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A recent coverage determination by National Government Services threatens to compromise the ability of patients to achieve complete control of chemotherapy-induced nausea and vomiting by limiting oncologist discretion in prescribing antiemetics.
A number of surveys have consistently shown that among the potential adverse effects of cancer treatment, patients rate chemotherapy-induced nausea and vomiting (CINV) as one of the most feared problems.1,2 Over the past 20 years, substantial progress has been made in developing more effective and better tolerated means to prevent CINV. With appropriate application of evidence-based antiemetic treatment, nausea and vomiting can be completely prevented in the majority of patients with cancer receiving chemotherapy.3
A recent coverage determination by National Government Services (NGS)—a Part A/Part B Medicare Administrative Contractor—threatens to compromise the ability of patients to achieve complete control of CINV by limiting the discretion of oncologists in prescribing antiemetics. In a directive issued on January 13, 2009, NGS indicated that “the use of injectable medications when an oral form is available must meet medical necessity requirements for use of the drug, and for the route of administration. Documentation should indicate that the patient was unable to tolerate the oral preparation before initiation of the intravenous form of the medication. An example is a failed course of the oral antiemetic before starting an intravenous form of the same antiemetic.”4–6
In a perfect world, this policy directive would appear to be quite reasonable. There is no evidence that when dosed appropriately, oral formulations are any less effective than parenteral formulations of the same antiemetics, and this is reflected in various evidence-based guidelines. Oral antiemetics are effective, safe, and, in many instances, the preferred antiemetic treatment. However, when one attempts to apply the new NGS policy in the real world of daily cancer care, a number of problems emerge. In most private practices and many hospital-based practices in the United States, providers do not dispense oral drugs. This means that patients with cancer must obtain their oral antiemetics from pharmacies and bring them to their sites of care on treatment days. Depending on their type of Medicare coverage, patients may encounter a number of hardships and inconveniences. With Part B coverage, physicians are not permitted to write prescriptions for antiemetics that cover entire courses of chemotherapy. Rather, they are only permitted to prescribe coverage for single cycles at a time. With Part D plans, patients must deal with prior authorizations and quantity limitations.
Compliance with care recommendations is a challenge for a significant segment of patients. Limiting the discretion of providers to administer intravenous formulations of antiemetics when there is concern about patients' ability to comply with treatment recommendations could compromise outcomes. Consistently adhering to oral medication schedules can be difficult even for the most astute patients when supportive care medications are added to the often lengthy lists of other chronic medications. Every provider has encountered the situation in which a patient has not brought his or her prescribed oral antiemetic medications on the scheduled day of treatment. Having the ability to provide intravenous antiemetics in such situations is essential.
One could argue that withholding the intravenous formulation of an antiemetic until failure of the oral form of the same antiemetic has been demonstrated is a cost-effective and prudent policy given the bioequivalence of the different formulations. Nevertheless, for many of the reasons noted, actually ensuring that oral antiemetics are taken as prescribed can be much more problematic than doing the same for intravenous formulations. The policy of withholding one form of antiemetic treatment until another less costly alternative has been demonstrated to be ineffective has historical precedent. This practice was followed in a number of settings when the 5-hydroxytryptamine-3 receptor antagonists were first used and, more recently, after the introduction of aprepitant, the first neurokinin-1 receptor antagonist. Unfortunately, the adverse consequences of such an approach are not limited to an unacceptable antiemetic outcome during the first cycle of therapy. Because of the potential for anticipatory emesis when an initial poor experience increases the likelihood of nausea and vomiting with subsequent cycles, a fundamental tenet of quality antiemetic care is optimization of antiemetic outcome with the first cycle of treatment. In addition, any cost savings realized in the upfront cost of antiemetics may be more than offset by greater resource utilization for patients with poorly controlled emesis.
There are few examples in life in which the “one model fits all” rule can be successfully applied. Clearly this is not the case in most cancer care settings, including antiemetic use in patients receiving chemotherapy. As long as evidence-based guidelines are followed, physicians must retain the ability to tailor antiemetic treatment to meet the needs of their individual patients.7,8
Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a “U” are those for which no compensation was received; those relationships marked with a “C” were compensated. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.
Employment or Leadership Position: None Consultant or Advisory Role: Paul J. Hesketh, Merck (C), GlaxoSmithKline (C), Eisai (C), Helsinn (C), Schering-Plough (C) Stock Ownership: None Honoraria: Paul J. Hesketh, Merck, GlaxoSmithKline Research Funding: Paul J. Hesketh, Merck, GlaxoSmithKline, Eisai Expert Testimony: None Other Remuneration: None