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Jemperli® (dostarlimab-gxly)

Policy Number: VP-0599

 

Intravenous

 

Last Review Date: 12/07/2023

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

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.

  1. Length of Authorization 1

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

  • Endometrial Carcinoma (Uterine Neoplasms) and MSI-H/dMMR Endometrial Cancer: Use in combination with carboplatin and paclitaxel may be renewed for up to a maximum of 3 years of therapy (30 doses).
  1. 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
  1. 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

  1. 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-rmbw, etc.), unless otherwise specified Δ; AND

Endometrial Carcinoma (Uterine Neoplasms) ‡ 2,3,10

  • Used in combination with carboplatin and paclitaxel, followed by single agent maintenance therapy; AND
    • 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 first-line 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 † ‡ 1-4,9,10

  • 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 in combination with carboplatin and paclitaxel, followed by single agent therapy; AND
      • Patient has primary advanced or recurrent endometrial cancer ; OR
    • 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 initial therapy ; AND
    • Patient has one of the following cancers:
      • Advanced or Metastatic Appendiceal Adenocarcinoma
      • Metastatic Colon Cancer
      • Esophageal and Esophagogastric Junction Cancers Δ
      • Gastric Cancer Δ
      • Rectal Cancer
      • Advanced or Metastatic Small Bowel Adenocarcinoma; AND
  • Patient has had prior oxaliplatin exposure in the adjuvant treatment setting or has a contraindication to oxaliplatin therapy; OR
                • Endometrial Carcinoma (Uterine Neoplasms) (excluding patients with isolated metastases); OR
      • Used as neoadjuvant therapy ; AND
    • Patient has colon cancer with resectable liver and/or lung metastases; OR
    • Patient has rectal cancer with one of the following:
      • T3, N Any; T1-2, N1-2; T4, N Any
      • Locally unresectable or medically inoperable disease
      • Resectable liver and/or lung metastases

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

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

  1. 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) and MSI-H/dMMR Endometrial Cancer (in combination with carboplatin and paclitaxel) 1,10

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

 

Δ Notes:

  • Patients responding to therapy who relapse ≥ 6 months after discontinuation due to duration (i.e., receipt of 3 years of therapy) are eligible to re-initiate PD-directed therapy.
  • Patients previously presenting with aggressive disease who are exhibiting stable disease on treatment as their best response (or if therapy improved performance status) may be eligible for continued therapy beyond the 3-year limit without interruption or discontinuation.
  • Patients who complete adjuvant therapy and progress ≥ 6 months after discontinuation are eligible to re-initiate PD-directed therapy for metastatic disease.
  • Patients whose tumors, upon re-biopsy, demonstrate a change in actionable mutation (e.g., MSS initial biopsy; MSI-H subsequent biopsy) may be eligible to re-initiate PD-directed therapy and will be evaluated on a case-by-case basis.
  • Patients diagnosed with Gastric, Esophageal, and Esophagogastric Junction Cancers who have received previous checkpoint inhibitor therapy are eligible for treatment with dostarlimab as first-line therapy provided there has been no prior tumor progression while on therapy with a checkpoint inhibitor.
  1. Dosage/Administration 1,3,10

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) until disease progression or unacceptable toxicity, or up to 3 years.

MSI-H/dMMR Endometrial Cancer

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) until disease progression or unacceptable toxicity, or up to 3 years.

MSI-H/dMMR Solid Tumors

Single agent:.

Administer 500 mg intravenously every three 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.

  1. 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
  1. References
  1. Jemperli [package insert]. Research Triangle Park, NC; GlaxoSmithKline, LLC; July 2023. Accessed November 2023.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) dostarlimab-gxly. National Comprehensive Cancer Network, 2023. 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 November 2023.
  3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Uterine Neoplasms. Version 1.2024. National Comprehensive Cancer Network, 2023. 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 November 2023.
  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.

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

Z85.42

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)

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 Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered 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, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

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

 

 

 

 

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