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Dostarlimab-gxly (Jemperli)
MA08.136e

Policy

When services can be administered in various settings, 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.

INDEX OF MEDICALLY NECESSARY INDICATIONS

This policy addresses numerous medically necessary indications for the use of dostarlimab-gxly (Jemperli) listed in order of appearance within the Policy section. Please see below for the specific medical necessity criteria. (NOTE: Experimental/Investigational section below must also be reviewed).

CANCER TYPE
Ampullary Adenocarcinoma
Breast Cancer
Colon Cancer (including Appendiceal Adenocarcinoma)
Endometrial Cancer
Esophageal and Esophagogastric Junction Cancers
Gastric Cancer
Occult Primary Cancer
Ovarian/Fallopian Tube/Primary Peritoneal Cancer
​​​Pancreatic Adenocarcinoma
Rectal Cancer
Small Bowel Adenocarcinoma


MEDICALLY NECESSARY

AMPULLARY ADENOCARCINOMA
Dostarlimab-gxly (Jemperli), as a single agent, is considered medically necessary and, therefore, covered for the subsequent treatment of adult individuals with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced ampullary adenocarcinoma, as determined by a US Food and Drug Administration (FDA)-approved test, and meet both of the following:
  • Have progressed on, or following, prior treatment 
  • Have no satisfactory alternative treatment option
BREAST CANCER 
Dostarlimab-gxly (Jemperli), as a single agent, is considered medically necessary and, therefore, covered for the treatment of adult individuals with dMMR or MSI-H breast cancer, as determined by an FDA-approved test, and meet all of the following:
  • Have progressed on, or following, prior treatment 
  • Have no satisfactory alternative treatment option 
  • One of the following is met:
    • Invasive breast cancer with ​​all of the following:
      • One of the following histology types:
        1. Lobular
        2. Mixed
        3. Metaplastic
        4. Ductal/NST
        5. Micropapillary
        6. Pure tubular
        7. Pure mucinous
        8. Pure cribriform
        9. Encapsulated or solid papillary carcinoma
        10. Other rare forms
        11. Adenoid cystic and other salivary carcinomas
        12. Secretory carcinoma
        13. Rare low-grade forms of metaplastic carcinoma
      • One of the following levels of disease:
        1. Recurrent unresectable (local or regional) disease
        2. Stage IV (M1) disease​
    • Inflammatory breast cancer (special consideration) with one of the following levels of disease:
      • No response to preoperative systemic therapy
      • Recurrent unresectable (local or regional) disease
      • Stage IV (M1) disease
  • As one of the following:
    • As third-line therapy and beyond for hormone receptor positive and human epidermal growth factor receptor 2 (HER2)-negative with visceral crisis or endocrine therapy refractory or for triple negative breast cancer (TNBC)
    •  As fourth-line and beyond for HER2-positive disease​
COLON CANCER (INCLUDING APPENDICEAL ADENOCARCINOMA)
Dostarlimab-gxly (Jemperli), as a single agent, is considered medically necessary and, therefore, covered for the treatment of adult individuals with dMMR/MSI-H only advanced or metastatic colon cancer (including appendiceal adenocarcinoma), as determined by an FDA-approved test, and meet one of the following:
  • As neoadjuvant therapy for resectable synchronous liver and/or lung metastases (if no previous treatment with a checkpoint inhibitor) (National Comprehensive Cancer Network [NCCN] preferred)
  • As initial treatment for resectable metachronous metastases if no previous immunotherapy
  • ​Individual is a candidate for immunotherapy and no prior immunotherapy received in one of the following:
    • Following primary treatment for locally unresectable or medically inoperable disease
    • As primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for individuals with existing or imminent obstruction
    • For synchronous unresectable metastases
    • As treatment for unresectable metachronous metastases
  • As systemic therapy for an individual with appendiceal adenocarcinoma who is a candidate for immunotherapy and has not received prior immunotherapy ​
ENDOMETRIAL CANCER
Dostarlimab-gxly (Jemperli) is considered medically necessary ​and, therefore, covered for the treatment of adult individuals with dMMR or MSI-H​ recurrent or advanced endometrial cancer, as determined by an FDA-approved test, and meet ​one of the following:
  • Primary treatment, in combination with carboplatin and paclitaxel (for stage IIIA, IIIB, or IIIC1 with measurable disease, stage IIIC1 with carcinosarcoma, clear cell, serous, or mixed histology regardless of the presence of measurable disease; and stage IIIC2 or stage IV regardless of the presence of measurable disease), and dostarlimab (Jemperli) continued as a single-agent maintenance therapy (NCCN preferred) for individuals with stage III to IV endometroid adenocarcinoma in one of the following scenarios: 
    • May be considered preoperatively for individuals presenting with abdominal/pelvic-confined disease that is suitable for primary surgery
    • With or without external beam radiation therapy (EBRT), stereotactic body radiation therapy (SBRT), and/or total hysterectomy/bilateral salpingo-oophorectomy (TH/BSO) for distant metastases that are suitable for primary surgery
    • With sequential EBRT and with or without brachytherapy for locoregional extrauterine disease that is not suitable for primary surgery
    • For locoregional extrauterine disease or distant metastases that are not suitable for primary surgery
  • Adjuvant treatment, in combination with carboplatin and paclitaxel (for stage IIIA, IIIB, or IIIC1 with measurable disease, stage IIIC1 with carcinosarcoma, clear cell, serous, or mixed histology regardless of the presence of measurable disease; and stage IIIC2 or stage IV regardless of the presence of measurable disease), and dostarlimab (Jemperli) continued as a single-agent maintenance therapy (NCCN preferred), with or without EBRT and with or without vaginal brachytherapy for surgically staged individuals with stage III to IV endometrioid adenocarcinoma 
  • First-line therapy (or second-line or subsequent therapy as clinically appropriate), in combination with carboplatin and paclitaxel, and dostarlimab (Jemperli) continued as a single-agent maintenance therapy (NCCN preferred), for recurrent disease in one of the following scenarios:
    • May be considered for isolated metastases (except as first-line therapy)
    • For disseminated metastases with or without sequential palliative EBRT
    • With sequential EBRT and with or without brachytherapy for locoregional recurrence in individuals with no prior RT to site of recurrence, or previous vaginal brachytherapy only
    • After surgical exploration, with sequential EBRT for locoregional recurrence in individuals with disease confined to the vagina or paravaginal soft tissue, or in pelvic or para-aortic lymph nodes
    • After surgical exploration, with or without sequential EBRT for locoregional recurrence in individuals with upper abdominal or peritoneal disease
    • With or without sequential palliative EBRT or brachytherapy for locoregional recurrence in individuals who have received prior EBRT to site of recurrence
  • Used in combination with carboplatin and paclitaxel, and dostarlimab (Jemperli) continued as a single-agent maintenance therapy (NCCN preferred), for stage III to IV tumors (for stage IIIA, IIIB, or IIIC1 with measurable disease, stage IIIC1 with carcinosarcoma, clear cell, serous, or mixed histology regardless of the presence of measurable disease; and stage IIIC2 or stage IV regardless of the presence of measurable disease), including serous carcinoma, clear cell carcinoma, undifferentiated/dedifferentiated carcinoma, or carcinosarcoma in one of the following scenarios:
    • That is suitable for primary surgery as additional treatment with or without sequential EBRT and with or without vaginal brachytherapy after TH/BSO
    • That is not suitable for primary surgery as primary treatment with or without sequential EBRT and with or without brachytherapy
  • First-line therapy (useful in certain circumstances after prior platinum-based therapy), or second-line or subsequent therapy, as clinically appropriate, as a single agent for recurrent microsatellite MSI-H or dMMR disease that has progressed on or following prior treatment with a platinum-containing regimen in ​any of the following scenarios:
    • May be considered for isolated metastases (except as first-line therapy)
    • For disseminated metastases with or without sequential palliative EBRT
    • With sequential EBRT and with or without brachytherapy for locoregional recurrence in individuals with no prior RT to site of recurrence, or previous vaginal brachytherapy only
    • After surgical exploration, with sequential EBRT for locoregional recurrence in individuals with disease confined to the vagina or paravaginal soft tissue, or in pelvic or para-aortic lymph nodes
    • After surgical exploration, with or without sequential EBRT for locoregional recurrence in individuals with upper abdominal or peritoneal disease
    • With or without sequential palliative EBRT or brachytherapy for locoregional recurrence in individuals who have received prior EBRT to site of recurrence​
    • Are not candidates for curative surgery or RT
ESOPHAGEAL AND ESOPHAGOGASTRIC JUNCTION CANCERS
Dostarlimab-gxly (Jemperli), as a single agent, is considered medically necessary and, therefore, covered for the treatment of adult individuals with dMMR or MSI-H esophageal or esophagogastric junction cancers (squamous cell or adenocarcinoma histology)​, as determined by an FDA-approved test, and meet all of the following:
  • As palliative therapy in individuals who have one of the following:
    • Are not surgical candidates 
    • Have unresectable locally advanced, recurrent, or metastatic disease
  • Karnofsky performance status (PS) 60 percent or greater or Eastern Cooperative Oncology Group (ECOG) PS 2 or less​
  • Meet one of the following:
    • First-line (NCCN preferred) and meet all of the following:
      • Independent of programmed death-ligand 1 (PD-L1) status
      • No prior tumor progression while on therapy with a checkpoint inhibitor
    • As second-line or subsequent therapy (prior use of immuno-oncology therapy will make these individuals ineligible for dostarlimab-gxly [Jemperli]) and meet all of the following:
      • Cancer is progressing on, or following, prior treatment 
      • No prior tumor progression while on therapy with a checkpoint inhibitor
      • ​Have no satisfactory alternative treatment options
GASTRIC CANCER
Dostarlimab-gxly (Jemperli), as a single agent, is considered medically necessary and, therefore, covered for the treatment of adult individuals with dMMR or MSI-H gastric tumors, as determined by an FDA-approved test, as one of the following:
  • Primary treatment, independent of PD-L1 status, in individuals who are medically fit for surgery but with surgically unresectable locoregional disease (NCCN preferred)
  • Palliative therapy, independent of PD-L1 status, in individuals who meet all of the following:
    • Are not surgical candidates or have unresectable locally advanced, recurrent, or metastatic disease
    • Karnofsky PS 60 percent or greater or ECOG PS 2 or less
    • As first-line therapy (if no prior tumor progression while on therapy with a checkpoint inhibitor) (NCCN preferred)​
  • ​Palliative therapy for locoregional disease in individuals who meet all of the following: 
    • Are not surgical candidates ​or have unresectable locally advanced, recurrent, or metastatic disease 
    • Karnofsky PS 60 percent or greater or ECOG PS 2 or less
    • Have progressed on or following prior treatment 
    • Have no satisfactory alternative treatment options (if no prior tumor progression while on therapy with a checkpoint inhibitor)
    • As second-line or subsequent therapy (prior use of immuno-oncology therapy will make these individuals ineligible for dostarlimab-gxly [Jemperli])
OCCULT PRIMARY CANCER
Dostarlimab-gxly (Jemperli), as a single agent, is considered medically necessary and, therefore, covered for the treatment of adult individuals with dMMR/MSI-H occult primary tumors (with adenocarcinoma or carcinoma not otherwise specified histology), as determined by an FDA-approved test, in symptomatic individuals with ECOG PS 1 to 2 or asymptomatic individuals with PS 0 and aggressive recurrent or advanced disease that have progressed on or following prior treatment and who have no satisfactory alternative treatment option for any of the following:
  • Axillary involvement in individuals with a prostate or post-prostatectomy if clinically indicated
  • Lung nodules or breast marker-negative pleural effusion
  • Resectable liver disease
  • Peritoneal mass or ascites with non-ovarian histology
  • Retroperitoneal mass of non-germ cell histology in selected individuals​
  • Unresectable liver disease or disseminated metastases​
OVARIAN/FALLOPIAN TUBE/PRIMARY PERITONEAL CANCER
  • Dostarlimab-gxly (Jemperli), as a single agent, is considered medically necessary and, therefore, covered for the treatment of adult individuals with recurrent or advanced dMMR or MSI-H ovarian, fallopian tube, or primary peritoneal disease, as determined by an FDA-approved test, with persistent or recurrent tumors, and meet both of the following:
