BlueCross BlueShield of Tennessee Medical Policy Manual
Dostarlimab-gxly (Jemperli®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications
Compendial Uses
All other indications are considered experimental/investigational and not medically necessary.
DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
Documentation of laboratory report confirming microsatellite instability-high (MSI-H), mismatch repair deficient (dMMR), or polymerase epsilon/delta (POLE/POLD1) tumor status, where applicable.
EXCLUSIONS
Coverage will not be provided for members who have experienced disease progression while on PD-1 or PD-L1 inhibitor therapy.
COVERAGE CRITERIA
Endometrial Carcinoma
Solid Tumors
Authorization of 6 months may be granted as a single agent for treatment of mismatch repair deficient (dMMR) solid tumors in members with recurrent, or advanced disease that have progressed on or following prior treatment and for whom there are no satisfactory alternative treatment options.
Breast Cancer
Authorization of 6 months may be granted as a single agent in members with no response to preoperative systemic therapy, recurrent unresectable or stage IV breast cancer, that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) and has progressed on or following prior treatment and has no satisfactory alternative treatment options.
Colorectal Cancer
Authorization of 6 months may be granted as a single agent for treatment of colorectal cancer, including appendiceal adenocarcinoma and anal adenocarcinoma, with microsatellite instability-high (MSI-H), mismatch repair deficient (dMMR), or polymerase epsilon/delta (POLE/POLD1) tumors.
Esophageal, Esophagogastric Junction and Gastric Cancer
Authorization of 6 months may be granted for treatment of esophageal cancer, esophagogastric junction cancer, or gastric adenocarcinoma when all of the following criteria are met:
Authorization of 6 months may be granted for treatment of gastric adenocarcinoma if tumor is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) in members who have early stage disease or are medically fit for surgery with surgically unresectable locoregional disease.
Authorization of 6 months may be granted as single agent induction therapy for relieving dysphagia in members with esophageal cancer or esophagogastric junction cancer who are surgical candidates with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors.
Occult Primary Cancer
Authorization of 6 months may be granted as a single agent for treatment of occult primary cancer that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) and has progressed on or following prior treatment and has no satisfactory alternative treatment options.
Ovarian Cancer
Authorization of 6 months may be granted as a single agent for treatment of epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, carcinosarcoma (malignant mixed Mullerian tumors), clear cell carcinoma of the ovary, mucinous carcinoma of the ovary, grade 1 endometrioid carcinoma, and low-grade serous carcinoma/ovarian borderline epithelial tumors for recurrent, persistent, or advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors.
Small Bowel Adenocarcinoma
Authorization of 6 months may be granted as a single agent for treatment of advanced or metastatic small bowel adenocarcinoma for microsatellite instability-high (MSI-H), mismatch repair deficient (dMMR) tumors, or polymerase epsilon/delta (POLE/POLD1) tumors.
Ampullary Adenocarcinoma
Authorization of 6 months may be granted as a single agent for subsequent treatment of recurrent or advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) ampullary adenocarcinoma that has progressed on or following prior treatment and has no satisfactory alternative treatment options.
Pancreatic Adenocarcinoma
Authorization of 6 months may be granted as a single agent for treatment of recurrent, locally advanced, metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) pancreatic adenocarcinoma when member has ECOG 0-2.
CONTINUATION OF THERAPY
Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section 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.
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
ORIGINAL EFFECTIVE DATE: 7/31/2021
MOST RECENT REVIEW DATE: 5/31/2025
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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