Medical Drug Criteria (MDC)

MDC Num:      P1.001.005
MDC Name:    JEMPERLI (dostarlimab-gxly)
MDC ID:          [P1.001.005] [Ac/ L / M+ / P+ ]

Last Review:  September 22, 2025
Next Review:  September 20, 2026
 

Related MDC: None

JEMPERLI (dostarlimab-gxly)

Summary

Jemperli is a programmed death receptor-1 (PD-1)–blocking antibody indicated for:

Endometrial Cancer

• in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC). 

• as a single agent for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, as determined by an FDA approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation

Mismatch Repair Deficient Recurrent or Advanced Solid Tumors

• as a single agent for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Dostarlimab-gxly (Jemperli) is a monoclonal antibody that works by targeting the programmed death-1 receptor (PD-1), which is involved in T-cell immune surveillance of tumors. Binding of the PD-1 receptor results in blockade of the PD-1 and PD-2 ligands which generates an anti-tumor immune response and decreased tumor growth. Mismatch repair deficient (dMMR) tumors are expressed in various cancers and have high mutation rates due to the inability to repair DNA replication errors. These tumors have higher levels of neoantigens and have been found to be responsive to PD-1 targeted immunotherapy.

 
Guidelines: NCCN 2025 lists dostarlimab as preferred for dMMR/MSI-H endometrial cancer (monotherapy) and as Category 1 with chemo in frontline advanced EC.

OBJECTIVE

To define safe, evidence-based criteria for the use of dostarlimab in advanced endometrial cancer and other dMMR/MSI-H tumors.

Policy Statements

Initiation of dostarlimab-gxly (Jemperli) meets the definition of medical necessity for members diagnosed with ALL of the following are met:

I. ONE of the following to support clinical use is met:

    A. ALL of the following are met regarding FDA labeling or NCCN Compendium:

         i. ONE of the following (indication and usage):

            1. Member is diagnosed with a condition that is consistent with an indication listed in the product’s FDA-approved prescribing information (or package insert) AND member meets any additional requirements listed in the “Indications and  Usage” section of the FDA-approved prescribing information (or                              package insert).

            2. Indication is recognized in NCCN Drugs and Biologics Compendium AND usage as a Category 1 or 2A recommendation.

        ii. ONE of the following (diagnostic testing):

            1. ALL of the following:

                a. The requested indication requires genetic/specific diagnostic testing per FDA labeling or NCCN Compendium for the requested agent                                                                                                                                                                             

    b. Genetic/specific diagnostic testing has been completed                                                                                                                                                                                                                                                                                                         

    c. The results of the genetic/specific diagnostic testing indicate therapy with the requested agent is appropriate.

            2. The requested indication does NOT require specific genetic/diagnostic testing per FDA labeling or NCCN Compendium.

     B. Requested product is designated as an orphan drug by the FDA for the requested indication AND the indication is not included in the FDA labeling or the NCCN compendium as a 1 or 2A recommendation (i.e., “Designated/Approved”, “Designated”)

        (Orphan drug designations can be found at http://www.accessdata.fda.gov/scripts/opdlisting/oopd/).

     C. The indication AND usage of the requested product is supported by the results of TWO or more published clinical studies – prescriber must submit full text copies of each article.

          NOTE:

 Case reports, posters, and abstracts (including published meeting abstracts) are not accepted as evidence to support for use.
Clinical studies must be supportive of use for a similar patient population (e.g., indication, diagnosis, disease severity, genetic or tumor mutations) and for the intended treatment plan, including any concomitant therapy.
II. Dostarlimab will be used as monotherapy with the following exceptions:

    A. Combination therapy for the indication is supported by FDA labeling, NCCN Compendium, or standard reference compendia.

    B. Combination therapy for the indication is supported by the results of TWO or more published clinical studies – prescriber must submit full text copies of each article.

         i. NOTE: Dose ranging studies, case reports, posters, and abstracts (including published meeting abstracts) are not accepted as evidence to support use.

III. The dose does not exceed the maximum FDA-approved dose and frequency* with the following exceptions:

    A. Dose and frequency for indication are supported by NCCN Compendium or standard reference compendia.

    B. Dose and frequency for indication are supported by the results of TWO or more published clinical studies – prescriber must submit full text copies of each article.

        NOTE: Dose ranging studies, case reports, posters, and abstracts (including published meeting abstracts) are not accepted as evidence to support use.

Continuation of dostarlimab (Jemperli) meets the definition of medical necessity for members meeting ALL of the following criteria:

1. The member has been previously approved by Triple-S or another health plan in the past 2 years, OR the member has previously met all indication-specific criteria for coverage.