    • One of the following tumor histology types is present:
      • Endometrioid, serous
      • Carcinosarcoma (malignant mixed mullerian tumors)
      • Clear cell carcinoma
      • Mucinous carcinoma
      • Endometrioid, grade 1
    • One of the following is present:
      • For progression on primary, maintenance, or recurrence therapy (platinum-resistant disease)
      • For stable or persistent disease (if not on maintenance therapy) (platinum-resistant disease)
      • For complete remission and relapse <6 months after completing chemotherapy (platinum-resistant disease)
      • For radiographic and/or clinical relapse in individuals with previous complete remission and relapse 6 months or more after completing prior chemotherapy (platinum-sensitive disease)
  • ​Dostarlimab-gxly (Jemperli) is considered medically necessary and, therefore, covered for the treatment of adult individuals with dMMR or MSI-H ovarian, fallopian tube, or primary peritoneal disease (with low-grade serous, borderline epithelial histology), as determined by an FDA-approved test, in recurrent or advanced tumors as therapy for platinum-sensitive or platinum-resistance recurrence
PANCREATIC ADENOCARCINOMA
Dostarlimab-gxly (Jemperli), as a single agent, is considered medically necessary and, therefore, covered for the treatment of adult individuals with dMMR or MSI-H pancreatic adenocarcinoma, as determined by an FDA-approved test, with both of the following:
  • One of the following scenarios:
    • Local recurrence in the pancreatic operative bed after resection and no prior immunotherapy
    • Recurrent metastatic disease with or without local recurrence after resection and no prior immunotherapy
    • As subsequent therapy if no prior immunotherapy for locally advanced or metastatic disease and disease progression
  • One of the following statuses:
    • Good ECOG PS (PS 0-1)
    • Intermediate ECOG PS (PS 2)
RECTAL CANCER
Dostarlimab-gxly (Jemperli), as a single agent, is considered medically necessary and, therefore, covered for the treatment of adult individuals with dMMR/MSI-H only advanced or metastatic rectal cancer, as determined by an FDA-approved test, and meet one of the following:
  • Individual is a candidate for immunotherapy and has not received prior immunotherapy as one of the following:
    • As primary treatment for T3, N any; T1-2, N1-2; T4, N any; or locally unresectable or medically inoperable disease if resection is contraindicated following neoadjuvant/definitive immunotherapy (NCCN preferred) or total neoadjuvant therapy
    • As primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for individuals with existing or imminent obstruction
    • As primary treatment for synchronous unresectable metastases
    • As primary treatment for potentially resectable or unresectable isolated pelvic/anastomotic recurrence
    • As primary treatment for unresectable metachronous metastases
  • As neoadjuvant/definitive immunotherapy (NCCN preferred) for T3, N any; T1-2, N1-2; T4, N any; or locally unresectable or medically inoperable disease (no previous treatment with a checkpoint inhibitor)
  • As neoadjuvant treatment for resectable synchronous liver only and/or lung only metastases (no previous treatment with a checkpoint inhibitor)
  • As neoadjuvant treatment for resectable synchronous liver only and/or lung only metastases with involved circumferential resection margin (CRM) (by magnetic resonance imaging [MRI]) and previously treated with neoadjuvant radiation with or without concurrent chemotherapy (no previous treatment with a checkpoint inhibitor)
  • As initial treatment for resectable metachronous metastases and no previous immunotherapy​
SMALL BOWEL ADENOCARCINOMA
Dostarlimab-gxly (Jemperli), as a single agent, is considered medically necessary and, therefore, covered for the treatment of adult individuals with dMMR/MSI-H only advanced or metastatic small bowel adenocarcinoma, as determined by an FDA-approved test, who have not received previous treatment with a checkpoint inhibitor ​and meet ​one of the following:
  • As initial therapy if received previous FOLFOX/CapeOX in the adjuvant setting within the past 12 months or if FOLFOX/CapeOX is contraindicated
  • As second-line and subsequent therapy (if not previously given)
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.​

