The Centers for Medicare & Medicaid Services (CMS) announced today it intends to cover the oral drug aprepitant for the treatment of chemotherapy-induced nausea and vomiting (CINV) in patients who do not respond to the standard drugs used to treat these symptoms that often occur with some anti-cancer chemotherapeutic drugs.
Because evidence in clinical trials has shown that aprepitant is more effective for the treatment of CINV when used in combination with other anti-emetic (anti-vomiting) drugs, aprepitant would be covered by Medicare only when used in combination with two standard anti-emetics drugs, a 5-HT3 antagonist and dexamethasone.
“We are continuing to work to keep our coverage up-to-date with advances in medical technology that improve beneficiary health,” said CMS Administrator, Dr. Mark McClellan, MD, PhD. “This new drug coverage will provide important help for some patients undergoing chemotherapy who don’t respond to the usual nausea treatments.”
Generally Medicare does not cover drugs that are self-administered by the patient, such as oral drugs. However, the law provides coverage for oral drugs used to treat CINV if the oral anti-emetic drug functions as a replacement for the intravenous drugs that would have otherwise been administered. In this case, the combination of the three drugs will replace the intravenous drugs that would otherwise be necessary.
CMS is aware that aprepitant may likely have other uses beyond those consistent with the part B proposed benefit category determination. Beginning January 1, 2006 aprepitant for these other uses will be covered under Medicare Part D, the new prescription drug benefit created by the Medicare Modernization Act of 2003 (MMA). As a result, aprepitant would be covered under part B for the indications specified in the proposed National Coverage Decision (NCD) and under part D for others. Based on the NCD guidelines, it will then be up to the provider to determine whether aprepitant is prescribed under part B or part D. Part D indications may likely represent the largest proportion of the use of aprepitant by Medicare beneficiaries.
Specifically under this draft NDC, CMS is proposing that Medicare cover aprepitant when it is used as part of a three-drug anti-emetic regimen used to treat the nausea and vomiting caused when patients undergo treatment with anti-cancer chemotherapeutic drugs that fall into level 5 on the Hesketh’s classification system of anti-cancer chemotherapeutic agents that are highly likely to cause nausea and vomiting. In addition, these patients have not responded to standard antiemetic regimens that did not include aprepitant.
CMS is requesting public comments on the proposed national coverage determination available for review online by clicking on the link, “Aprepitant for Chemotherapy-Induced Emesis” on the CMS coverage website: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=nca