CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Drug Policy: Jemperli (dostarlimab-gxly) — Coverage Criteria

Defines clinical indications, continuation and exclusion criteria, and utilization management authority for coverage of Jemperli (dostarlimab-gxly) for members; applies to prior authorization and medical necessity decisions processed by the UM/benefit contractor.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyJemperli (dostarlimab-gxly) — Coverage Criteria (Clinical/Medical Policy)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 27, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation supporting the FDA-approved indication or applicable compendia/guidelines and tumor dMMR/MSI-H test results when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4distinct covered indications

6 morectal monotherapy max duration

500/1000dosing limit

FDA+CMS+NCCNsupporting sources required

Coverage Criteria for Jemperli (dostarlimab-gxly)

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Endometrial Carcinoma

Covered when ANY of the following are met:

Endometrial carcinoma coverage: Covered when ANY of the following are met

1) Single-agent Jemperli for unresectable or metastatic dMMR/MSI-H endometrial carcinoma after progression on a platinum-containing regimen with tumor confirmed dMMR/MSI-H by any standard test; OR 2) Jemperli given with carboplatin and paclitaxel followed by single-agent dostarlimab-gxly as first/initial-line therapy for stage III/IV primary advanced or recurrent endometrial cancer.

MSI-H / dMMR Solid Tumors

Covered when ALL of the following are met:

MSI-H/dMMR solid tumor coverage: Covered when ALL of the following are met

Monotherapy allowed for recurrent, advanced, or metastatic solid tumors that have progressed following all satisfactory treatment alternatives AND the tumor is confirmed MSI-H/dMMR by any standard test.

Rectal Cancer (Stage II/III, non-metastatic)

Covered when ALL of the following are met:

Rectal cancer monotherapy coverage: Covered when ALL of the following are met6 months

Monotherapy for locally advanced, treatment-naïve, dMMR/MSI-H rectal cancer limited to Stage II or III, non-metastatic disease and duration limited to 6 months.

Continuation Requests

Continuation therapy exemption

Continuation requests eligible for exemption: All of the following must be met

Continuation requests for a not-approvable medication are exempt if: (1) the requested medication was used within the last year; AND (2) the member has not experienced disease progression and/or intolerance to the requested medication; AND (3) additional medication(s) are not being added to the continuation request.

Requests for Jemperli (dostarlimab-gxly) will be denied when the proposed use is investigational or an off‑label indication that lacks sufficient supporting evidence. The policy defines “sufficient evidence” as support from CMS‑recognized compendia or acceptable peer‑reviewed literature and evaluates whether: the patient and cancer characteristics are represented in the evidence; the regimen used is represented; outcomes are clinically meaningful (e.g., ASCO‑recommended thresholds such as hazard ratio < 0.80 or survival benefit thresholds); the study design is appropriate; nonrandomized trials with substantial subject numbers may be supportive; and isolated case reports are inadequate. Additionally, meeting abstracts without a corresponding full peer‑reviewed publication do not constitute adequate evidence.

Requests for continuation or new therapy will be excluded when there is documented disease progression that occurred while the member was receiving Jemperli or after prior treatment with another PD‑1/PD‑L1 inhibitor. Such progression or intolerance on prior anti‑PD‑1/PD‑L1 therapy removes eligibility for coverage under this policy.

Coverage will be denied for dosing that exceeds the policy’s stated single‑dose limits. The maximum allowable dosing is 500 mg every 3 weeks or 1,000 mg every 6 weeks; requests for higher doses or more frequent dosing are excluded.

For the rectal cancer indication, Jemperli monotherapy is limited to a maximum duration of 6 months for members with locally advanced, treatment‑naïve, dMMR/MSI‑H Stage II–III, non‑metastatic rectal cancer. Requests for continuation of monotherapy beyond this 6‑month limit will be excluded.

Use of Jemperli in clinical settings or indications that lack adequate clinical evidence as defined by this policy is considered not medically necessary. Examples include unsupported off‑label uses where the patient/regimen/outcomes are not represented in the literature, reliance on case reports, or use supported only by abstracts without full peer‑reviewed articles.

Initial Therapy Criteria

Initial Therapy

Initial / first-line use

First-line endometrial: Covered when used with carboplatin and paclitaxel followed by single-agent dostarlimab-gxly for stage III/IV primary advanced or recurrent endometrial cancer.

First/initial-line combination therapy: Jemperli with carboplatin and paclitaxel followed by single-agent dostarlimab-gxly for stage III/IV primary advanced or recurrent endometrial cancer.

Continuation Therapy Criteria

Continuation Therapy Exemption

Continuation requests for previously used medications

Continuation exemption: Continuation covered when ALL conditions met

Medication was used within the last year; the member has not experienced disease progression or intolerance to the medication; and no additional medications are being added to the continuation request.

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization and approval

Prior authorization and final approval are required. Prior authorization requests are processed by the Utilization Management (UM) Department; final approval decisions are made by the Utilization Management Committee.

All medication requests must be submitted to Evolent for authorization.
Requests not authorized by Evolent may be deemed not approvable and not reimbursable.

Step Therapy

Step therapy note

Continuation requests are exempt from re‑authorization under this policy only when the medication was used within the last year, there has been no disease progression or intolerance, and no additional medications are being added to the continuation request.

Continuation requests meeting these conditions may bypass full policy criteria review.

Documentation Required

Required clinical documentation

The following clinical documentation must be provided to support the requested use: documentation confirming the FDA‑approved indication or, for off‑label uses, citations from CMS‑recognized compendia, NCCN/ASCO guidelines, or peer‑reviewed literature that meet CMS evidence standards.

Pathology or molecular testing confirming dMMR or MSI‑High status when applicable.
Medical records showing prior lines of therapy (e.g., prior platinum‑containing regimen for endometrial carcinoma).
Treatment history and rationale for monotherapy vs combination therapy.
For off‑label requests, literature or compendia references demonstrating adequate patient representation, regimen similarity, and clinically meaningful outcomes.

Denial Risk

Investigational / insufficient evidence

Requests that lack sufficient supporting evidence or that propose investigational/off‑label uses not generally accepted by the medical community may be denied. Evidence is evaluated against CMS compendia, guideline support, and peer‑reviewed literature using the policy’s evidence standards.

Insufficient evidence includes reliance on uncontrolled case reports or literature that does not adequately represent the patient population or regimen.
Non‑randomized trials may be considered if subject numbers and design provide reasonable support; absence of such support increases denial risk.

Denial Risk

Dosing limit exceeded

Requests exceeding dosing limits or frequency may be denied. The policy specifies maximum single‑dose and dosing-interval limits.

Maximum single‑dose limits: 500 mg every 3 weeks or 1,000 mg every 6 weeks.
Requests proposing doses or schedules beyond these limits should include justification and supporting clinical evidence; lacking this, they may be denied.

Denial Risk

Disease progression or intolerance

Continuation requests that demonstrate disease progression while on Jemperli or intolerance to Jemperli or prior PD‑1/PD‑L1 inhibitors may be denied.

If progression or intolerance is documented, continuation is not approvable under this policy.
Provide documentation of response/stability and absence of intolerance for continuation approvals.

Denial Risk

Rectal cancer duration limit

Use of Jemperli for rectal cancer is limited to a maximum duration of 6 months for stage II/III, non‑metastatic, treatment‑naïve dMMR/MSI‑H disease. Requests beyond 6 months will be considered non‑approvable absent clear, compelling justification and supporting evidence.

Duration limit: 6 months for locally advanced, treatment‑naïve, dMMR/MSI‑H rectal cancer (Stage II or III).
Requests exceeding 6 months must include rationale and supportive data; otherwise they may be denied.

Step Therapy Requirements

Clinical Scenario	Required prior therapy / step	Coverage status
Unresectable or metastatic dMMR/MSI-H endometrial carcinoma
Progression following prior treatment with a platinum-containing regimen (required before single‑agent Jemperli in subsequent-line setting)
Covered when prior platinum-containing regimen has failed and tumor confirmed dMMR/MSI-H by any standard test

Quantity and Dosing Limits

dostarlimab-gxly — Dosing limits

Maximum single-dose limits500 mg every 3 weeks OR 1,000 mg every 6 weeks

Exceeding limits consequencesRequests exceeding these dosing limits may be denied as excluded use.

Reference in exclusionsPolicy explicitly lists dosing above 500 mg q3w or 1,000 mg q6w as an exclusion criterion.

Definitions and Test Requirements

dMMR / MSI-H — definition and testing requirements

DefinitionMismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) tumor status as confirmed by any standard test

Testing requirement for endometrial carcinomaTumor must be confirmed dMMR/MSI-H by any standard test for use in unresectable or metastatic endometrial carcinoma after platinum therapy.

Testing requirement for MSI-H/dMMR solid tumorsMonotherapy for recurrent, advanced, or metastatic solid tumors requires tumor positive for MSI-H or dMMR as confirmed by any standard test.

Testing requirement for rectal cancer indicationLocally advanced, treatment-naïve Stage II or III non‑metastatic rectal cancer must be dMMR/MSI-H as confirmed by any standard test for the 6‑month monotherapy indication.

Background

Jemperli (dostarlimab‑gxly) is a programmed cell death protein‑1 (PD‑1) inhibitor indicated for certain mismatch repair deficient (dMMR)/microsatellite instability‑high (MSI‑H) malignancies. Covered indications in this policy include select uses in endometrial carcinoma, monotherapy for recurrent/advanced/metastatic MSI‑H/dMMR solid tumors after progression on satisfactory alternatives, and a specific neoadjuvant‑style rectal cancer monotherapy indication limited to 6 months for Stage II–III, non‑metastatic dMMR/MSI‑H rectal cancer. Use must align with FDA labeling, CMS‑recognized compendia, or acceptable peer‑reviewed evidence as outlined in the policy.

Site of Care and Administration

Note

Follow FDA label for administration and monitoring; no site restrictions in policy

Refer to the FDA label/package insert for administration, monitoring, and medication management details; this policy does not impose site‑of‑care restrictions for infusion centers.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyJemperli (dostarlimab-gxly) — Coverage Criteria (Clinical/Medical Policy)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 27, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation supporting the FDA-approved indication or applicable compendia/guidelines and tumor dMMR/MSI-H test results when required.

SourceLink

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