CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Jemperli (dostarlimab-gxly) — Coverage Criteria

Defines medical necessity criteria, indications, exclusions, and utilization management for Jemperli (dostarlimab-gxly) for Neighborhood Health Plan of Rhode Island members across applicable lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyJemperli (dostarlimab-gxly) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 8, 2023

Next Review DateN/A

Key ActionSubmit prior authorization documenting indication, confirmatory dMMR/MSI‑H testing, prior therapies and progression, and planned dosing within limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

dMMR / MSI-Hbiomarker requirement for covered indications

6 monthsmaximum duration for rectal cancer indication

500 mg q3w / 1,000 mg q6wmaximum single dose limits

Commercial; Exchange; Medicaidapplicable lines of business

Coverage Criteria

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Covered Indications

Covered when ALL of the following are met for each indication:

Endometrial carcinoma (subsequent-line): Member has unresectable or metastatic endometrial carcinoma confirmed dMMR/MSI-H; disease progressed following prior treatment with a platinum-containing regimen; Jemperli (dostarlimab-gxly) used as single-agent subsequent-line systemic therapy; tumor confirmation of dMMR/MSI-H by any standard test is documented.

from chunk 4

MSI-H/dMMR solid tumors (recurrent/advanced/metastatic): Member has recurrent, advanced, or metastatic solid tumor positive for MSI-H or dMMR by any standard test; disease progressed following all satisfactory treatment alternatives; Jemperli (dostarlimab-gxly) used as monotherapy.

from chunk 5

Rectal cancer (treatment-naive, locally advanced): Member has locally advanced, treatment‑naive rectal cancer (Stage III or lower) with dMMR/MSI-H; Jemperli (dostarlimab-gxly) used as monotherapy for up to 6 months.6 months maximum

from chunk 6

Concurrent administration of Jemperli (dostarlimab-gxly) with other anti-cancer therapies is an exclusion. Specifically, concurrent use with chemotherapy, endocrine therapy, targeted therapy, radiotherapy, or other immunotherapy is not allowed. Treatment that exceeds the policy’s dosing or duration limits is also excluded: single-dose limits of 500 mg every 3 weeks or 1,000 mg every 6 weeks and the specified maximum duration where applicable. Additionally, requests may be denied if there is documented disease progression while on or after Jemperli or while on prior PD-1/PD-L1 inhibitor therapy.

An investigational or off‑label use of Jemperli is considered unsupported when adequate, generalizable clinical evidence is lacking. The policy defines sufficient evidence as use that is supported by CMS‑recognized compendia or acceptable peer‑reviewed literature; absent that, considerations include whether the patient and tumor characteristics are represented in the published evidence, whether the comparator therapies/regimens are adequately represented, whether reported outcomes are clinically meaningful (e.g., ASCO‑recommended thresholds such as hazard ratio < 0.80 or ≥3 months OS/PFS benefit), and whether the study design appropriately addresses the question. Nonrandomized trials with substantial subject numbers may be supportive, while case reports and abstracts without a full peer‑reviewed article are not adequate evidence.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must document the clinical indication and supporting evidence that the requested use meets policy criteria (FDA label, CMS‑recognized compendia, NCCN/ASCO guidelines, or peer‑reviewed literature). New Century Health (NCH) processes medication requests for this drug; medications not authorized by NCH may be deemed not approvable and not reimbursable.

Authorization review by NCH required
Include indication and evidence supporting the requested use

Step Therapy

Step therapy / Line of therapy Requirements

For MSI‑H/dMMR solid tumors, Jemperli may be authorized only after the member’s disease has progressed following all satisfactory treatment alternatives. For endometrial carcinoma, Jemperli is allowed as subsequent‑line single‑agent systemic therapy after progression on a platinum‑containing regimen and only when the tumor is confirmed dMMR/MSI‑H. For locally advanced, treatment‑naive dMMR/MSI‑H rectal cancer (stage III or lower), Jemperli may be used as monotherapy for up to 6 months.

