JEMPERLI (dostarlimab-gxly)

JEMPERLI (dostarlimab-gxly)

Office-Administration – intravenous (IV)

Indications for Prior Authorization:

• Endometrial Cancer - Indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer (EC), as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Coverage Criteria:

For diagnosis of endometrial cancer:

• Dose does not exceed 500 mg every 3 weeks for doses 1 through 4, followed by 1000 mg every 6 weeks thereafter; AND 
• Patient is 18 years of age or older; AND
• Prescribed by or in consultation with an oncologist; AND
• Disease is classified as advanced, recurrent, or metastatic; AND
• Disease is mismatch repair deficient (dMMR) as detected by a U.S. Food and Drug Administration (FDA)-approved test (i.e., Ventana MMR RxDx Panel); AND
• Patient has progressed on or following treatment with a platinum-containing regimen (e.g., carboplatin, cisplatin).

Reauthorization Criteria:

For diagnosis of endometrial cancer:

• Dose does not exceed 1000 mg every 6 weeks; AND
• Patient does not show evidence of progressive disease while on therapy.

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee

Additional Information:

Policy Updates:

• 10/19/2021 – New policy approved by P&T.

References:

• American Cancer Society. Endometrial cancer stages. Last revised March 27, 2019. https://www.cancer.org/content/dam/CRC/PDF/Public/8611.00.pdf. Accessed August 31, 2021.
• Clinicaltrials.gov. A study to evaluate dostarlimab plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel in participants with recurrent or primary advanced endometrial cancer (RUBY). [NCT03981796]. Last update posted July 27, 2021. https://clinicaltrials.gov/ct2/show/NCT03981796?term=NCT03981796&draw=2&rank=1. Accessed August 31, 2021.
• Clinicaltrials.gov. Study of TSR-042, an anti-programmed cell death-1 receptor (PD-1) monoclonal antibody, in participants with advanced solid tumors (GARNET). [NCT02715284]. Last update posted August 26, 2021. https://clinicaltrials.gov/ct2/show/NCT02715284?term=NCT02715284&draw=2&rank=1. Accessed August 31, 2021.
• FDA in vitro diagnostics. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). Current as of August 4, 2021. https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools. Accessed August 31, 2021.
• Food and Drug Administration (FDA). Jemperli summary review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761174Orig1s000MultidisciplineR.pdf. December 19, 2019. Accessed August 31, 2021.
• Jemperli [package insert], Research Triangle Park, NC: GlaxoSmithKline LLC; April 2021.
• National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology – Uterine Neoplasms. v3.2021 – June 3, 2021. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf. Accessed August 31, 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 (GARNET). JAMA Oncol. 2020;6(11):1766-1772.