Commercial

Dostarlimab-gxly (Jemperli)
08.01.79

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member's medical needs and condition.

MEDICALLY NECESSARY

Dostarlimab-gxly (Jemperli) is considered medically necessary for the treatment of individuals with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an US Food and Drug Administration (FDA)-approved test, when all of the following are met:
  • The individual has progressed on or following prior treatment with a platinum-containing regimen
  • The individual has not received more than two lines of therapy for the advanced or recurrent disease
  • The individual has not received prior treatment with programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1)-blocking antibodies or other immune checkpoint inhibitor therapy
  • The individual does not have autoimmune disease that required systemic therapy with immunosuppressant agents within two years​​
EXPERIMENTAL/INVESTIGATIONAL

All other uses of dostarlimab-gxly (Jemperli) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

MANDATES

PENNSYLVANIA MEMBERS
In accordance with the Commonwealth of Pennsylvania's >Act 6 of 2020< or >Fair Access to Cancer Treatment Act, for members who are enrolled in Pennsylvania commercial products who have Stage 4, advanced metastatic cancer, refer to the Medical Policy titled "Coverage of Anticancer Prescription Oral and Injectable Drugs and Biologics and Supportive agents (08.01.08) for additional information regarding the applicable coverage of drugs and biologics.


Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, dostarlimab-gxly (Jemperli) may be covered under the medical benefits of the Company's products when medical necessity listed in this medical policy are met.

MANDATES

This policy is consistent with applicable state mandates. The laws of the state where the group benefit contract is issued determine the mandated coverage.
 
US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Dostarlimab-gxly (Jemperli)  was approved by the FDA on April 22, 2021, as an accelerated approval based on tumor response rate and durability of response for the treatment of individuals with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.

Refer to the dostarlimab-gxly (Jemperli) prescribing information for further information on FDA-approved tests for determining mismatch repair deficiency.

PEDIATRIC USE
The safety and effectiveness of dostarlimab-gxly (Jemperli) in pediatric individuals have not been established.

Description

Approximately 15,000 individuals in the United States are diagnosed with either advanced or recurrent endometrial cancer (EC) annually. Some of the risk factors for EC are hormone therapy, obesity, metabolic syndrome, diabetes, family history, and certain genetic syndromes (e.g. Lynch syndrome). A common sign of EC is irregular vaginal bleeding, which usually occurs early in the cancer process, leading to a diagnosis of EC while the cancer is in an early stage. When identified in an early stage, EC can be successfully treated with either surgery alone, or in combination with radiotherapy and/or chemotherapy, which is often platinum based. If identified in later stages, or if it is recurrent or refractory to treatment, the prognosis for EC is poor. The current treatment options are limited.

There are genes within the cells of the body that correct mistakes made when the deoxyribonucleic acid (DNA) is copied. The process is called mismatch repair. Mismatch repair deficiency (dMMR) can result in errors in short, repetitive DNA sequences called microsatellites, which are genetic mutations. If a tumor has a high number of these mutations, it is classified as expressing microsatellite instability (MSI). EC tumors with dMMR and microsatellite instability-high (MSI-H) expression are difficult to treat. Based on clinical studies involving other drugs, tumors with dMMR and MSI-H respond well to anti-programmed death 1 (PD-1)-based immune checkpoint inhibitor immunotherapy.

Dostarlimab-gxly (Jemperli) is a programmed death-1 (PD-1)-blocking immunoglobulin G4 (IgG4) humanized monoclonal antibody. Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, part of the body's immune response against foreign material, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors leading to tumor growth. Dostarlimab-gxly (Jemperli) binds to the PD-1 receptor on the T cells and blocks its interaction with PD-L1 and PD-L2 which allows the anti-tumor immune response to occur.

​Dostarlimab-gxly (Jemperli) was approved by the US Food and Drug Administration (FDA) on April 22, 2021 for the treatment of individuals with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.​

PEER-REVIEWED LITERATURE
Summary

Dostarlimab-gxly (Jemperli) was evaluated in the GARNET study, which is an ongoing multicenter, multicohort, open-label study conducted in individuals with advanced solid tumors. The efficacy population consisted of a cohort of 71 individuals with mismatch repair deficient (dMMR) recurrent or advanced EC who had progressed on or after treatment with a platinum-containing regimen. The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR).