MSI‑H/dMMR solid tumors: after progression following all satisfactory alternatives
Endometrial carcinoma: after platinum regimen and tumor confirmed dMMR/MSI‑H
Rectal cancer (stage III or lower): treatment‑naive, dMMR/MSI‑H, monotherapy up to 6 months

Documentation Required

Documentation Requirements

Required documentation must be submitted with the authorization request. This includes confirmation of tumor MSI‑H or dMMR status by any standard test and prior treatment history demonstrating progression after required therapies. Requests may also need supporting citations (FDA label, CMS compendia, NCCN/ASCO guidelines, or peer‑reviewed literature) when the indication relies on non‑label or compendia‑supported evidence.

Tumor MSI‑H or dMMR confirmation (report/result)
Detailed prior treatment history showing progression and dates
Supporting literature or compendia/guideline references when applicable

Denial Risk

Triggers for Denial

Conditions that will trigger denial of the request include: disease progression while on or after Jemperli or prior PD‑1/PD‑L1 immunotherapy; concurrent use with other anti‑cancer therapies; treatment exceeding the 6‑month duration limit for the rectal cancer indication; doses exceeding 500 mg every 3 weeks or 1,000 mg every 6 weeks; and investigational or off‑label uses not supported by accepted evidence.

Disease progression on or after Jemperli or prior PD‑1/PD‑L1 therapy
Concurrent use with chemotherapy, endocrine therapy, targeted therapy, radiotherapy, or other immunotherapy
Treatment beyond the 6‑month maximum for the rectal cancer indication
Dosing above 500 mg q3w or 1,000 mg q6w
Off‑label/experimental uses not supported by FDA label, CMS compendia, accepted guidelines, or sufficient peer‑reviewed evidence

Background

Dostarlimab (Jemperli) is a programmed death‑1 (PD‑1) immune checkpoint inhibitor used in dMMR/MSI‑H tumors under the specific indications and limits described in this policy. The policy’s exclusion criteria reiterate that Jemperli should not be combined with other anti‑cancer therapies and that investigational or off‑label uses require adequate supporting evidence to be considered acceptable. Dosage and duration constraints referenced in this background (single‑dose limits and maximum duration where applicable) are enforced by the coverage policy.

Definitions

dMMR / MSI-H — definition and testing requirements

DefinitionDeficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) status as determined by any standard diagnostic test.

Required for covered indicationsdMMR/MSI-H tumor confirmation is required for all covered indications (endometrial carcinoma, MSI-H/dMMR solid tumors, and rectal cancer).

Acceptable testsAny standard test that confirms dMMR or MSI-H status (as referenced in coverage criteria).

Scope of requirementApplies to unresectable or metastatic endometrial carcinoma, recurrent/advanced/metastatic MSI-H/dMMR solid tumors, and locally advanced treatment‑naive dMMR/MSI‑H rectal cancer (Stage III or lower).

Documentation notePrior authorization requests must include documentation confirming tumor dMMR/MSI‑H status by a standard diagnostic test.

Initial Therapy Criteria

Initial therapy requirements

Initial therapy general: Use is supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature meeting CMS standards; indication‑ and biomarker‑specific criteria (dMMR/MSI‑H) must be documented and met for the requested indication.

from chunks 2,4,5

Continuation Therapy Criteria

Continuation therapy exemptions

Continuation requests may be exempt from prior authorization under conditions:

Continuation exemption: Requested medication was used within the last year; the member has not experienced disease progression and/or intolerance to the requested medication; and no additional medications are being added to the continuation request.

from chunk 3

Step Therapy

Step	Requirement	Failure criteria / notes
1	Jemperli (dostarlimab-gxly) may be used after other satisfactory treatment alternatives have been tried and progressed for members with recurrent, advanced, or metastatic MSI-H/dMMR solid tumors.	Use requires documented progression following all satisfactory treatment alternatives; tumor must be MSI-H or dMMR confirmed by any standard test.

Quantity Limits

Jemperli (dostarlimab‑gxly) — dosing limits

Standard dosing limits500 mg every 3 weeks or 1,000 mg every 6 weeks.

ApplicationThese single‑dose limits apply to Jemperli (dostarlimab‑gxly) dosing for all covered indications.

Excess dosingDosing that exceeds these single‑dose limits is listed as an exclusion and may result in denial of coverage.