Asset Publisher
Jemperli® (dostarlimab-gxly)
Policy Number: VP-0599
Intravenous
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
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- 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).
- Dosing Limits
- 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
- Max Units (per dose and over time) [HCPCS Unit]:
Indication |
Billable Units (BU) |
Per unit time (days) |
Endometrial Cancer |
Initial: 50 BU |
21 days x 6 doses |
Subsequent: 100 BU |
42 days |
|
All other indications |
Initial: 50 BU |
21 days x 4 doses |
Subsequent: 100 BU |
42 days |
- 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
- Used as a single agent; 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 induction systemic therapy for relieving dysphagia (applies to Esophageal and Esophagogastric Junction Cancers ONLY ); AND
-
- 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
- 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)
Δ Notes:
|
- Dosage/Administration ∆ 1,11-13
Indication |
Dose |
Endometrial Carcinoma (Uterine Neoplasms) |
In combination with carboplatin and paclitaxel: Administer 500 mg intravenously every 3 weeks for 6 doses in combination with carboplatin and paclitaxel, followed by 1,000 mg monotherapy every 6 weeks (dose 7 begins three weeks after the 6th dose) for up to 3 years or until disease progression or unacceptable toxicity. |
MSI-H/dMMR Endometrial Cancer and Solid Tumors |
Single agent: Administer 500 mg intravenously every 3 weeks for 4 doses, followed by 1,000 mg every 6 weeks (dose 5 begins three weeks after the 4th dose) until disease progression or unacceptable toxicity. |
POLE/POLD1 Mutation Tumors |
Single agent: Administer 500 mg intravenously every 3 weeks for 4 doses, followed by 1,000 mg every 6 weeks (dose 5 begins three weeks after the 4th dose) until disease progression or unacceptable toxicity. |
- 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
- References
- Jemperli [package insert]. Durham, NC; GlaxoSmithKline, LLC; August 2024. Accessed August 2024.
- 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.
- 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.
- 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]
- 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.
- 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.
- 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
- Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
- 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.
- Mirza M, Chase D, Slomovitz B, et al. Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer. March 27, 2023. doi: 10.1056/NEJMoa2216334.
- 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.
- 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.
- 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
ICD-10 |
ICD-10 Description |
C15.3 |
Malignant neoplasm of upper third of esophagus |
C15.4 |
Malignant neoplasm of middle third of esophagus |
C15.5 |
Malignant neoplasm of lower third of esophagus |
C15.8 |
Malignant neoplasm of overlapping sites of esophagus |
C15.9 |
Malignant neoplasm of esophagus, unspecified |
C16.0 |
Malignant neoplasm of cardia |
C16.1 |
Malignant neoplasm of fundus of stomach |
C16.2 |
Malignant neoplasm of body of stomach |
C16.3 |
Malignant neoplasm of pyloric antrum |
C16.4 |
Malignant neoplasm of pylorus |
C16.5 |
Malignant neoplasm of lesser curvature of stomach, unspecified |
C16.6 |
Malignant neoplasm of greater curvature of stomach, unspecified |
C16.8 |
Malignant neoplasm of overlapping sites of stomach |
C16.9 |
Malignant neoplasm of stomach, unspecified |
C17.0 |
Malignant neoplasm of duodenum |
C17.1 |
Malignant neoplasm of jejunum |
C17.2 |
Malignant neoplasm of ileum |
C17.3 |
Meckel’s diverticulum, malignant |
C17.8 |
Malignant neoplasm of overlapping sites of small intestine |
C17.9 |
Malignant neoplasm of small intestine, unspecified |
C18.0 |
Malignant neoplasm of cecum |
C18.1 |