At the time of study entry 66 percent of the individuals with dMMR EC had stage IV disease. All individuals with dMMR EC had received prior anticancer treatment, with 90 percent having received prior anticancer surgery and 79 percent having received prior anticancer radiotherapy. Approximately 40 percent had two lines or more of prior anticancer treatment, 11 percent had received three regimens, and four percent had received four or more prior regimens. The ORR was 42.3 percent with 12.7 percent achieving complete response and 29.6 percent achieving a partial response. The DOR was not reached, but 93.3 percent of individuals had a duration of response greater than or equal to six months. A couple limitations of the study were the lack of a comparator group and the small cohort size. Additional studies are currently enrolling participants. ​

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

ClinicalTrials.gov. Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in participants with advanced solid tumors (GARNET). ClinicalTrials.gov identifier: NCT02715284. First Posted: 03/22/2016; Last Update Posted: 06/11/2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02715284?term=NCT02715284&draw=2&rank=1. Accessed April 29, 2021.

Elsevier’s Clinical Pharmacology Compendium. Dostarlimab-gxly (Jemperli). [Clinicalkey Web site]. 04/28/2021. Available at: https://www.clinicalkey.com/phamacology/ [via subscription only]. Accessed April 29, 2021.

IBM Micromedex® DRUGDEX® (electronic version). Dostarlimab-gxly (Jemperli). [Micromedex Web site]. IBM Watson Health, Greenwood Village, Colorado, USA. 04/27/2021. Available at: https://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed April 29, 2021.

Lexi-Drugs Compendium. Dostarlimab-gxly (Jemperli). [Lexicomp Online Web site]. 04/28/2021. Available at: https://online.lexi.com/lso/action/home [via subscription only]. Accessed April 29, 2021.

National Cancer Institute. Endometrial cancer treatment. 04/09/2021. Available at: https://www.cancer.gov/types/uterine/hp/endometrial-treatment-pdq#_73. Accessed April 29, 2021.

National Cancer Institute (NCI). NCI Dictionary of Cancer Terms. Microsatellite instability-high cancer. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/microsatellite-instability-high-cancer. Accessed April 29, 2021.

National Cancer Institute (NCI). NCI Dictionary of Cancer Terms. Mismatch repair deficiency. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/mismatch-repair-deficiency. Accessed April 29, 2021.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology – Uterine Neoplasms. Version 2.2021. [NCCN Web site]. 05/07/2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/uterine/pdf. Accessed May 18, 2021.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Dostarlimab-gxly (Jemperli). [NCCN Web site]. 2021. Available at: https://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed May 18, 2021.​​

Oaknin A, Tinker AV, Gilbert L, et al. Clinical activity and safety of the anti-programmed death 1 monoclonal antibody dostarlimab for patients with recurrent or advanced mismatch repair-deficient endometrial cancer: a nonrandomized phase 1 clinical trial. JAMA Oncol. 2020;6(11);1-7.

Overman MJ, Morse M. Tissue-agnostic cancer therapy: DNA mismatch repair deficiency, tumor mutational burden, and response to immune checkpoint blockade in solid tumors. [UpToDate Web Site]. Updated 10/23/2020. Available at: http://www.uptodate.com/home [via subscription only]. Accessed April 29, 2021.​

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Dostarlimab-gxly (Jemperli) prescribing information and approval letter. [FDA Web site]. 04/22/2021. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed April 29, 2021.

US Food and Drug Administration (FDA). List of cleared or approved companion diagnostic devices (in vitro and imaging tools). 04/27/2021. Available at: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools. Accessed April 29, 2021.​

Coding

CPT Procedure Code Number(s)
N/A

ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)
C54.1 Malignant neoplasm of endometrium​

HCPCS Level II Code Number(s)
THE FOLLOWING CODES ARE USED TO REPRESENT Dostarlimab-gxly (Jemperli):

C9399  Unclassified drugs or biologicals
J3590   Unclassified biologics​


Revenue Code Number(s)
N/A






Coding and Billing Requirements


Policy History

7/12/2021
7/12/2021
08.01.79
Medical Policy Bulletin
Commercial
No