Medicare Advantage

Medical Policy

Title:

Dostarlimab-gxly (Jemperli)

Policy #:

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:

Lobular
Mixed
Metaplastic
Ductal/NST
Micropapillary
Pure tubular
Pure mucinous
Pure cribriform
Encapsulated or solid papillary carcinoma
Other rare forms
Adenoid cystic and other salivary carcinomas
Secretory carcinoma
Rare low-grade forms of metaplastic carcinoma

One of the following levels of disease:

Recurrent unresectable (local or regional) disease
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 percent	Normal, no complaints; no signs of disease
90 percent	Capable of normal activity; few symptoms or signs of disease
80 percent	Normal activity with some difficulty; some symptoms or signs of disease
70 percent	Caring for self; not capable of normal activity or work
60 percent	Requiring some help; can take care of most personal requirements
50 percent	Requires help often; requires frequent medical care
40 percent	Disabled; requires special care and help
30 percent	Severely disabled, but no risk of death
20 percent	Very ill; requires supportive measures or treatment
10 percent	Moribund; rapidly progressive fatal disease processes
0 percent	Death

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
Grade	ECOG
0	Fully active, able to carry on all pre-disease performance without restriction
1	Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light housework, office work)
2	Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50 percent of waking hours
3	Capable of only limited self care, confined to bed or chair more than 50 percent of waking hours
4	Completely disabled. Cannot carry on any self care: Totally confined to bed or chair
5	Dead

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
C16.0	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
C21.0	Malignant neoplasm of anus, unspecified
C21.1	Malignant neoplasm of anal canal
C21.2	Malignant neoplasm of cloacogenic zone
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
C50.021	Malignant neoplasm of nipple and areola, right male breast
C50.022	Malignant neoplasm of nipple and areola, left male breast
C50.111	Malignant neoplasm of central portion of right female breast
C50.112	Malignant neoplasm of central portion of left female breast
C50.121	Malignant neoplasm of central portion of right male breast
C50.122	Malignant neoplasm of central portion of left 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
C50.221	Malignant neoplasm of upper-inner quadrant of right male breast
C50.222	Malignant neoplasm of upper-inner quadrant of left 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
C50.321	Malignant neoplasm of lower-inner quadrant of right male breast
C50.322	Malignant neoplasm of lower-inner quadrant of left 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
C50.421	Malignant neoplasm of upper-outer quadrant of right male breast
C50.422	Malignant neoplasm of upper-outer quadrant of left 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
C50.521	Malignant neoplasm of lower-outer quadrant of right male breast
C50.522	Malignant neoplasm of lower-outer quadrant of left male breast
C50.611	Malignant neoplasm of axillary tail of right female breast
C50.612	Malignant neoplasm of axillary tail of left female breast
C50.621	Malignant neoplasm of axillary tail of right male breast
C50.622	Malignant neoplasm of axillary tail of left male breast
C50.811	Malignant neoplasm of overlapping sites of right female breast
C50.812	Malignant neoplasm of overlapping sites of left female breast
C50.821	Malignant neoplasm of overlapping sites of right male breast
C50.822	Malignant neoplasm of overlapping sites of left male breast
C50.911	Malignant neoplasm of unspecified site of right female breast
C50.912	Malignant neoplasm of unspecified site of left female breast
C50.921	Malignant neoplasm of unspecified site of right male breast
C50.922	Malignant neoplasm of unspecified site of left 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
C57.01	Malignant neoplasm of right fallopian tube
C57.02	Malignant neoplasm of left fallopian tube
C57.11	Malignant neoplasm of right broad ligament
C57.12	Malignant neoplasm of left broad 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
C78.01	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
D07.0	Carcinoma in situ of endometrium
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

HCPCS Level II Code Number(s)

J9272 Injection, dostarlimab-gxly, 10 mg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA08.136e:

03/11/2024

This version of the policy will become effective 03/11/2024.

The following policy criterion has been added to this policy in accordance with the National Comprehensive Cancer Network (NCCN) compendium (accessed 01/17/2024) and the following NCCN guideline:
Pancreatic adenocarcinoma V1.2024 (12/13/2023)

The following policy criteria have been revised in accordance with the NCCN compendium and the following NCCN guidelines:
Ampullary adenocarcinoma V1.2024 (12/13/2023)
Breast cancer V5.2023 (12/05/2023)
Colon cancer V4.2023 (11/16/2023)
Esophageal and esophagogastric junction cancers V3.2023 (08/29/2023)
Gastric cancer V2.2023 (08/29/2023)
Occult primary V1.2024 (09/06/2023)
Ovarian/fallopian tube/primary peritoneal cancer V2.2023 (06/02/2023)
Rectal cancer V6.2023 (11/16/2023)
Small bowell adenocarcinoma V1.2024 (12/20/2023)
Uterine neoplasms V1.2024 (09/20/2023)

The following ICD-10 codes have been added to the policy:
C15.3, C15.4, C15.5, C15.8, C15.9, C25.0, C25.1, C25.2, C25.3, C25.7, C25.8, C25.9, D37.8, D37.9.

