may be granted for treatment of
mismatch repair deficient (dMMR) recurrent or advanced solid
tumors that has progressed on or following prior treatment and for
whom there are no satisfactory alternative treatment options, when
used as a single agent.
C. Breast Cancer
Authorization of 6 months may be granted as a single agent for
treatment of recurrent unresectable or stage IV breast cancer that is
microsatellite instability-high (MSI-H) or mismatch repair deficient
(dMMR) and has progressed on or following prior treatment and has
no satisfactory alternative treatment options.
D. Colorectal Cancer
Authorization of 6 months may be granted as a single agent for
subsequent treatment of advanced or metastatic colon cancer that
is microsatellite instability-high (MSI-H) or mismatch repair deficient
(dMMR) following previous oxaliplatin- irinotecan- and/or
fluoropyrimidine-based therapy.
E. Gastric Cancer
Authorization of 6 months may be granted as a single agent for
subsequent treatment of unresectable locally advanced, recurrent,
or metastatic disease gastric cancer that is microsatellite instability-
high (MSI-H) or mismatch repair deficient (dMMR) and has
progressed on or following prior treatment and has no satisfactory
alternative treatment options.
F. Occult Primary
Authorization of 6 months may be granted as a single agent for
treatment of occult primary cancer that is microsatellite instability-
high (MSI-H) or mismatch repair deficient (dMMR).
G. Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary
Peritoneal Cancer
Authorization of 6 months may be granted as a single agent for
treatment of epithelial ovarian cancer, fallopian tube cancer, primary
peritoneal cancer, carcinosarcoma (malignant mixed Mullerian
tumors), clear cell carcinoma, mucinous carcinoma, grade 1
endometrioid carcinoma, and low-grade serous carcinoma/ ovarian
borderline epithelial tumors (low malignant potential with invasive
implants) for recurrent or persistent microsatellite instability-high
(MSI-H) or mismatch repair deficient (dMMR) tumors if there is
disease progression and there are no satisfactory alternative
treatment options.
H. Small Bowel Adenocarcinoma
Authorization of 6 months may be granted as a single agent for
treatment of advanced or metastatic small bowel adenocarcinoma,
including advanced ampullary cancer, for microsatellite instability-
high (MSI-H) or mismatch repair deficient (dMMR) tumors.
V. CONTINUATION OF THERAPY
Authorization of 6 months may be granted for continued treatment in
members requesting reauthorization for an indication listed in Section
IV 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:
- Jemperli [package insert]. Research Triangle Park, NC: GlaxoSmithKline; August 2021.
- The NCCN Drugs & Biologics Compendium® © 2021 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed November 1, 2021.
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.
November 12, 2021