2. Member’s disease has not progressed during treatment with dostarlimab.

3. Dostarlimab will be used as monotherapy with the following exceptions:

     a. Combination therapy for the indication is supported by FDA labeling, NCCN Compendium, or standard reference compendia.

     b. Combination therapy for indication is supported by the results of TWO or more published clinical studies – prescriber must submit full text copies of each article.

          i. NOTE: Dose ranging studies, case reports, posters, and abstracts (including published meeting abstracts) are not accepted as evidence to support use.

4. The dose does not exceed the maximum FDA-approved dose and frequency* with the following exceptions:

     a. Dose and frequency for the indication is supported by NCCN Compendium or standard reference compendia.

     b. Dose and frequency for indication is supported by the results of TWO or more published clinical studies – prescriber must submit full text copies of each article.

        i. NOTE: Dose ranging studies, case reports, posters, and abstracts (including published meeting abstracts) are not accepted as evidence to support use.

*NOTE: The maximum FDA approved dose is 500 mg every 3 weeks for dose 1 through dose 4 and 1000 mg every 6 weeks for dose 5 and onward. Dose 5 is administered 3 weeks after dose 4

Policy Guidelines

Required Medical Documentation
 
Pathology confirming endometrial cancer or solid tumor type.
 
Laboratory/immunohistochemistry report confirming dMMR/MSI-H.
 
Prior treatment history.
 
ECOG performance status 0–2.
 
Specialty provider attestation (oncology).
 
Monitoring plan for immune-related AEs.

DOSAGE/ADMINISTRATION:

Monotherapy: 500 mg IV q3w ×4 → 1000 mg IV q6w until progression or toxicity.
 
Combination: With carboplatin + paclitaxel q3w for 6 cycles → dostarlimab 1000 mg q6w maintenance.
 
Infusion: 30 min IV; premedication not required unless prior reaction.

REQUIRED MEDICAL INFORMATION

Initial Coverage (6–12 months)
 
Authorization requires all:
 
1. Diagnosis:
 
dMMR/MSI-H recurrent/advanced endometrial cancer, OR
 
dMMR recurrent/advanced solid tumor after ≥1 prior therapy, OR
 
Primary advanced/recurrent endometrial cancer when given with carboplatin/paclitaxel.
  
 
2. Age: ≥18 years.
 
 
3. Testing: Documentation of MMR/MSI status (IHC, PCR, NGS).
 
 
4. Prescriber: Oncologist/gynecologic oncologist.
 
 
5. Use per FDA dosing schedule.
 
 
Reauthorization
 
Evidence of disease response or stability.
 
No unresolved grade ≥3 immune-related toxicity.
 
 
Non-Coverage
 
Patients <18 years.
 
Use without documented dMMR/MSI-H status (unless in combination frontline EC per PI).
 
Use outside FDA label or NCCN compendia support.

EXCLUSION CRITERIA

Age <18.
 
Active autoimmune disease requiring systemic therapy.
 
Prior organ transplant (risk of rejection).
 
Active uncontrolled infection.
 
Pregnancy or breastfeeding.
 
ECOG >2.

BENEFIT APPLICATION

BlueCard/National Account Issues:

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

OTHER CRITERIA

Prescribed by oncologist/gynecologic oncologist.
 
Administered in a setting capable of managing severe infusion/immune-related reactions.
 
Documented baseline thyroid, liver, renal function, and imaging before initiation.
 
Discontinue for confirmed progression or life-threatening irAEs.

Validate that the treatment regimen is following the most up to date NCCN guidelines recommendations.

Background / Regulatory Status

FDA accelerated approval for dMMR EC (Apr 2021).
 
Tumor-agnostic dMMR approval (Aug 2021).
 
RUBY trial → full approval for frontline dMMR/pMMR EC (Apr 2024).
 
NCCN 2025: Category 1 for dMMR EC frontline combo; Category 2A for dMMR solid tumors.

PRACTICE GUIDELINES

NCCN 2025: dostarlimab + chemo is preferred regimen in frontline advanced EC.
 
Dostarlimab monotherapy remains standard in recurrent dMMR EC and solid tumors.

REFERENCES

1. Florida Blue Medical Coverage Guidelines. http://mcgs.bcbsfl.com/MCG
2. Jemperli (dostarlimab-gxly) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline LLC; 8/2024
3. FDA PI, Jemperli® (dostarlimab-gxly). May 2024.
4. Oaknin A et al. GARNET trial. JCO 2022.
5.  Mirza MR et al. RUBY trial. NEJM 2023.
6. NCCN Guidelines: Uterine Neoplasms, v.2025; Colon/Rectal Cancer, v.2025.

Codes

Applicable Modifiers

N/A

Policy History