News

Medicare: Some Cancer Drugs to Be Covered for Off-Label Use in Trials


 

The Centers for Medicare and Medicaid Services has announced that the Medicare program will cover the chemotherapeutic agents oxaliplatin (Eloxatin), irinotecan (Camptosar), cetuximab (Erbitux), and bevacizumab (Avastin) in certain clinical trials for cancer patients.

In a Federal Register notice, CMS noted that all four agents are already approved as first- or second-line treatment for advanced colorectal cancer.

In addition, “the off-label use of irinotecan for the treatment of non-small cell lung cancer is supported in one of the approved drug compendia; therefore, this off-label use is covered by Medicare.” However, no other off-label uses of the drugs are covered.

At the agency's request, the National Cancer Institute identified high priority clinical trials studying off-label uses of these four cancer drugs.

“By covering the use of these agents in selected trials, [CMS] will … ensure continued advancement in knowledge for the appropriate use of these agents … and ensure beneficiaries rapid access to promising new uses of approved technologies under controlled clinical trial conditions,” the agency said. Covering the trials will also “serve as a potential model for additional coverage expansions in clinical trials for other anticancer chemotherapeutic agents,” CMSnoted.

In a standard section of the notice inviting public comments, the agency noted that implementation of the new coverage could be delayed “if we receive comments that persuade us to defer implementation.”

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