CurrentBlue Cross Blue Shield - TennesseePolicy N/A

Jemperli (dostarlimab-gxly) coverage for MSI-H/dMMR and other indications

Defines medical necessity, prior authorization documentation requirements, covered FDA and compendial indications, exclusions, authorization durations, and continuation rules for Jemperli (dostarlimab) for members of Blue Cross Blue Shield - Tennessee.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyJemperli (dostarlimab-gxly) coverage for MSI-H/dMMR and other indications

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 2, 2026

Next Review DateN/A

Key ActionProviders must submit prior authorization with laboratory reports confirming MSI-H/dMMR, POLE/POLD1 tumor status, or TMB where applicable and include HER2 status when relevant.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6Typical initial authorization period

36Maximum monotherapy duration after combination (months)

ECOG 0-2Pancreatic performance status requirement

TMB>50Ultra-hypermutated phenotype threshold

Indications, Eligibility, and Authorization

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FDA-Approved Indications (Covered when ALL criteria met)

Covered when the FDA indication applies and approval criteria are met (and member has no exclusions):

ALL of the following

ANY of the following
- Jemperli in combination with carboplatin and paclitaxel, followed by Jemperli as single agent for adult patients with primary advanced or recurrent endometrial cancer.
- Jemperli as a single agent for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA‑approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
- Jemperli as a single agent for adult patients with dMMR recurrent or advanced endometrial cancer that progressed on or after prior platinum-containing regimen and who are not candidates for curative surgery or radiation.

Compendial Uses (Covered when ALL criteria met)

The following compendial tumor types are considered covered when member meets the requested indication-specific criteria and documentation requirements:

ALL of the following

ANY of the following
- Breast cancer (see specific breast cancer criteria below).
- Esophageal and esophagogastric junction cancers.
- Colorectal cancer.
- Gastric cancer.
- Ovarian cancer and related epithelial/fallopian tube/primary peritoneal carcinomas and specific histologies listed.
- Occult primary cancer.

General Documentation and Test Requirements (Required for PA review)

Prior authorization requires submission of tumor testing documentation as applicable:

ALL of the following

Laboratory report confirming microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumor status, or polymerase epsilon/delta (POLE/POLD1) tumor status, or tumor mutational burden (TMB) where applicable.
HER2 status where applicable (e.g., breast cancer criteria).

Exclusions (Not covered)

Coverage will NOT be provided when the following exclusion is present:

ALL of the following

Member has experienced disease progression while on a PD-1 or PD-L1 inhibitor therapy.

Indication-specific Coverage Criteria and Authorization Durations

Authorization decisions and specific criteria by tumor type:

ANY of the following

Endometrial carcinoma (recurrent/advanced dMMR/MSI-H after platinum)
- Treatment as single agent for recurrent or advanced MSI-H/dMMR endometrial cancer that progressed on or after prior platinum-containing regimen.
- Authorization of 6 months may be granted.
  Authorization of 6 months may be granted.
Endometrial carcinoma (combination with carboplatin/paclitaxel)
- Stage III-IV or recurrent disease.
  Up to 6 doses of combination therapy followed by Jemperli monotherapy.

Continuation of Therapy (Reauthorization)

Criteria for reauthorization:

ALL of the following

Authorization of 6 months may be granted for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
Treatment as monotherapy after combination use with carboplatin and paclitaxel for endometrial carcinoma will not be approved beyond 36 months total therapy.

Procedure and Diagnosis Codes

Procedure / Diagnosis Codesmixed

No codes listed

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior authorization required with tumor testing documentation

Submit prior authorization with lab reports confirming tumor biomarker status as applicable: a laboratory report confirming microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumor status, or polymerase epsilon/delta (POLE/POLD1) tumor status, or tumor mutational burden (TMB) where applicable; include HER2 status when relevant (e.g., for breast cancer).

Required documentation: laboratory report confirming MSI-H/dMMR, POLE/POLD1, or TMB where applicable.
Include HER2 status when applicable (for breast cancer requests).

Denial Risk

Denial if prior PD-1/PD-L1 progression

Coverage will not be provided if the member experienced disease progression while receiving a PD-1 or PD-L1 inhibitor; such prior progression is an exclusion to coverage.

If member progressed on PD-1 or PD-L1 therapy, the request should be denied per policy exclusion.

Documentation Required

Line-of-therapy documentation for breast cancer

For breast cancer requests, document prior lines of systemic therapy and the member's HER2 status to show the requested line-of-therapy criteria are met.

HER2-positive disease: Jemperli considered only for fourth-line or later systemic therapy.
HER2-negative disease: Jemperli considered only for third-line or later systemic therapy.
Include tumor biomarker documentation (MSI-H/dMMR) as applicable.

Numeric & Clinical Thresholds

Key Thresholds and Authorization Durations

Authorization duration6 months (typical initial and reauthorization period)

Max monotherapy duration for endometrial carcinoma post-combination36 months total therapy

Tumor mutational burden threshold (example)TMB > 50 mut/Mb for ultra-hypermutated POLE/POLD1 phenotype

Performance statusECOG 0-2 required for pancreatic adenocarcinoma

6 monthsTypical initial authorization period

36 monthsMaximum monotherapy duration after combination therapy for endometrial carcinoma

ECOG 0-2Performance status requirement for pancreatic adenocarcinoma

TMB > 50Example threshold for ultra-hypermutated phenotype (POLE/POLD1)

Clinical and Policy Background

Jemperli (dostarlimab-gxly) is an anti–PD‑1 monoclonal antibody with FDA approvals for specific mismatch repair deficient (dMMR)/microsatellite instability‑high (MSI‑H) tumors and for endometrial cancer. Specifically, Jemperli is FDA‑indicated as: 1) in combination with carboplatin and paclitaxel followed by Jemperli monotherapy for adult patients with primary advanced or recurrent endometrial cancer; 2) as a single agent for adult patients with dMMR recurrent or advanced solid tumors (as determined by an FDA‑approved test) that have progressed on or after prior treatment with no satisfactory alternative options; and 3) as a single agent for adult patients with dMMR recurrent or advanced endometrial cancer that progressed on or after prior platinum‑containing therapy and who are not candidates for curative surgery or radiation (FDA indications).

BlueCross BlueShield of Tennessee considers these FDA‑approved indications covered when all approval criteria are met and the member has no exclusions to therapy. In addition, certain compendial tumor types are covered when the member meets the indication‑specific criteria and required documentation; prior authorization requires submission of tumor testing documentation (for example, laboratory reports confirming MSI‑H/dMMR, POLE/POLD1 tumor status, or tumor mutational burden where applicable, and HER2 status when relevant).

Coverage exclusions include members who have experienced disease progression while on a PD‑1 or PD‑L1 inhibitor; such cases will not be provided coverage. Typical initial authorization periods and reauthorizations are 6 months, with specific indication‑based limits (for example, monotherapy following combination use in endometrial carcinoma will not be approved beyond a total of 36 months of therapy).

Policy implementation for Tennessee follows state mandate requirements: BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56‑7‑2352 regarding coverage of off‑label uses of FDA‑approved drugs when the off‑label use is supported by a statutorily recognized compendium or published peer‑reviewed literature. For recommended dosing, monitoring, contraindications, and other chemotherapy regimen details, refer to standard reference compendia (e.g., NCCN Drugs & Biologics Compendium, Micromedex/Drugeval) and the Jemperli package insert.

Key Terms

Definitions

MSI-HMicrosatellite instability-high status indicating deficient mismatch repair.

dMMRMismatch repair deficient tumor status.

POLE/POLD1 ultra-hypermutated phenotypeTumors with polymerase epsilon/delta mutations often associated with very high tumor mutational burden (example threshold TMB > 50 mut/Mb).

