![]() ![]() To do this, the information provided would need to show elements of a health plan budget, as well as how utilization and per-member per-month (PMPM) claim costs may be impacted by the addition of the new drug. While CE model results are worthwhile, especially in coming to a yes-or-no coverage decision-e.g., "the $45,000 per QALY gained passes our test for inclusion as a preferred drug"-they don't help with monitoring of experience or health plan pricing. Such questions include requests for information tailored to a health plan, with overt specification as to the greater impacts of formulary decisions on the health plan as a whole as well as its members and specific demonstration of value compared with competitors. What are the expected impacts on pharmacy, hospital, and physician budgets?Ĭlearly, these questions go beyond the generic cost-effectiveness results typically provided by manufacturers.What about the reimbursement, utilization, and morbid-outcome assumptions made in modeling these data? How does this intervention stack up against other available treatments?.How will the older-than-average age of our population affect outcomes?.Then the committee starts asking questions: ![]() The model demonstrates that the drug is cost-effective while it costs 50 percent more per pill and has a rare-but-catastrophic side effect, it results in a 50 percent increase in quality-adjusted life years (QALYs) compared to another treatment. A drug company representative has provided the dossier, including a cost-effectiveness (CE) model that meets the requirements laid out by the Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions. More clarity-and, ideally, flexible interpretation-from the FDA is warranted, especially given the rise of CER.It happens in health plans all over the country: Pharmacy and Therapeutics Committees meet to consider the placement of a new drug on the formulary. It also reflects a belief that CER will increase use of Section 114 promotions, and that guidance from the FDA is needed. Conclusions: The survey suggests strong awareness about Section 114 among the outcomes directors and some use of the Section for promotional purposes. 75% stated that the FDA should issue guidance on how to make such promotions to payers, especially what qualifies as "healthcare economic information" and "competent and reliable scientific evidence." Most expected to use Section 114 to a greater extent in the future, and agreed that the increased focus on CER would increase Section 114 use. 81% stated they always or frequently consider using Section 114 when making promotional claims for drugs. Results: Of the 35 experts, 16 (46%) completed the survey. We asked them about their interpretation of, and experiences with, Section 114, as well as their views regarding the FDA's role in the matter, and whether the advent of comparative effectiveness research (CER) will affect the use of Section 114 promotions. Methods: We conducted a web-based survey of a convenience sample of 35 outcomes directors of major pharmaceutical and biotechnology companies. Abstract : Background: Section 114 of the 1997 US FDA Modernization Act (FDAMA) is an important vehicle for pharmaceutical companies to promote the economic value of their drugs to formulary decision makers, but little is known about how the Section has been interpreted and used. ![]()
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