CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Jemperli (dostarlimab-gxly)

Defines accepted indications, inclusion and exclusion criteria, dosing limits, continuation rules, evidence sources, and approval authorities for coverage of Jemperli (dostarlimab-gxly) for cancer treatment under the payer's drug policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyJemperli (dostarlimab-gxly)

Policy CodePolicy N/A

Change TypeCommittee review/approval

Effective DateSep 27, 2024

Next Review Date

Key ActionEvolent processes all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

SourceLink

POLICY UPDATE CHANGES

Policy committee reviewed and approved Jemperli policy on September 18, 2024 with effective date September 27, 2024.

4Covered Indications (listed)

2Hard Exclusions (progression, dosing exceedance)

1Rectal cancer duration limit

Coverage Summary

Policy stance: covered_with_criteria for Jemperli (dostarlimab-gxly). Subject: Jemperli (dostarlimab-gxly). Scope: Defines accepted indications, inclusion and exclusion criteria, dosing limits, continuation rules, evidence sources, and approval authorities for coverage of Jemperli (dostarlimab-gxly) for cancer treatment under the payer's drug policy. Effective date: 2024-09-27. Last review date / committee approval: 2024-09-18.

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Initial Therapy Criteria

Endometrial Carcinoma - First-line therapy (combination)

Jemperli may be used in combination when ALL of the following are met:

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

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

Jemperli may be used as monotherapy when ALL of the following are met:

Disease status: Recurrent, advanced, or metastatic solid tumor
Biomarker: Tumor is positive for MSI-H or dMMR as confirmed by any standard test
Documentation of MSI-H or dMMR status by any standard test is required.
Prior therapy: Tumor has progressed following all satisfactory treatment alternatives

Locally Advanced dMMR/MSI-H Rectal Cancer (Neoadjuvant / Nonoperative intent)

Jemperli may be used as monotherapy when ALL of the following are met:

Treatment status: Member has locally advanced, treatment-naive rectal cancer
Biomarker: Tumor is mismatch repair deficient (dMMR) or MSI-High
Stage II or III, non-metastatic rectal cancer
Duration: Use limited to a period of 6 monthsMaximum 6 months
Treatment exceeding 6 months is an exclusion.

Continuation Therapy Criteria

General Continuation Rule

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

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

(redundant) General Continuation Rule copy

Endometrial Carcinoma - Subsequent-line therapy (dMMR/MSI-H)

Jemperli may be used as a single agent when ALL of the following are met:

Disease: Unresectable or metastatic endometrial carcinoma
Biomarker: Tumor confirmed to be dMMR or MSI-High by any standard test
Prior therapy: Disease has progressed following prior treatment with a platinum-containing regimen
Agent: Used as single-agent dostarlimab-gxly

Exclusions / Denial Conditions

Hard Exclusions and Dosing Limits

Hard exclusions and dosing limits that result in denial if met (ALL must be false to approve):

Disease progression exclusion: Disease progression while on or after Jemperli (dostarlimab-gxly) or on prior immunotherapy
If member experienced disease progression while on/after Jemperli or on prior immunotherapy, request is excluded.
Rectal cancer duration exceedance: Treatment exceeds the maximum 6 months duration limit for Jemperli use in Stage II/III rectal cancerMaximum 6 months
Exceeding this duration is an exclusion.
Dosing exceedance: Dosing exceeds single dose limit of Jemperli 500 mg every 3 weeks or 1,000 mg every 6 weeks500 mg q3 weeks or 1,000 mg q6 weeks
Claims exceeding single dose limits may be excluded.

(provider action) Prior authorization: Evolent processes all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Administrative denial risk (not clinical).

Off-label uses are permitted only when supported by one of the following: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual.

Provider Actions

Prior Authorization

Medication requests processed by Evolent

Evolent processes all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Medication requests come from network ordering providers.

Documentation Required

Tumor biomarker confirmation

Documentation of MSI-H or dMMR status by any standard test is required for covered MSI-H/dMMR indications.

MSI-H or dMMR by any standard test required for covered MSI-H/dMMR indications

Denial Risk

Exclusion for disease progression

Request is excluded if there is disease progression while on or after Jemperli or on prior immunotherapy.

Billing Rule

Dosing limit enforcement

Claims exceeding single dose limits (500 mg every 3 weeks or 1,000 mg every 6 weeks) may be excluded.

Maximum single dose 500 mg every 3 weeks or 1,000 mg every 6 weeks
Claims exceeding these limits may be excluded

Clinical Evidence

Evidence sources:

- GARNET trial (endometrial dMMR) — Oaknin A et al., JAMA Oncol 2020

- RUBY trial (primary advanced/recurrent endometrial cancer) — Mirza MR et al., NEJM 2023

- PD-1 blockade in dMMR rectal cancer — Cercek A et al., NEJM 2022

- Jemperli prescribing information — GSK Jemperli PI 2024

Background

This policy governs use of dostarlimab-gxly for FDA-approved indications and selected off-label indications only when the use is supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO clinical guidelines, or acceptable peer-reviewed literature in accordance with CMS Medicare Benefit Policy Manual standards. Evolent processes medication requests from network ordering providers and may deem medications not authorized by Evolent as not approvable and not reimbursable.

dMMR: Deficient mismatch repair.

MSI-H: Microsatellite instability-high.