Malignant neoplasm of appendix |
C18.2 |
Malignant neoplasm of ascending colon |
C18.3 |
Malignant neoplasm of hepatic flexure |
C18.4 |
Malignant neoplasm of transverse colon |
C18.5 |
Malignant neoplasm of splenic flexure |
C18.6 |
Malignant neoplasm of descending colon |
C18.7 |
Malignant neoplasm of sigmoid colon |
C18.8 |
Malignant neoplasm of overlapping sites of colon |
C18.9 |
Malignant neoplasm of colon, unspecified |
C19 |
Malignant neoplasm of rectosigmoid junction |
C20 |
Malignant neoplasm of rectum |
C21.8 |
Malignant neoplasm of overlapping sites of rectum, anus and anal canal |
C24.1 |
Malignant neoplasm of ampulla of Vater |
C25.0 |
Malignant neoplasm of head of pancreas |
C25.1 |
Malignant neoplasm of body of pancreas |
C25.2 |
Malignant neoplasm of tail of pancreas |
C25.3 |
Malignant neoplasm of pancreatic duct |
C25.7 |
Malignant neoplasm of other parts of pancreas |
C25.8 |
Malignant neoplasm of overlapping sites of pancreas |
C25.9 |
Malignant neoplasm of pancreas, unspecified |
C48.1 |
Malignant neoplasm of specified parts of peritoneum |
C48.2 |
Malignant neoplasm of peritoneum, unspecified |
C48.8 |
Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum |
C50.011 |
Malignant neoplasm of nipple and areola, right female breast |
C50.012 |
Malignant neoplasm of nipple and areola, left female breast |
C50.019 |
Malignant neoplasm of nipple and areola, unspecified female breast |
C50.021 |
Malignant neoplasm of nipple and areola, right male breast |
C50.022 |
Malignant neoplasm of nipple and areola, left male breast |
C50.029 |
Malignant neoplasm of nipple and areola, unspecified male breast |
C50.111 |
Malignant neoplasm of central portion of right female breast |
C50.112 |
Malignant neoplasm of central portion of left female breast |
C50.119 |
Malignant neoplasm of central portion of unspecified female breast |
C50.121 |
Malignant neoplasm of central portion of right male breast |
C50.122 |
Malignant neoplasm of central portion of left male breast |
C50.129 |
Malignant neoplasm of central portion of unspecified male breast |
C50.211 |
Malignant neoplasm of upper-inner quadrant of right female breast |
C50.212 |
Malignant neoplasm of upper-inner quadrant of left female breast |
C50.219 |
Malignant neoplasm of upper-inner quadrant of unspecified female breast |
C50.221 |
Malignant neoplasm of upper-inner quadrant of right male breast |
C50.222 |
Malignant neoplasm of upper-inner quadrant of left male breast |
C50.229 |
Malignant neoplasm of upper-inner quadrant of unspecified male breast |
C50.311 |
Malignant neoplasm of lower-inner quadrant of right female breast |
C50.312 |
Malignant neoplasm of lower-inner quadrant of left female breast |
C50.319 |
Malignant neoplasm of lower-inner quadrant of unspecified female breast |
C50.321 |
Malignant neoplasm of lower-inner quadrant of right male breast |
C50.322 |
Malignant neoplasm of lower-inner quadrant of left male breast |
C50.329 |
Malignant neoplasm of lower-inner quadrant of unspecified male breast |
C50.411 |
Malignant neoplasm of upper-outer quadrant of right female breast |
C50.412 |
Malignant neoplasm of upper-outer quadrant of left female breast |
C50.419 |
Malignant neoplasm of upper-outer quadrant of unspecified female breast |
C50.421 |
Malignant neoplasm of upper-outer quadrant of right male breast |
C50.422 |
Malignant neoplasm of upper-outer quadrant of left male breast |
C50.429 |
Malignant neoplasm of upper-outer quadrant of unspecified male breast |
C50.511 |
Malignant neoplasm of lower-outer quadrant of right female breast |
C50.512 |
Malignant neoplasm of lower-outer quadrant of left female breast |
C50.519 |
Malignant neoplasm of lower-outer quadrant of unspecified female breast |
C50.521 |
Malignant neoplasm of lower-outer quadrant of right male breast |
C50.522 |
Malignant neoplasm of lower-outer quadrant of left male breast |
C50.529 |
Malignant neoplasm of lower-outer quadrant of unspecified male breast |
C50.611 |
Malignant neoplasm of axillary tail of right female breast |