Guidelines

There is no Medicare coverage determination addressing dostarlimab-gxly (Jemperli), therefore, the Company policy is applicable.

Certain drugs are available only through the member's medical benefit (Part B benefit), depending on how the drug is prescribed, dispensed, or administered. For Medicare Advantage members, dostarlimab-gxly (Jemperli) is covered ONLY under a member's medical benefit (Part B benefit).

BENEFIT APPLICATION

Subject to the applicable Evidence of Coverage, dostarlimab-gxly (Jemperli) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria 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.

THE KARNOFSKY PERFORMANCE STATUS

The Karnofsky Performance Status (KPS) is a standard way of measuring the ability of individuals with cancer to perform ordinary tasks. Performance scores range from 0 to 100; a higher score indicates that the individual is better able to perform activities. KPS may be used to determine an individual's prognosis, to measure changes in an individual's ability to function, or to decide if an individual can participate in a clinical trial.

The Karnofsky Performance Status Scale
100 percentNormal, no complaints; no signs of disease
90 percentCapable of normal activity; few symptoms or signs of disease
80 percentNormal activity with some difficulty; some symptoms or signs of disease
70 percentCaring for self; not capable of normal activity or work
60 percentRequiring some help; can take care of most personal requirements
50 percentRequires help often; requires frequent medical care
40 percentDisabled; requires special care and help
30 percentSeverely disabled, but no risk of death
20 percentVery ill; requires supportive measures or treatment
10 percentMoribund; rapidly progressive fatal disease processes
0 percentDeath
OncologyPro. Performance scales: Karnofsky & ECOG scores. [OncologyPro Web site]. Available at: https://oncologypro.esmo.org/oncology-in-practice/practice-tools/performance-scales.

THE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS

The Eastern Cooperative Oncology Group (ECOG), established in 1955, was one of the first groups to coordinate multicenter cancer clinical trials. The National Cancer Institute (NCI) is the primary funding source, and ECOG has evolved from a small consortium of institutions in the eastern United States to one of the largest clinical cancer research organizations in the country. As part of their work in the treatment of cancer, ECOG has developed the ECOG Performance Status (EPS), originally published in 1982 in the American Journal of Clinical Oncology. The use of the scales and the criteria in the EPS allows clinicians and researchers to determine an individual’s disease progression in terms of how the activities of daily living (ADL) are affected.

ECOG Performance Status
GradeECOG
0Fully active, able to carry on all pre-disease performance without restriction
1Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light housework, office work)
2Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50 percent of waking hours
3Capable of only limited self care, confined to bed or chair more than 50 percent of waking hours
4Completely disabled. Cannot carry on any self care: Totally confined to bed or chair
5Dead
Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol.1982;5(6):649-655.

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. Supplemental approvals for dostarlimab-gxly (Jemperli) have since been issued by the FDA.

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

PEDIATRIC USE
Dostarlimab-gxly (Jemperli) is not indicated for use in pediatric individuals less than 18 years of age.​

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
Endometrial Cancer

Dostarlimab-gxly (Jemperli) was evaluated in the GARNET study (NCT02715284), 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 objective response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.

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 6 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.

The efficacy and safety of the use of dostarlimab-gxly (Jemperli), in combination with carboplatin and paclitaxel, was evaluated in the RUBY study (NCT03981796) for the treatment of individuals with dMMR/MSI-H primary advanced or recurrent endometrial cancer. The study is an ongoing phase 3, randomized, multicenter, double-blind, placebo-controlled trial with multiple arms. In this reporting, a group of 122 individuals was randomized 1:1 into 2 cohorts. The first cohort received dostarlimab-gxly (Jemperli), carboplatin, and paclitaxel. The second cohort received only carboplatin and paclitaxel. Treatment was continued until disease progression was identified, unacceptable toxicity was experienced by the individual, or to a maximum of three years (the study is continuing to six years). The primary outcome measures are the progression-free survival (PFS) and the overall survival (OS). Some secondary outcome measures include ORR, DOR, disease control rate (DCR), and adverse event (AE) reporting. In the combination treatment group with dostarlimab (Jemperli) (n=60) the median PFS was 30.3 months versus the median PFS in the combination treatment group without dostarlimab (Jemperli) (n=62) of 7.7 months (p <0.0001). The OS data was immature at the time of reporting. The ORR in the combination treatment group with dostarlimab (Jemperli) was 31 (11 complete responses, 20 partial responses) versus 28 (5 complete responses, 23 partial responses) in the combination treatment group without dostarlimab (Jemperli). The DOR was not reached for the combination treatment group with dostarlimab (Jemperli) and was 5.4 months for the combination treatment group without dostarlimab (Jemperli).