Policy Version & Changes

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyJemperli (dostarlimab-gxly) coverage for MSI-H/dMMR and other indications

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 2, 2026

Next Review DateN/A

Key ActionProviders must submit prior authorization with laboratory reports confirming MSI-H/dMMR, POLE/POLD1 tumor status, or TMB where applicable and include HER2 status when relevant.

SourceLink

On This Page

Small bowel adenocarcinoma.

Endometrial carcinoma.

Ampullary adenocarcinoma.

Pancreatic adenocarcinoma.

Non-small cell lung cancer.

Authorization of 6 months may be granted.

Total monotherapy after combination will not be approved beyond 36 months total therapy.

Solid tumors (dMMR/MSI-H)

Recurrent or advanced disease progressed on or following prior treatment.
No satisfactory alternative treatment options.
Authorization of 6 months may be granted as single agent.
Authorization of 6 months may be granted as single agent.

Breast cancer (MSI-H/dMMR)

Recurrent unresectable or stage IV (M1) disease, or no response to preoperative systemic therapy.
Tumor must be MSI-H/dMMR and progressed on or after prior treatment and no satisfactory alternatives exist.
Line of therapy requirements
- Requested medication will be used as fourth-line or later and member has HER2-positive disease.
- Requested medication will be used as third-line therapy or later and member has HER2-negative disease.
Authorization of 6 months may be granted.

Colorectal cancer (including appendiceal and anal adenocarcinoma)

Tumor must be MSI-H, dMMR, or POLE/POLD1 ultra-hypermutated phenotype (e.g., TMB > 50 mut/Mb).
Authorization of 6 months may be granted as single agent.
Authorization of 6 months may be granted as single agent.

Esophageal / Esophagogastric junction / Gastric cancer

Tumor must be MSI-H or dMMR.
Member not surgical candidate or has unresectable locally advanced, recurrent, or metastatic disease and therapy is palliative.
Used as single agent.
Authorization of 6 months may be granted.
For gastric adenocarcinoma with surgically unresectable locoregional disease and MSI-H/dMMR, authorization of 6 months may be granted.
Single agent induction therapy to relieve dysphagia for esophageal/esophagogastric junction cancer planned for esophagectomy may be authorized for 6 months.

Occult primary cancer

Recurrent or advanced disease that is MSI-H or dMMR and has progressed on or following prior treatment and has no satisfactory alternative treatment options.
Authorization of 6 months may be granted as single agent.
Authorization of 6 months may be granted as single agent.

Ovarian and related tumors

Includes epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, carcinosarcoma, clear cell carcinoma of the ovary, mucinous carcinoma of the ovary, grade 1 endometrioid carcinoma, low-grade serous carcinoma/ovarian borderline epithelial tumors.
Tumor must be MSI-H or dMMR and recurrent, persistent, or advanced.
Authorization of 6 months may be granted as single agent.

Small bowel adenocarcinoma

Locally unresectable, medically inoperable, advanced or metastatic disease with MSI-H, dMMR, or POLE/POLD1 ultra-hypermutated phenotype (e.g., TMB > 50 mut/Mb).
Authorization of 6 months may be granted as single agent.
Authorization of 6 months may be granted as single agent.

Ampullary adenocarcinoma

Recurrent or advanced MSI-H/dMMR ampullary adenocarcinoma that progressed on or after prior treatment and has no satisfactory alternative treatment options.
Authorization of 6 months may be granted as single agent for subsequent treatment.
Authorization of 6 months may be granted as single agent for subsequent treatment.

Pancreatic adenocarcinoma

Recurrent, locally advanced, metastatic, MSI-H or dMMR pancreatic adenocarcinoma.
Member performance status ECOG 0-2 required.
Authorization of 6 months may be granted as single agent.

Anal carcinoma (squamous cell)

Metastatic squamous cell anal carcinoma for subsequent treatment when member has not received prior immunotherapy.
Authorization of 6 months may be granted as single agent.

Non-small cell lung cancer (nonsquamous)

Metastatic nonsquamous NSCLC without genomic aberrations.
First-line treatment in combination with pemetrexed and platinum chemotherapy; authorization of 6 months may be granted.