Dostarlimab-gxly (Jemperli) Form

Dostarlimab-gxly (Jemperli™) is a programmed death receptor-1 (PD-1)–blocking antibody. FDA Approved Indication(s) Jemperli is indicated: 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 progress 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). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Jemperli is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Endometrial Carcinoma (must meet all):

1. Diagnosis of EC;

   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. One of the following (a or b): a. Prescribed in combination with carboplatin and paclitaxel for stage III-IV or recurrent disease; Page 1 of 7

   CLINICAL POLICY Dostarlimab-gxly
   b. All of the following (i, ii, iii, and iv): i. Disease is recurrent or advanced; ii. Disease is dMMR (i.e., disease is indicative of MMR gene mutation or loss of expression) or microsatellite instability-high (MSI-H); iii. Disease has progressed following prior treatment with a platinum-containing regimen (e.g., carboplatin/cisplatin); iv. Member is not a candidate for curative surgery or radiation;

2. Request meets one of the following (a, b or c): a. Dose does not exceed 500 mg every 3 weeks for dose 1 through 6, in combination with carboplatin and paclitaxel, followed by 1,000 mg monotherapy every 6 weeks starting 3 weeks after dose 6; b. Dose does not exceed 500 mg every 3 weeks for dose 1 through 4, followed by 1,000 mg every 6 weeks starting 3 weeks after dose 4; c. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 6 months B. Solid Tumor (must meet all):
3. Diagnosis of solid tumor (e.g., ampullary adenocarcinoma, breast cancer, colon cancer [including appendiceal adenocarcinoma], esophageal and esophagogastric junction cancers, gallbladder cancer, gastric cancer, hepatocellular carcinoma, extra/intrahepatic cholangiocarcinoma, occult primary cancer, ovarian/fallopian tube/primary peritoneal cancer, pancreatic adenocarcinoma, rectal cancer, small bowel adenocarcinoma);
4. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Disease has both of the following characteristics (a and b): a. Metastatic, recurrent, or advanced; b. dMMR (i.e., disease is indicative of MMR gene mutation or loss of expression) or MSI-H;
5. One of the following (a or b): a. Disease has progressed on or following prior treatment and who have no satisfactory alternative options; b. Request is for small bowel adenocarcinoma or pancreatic adenocarcinoma;

6. Prescribed as a single agent;

   7. Request meets one of the following (a or b): a. Dose does not exceed 500 mg every 3 weeks for dose 1 through 4, followed by
      1,000 mg every 6 weeks starting 3 weeks after dose 4; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 6 months Page 2 of 7

   CLINICAL POLICY Dostarlimab-gxly
   C. Other diagnoses/indications (must meet 1 or 2):

7. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
8. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. All Indications in Section I (must meet all):
9. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Jemperli and has received this medication for at least 30 days;
10. Member is responding positively to therapy;
    3. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 1,000 mg every 6 weeks; b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
11. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

12. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND Page 3 of 7

    CLINICAL POLICY Dostarlimab-gxly
    criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key dMMR: mismatch repair deficient EC: endometrial carcinoma FDA: Food and Drug Administration MSI-H: microsatellite instability-high NCCN: National Comprehensive Cancer Network
    Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Varies EC systemic therapies: carboplatin, cisplatin, carboplatin/paclitaxel, cisplatin/docetaxel, cisplatin/doxorubicin, cisplatin/doxorubicin/paclitaxel, carboplatin/paclitaxel/bevacizumab, carboplatin/paclitaxel/trastuzumab, cisplatin/ifosfamide Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Dose Limit/ Maximum Dose Varies Appendix C: Contraindications/Boxed Warnings None reported V. Dosage and Administration
    Indication EC as combination therapy Dosing Regimen Dose 1 through 6: 500mg every 3 weeks in combination with carboplatin and paclitaxel Maximum Dose See doing regimen Subsequent dosing beginning 3 weeks after Dose 6 (Dose 7 onwards): 1,000 mg monotherapy every 6 weeks
    Page 4 of 7

    CLINICAL POLICY Dostarlimab-gxly
    Indication EC as single agent therapy; Solid tumors Dosing Regimen Dose 1 through 4: 500 mg every 3 weeks Maximum Dose See dosing regimen Subsequent dosing beginning 3 weeks after Dose 4 (Dose 5 onwards): 1,000 mg every 6 weeks VI. Product Availability
    Single-dose vial: 500 mg/10 mL VII.