CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Jemperli™ (dostarlimab-gxly) Drug Policy

Defines accepted indications, inclusion and exclusion criteria, prior authorization/approval authority, and clinical evidence sources for Jemperli (dostarlimab-gxly) use for oncology indications including endometrial carcinoma, MSI-H/dMMR solid tumors, and localized rectal cancer. Applies to medication requests processed by Evolent/UM for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyJemperli™ (dostarlimab-gxly) Drug Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 27, 2024

Next Review Date

Key ActionMedication requests are processed by Evolent/UM and must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15.

POLICY UPDATE CHANGES

No material clinical or coverage changes — has_material_change=false.

4Covered Indications (major)

3Exclusion Criteria Items

2024-09-27Effective Date

Coverage Summary

This policy (effective 2024-09-27, last reviewed 2024-09-18) defines coverage for Jemperli (dostarlimab-gxly) and applies to medication requests processed by Evolent/UM for Neighborhood Health Plan of Rhode Island. Coverage stance: covered with criteria. The policy scope includes FDA‑approved and selected off‑label oncology uses supported by recognized compendia or guidelines. Covered indications specified by the policy include: subsequent‑line single‑agent use for unresectable/metastatic endometrial carcinoma that is dMMR/MSI‑H after platinum therapy; first/initial‑line use in stage III/IV endometrial cancer with carboplatin + paclitaxel followed by dostarlimab; tumor‑agnostic monotherapy for recurrent/advanced/metastatic MSI‑H/dMMR solid tumors after satisfactory alternatives; and monotherapy for locally advanced, treatment‑naïve Stage II/III dMMR/MSI‑H rectal cancer for up to 6 months. Evolent processes requests and determines approvability consistent with FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature.

Initial Therapy Criteria

Indication: Endometrial Carcinoma - First/initial line with carboplatin + paclitaxel

Covered when ALL of the following are met:

ALL of the following

Stage III/IV primary advanced or recurrent endometrial cancer (EC)
Use of Jemperli with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, as first/initial line therapy

Indication: MSI-H/dMMR Solid Tumors (Tumor-agnostic)

Covered when ALL of the following are met:

ALL of the following

Recurrent, advanced, or metastatic solid tumor
Tumor is positive for MSI-H or dMMR as confirmed by any standard test
Disease has progressed following all satisfactory treatment alternatives
Jemperli used as monotherapy

Indication: Locally Advanced dMMR/MSI-H Rectal Cancer (treatment-naïve)

Covered when ALL of the following are met:

ALL of the following

Locally advanced, treatment-naïve rectal cancer
Stage II or III, non-metastatic disease
Tumor is mismatch repair deficient (dMMR) or MSI-High
Jemperli used as monotherapy for a period of 6 months6 months

Continuation & Subsequent-line Therapy Criteria

Indication: Endometrial Carcinoma - Subsequent line for unresectable/metastatic dMMR/MSI-H

Covered when ALL of the following are met:

ALL of the following

Unresectable or metastatic endometrial carcinoma
Tumor is confirmed to be dMMR (deficient mismatch repair) or MSI-High by any standard test
Disease has progressed following prior treatment with a platinum-containing regimen
Jemperli used as single-agent subsequent-line systemic therapy

Continuation Requests Exemption

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

ALL of the following

The requested medication was used within the last year
The member has not experienced disease progression and/or no intolerance to the requested medication
Additional medication(s) are not being added to the continuation request

Unproven / Exclusions

Exclusion / Not Medically Necessary Criteria

Use is NOT covered when ANY of the following apply:

ANY of the following

Disease progression while on or after Jemperli (dostarlimab-gxly) or on prior immunotherapy (anti-PD-L1 or PD-1 inhibitor)
Treatment exceeds the maximum 6 months duration limit for Jemperli use in Stage III or lower stage rectal cancer6 months
Dosing exceeds single dose limit of 500 mg every 3 weeks or 1,000 mg every 6 weeks<= 500 mg q3w OR <= 1000 mg q6w
Dosing above these limits is excluded
Investigational use for off-label indications lacking sufficient evidence or not generally accepted by the medical community
Includes insufficient evidence: inadequate representation, regimen not represented, outcomes not clinically meaningful, inappropriate experimental design, reliance on case reports/abstracts without full peer-reviewed article

Investigational use: the policy excludes off‑label indications that lack sufficient evidence or are not generally accepted by the medical community. Specific evidence‑based exclusions include inadequate representation of the patient/cancer population in published evidence; the regimen not being represented in the published evidence; reported outcomes that are not clinically meaningful (ASCO criteria, e.g., HR ≥ 0.80 or OS/PFS benefit < 3 months); inappropriate experimental design for the clinical question; reliance on case reports or abstracts without full peer‑reviewed publications.

Provider Actions

Prior Authorization

Authorization requirement and supporting evidence

Medication requests are processed by Evolent/UM and must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15; medications not authorized may be deemed not approvable and not reimbursable.

FDA approved product labeling
CMS‑approved compendia
NCCN clinical guidelines
ASCO clinical guidelines
Acceptable peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15

Documentation Required

Tumor biomarker confirmation

Provide documentation of tumor dMMR (deficient mismatch repair) or MSI‑High status when required by an indication. Confirmation may be by any standard test.

Denial Risk

Exclusion triggers leading to denial

Claims may be denied when any of the following apply: disease progression while on or after Jemperli or on prior PD‑1/PD‑L1 therapy; treatment that exceeds the 6‑month maximum duration limit for Stage III or lower rectal cancer; dosing that exceeds the single‑dose limits (500 mg every 3 weeks or 1,000 mg every 6 weeks); or investigational/off‑label use lacking sufficient evidence as defined by the policy.

Disease progression while on or after Jemperli or prior anti‑PD‑1/PD‑L1 therapy
Treatment exceeding 6 months for Stage III or lower rectal cancer
Dosing above 500 mg every 3 weeks or 1,000 mg every 6 weeks
Off‑label/ investigational use lacking sufficient evidence per policy criteria

Definitions & Background

Background: The policy defines accepted indications for Jemperli including FDA‑approved and selected off‑label uses supported by recognized compendia or guidelines. Evolent (Utilization Management) processes medication requests and determines approvability; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Term	Definition
dMMR	Deficient mismatch repair
MSI-H	Microsatellite instability-high

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyJemperli™ (dostarlimab-gxly) Drug Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 27, 2024

Next Review Date

On This Page

OpenPayer

Jemperli™ (dostarlimab-gxly) Drug Policy

Coverage Summary

Initial Therapy Criteria

Continuation & Subsequent-line Therapy Criteria

Unproven / Exclusions

Provider Actions

Applicable Codes & Dosing Limits

Clinical Evidence

Definitions & Background

Revision History