Last Review Date: 09/05/2024

Date of Origin: 05/03/2021

Dates Reviewed: 05/2021, 09/2021, 10/2021, 12/2021, 03/2022, 06/2022, 09/2022, 12/2022, 03/2023, 06/2023, 08/2023, 12/2023, 03/2024, 07/2024, 09/2024

1. Length of Authorization ^{∆ 1}

Coverage will be provided for 6 months and may be renewed, unless otherwise specified.

• Endometrial Carcinoma (Uterine Neoplasms): Use in combination with carboplatin and paclitaxel followed by single agent maintenance therapy thereafter may be renewed for up to a maximum of 3 years (30 doses).

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Jemperli 500 mg/10 mL single-dose vial:
  • Initial: 1 vial every 21 days for 6 doses
  • Subsequent: 2 vials every 42 days

2. Max Units (per dose and over time) [HCPCS Unit]:

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria

• Patient has not received previous therapy with a programmed death (PD-1/PD-L1)-directed therapy (e.g., cemiplimab, avelumab, nivolumab, atezolizumab, durvalumab, pembrolizumab, nivolumab/relatlimab, retifanlimab, tislelizumab, toripalimab, etc.), unless otherwise specified ^Δ; AND

Endometrial Carcinoma (Uterine Neoplasms) † ‡ ^1-3

• Used in combination with carboplatin and paclitaxel, followed by single agent maintenance therapy; AND
  • Patient has primary advanced or recurrent disease †; OR
  • Used as primary treatment for patients with stage III-IV tumors ‡; OR
  • Used as adjuvant therapy for patients with stage III-IV tumors ‡; OR
  • Used as first-line therapy for recurrent disease ‡; AND
    • Patient does not have isolated metastases; OR
  • Used as subsequent therapy for recurrent disease ‡

Mismatch Repair Deficient (dMMR)/Microsatellite Instability-High (MSI-H) Cancer † ‡ ^1-3,11-13

• Patient has mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) cancer as determined by an FDA-approved or CLIA-compliant testv; AND
  • Used as a single agent; AND
    • Used as subsequent therapy for unresectable or medically inoperable, advanced, recurrent, persistent, or metastatic disease; AND

• Patient has endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen in any setting †; OR
• Patient has solid tumors that have progressed on or following prior treatment; OR
  • Used as induction systemic therapy for relieving dysphagia (applies to Esophageal and Esophagogastric Junction Cancers ONLY ); AND
    • Patient is medically fit and planned for esophagectomy with cT2, N0 (high-risk lesions: lymphovascular invasion, ≥ 3 cm, poorly differentiated), cT1b-cT2, N+ or cT3-cT4a, Any N disease; OR

• • Used as initial therapy ‡; AND

• Patient has one of the following cancers:
  • Advanced or metastatic Appendiceal Adenocarcinoma
  • Advanced or metastatic Colon Cancer
  • Esophageal and Esophagogastric Junction Cancers ^Δ
  • Gastric Cancer ^Δ

• • Advanced or metastatic Rectal Cancer

• • Advanced or metastatic Small Bowel Adenocarcinoma; AND
• Patient has had previous FOLFOX/CAPEOX in the adjuvant setting within the past 12 months or has a contraindication to FOLFOX/CAPEOX use; OR
  • • • • • Endometrial Carcinoma (Uterine Neoplasms) (excluding patients with isolated metastases); OR
  • Used as neoadjuvant therapy ‡; AND
  • Patient has advanced or metastatic Appendiceal Adenocarcinoma, Colon Cancer, or Rectal Cancer

Polymerase Epsilon/Delta (POLE/POLD1) Mutation Cancer ‡ ^2,11-13

• Used as a single agent; AND
  • Patient has advanced or metastatic Appendiceal Adenocarcinoma, Colon Cancer, or Rectal Cancer; OR
  • Patient has advanced or metastatic Small Bowel Adenocarcinoma; AND
    • Used as initial therapy if patient has had previous FOLFOX/CAPEOX in the adjuvant setting within the past 12 months or has a contraindication to FOLFOX/CAPEOX use; OR
    • Used as subsequent therapy

v If confirmed using an FDA approved assay – http://www.fda.gov/companiondiagnostics

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^{∆ 1}

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in Section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe infusion-related reactions, severe immune-mediated adverse reactions (e.g., pneumonitis, hepatitis, colitis, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions/rash, etc.), complications of allogeneic hematopoietic stem cell transplantation (HSCT), etc.; AND

Endometrial Carcinoma (Uterine Neoplasms) (in combination with carboplatin and paclitaxel followed by single agent maintenance therapy thereafter) ¹

• Patient has not exceeded a maximum of three (3) years of therapy (30 doses)

5. Dosage/Administration ^{∆ 1,11-13}

6. Billing Code/Availability Information

HCPCS Code:

• J9272 – Injection, dostarlimab-gxly, 10 mg; 1 billable unit = 10 mg

NDC:

• Jemperli 500 mg/10 mL solution in a single-dose vial: 00173-0898-xx

7. References

1. Jemperli [package insert]. Durham, NC; GlaxoSmithKline, LLC; August 2024. Accessed August 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) dostarlimab-gxly. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed August 2024.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Uterine Neoplasms. Version 2.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed August 2024.
4. 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 Oct 1. doi: 10.1001/jamaoncol.2020.4515. [Epub ahead of print]
5. Gupta S, Sonpavde G, Grivas P, et al. Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC). J Clin Oncol. 2019 Mar 1;37(7_suppl):451.
6. Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
7. Hematology/Oncology Pharmacy Association (2019). Intravenous Cancer Drug Waste Issue Brief. Retrieved from http://www.hoparx.org/images/hopa/advocacy/Issue-Briefs/Drug_Waste_2019.pdf
8. Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
9. Berton D, Banerjee S, Curigliano G, et al. Antitumor activity of dostarlimab in patients with mismatch repair-deficient/microsatellite instability–high tumors: A combined analysis of two cohorts in the GARNET study. Journal of Clinical Oncology. Volume 39, Issue 15_suppl. doi/abs/10.1200/JCO.2021.39.15_suppl.2564.
10. Mirza M, Chase D, Slomovitz B, et al. Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer. March 27, 2023. doi: 10.1056/NEJMoa2216334.
11. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Small Bowel Adenocarcinoma. Version 4.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed August 2024.
12. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Colon Cancer. Version 4.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed August 2024.
13. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Rectal Cancer. Version 3.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed August 2024.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A