C50.612 |
Malignant neoplasm of axillary tail of left female breast |
C50.619 |
Malignant neoplasm of axillary tail of unspecified female breast |
C50.621 |
Malignant neoplasm of axillary tail of right male breast |
C50.622 |
Malignant neoplasm of axillary tail of left male breast |
C50.629 |
Malignant neoplasm of axillary tail of unspecified male breast |
C50.811 |
Malignant neoplasm of overlapping sites of right female breast |
C50.812 |
Malignant neoplasm of overlapping sites of left female breast |
C50.819 |
Malignant neoplasm of overlapping sites of unspecified female breast |
C50.821 |
Malignant neoplasm of overlapping sites of right male breast |
C50.822 |
Malignant neoplasm of overlapping sites of left male breast |
C50.829 |
Malignant neoplasm of overlapping sites of unspecified male breast |
C50.911 |
Malignant neoplasm of unspecified site of right female breast |
C50.912 |
Malignant neoplasm of unspecified site of left female breast |
C50.919 |
Malignant neoplasm of unspecified site of unspecified female breast |
C50.921 |
Malignant neoplasm of unspecified site of right male breast |
C50.922 |
Malignant neoplasm of unspecified site of left male breast |
C50.929 |
Malignant neoplasm of unspecified site of unspecified male breast |
C54.0 |
Malignant neoplasm of isthmus uteri |
C54.1 |
Malignant neoplasm of endometrium |
C54.2 |
Malignant neoplasm of myometrium |
C54.3 |
Malignant neoplasm of fundus uteri |
C54.8 |
Malignant neoplasm of overlapping sites of corpus uteri |
C54.9 |
Malignant neoplasm of corpus uteri, unspecified |
C55 |
Malignant neoplasm of uterus, part unspecified |
C56.1 |
Malignant neoplasm of right ovary |
C56.2 |
Malignant neoplasm of left ovary |
C56.3 |
Malignant neoplasm of bilateral ovaries |
C56.9 |
Malignant neoplasm of unspecified ovary |
C57.00 |
Malignant neoplasm of unspecified fallopian tube |
C57.01 |
Malignant neoplasm of right fallopian tube |
C57.02 |
Malignant neoplasm of left fallopian tube |
C57.10 |
Malignant neoplasm of unspecified broad ligament |
C57.11 |
Malignant neoplasm of right broad ligament |
C57.12 |
Malignant neoplasm of left broad ligament |
C57.20 |
Malignant neoplasm of unspecified round ligament |
C57.21 |
Malignant neoplasm of right round ligament |
C57.22 |
Malignant neoplasm of left round ligament |
C57.3 |
Malignant neoplasm of parametrium |
C57.4 |
Malignant neoplasm of uterine adnexa, unspecified |
C57.7 |
Malignant neoplasm of other specified female genital organs |
C57.8 |
Malignant neoplasm of overlapping sites of female genital organs |
C57.9 |
Malignant neoplasm of female genital organ, unspecified |
C78.00 |
Secondary malignant neoplasm of unspecified lung |
C78.01 |
Secondary malignant neoplasm of right lung |
C78.02 |
Secondary malignant neoplasm of left lung |
C78.6 |
Secondary malignant neoplasm of retroperitoneum and peritoneum |
C78.7 |
Secondary malignant neoplasm of liver and intrahepatic bile duct |
C80.0 |
Disseminated malignant neoplasm, unspecified |
C80.1 |
Malignant (primary) neoplasm, unspecified |
D37.1 |
Neoplasm of uncertain behavior of stomach |
D37.8 |
Neoplasm of uncertain behavior of other specified digestive organs |
D37.9 |
Neoplasm of uncertain behavior of digestive organ, unspecified |
Z85.00 |
Personal history of malignant neoplasm of unspecified digestive organ |
Z85.01 |
Personal history of malignant neoplasm of esophagus
|
Z85.028 |
Personal history of other malignant neoplasm of stomach |
Z85.068 |
Personal history of other malignant neoplasm of small intestine |
Z85.07 |
Personal history of malignant neoplasm of pancreas |
Z85.09 |
Personal history of malignant neoplasm of other digestive organs |
Z85.3 |
Personal history of malignant neoplasm of breast |
Z85.42 |
Personal history of malignant neoplasm of other parts of uterus |
Z85.43 |
Personal history of malignant neoplasm of ovary |
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
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |