Traditionally, the standard treatment for locally advanced rectal cancer has been neoadjuvant chemotherapy and radiation followed by surgical resection of the rectum. Recently, however, research published in the New England Journal of Medicine¹ and the Journal of Clinical Oncology² demonstrated that for stage 2 and 3 rectal cancers, including metastatic, it is possible patients may benefit from immunotherapy, a less intensive approach, when indicated by biomarker testing. Biomarker testing helps ensure cancer patients get the right treatment at the right time. It allows doctors to precisely target a specific cancer so patients may not have to undergo more generalized treatments, such as chemotherapy and radiation, that may not work as well for them.

The National Comprehensive Cancer Network^® (NCCN^®) guidelines were also recently updated to recommend microsatellite instability/mismatch repair (MSI/MMR) testing for all newly diagnosed stage 2 and 3 rectal tumors. When test results are scored as high (MSI-H), the NCCN recommends immunotherapy. Cigna Healthcare^SM aligns with NCCN as the standard for medical oncology coverage policy decisions.

How we are aligning with the NCCN MSI-H recommendation for immunotherapy

Today, Cigna Healthcare already requires MSI/MMR testing before a provider can submit a medical oncology prior authorization request for rectal cancer treatment. The process will remain the same, and no medical necessity denial will occur, but a peer-to-peer discussion may be added when test results are MSI-H and the authorization request is for chemotherapy.

Starting February 14, 2025, when MSI/MMR test results are MSI-H and the provider submits a prior authorization request to treat the cancer with:

• Immunotherapy, the request will follow the standard medical oncology prior authorization process. (There will be no change.)
• Chemotherapy, the request will be pended for a peer-to-peer discussion with an EviCore by Evernorth^®3 (EviCore) medical oncologist, who will discuss the rationale for requesting chemotherapy, share the NCCN recommendation for immunotherapy, and discuss whether immunotherapy is an option for the patient.
• If after this discussion the provider:
  • Changes the request from chemotherapy to immunotherapy, the medical oncology prior authorization process will continue
  • Does not change the request from chemotherapy to immunotherapy, the medical oncology prior authorization process will continue, and no medical necessity denial will occur.

About the MSI/MMR biomarker test

This test:

• Provides a genomic-based, comprehensive risk profile with personalized information for the assessment of stage 2 and 3 rectal cancers, including metastatic.
• Looks for changes in the DNA sequence between normal tissue and tumor tissue, and can identify whether or not there is a high amount of instability, which is called MSI-H, found in about 15 percent of colorectal cancer tumors.
• Offers valuable information providers can use to customize a treatment plan specifically for a patient’s unique situation (e.g., risk of distant recurrence, the potential benefit from chemotherapy).

1. Andrea Cercek, et al. “PD-1 Blockade in Mismatch Repair–Deficient, Locally Advanced Rectal Cancer.” The New England Journal of Medicine. 23 June 2022. Retrieved from https://www.nejm.org/doi/full/10.1056/NEJMoa2201445.

2. Andrea Cercek, et al. “Durable complete responses to PD-1 blockade alone in mismatch repair deficient locally advanced rectal cancer.” Journal of Clinical Oncology. 05 June 2024. Retrieved from https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2024.42.17_suppl.LBA3512.

3. This is a Cigna Healthcare national ancillary provider to which we have delegated prior authorization of chemotherapy.