Revisions From MA08.136d:

01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
03/13/2023	This version of the policy will become effective 03/13/2023 The following policy criteria have been added to this policy in accordance with the National Comprehensive Cancer Network (NCCN) compendium (accessed 12/27/2022) and the following NCCN guidelines: Ampullary adenocarcinoma (NCCN V2.2022; 12/06/2022) Esophageal and esophagogastric junction cancers (NCCN V5.2022; 12/05/2022) The following policy criteria have been revised in accordance with the NCCN compendium and the following NCCN guidelines: Colon cancer (including appendiceal adenocarcinoma) (NCCN V2.2022; 10/27/2022) Gastric cancer (NCCN V2.2022; 01/11/2022) Occult primary cancer (NCCN V3.2023; 12/21/2022) Ovarian/fallopian tube/primary peritoneal cancer (NCCN V1.2023; 12/22/2022) Small bowel adenocarcinoma (NCCN V2.2022; 10/27/2022) Uterine neoplasms (NCCN V1.2023; 12/22/2022) The following ICD-10 codes have been removed from the policy: C50.019, C50.029, C50.119, C50.129, C50.219, C50.229, C50.319, C50.329, C50.419, C50.429, C50.519, C50.529, C50.619, C50.629, C50.819, C50.829, C50.919, C50.929, C56.9, C57.00, C57.10, C57.20, C78.00

01/01/2024

Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.

03/13/2023

This version of the policy will become effective 03/13/2023

The following policy criteria have been added to this policy in accordance with the National Comprehensive Cancer Network (NCCN) compendium (accessed 12/27/2022) and the following NCCN guidelines:
Ampullary adenocarcinoma (NCCN V2.2022; 12/06/2022)
Esophageal and esophagogastric junction cancers (NCCN V5.2022; 12/05/2022)

The following policy criteria have been revised in accordance with the NCCN compendium and the following NCCN guidelines:
Colon cancer (including appendiceal adenocarcinoma) (NCCN V2.2022; 10/27/2022)
Gastric cancer (NCCN V2.2022; 01/11/2022)
Occult primary cancer (NCCN V3.2023; 12/21/2022)
Ovarian/fallopian tube/primary peritoneal cancer (NCCN V1.2023; 12/22/2022)
Small bowel adenocarcinoma (NCCN V2.2022; 10/27/2022)
Uterine neoplasms (NCCN V1.2023; 12/22/2022)

The following ICD-10 codes have been removed from the policy:
C50.019, C50.029, C50.119, C50.129, C50.219, C50.229, C50.319, C50.329, C50.419, C50.429, C50.519, C50.529, C50.619, C50.629, C50.819, C50.829, C50.919, C50.929, C56.9, C57.00, C57.10, C57.20, C78.00

Revisions From MA08.136c:

03/28/2022

This version of the policy will become effective 03/28/2022.

The following policy criteria have been added to this policy:
Medically necessary criteria for Solid Tumor cancer in accordance with the US Food and Drug Administration (FDA) label (08/17/2021) and the National Comprehensive Cancer Network (NCCN) compendium (accessed 12/15/2021)

Breast cancer (NCCN V1.2022; 11/24/2021)
Colon cancer (NCCN V3.2021; 09/10/2021)
Gastric cancer (NCCN V5.2021; 10/06/2021)
Occult primary cancer (Cancer of Unknown Primary [CUP]) (NCCN V1.2022; 09/02/2021)
Ovarian/Fallopian tube/Primary peritoneal cancer (NCCN V3.2021; 09/09/2021)
Rectal cancer (NCCN V2.2021; 09/10/2021)
Small bowel adenocarcinoma (NCCN V1.2022; 09/10/2021)
Peer-reviewed literature

The following ICD-10 codes have been added to this policy:
C16.0, C16.1, C16.2, C16.3, C16.4, C16.5, C16.6, C16.8, C16.9, C17.0, C17.1, C17.2, C17.3, C17.8, C17.9, C18.0, C18.1, C18.2, C18.3, C18.4, C18.5, C18.6, C18.7, C18.8, C18.9, C19, C20, C21.0, C21.1, C21.2, C21.8, C24.1, C48.1, C48.2, C48.8, C50.011, C50.012, C50.019, C50.021, C50.022, C50.029, C50.111, C50.112, C50.119, C50.121, C50.122, C50.129, C50.211, C50.212, C50.219, C50.221, C50.222, C50.229, C50.311, C50.312, C50.319, C50.321, C50.322, C50.329, C50.411, C50.412, C50.419, C50.421, C50.422, C50.429, C50.511, C50.512, C50.519, C50.521, C50.522, C50.529, C50.611, C50.612, C50.619, C50.621, C50.622, C50.629, C50.811, C50.812, C50.819, C50.821, C50.822, C50.829, C50.911, C50.912, C50.919, C50.921, C50.922, C50.929, C54.0, C54.2, C54.3, C54.8, C54.9, C55, C56.1, C56.2, C56.3, C56.9, C57.00, C57.01, C57.02, C57.10, C57.11, C57.12, C57.20, C57.21, C57.22, C57.3, C57.4, C57.7, C57.8, C57.9, C78.00, C78.01, C78.02, C78.6, C78.7, C80.0, C80.1, D07.0, D37.1

The following policy criteria have been revised:
Endometrial cancer (NCCN V1.2022; 11/04/2021)

Revisions From MA08.136b:

01/01/2022

This version of the policy will become effective 01/01/2022

Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.

The following HCPCS code has been deleted from this policy:
C9082: Injection, dostarlimab-gxly, 100 mg

The following HCPCS code has been added to this policy:

J9272: Injection, dostarlimab-gxly, 10 mg

Revisions From MA08.136a:

10/01/2021

This version of the policy will become effective 10/01/2021

Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.

The following HCPCS code has been deleted from this policy:
C9399: Unclassified drug or biological

The following HCPCS code has been added to this policy:

C9082: Injection, dostarlimab-gxly, 100 mg

New policy MA08.136:

07/12/2021

The following new policy has been developed to communicate the Company’s coverage criteria for dostarlimab-gxly (Jemperli) in accordance with the US Food and Drug Administration (04/22/2021).

Version Effective Date:

3/11/2024

Version Issued Date: