CurrentViva HealthPolicy IC-0599

Jemperli (dostarlimab-gxly) — Medical Necessity and Coverage Criteria

Clinical medical necessity criteria, dosing, authorization limits, and renewal requirements for Jemperli (dostarlimab-gxly) for Viva Health members; applies to oncology indications detailed in the document.

Policy Summary

PayerViva Health

PolicyJemperli (dostarlimab-gxly) — Medical Necessity and Coverage Criteria

Policy CodePolicy IC-0599

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization (initial approval for 6 months) and document indication-specific criteria including biomarker status and prior therapies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial PA validity

3 yearsMax renewal (endometrial)

18+Minimum age

J9272HCPCS code

500→1000 mgTypical dosing

Coverage Criteria for Jemperli (dostarlimab-gxly)

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inv-01: Universal Criteria — Covered when ALL of the following are met

Covered when ALL of the following are met

Universal eligibility: Member is at least 18 years of age

Applies to all indication-specific criteria

Prior PD-1/PD-L1 exposure: Member has not received previous therapy with a PD-1/PD-L1-directed therapy unless otherwise specified for the indication

See indication-specific exceptions where noted

inv-02: Endometrial Carcinoma (combination regimen) — combination with carboplatin and paclitaxel followed by maintenance; ALL required

Endometrial carcinoma — combination with carboplatin and paclitaxel followed by maintenance is covered when ALL of the following are met

Regimen and setting: Used in combination with carboplatin and paclitaxel followed by single-agent maintenance (dosing per regimen guidance); member has primary advanced or recurrent disease OR is being treated as primary, adjuvant for stage III-IV, or first-line/subsequent therapy for recurrent disease

Will not be used for locoregional recurrence in members with no prior radiation to the site of recurrence or prior vaginal brachytherapy only; not for locoregional recurrence after surgical exploration when disease is confined to vagina/paravaginal tissue

Dosing: Induction: 500 mg IV every 3 weeks for 6 doses in combination with carboplatin and paclitaxel; Maintenance: 1,000 mg IV every 6 weeks beginning three weeks after dose 6, up to 3 years or until progression/toxicity

Refer to dosing section for administration timing and maximum duration

inv-03: Mismatch Repair Deficient (dMMR)/MSI-H Cancer — single-agent use; ALL required

dMMR/MSI-H cancers — single-agent use is covered when ALL of the following are met

Biomarker requirement: Tumor is dMMR or MSI-H as determined by an FDA-approved or CLIA-compliant test

Documentation of assay and result required

Indication and prior therapy: Used as single agent for subsequent therapy of unresectable, medically inoperable, advanced, recurrent, persistent, or metastatic disease OR in specified neoadjuvant/initial therapy settings described in policy

Where required for a setting, progression on or after a prior platinum-containing regimen must be documented

Dosing: Typical regimen: 500 mg IV every 3 weeks for 4 doses (or 9 doses for neoadjuvant gastric/esophageal as specified), followed by 1,000 mg IV every 6 weeks until progression or unacceptable toxicity

Refer to dosing section for tumor-specific neoadjuvant exceptions

inv-04: POLE/POLD1 Mutation Cancer — ultra-hypermutated tumors; ALL required

POLE/POLD1 mutation–associated ultra-hypermutated tumors — single-agent use is covered when ALL of the following are met

Regimen and biomarker: Used as a single agent; tumor demonstrates an ultra-hypermutated phenotype (e.g., tumor mutational burden > 50 mut/Mb)TMB > 50 mut/Mb

TMB threshold example provided in policy; documentation of mutation/TMB required

Tumor types and disease state: Indication-specific tumor types include colon or rectal cancer with locally unresectable, medically inoperable, advanced, or metastatic disease; appendiceal neoplasms with recurrent/progressive/metastatic peritoneal-only or extraperitoneal disease; or small bowel adenocarcinoma with advanced/metastatic or locally unresectable/medically inoperable disease

Compendia-recommended indications

Dosing: Regimen: 500 mg IV every 3 weeks for 4 doses, followed by 1,000 mg IV every 6 weeks until disease progression or unacceptable toxicity

inv-05: Anal Carcinoma — covered when ALL of the following are met

Anal carcinoma — covered when ALL of the following are met

Histology: Member has squamous cell carcinoma of the anus

Histologic confirmation required

Treatment options: Single-agent use as subsequent therapy for metastatic disease OR use in combination with paclitaxel and carboplatin (then continued as single agent) for inguinal node recurrence or as first-line treatment for metastatic disease

Combination therapy may be given up to a maximum (see dosing); maintenance and renewal limits apply

Dosing limits: Single-agent dosing: 500 mg IV every 3 weeks x4 then 1,000 mg IV every 6 weeks until progression or unacceptable toxicity. Combination: 500 mg IV every 3 weeks x4 with carboplatin/paclitaxel, then 1,000 mg IV every 6 weeks for up to 1 year

Combination therapy maximum duration noted in dosing section

inv-06: Covered with criteria — Coverage applies when diagnosis is one of the listed ICD-10 codes and medical necessity criteria are met

Coverage applies when diagnosis is one of the listed ICD-10 codes and medical necessity criteria are met; prior authorization may be considered per the NQTL checklist.

Diagnosis requirement: Member has a diagnosis represented in Appendix 1 covered ICD-10 list

See Appendix 1 for the complete list of covered diagnosis codes

Medical necessity documentation: Medical necessity criteria for the specific indication are documented in the medical record (including biomarker and prior therapy documentation where required)

Prior authorization may be considered per NQTL factor checklist

Coverage does not include use for locoregional recurrence in members who have had no prior radiation therapy to the site of recurrence or only prior vaginal brachytherapy. The therapy is also not covered when used after surgical exploration for locoregional recurrence confined to the vagina or paravaginal soft tissue.

When treating Medicare beneficiaries, CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) take precedence over the non‑Medicare coverage statements in this document where applicable. Providers may consult the CMS Coverage Database for applicable NCD/LCD/LCA guidance.

Prior authorization renewals will be approved only if the member continues to meet both the universal and indication‑specific criteria, the authorized duration has not been exceeded, there is evidence of disease response defined as stabilization or reduction in tumor size or spread, and the member has no unacceptable drug‑related toxicity (for example severe infusion reactions or severe immune‑mediated adverse events).

Medicare Part B covered diagnosis codes for this policy section are N/A in this document. Where CMS rules or existing NCD/LCD/LCA specify Part B diagnosis requirements, those Medicare‑specific lists apply.

Dosing and Regimens

Indication	Regimen / Dosing	Maximum Duration / Notes	Coverage
Endometrial carcinoma (uterine neoplasms) — used in combination with carboplatin and paclitaxel followed by single-agent maintenance	Induction: 500 mg IV every 3 weeks for 6 doses in combination with carboplatin and paclitaxel; Maintenance: 1,000 mg IV every 6 weeks (dose 7 begins 3 weeks after the 6th dose)	Maintenance up to 3 years or until disease progression or unacceptable toxicity	Covered with criteria

Indication	Regimen / Dosing	Setting-specific Variation	Coverage
MSI-H/dMMR solid tumors (including MSI-H/dMMR endometrial cancer and other tumor types)	Induction: 500 mg IV every 3 weeks for 4 doses; Maintenance: 1,000 mg IV every 6 weeks (dose 5 begins 3 weeks after the 4th dose)	Neoadjuvant gastric, esophageal, and esophagogastric junction cancers: induction 500 mg IV every 3 weeks for 9 cycles; all other MSI-H/dMMR regimens use 4 induction doses then maintenance until progression or unacceptable toxicity	Covered with criteria

Indication	Regimen / Dosing	Maximum Duration / Notes	Coverage
Anal carcinoma — squamous cell carcinoma	Single-agent: Induction 500 mg IV every 3 weeks for 4 doses; Maintenance: 1,000 mg IV every 6 weeks until disease progression or unacceptable toxicity	N/A — continued until progression or unacceptable toxicity for single-agent use	Covered with criteria
Anal carcinoma — in combination with carboplatin and paclitaxel (first-line metastatic disease or specified scenarios)	Combination induction: 500 mg IV every 3 weeks for 4 doses with carboplatin and paclitaxel; Maintenance: 1,000 mg IV every 6 weeks	Combination therapy may be administered for up to 24 weeks (up to a maximum of 1 year total when including maintenance as specified)	Covered with criteria

inv-28: Line of therapy — first-line | subsequent | neoadjuvant considerations (1 top-level node)

Line of therapy examples: First-line (e.g., in combination with carboplatin and paclitaxel for endometrial carcinoma), subsequent therapy for unresectable/metastatic disease (e.g., dMMR/MSI-H single-agent or anal carcinoma single-agent), and neoadjuvant indications for select gastrointestinal tumors as specified

Specific line of therapy depends on tumor type and prior treatments; see indication-specific nodes for details

Coding — HCPCS, NDC, and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J9272

Injection, dostarlimab-gxly, 10 mg; 1 billable unit = 10 mg

NDCNDC

00173-0898-xx

Jemperli 500 mg/10 mL solution in a single-dose vial (NDC)

Covered ICD-10 Diagnosis CodesICD-10Covered

C15.3	Malignant neoplasm of upper third of esophagus.
C15.4	Malignant neoplasm of middle third of esophagus.
C15.5	Malignant neoplasm of lower third of esophagus.
C15.8	Malignant neoplasm of overlapping sites of esophagus.
C15.9	Malignant neoplasm of esophagus, unspecified.
C16.0	Malignant neoplasm of cardia.
C16.1	Malignant neoplasm of fundus of stomach.
C16.2	Malignant neoplasm of body of stomach.
C16.3	Malignant neoplasm of pyloric antrum.
C16.4	Malignant neoplasm of pylorus.

1–10 of 150

1/15

Tumor Mutational Burden (TMB) — value note

Tumor Mutational Burden (TMB) threshold> 50 mut/Mb

ContextDefines ultra-hypermutated phenotype for POLE/POLD1 mutation–associated tumors

Required useApplied when assessing POLE/POLD1 mutation cancers for single-agent coverage

NQTL consideration — Indication

NQTL consideration (Indication)Yes — Consider for prior authorization (PA)

NQTL factors referencedIndication, Safety and efficacy, Potential for misuse/abuse, Cost of drug

ActionUse NQTL checklist to inform PA application for this indication

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approval will be provided for 6 months (180 days). Authorizations may be renewed every 6 months (180 days) thereafter unless otherwise specified for the indication (see Section I for indication-specific maximum renewal durations).

Initial prior authorization validity: 6 months (180 days).
Renewal prior authorization validity: May be renewed every 6 months (180 days) unless an indication-specific maximum is specified (e.g., endometrial carcinoma maintenance up to 3 years/30 doses; gastric/esophageal neoadjuvant up to 27 weeks/9 cycles; anal carcinoma combination therapy up to 1 year).
PA considered per NQTL factor checklist (see Appendix A).

Note

Prior Authorization Consideration (NQTL)

Prior authorization is considered and applied consistent with the Non-Quantitative Treatment Limitations (NQTL) factor checklist. Indication was judged as a factor to consider for PA; safety/efficacy and potential for misuse were not prioritized for PA in the assessment.

Indication: Yes — Consider for PA.
Safety and efficacy: No — PA not a priority.
Potential for misuse/abuse: No — PA not a priority.

Denial Risk

Prior PD-1/PD-L1 Therapy Restriction

Member must not have received prior PD-1/PD-L1-directed therapy unless an indication-specific exception is documented in the policy.

Universal restriction: No prior PD-1/PD-L1 therapy, unless otherwise specified for the indication.

Documentation Required

Required Clinical Documentation

Documentation must be provided to support the indication-specific criteria and medical necessity. Evidence must include diagnostic test results and prior treatment history where required.

For MSI-H/dMMR tumors: provide results from an FDA-approved or CLIA-compliant MSI/dMMR test.
When prior platinum-containing therapy is required: document prior regimen and progression on or after platinum therapy.
For renewal requests: provide evidence of disease response (stable disease or tumor reduction) and absence of unacceptable toxicity; confirm duration of therapy has not exceeded indication-specific limits.

Billing Rule

Diagnosis Codes Required

Use the comprehensive list of covered ICD-10 diagnosis codes to support medical necessity. Claims and prior authorization requests should cite an appropriate covered diagnosis code from Appendix 1.

Submit one or more applicable ICD-10 codes from Appendix 1 to support the requested indication (e.g., C15.x, C16.x, C17.x, C18.x, etc.).
Ensure diagnosis code(s) match the clinical documentation submitted for the prior authorization request.

Denial Risk

Denial Triggers

Denial may be issued if the member does not meet universal criteria, indication-specific criteria, duration limits, or if there is evidence of unacceptable toxicity. Providers should ensure all required documentation and criteria are met before submission.

Denial triggers include: prior PD-1/PD-L1 therapy when not allowed, missing required diagnostic test results (e.g., MSI/dMMR), failure to document prior platinum therapy when required, exceeding indication-specific duration limits, or presence of unacceptable toxicity.

Note

Provider Action — Prior Authorization Submission

Provider action: Submit prior authorization requests with all required documentation and applicable diagnosis codes; PA will be reviewed per the NQTL checklist and policy criteria.

Include clinical rationale, prior treatment history, relevant test results (e.g., MSI/dMMR), and applicable ICD-10 code(s) from Appendix 1 with the PA submission.
PA requests will be evaluated against universal and indication-specific criteria; incomplete submissions may delay or result in denial.

Definitions and Biomarker Requirements

dMMR / MSI-H — testing requirement

RequirementTumor dMMR/MSI-H status must be determined by an FDA‑approved or CLIA‑compliant test

Applies todMMR/MSI‑H cancers used as single‑agent therapy per policy

DocumentationTest result documentation must be provided to support medical necessity

POLE/POLD1 mutation / Tumor mutational burden — ultra‑hypermutated example

Ultra‑hypermutated phenotype exampleTMB > 50 mut/Mb

Associated biomarkersPOLE or POLD1 mutation–associated tumors

Dosing contextPOLE/POLD1 mutation tumors follow 500 mg IV q3w x4 then 1000 mg IV q6w maintenance until progression/toxicity

MMR / mismatch repair deficiency — biomarker

BiomarkerMMR (mismatch repair) deficiency

Clinical relevanceSupports non‑operative management and selection for PD‑1 therapy in dMMR tumors

ReferencePolicy cites NEJM article on non‑operative management of MMR‑deficient tumors (Cercek et al. 2025)

NCD/LCD/LCA applicability and Medicare Part B guidance

Medicare applicabilityMedicare NCDs/LCDs/LCAs may supersede non‑Medicare statements where applicable

Guidance sourceMedicare Benefit Policy Manual (Pub. 100‑02), Chapter 15, §50 and CMS coverage database

Medicare Part B diagnosis codesStated as N/A for Medicare Part B covered diagnosis codes in this document portion

Background

Dostarlimab (Jemperli) is a programmed death‑1 (PD‑1) directed monoclonal antibody indicated in multiple tumor types including endometrial carcinoma and biomarker‑selected solid tumors (for example dMMR/MSI‑H or POLE/POLD1‑associated ultra‑hypermutated tumors). Typical dosing regimens in this policy follow an induction phase of 500 mg IV every 3 weeks (number of induction doses varies by indication) followed by a maintenance schedule of 1000 mg IV every 6 weeks. Indication‑specific use includes combination with carboplatin and paclitaxel for certain endometrial cancers followed by single‑agent maintenance, and single‑agent use for dMMR/MSI‑H or ultra‑hypermutated tumors when biomarker criteria are met.

Biomarker Testing Requirements

dMMR / MSI‑H — biomarker entry

BiomarkerdMMR / MSI‑H

Testing requirementTumor status must be determined by an FDA‑approved or CLIA‑compliant test

Coverage roleRequired biomarker for single‑agent dMMR/MSI‑H cancer coverage per policy

POLE/POLD1 mutation / Tumor mutational burden — TMB threshold

TMB threshold for ultra‑hypermutation> 50 mut/Mb

Associated mutationsPOLE and POLD1 mutation–associated tumors

Dosing noteRegimen: 500 mg IV q3w x4 then 1000 mg IV q6w until progression or unacceptable toxicity