Solid Tumors

Dostarlimab-gxly (Jemperli) was evaluated in the GARNET study (NCT02715284), which is an ongoing, multicenter, multicohort, open-label study conducted in individuals with advanced solid tumors. The efficacy population consisted of a cohort of 209 individuals with dMMR recurrent or advanced solid tumors who had progressed following systemic therapy and had no satisfactory alternative treatment options. Individuals with dMMR colorectal cancer must have progressed after or been intolerant to a fluoropyrimidine, oxaliplatin, and irinotecan. The major efficacy outcome measures were ORR and DOR as assessed by BICR according to RECIST v 1.1.

At the time of study entry, 97.2 percent of individuals with non-endometrial dMMR solid tumors had stage IV disease. Approximately 43 percent of individuals had received one prior line of systemic anticancer treatment, 36 percent had received two prior lines, and 21 percent had received three or more prior lines. The ORR was 41.6 percent, with 9.1 percent achieving complete response and 32.5 percent achieving a partial response. The median DOR was 34.7 months with 95.4 percent of individuals surviving 6 months or more.​

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

American Hospital Formulary Service (AHFS). Dostarlimab-gxly (Jemperli®). AHFS Drug Information 2023. [LexiComp Web site]. 12/12/2023. Available at: https://online.lexi.com/lco/action/home# [via subscription only]. Accessed January 17, 2024.

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: 08/22/2023. Available at: https://clinicaltrials.gov. Accessed January 17, 2024.

Elsevier’s Clinical Pharmacology Compendium. Dostarlimab-gxly (Jemperli®). [ClinicalKey Web site]. 11/07/2023. Available at: https://www.clinicalkey.com/phamacology/ [via subscription only]. Accessed January 17, 2023.

Lexi-Drugs Compendium. Dostarlimab-gxly (Jemperli®). [Lexicomp Online Web site]. 12/05/2023. Available at: https://online.lexi.com/lso/action/home [via subscription only]. Accessed January 17, 2024.

Merative Micromedex® DRUGDEX® (electronic version). Dostarlimab-gxly (Jemperli®). [Micromedex Web site]. Merative L.P., Ann Arbor, Michigan, USA. 10/10/2023. Available at: https://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed January 17, 2024.

Mirza MR, Chase DM, Slomovitz BM, et al. Dostarlimab for primary advanced or recurrent endometrial cancer. N Engl J Med. 2023;388(23):2145-2158.​

National Cancer Institute. Endometrial cancer treatment. 12/28/2023. Available at: https://www.cancer.gov/types/uterine/hp/endometrial-treatment-pdq#_73. Accessed January 17, 2024.

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 January 17, 2024.

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 January 17, 2024.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® - Ampullary Adenocarcinoma. V1.2024. [NCCN Web site]. 12/13/2023. Available from: https://www.nccn.org/professionals/physician_gls/pdf/ampullary.pdf. [via subscription only]. Accessed January 17, 2024.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® - Breast Cancer. V5.2023. [NCCN Web site]. 12/05/2023. Available from: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. [via subscription only]. Accessed January 17, 2024.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® - Colon Cancer. V4.2023. [NCCN Web site]. 11/16/2023. Available from: https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. [via subscription only]. Accessed January 17, 2024.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® - Esophageal and Esophagogastric Junction Cancers. V3.2023. [NCCN Web site]. 08/29/2023. Available from: https://www.nccn.org/professionals/physician_gls/pdf/esophageal.pdf. [via subscription only]. Accessed January 17, 2024.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® - Gastric Cancer. V2.2023. [NCCN Web site]. 08/29/2023. Available from: https://www.nccn.org/professionals/physician_gls/pdf/gastric.pdf. [via subscription only]. Accessed January 17, 2024.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® - Occult Primary (Cancer of Unknown Primary [CUP]). V1.2024. [NCCN Web site]. 09/06/2023. Available from: https://www.nccn.org/professionals/physician_gls/pdf/occult.pdf. [via subscription only]. Accessed January 17, 2024.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® - Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer. V2.2023. [NCCN Web site]. 06/02/2023. Available from: https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. [via subscription only]. Accessed January 17, 2024.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® - Pancreatic Adenocarcinoma. V1.2024. [NCCN Web site]. 12/13/2023. Available from: https://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Accessed January 12, 2024.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® - Rectal Cancer. V6.2023. [NCCN Web site]. 11/16/2023. Available from: https://www.nccn.org/professionals/physician_gls/pdf/rectal.pdf. [via subscription only]. Accessed January 17, 2024.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® - Small Bowel Adenocarcinoma. V1.2024. [NCCN Web site]. 12/20/2023. Available from: https://www.nccn.org/professionals/physician_gls/pdf/small_bowel.pdf. [via subscription only]. Accessed January 17, 2024.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology®​ - Uterine Neoplasms. V1.2024. [NCCN Web site]. 09/20/2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/uterine/pdf [via subscription only]​. Accessed January 17, 2024.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium®. Dostarlimab-gxly (Jemperli®). [NCCN Web site]. 2024. Available at: https://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed January 17, 2024.​​

Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.

Oaknin A, Tinker AV, Gilbert L, et al. Clinical activity and safety of the anti-PD-1 monoclonal antibody dostarlimab for patients with recurrent or advanced dMMR endometrial cancer. Future Oncol. 2021;17(29):3781-3785.

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.

OncologyPro. Performance scales: Karnofsky & ECOG scores. [OncologyPro Web site]. Available at: https://oncologypro.esmo.org/oncology-in-practice/practice-tools/performance-scales. Accessed January 17, 2024.

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 06/26/2023. Available at: http://www.uptodate.com/home [via subscription only]. Accessed January 17, 2024.​

Patnaik A, Weiss GJ, Rasco DW, et al. Safety, antitumor activity, and pharmacokinetics of dostarlimab, an anti-PD-1, in patients with advanced solid tumors: a dose-escalation phase 1 trial. Cancer Chemother Pharmacol. 2022;89(1):93-103.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Dostarlimab-gxly (Jemperli®prescribing information and approval letter. [FDA Web site]. 07/31/2023. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed January 17, 2024.

US Food and Drug Administration (FDA). List of cleared or approved companion diagnostic devices (in vitro and imaging tools). 12/21/2023. Available at: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools. Accessed January 17, 2024.​​​​​

Coding

CPT Procedure Code Number(s)
N/A

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

ICD - 10 Diagnosis Code Number(s)
C15.3
Malignant neoplasm of upper third of esophagus
C15.4
​Malignant neoplasmv 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
C16.0Malignant neoplasm of cardia
C16.1Malignant neoplasm of fundus of stomach​
C16.2Malignant neoplasm of body of stomach
C16.3Malignant neoplasm of pyloric antrum
C16.4Malignant neoplasm of pylorus
C16.5Malignant neoplasm of lesser curvature of stomach, unspecified
C16.6Malignant neoplasm of greater curvature of stomach, unspecified
C16.8Malignant neoplasm of overlapping sites of stomach
C16.9Malignant neoplasm of stomach, unspecified
C17.0Malignant neoplasm of duodenum
C17.1Malignant neoplasm of jejunum
C17.2Malignant neoplasm of ileum
C17.3Meckel's diverticulum, malignant
C17.8Malignant neoplasm of overlapping sites of small intestine
C17.9Malignant neoplasm of small intestine, unspecified
C18.0Malignant neoplasm of cecum
C18.1Malignant neoplasm of appendix
C18.2Malignant neoplasm of ascending colon
C18.3Malignant neoplasm of hepatic flexure
C18.4Malignant neoplasm of transverse colon
C18.5Malignant neoplasm of splenic flexure
C18.6Malignant neoplasm of descending colon
C18.7Malignant neoplasm of sigmoid colon
C18.8Malignant neoplasm of overlapping sites of colon
C18.9Malignant neoplasm of colon, unspecified
C19Malignant neoplasm of rectosigmoid junction
C20Malignant neoplasm of rectum
C21.0 Malignant neoplasm of anus, unspecified
C21.1  Malignant neoplasm of anal canal
C21.2 Malignant neoplasm of cloacogenic zone
C21.8Malignant neoplasm of overlapping sites of rectum, anus and anal canal
C24.1Malignant 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​
C48.1Malignant neoplasm of specified parts of peritoneum
C48.2Malignant neoplasm of peritoneum, unspecified
C48.8Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
C50.011Malignant neoplasm of nipple and areola, right female breast
C50.012Malignant neoplasm of nipple and areola, left female breast
C50.021Malignant neoplasm of nipple ​and areola, right male breast
C50.022Malignant neoplasm of nipple and areola, left male breast
C50.111Malignant neoplasm of central portion of right female breast
C50.112Malignant neoplasm of central portion of left female breast
