An oral three-drug regimen of aprepitant, a 5HT3 antagonist, and dexamethasone is reasonable and necessary immediately before and within 48 hours after moderately emetogenic chemotherapy is administered to Medicare beneficiaries, the Centers for Medicare and Medicaid Services stated in a proposed decision memo.
This regimen would be covered when it is administered in that time frame with any of the following chemotherapeutic agents, administered either singularly or in combination: alemtuzumab, azacitidine, bendamustine, carboplatin, carmustine, cisplatin, clofarabine, cyclophosphamide, cytarabine, dacarbazine, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, lomustine, mechlorethamine, oxaliplatin, and streptozocin, according to the CMS.
The proposal would expand coverage of the three-drug regimen to include its use with additional chemotherapy drugs that are not currently covered, including alemtuzumab, azacitidine, bendamustine, carboplatin, clofarabine, cytarabine, daunorubicin, idarubicin, ifosfamide, irinotecan and oxaliplatin.
CMS defines moderately emetogenic chemotherapy as any anticancer agents so designated in at least two of three guidelines published by the National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), and European Society of Medical Oncology (ESMO)/Multinational Association of Supportive Care in Cancer (MASCC).
According to the CMS, 70%-80% of all patients receiving chemotherapy experience nausea and vomiting. Chemotherapy induced emesis can impair quality of life, as well as cause dehydration, malnutrition, fatigue, confusion, electrolyte imbalance, esophageal tears and aspiration pneumonia. Further, poor control of the emesis can interrupt or force withdrawal from critical chemotherapy.
"We are mindful of the relatively minimal risks of the three-drug antiemetic regimen; the severe consequences that can occur if chemotherapy is delayed or halted altogether because of emesis; and the frequency with which new anticancer chemotherapeutic agents appear. We also recognize that the available classification schemes for chemotherapy emetogenicity may evolve as evidence continues to be developed on this problem," CMS officials stated in their proposed decision memo.
They also proposed that Medicare Administrative Contractors be allowed to determine coverage for an oral three-drug antiemesis regimen of aprepitant, a 5HT3 antagonist and dexamethasone with other anticancer chemotherapeutic agents that are FDA approved and are defined as highly or moderately emetogenic in at least two of three guidelines from NCCN, ASCO, and ESMO)/MASCC.
The CMS is seeking comments on the proposal, especially in regard to whether the term “NK-1 antagonists” should be used in its coverage manual. Aprepitant is currently the sole NK-1 antagonist component of the three drug antiemetic regimen. The CMS will respond to public comments in a final decision memorandum.