CurrentCareSourcePolicy N/A

Jemperli (dostarlimab) — Oncology prior-authorization and coverage criteria

Medical benefit prior-authorization and coverage criteria for Jemperli (dostarlimab intravenous infusion) for oncology indications affecting CareSource members and providers prescribing or managing treatment.

Policy Summary

PayerCareSource

PolicyJemperli (dostarlimab) oncology utilization management — coverage with criteria

Policy CodePolicy N/A

Change TypeClinical criteria and dosing updates

Effective DateN/A

Next Review DateMay 14, 2025

Key ActionSubmit prior authorization showing the patient meets the listed clinical criteria and documented dosing; prescriber must be or consult with an oncologist.

SourceLink

POLICY UPDATE CHANGES

Anal carcinoma added as a new condition of approval.

Endometrial cancer criteria updated to require recurrent, advanced, or metastatic disease and removed prior requirement for prior platinum therapy and dMMR requirement in one revision summary.

Updated dosing schedule specifying 500 mg IV every 3 weeks x4 then 1000 mg IV every 6 weeks (monotherapy and with chemotherapy regimens) included.

1 yeartypical approval duration

500→1000 mgdosing schedule

dMMR/MSI-H/POLEbiomarker-directed

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Prior authauthorization

Recommended Authorization Criteria

Endometrial Cancer (FDA-approved)

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

Endometrial Cancer criteria: A) Patient is ≥ 18 years of age; B) Patient has recurrent, advanced, or metastatic disease; C) The medication is prescribed by or in consultation with an oncologist.

Dosing: Monotherapy - 500 mg IV no more frequently than every 3 weeks for 4 doses, then 1000 mg IV no more frequently than every 6 weeks; Combination with chemotherapy - 500 mg IV no more frequently than every 3 weeks for 6 doses, then 1000 mg IV no more frequently than every 6 weeks.

dMMR/MSI-H Solid Tumors (FDA accelerated)

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

dMMR/MSI-H Solid Tumors criteria: A) Patient is ≥ 18 years of age; B) Patient has progressed on or after prior treatment; C) According to the prescriber, there are no satisfactory alternative treatment options; D) The medication is prescribed by or in consultation with an oncologist.

Dosing: 500 mg IV no more frequently than every 3 weeks for 4 doses, then 1000 mg IV no more frequently than every 6 weeks.

Anal Carcinoma (Other Uses with Supportive Evidence)

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

Anal carcinoma criteria: A) Patient is ≥ 18 years of age; B) Patient meets ONE of the following: (i) patient has locally recurrent or progressive disease AND medication is administered before proceeding to abdominoperineal resection; OR (ii) patient has metastatic disease AND medication is used as subsequent therapy; C) Patient has NOT received prior immunotherapy; D) The medication is prescribed by or in consultation with an oncologist.

Dosing: 500 mg IV no more frequently than every 3 weeks for 4 doses, then 1000 mg IV no more frequently than every 6 weeks. Medication used as a single agent.

Colon, Rectal, or Appendiceal Cancer (Other Uses with Supportive Evidence)

Approve if the patient meets ALL of the following (A, B, C, D, and E):

Colon/Rectal/Appendiceal criteria: A) Patient is ≥ 18 years of age; B) Patient meets ONE of: (i) mismatch repair deficient (dMMR) / microsatellite instability-high (MSI-H) disease; OR (ii) DNA polymerase epsilon/delta (POLE/POLD1) mutation; C) Patient has progressed on or after prior treatment; D) Patient meets ONE of: (i) patient has advanced or metastatic disease; OR (ii) other stated disease-state options including neoadjuvant use (see note); E) The medication is prescribed by or in consultation with an oncologist.

Dosing: 500 mg IV no more frequently than every 3 weeks for 4 doses, then 1000 mg IV no more frequently than every 6 weeks. Approvals vary by intent (neoadjuvant option noted).

Small Bowel Adenocarcinoma (Other Uses with Supportive Evidence)

Approve for 1 year if the patient meets ALL of the following (A, B, C, D, and E):

Small bowel adenocarcinoma criteria: A) Patient is ≥ 18 years of age; B) Patient has either mismatch repair deficient (dMMR) / microsatellite instability-high (MSI-H) disease OR DNA polymerase epsilon/delta (POLE/POLD1) mutation; C) Patient has advanced or metastatic disease; D) Depending on intent: approve for 6 months total if used neoadjuvantly OR approve for 1 year if used as primary or subsequent therapy; E) The medication is prescribed by or in consultation with an oncologist.

Dosing: 500 mg IV no more frequently than every 3 weeks for 4 doses, then 1000 mg IV no more frequently than every 6 weeks. Sequencing conditions reference prior adjuvant oxaliplatin exposure or contraindication to oxaliplatin for initial vs subsequent use.

Coverage is recommended only for the indications and patient scenarios explicitly listed in the Recommended Authorization Criteria. Requests for use outside those specified criteria are not recommended for coverage and may be denied unless and until the clinical criteria are expanded.

The criteria will be reviewed and updated as new peer‑reviewed publications, regulatory actions, or practice‑changing evidence become available; coverage policies may change when new data are published.

Dosing and Regimens

Regimen	Dosing
Monotherapy (FDA‑approved and other supported indications)
500 mg IV administered no more frequently than once every 3 weeks for 4 doses, then 1000 mg IV administered no more frequently than once every 6 weeks

Regimen	Dosing
In combination with chemotherapy (endometrial cancer)
500 mg IV administered no more frequently than once every 3 weeks for 6 doses, then 1000 mg IV administered no more frequently than once every 6 weeks

Prescriber Requirements and Operational Notes

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended for medical benefit coverage of Jemperli. Approval is recommended when the member meets the listed clinical criteria and dosing for the specified indications. All approvals are provided for the duration noted in the policy. Requests for doses outside the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist).

Automation: None
Approvals require Jemperli to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., oncologist).

Note

Sequencing Considerations

When considering sequencing of therapy and prior exposures, review tumor-specific indications and prior treatment history. Prior exposure to immunotherapy or specific chemotherapies, contraindications to recommended agents, and molecular tumor characteristics (e.g., dMMR, MSI-H, POLE mutations) should guide sequencing decisions. Coverage decisions reference prior lines of therapy and whether alternative satisfactory treatments exist.

Neoadjuvant and Subsequent Therapy Considerations

neoadjuvant | subsequent

Neoadjuvant vs subsequent use: For colon/rectal/appendiceal and small bowel indications: when used neoadjuvantly approve for 6 months total; when used as primary or subsequent therapy approve for 1 year. Sequencing language references prior adjuvant oxaliplatin exposure or contraindication to oxaliplatin to determine initial versus subsequent use.

Molecular and Biomarker Qualifications

dMMR / MSI‑H — Biomarker definition and requirements

DefinitionMismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status as determined by an FDA-approved test.

Acceptable testdMMR/MSI-H must be documented by an FDA-approved diagnostic test per the product labeling.

Applicable indicationsRequired or listed biomarker for multiple indications including endometrial cancer and dMMR/MSI-H solid tumors described in the policy.

POLE / POLD1 mutation — Alternate qualifying molecular alteration

DefinitionDNA polymerase epsilon/delta (POLE/POLD1) mutation described as a qualifying molecular alteration.

Applicable tumor types

Drug and Indication Background

Dostarlimab (Jemperli) is a programmed cell death protein‑1 (PD‑1) blocking monoclonal antibody used in oncology. It is indicated for certain mismatch repair deficient (dMMR) or microsatellite instability‑high (MSI‑H) tumors, including an FDA‑approved indication in endometrial cancer and accelerated approval across dMMR/MSI‑H solid tumors that have progressed following prior treatment. Dosing regimens include induction with 500 mg IV no more frequently than every 3 weeks for 4 doses followed by maintenance 1000 mg IV no more frequently than every 6 weeks, with an alternative induction schedule when given with chemotherapy for endometrial cancer.

Policy Revision Timeline

2025-05-14additionLatest

Anal carcinoma added as a new condition of approval with approval criteria and dosing (monotherapy dosing: 500 mg IV every 3 weeks x4 then 1000 mg IV every 6 weeks).

2024-10-15update

Document updated (10/15/2024) per history log — no specific clinical changes detailed in the summary.

2024-05-08annual_revision

Colon, rectal, and appendiceal cancer and small bowel adenocarcinoma criteria updated to add POLE/POLD1 mutation as an alternative qualifying biomarker and change dMMR/MSI-H from requirement to an option.

Policy Summary

PayerCareSource

PolicyJemperli (dostarlimab) oncology utilization management — coverage with criteria

Policy CodePolicy N/A

Change TypeClinical criteria and dosing updates

Effective DateN/A

Next Review DateMay 14, 2025

Key ActionSubmit prior authorization showing the patient meets the listed clinical criteria and documented dosing; prescriber must be or consult with an oncologist.

SourceLink

On This Page

Consider prior immunotherapy exposure status where noted (some indications require no prior immunotherapy).

For tumor-specific indications, ensure molecular markers (dMMR/MSI-H or POLE) and disease state (local, recurrent, metastatic) match criteria before sequencing Jemperli.

Contraindications to alternative agents (e.g., oxaliplatin) are allowable rationale where specified.

Documentation Required

Prescriber and Dosing Documentation

Jemperli must be prescribed by or in consultation with an oncologist. Documentation must include the prescriber's specialty or consultation note and justification for the requested dosing. Requests for doses outside the established dosing regimens in this policy require explicit clinical rationale and will be reviewed on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Prescriber specialty: oncology or documented oncology consultation required.
Essential documentation: diagnosis, tumor molecular status (e.g., dMMR/MSI-H, POLE), prior treatment history and lines of therapy, rationale for chosen dosing schedule.
Off-label or non-standard dosing: must include clinical justification and will be reviewed individually; approvals for non-standard doses are not guaranteed.

Denial Risk

Non‑listed Indications

Coverage is not recommended for indications or circumstances not listed in the Recommended Authorization Criteria. Requests that fall outside the listed criteria may be denied or require additional clinical review and supporting evidence.

Criteria will be updated as new published data become available.
Requests for indications not specified in this policy should include peer‑reviewed evidence to be considered and may still be denied.

Listed as an alternate qualifying biomarker for colorectal (colon/rectal/appendiceal) and small bowel adenocarcinoma indications.

Policy rolePresence of POLE/POLD1 mutation allows eligibility when dMMR/MSI-H is not the qualifying feature per the specified criteria set.

dMMR / MSI‑H definition — FDA‑approved test

Phrase from labelingEndometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-approved test.

FDA‑approved test requirementdMMR or MSI‑H status must be determined by an FDA-approved diagnostic test to meet biomarker-based indications.

Indication contextdMMR/MSI‑H is used to define patients with solid tumors eligible under the accelerated approval pathway when other criteria are met.

POLE mutation — mention in colorectal and small bowel contexts

Short definitionPOLE refers to DNA polymerase epsilon (and POLD1 to polymerase delta) gene mutations cited in the policy.

Clinical contextPOLE mutations are specifically mentioned for colorectal (colon/rectal/appendiceal) and small bowel adenocarcinoma criteria as an alternative to dMMR/MSI‑H.

Implication for coverageWhen POLE/POLD1 mutation is present, the member may meet the biomarker requirement in the corresponding criteria set without dMMR/MSI‑H.

2023-08-16selected_revision

Dosing descriptors revised to add phrase 'no more frequently than' across regimens and monotherapy/combo regimens labeled (monotherapy and combination with chemotherapy).

2023-05-10annual_revision

Endometrial cancer criteria revised to remove requirement for mismatch repair deficient disease and prior platinum-containing regimen and to add requirement for recurrent, advanced, or metastatic disease; colon/rectal examples removed from dMMR/MSI-H note and colon/rectal/appendiceal cancer noted as a new condition of approval in earlier history entries.