C50.121Malignant neoplasm of central portion of right male breast
C50.122Malignant neoplasm of central portion of left male breast
C50.211Malignant neoplasm of upper-inner quadrant of right female breast
C50.212Malignant neoplasm of upper-inner quadrant of left female breast
C50.221Malignant neoplasm of upper-inner quadrant of right male breast
C50.222Malignant neoplasm of upper-inner quadrant of left male breast
C50.311Malignant neoplasm of lower-inner quadrant of right female breast
C50.312Malignant neoplasm of lower-inner quadrant of left female breast
C50.321Malignant neoplasm of lower-inner quadrant of right male breast
C50.322Malignant neoplasm of lower-inner quadrant of left male breast
C50.411Malignant neoplasm of upper-outer quadrant of right female breast
C50.412Malignant neoplasm of upper-outer quadrant of left female breast
C50.421Malignant neoplasm of upper-outer quadrant of right male breast
C50.422Malignant neoplasm of upper-outer quadrant of left male breast
C50.511Malignant neoplasm of lower-outer quadrant of right female breast
C50.512Malignant neoplasm of lower-outer quadrant of left female breast
C50.521Malignant neoplasm of lower-outer quadrant of right male breast
C50.522Malignant neoplasm of lower-outer quadrant of left male breast
C50.611Malignant neoplasm of axillary tail of right female breast
C50.612Malignant neoplasm of axillary tail of left female breast
C50.621Malignant neoplasm of axillary tail of right male breast
C50.622Malignant neoplasm of axillary tail of left male breast
C50.811Malignant neoplasm of overlapping sites of right female breast
C50.812Malignant neoplasm of overlapping sites of left female breast
C50.821Malignant neoplasm of overlapping sites of right male breast
C50.822Malignant neoplasm of overlapping sites of left male breast
C50.911Malignant neoplasm of unspecified site of right female breast
C50.912Malignant neoplasm of unspecified site of left female breast
C50.921Malignant neoplasm of unspecified site of right male breast
C50.922Malignant neoplasm of unspecified site of left male breast
C54.0Malignant neoplasm of isthmus uteri
C54.1Malignant neoplasm of endometrium
C54.2Malignant neoplasm of myometrium
C54.3Malignant neoplasm of fundus uteri
C54.8Malignant neoplasm of overlapping sites of corpus uteri
C54.9Malignant neoplasm of corpus uteri, unspecified
C55Malignant neoplasm of uterus, part unspecified
C56.1Malignant neoplasm of right ovary
C56.2Malignant neoplasm of left ovary
C56.3Malignant neoplasm of bilateral ovaries
C57.01Malignant neoplasm of right fallopian tube
C57.02Malignant neoplasm of left fallopian tube
C57.11Malignant neoplasm of right broad ligament
C57.12Malignant neoplasm of left broad ligament
C57.21Malignant neoplasm of right round ligament
C57.22Malignant neoplasm of left round ligament
C57.3Malignant neoplasm of parametrium
C57.4Malignant neoplasm of uterine adnexa, unspecified
C57.7Malignant neoplasm of other specified female genital organs
C57.8Malignant neoplasm of overlapping sites of female genital organs
C57.9Malignant neoplasm of female genital organ, unspecified
C78.01Secondary malignant neoplasm of right lung
C78.02Secondary malignant neoplasm of left lung
C78.6Secondary malignant neoplasm of retroperitoneum and peritoneum
C78.7Secondary malignant neoplasm of liver and intrahepatic bile duct
C80.0Disseminated malignant neoplasm, unspecified
C80.1Malignant (primary) neoplasm, unspecified
D07.0Carcinoma in situ of endometrium
D37.1Neoplasm 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


HCPCS Level II Code Number(s)
J9272 Injection, dostarlimab-gxly, 10 mg​

Revenue Code Number(s)
N/A





Coding and Billing Requirements


Policy History

3/11/2024
3/11/2024
MA08.136
Medical Policy Bulletin
Medicare Advantage
No