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| Table 2 Prescription Drug Price Increases | | Year | Percentage | | 1990 | | | 1991 | | | 1992 | | | 1993 | |
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5. Pharmacoeconomic and Outcomes Research |
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The Boston Consulting Group has found that each year over 700 health economics studies are published, and each pharmaceutical company begins, on average, 23 new studies [86]. Pharmacoeconomic analysis, which assesses both costs and outcomes, has certainly gained importance in this era of cost containment. During the drug development process, pharmaceutical companies are looking more carefully at the price of other drugs in the same therapeutic class and the projected prescription volume. Quality of life studies are becoming pivotal in determining cost effectiveness or the value of a drug. The industry is incorporating quality of life data when making an economic case for their drugs. Government agencies are increasingly using pharmacoeconomic research in making formulary, pricing, and reimbursement decisions. |
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Federal regulations do not require that new therapies be superior to or less expensive than existing therapies, only that they be safe and effective. However, a greater number of NDA submissions now include pharmacoeconomic study data. The Division of Drug Marketing, Advertising, and Communications (DDMAC) in the Center for Drug Evaluation and Research at the FDA is being drawn into the cost-effectiveness research field as a result of its regulation of prescription drug advertising. They review economic drug claims as a basis of comparative advertising of cost effectiveness or claims that the drug cuts health care spending. There would be a tremendous increase in the number of pharmacoeconomic studies if the FDA would require them as a condition for NDA approval [87,88]. In preparation for more industry research on cost effectiveness and outcomes and in view of the numerous requests the FDA is receiving from companies for advice in an effort to get claims approved, the FDA has recently formed a task force to educate staff and intends to issue written guidance on the topic [89]. Economic research is also popular throughout the European Community and elsewhere. Australia and five providences in Canada, for example, now require pharmaceutical manufacturers to submit |
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