Medical Drug Criteria (MDC)

MDC Num:      P1.001.005
MDC Name:    JEMPERLI (dostarlimab-gxly)
MDC ID:          [P1.001.005] [Ac/ L / M+ / P+ ] [0.00.00]

Last Review:  September 17, 2024
Next Review:  September 20, 2025
 

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.

Policy Statements

Jemperli may be considered medically necessary  if the conditions below are met. 
 

Policy Guidelines

Coverage eligibility for dostarlimab-gxly (Jemperli) will be considered when the following criteria are met:

•    Authorization of 12 months may be granted for treatment of 

• Endometrial Cancer (EC)
  • 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 that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).
  • as a single agent for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer, 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.

DOSAGE/ADMINISTRATION:

The recommended dosage is:

• In combination with carboplatin and paclitaxel, for dMMR or MSI-H primary advanced or recurrent endometrial cancer: 500 mg every 3 weeks for 6 doses followed by 1,000 mg monotherapy every 6 weeks.
• As a single agent, for dMMR recurrent or advanced endometrial cancer: 500 mg every 3 weeks for 4 doses followed by 1,000 mg every 6 weeks.
• As a single agent, for dMMR recurrent or advanced solid tumors: 500 mg every 3 weeks for 4 doses followed by 1,000 mg every 6 weeks. 
• Administer as an intravenous infusion over 30 minutes

REQUIRED MEDICAL INFORMATION

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

EXCLUSION CRITERIA

None

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

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

Population Reference No. 1 Policy Statement

Population Reference No. 1 Policy Statement

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

Codes

Applicable Modifiers

N/A

Policy History