Cost-Benefit Analysis and Pricing Considerations in the Regulatory Arena

Abstract

The objectives of a well-integrated regulatory affairs department should include a drug development strategy that assures a competitive dossier capable of receiving expeditious review and approval. Except for the United States. Canada, and Germany, price controls on new pharmaceuticals are a fact of life. Among the competitive factors that determine price are cost-effectiveness of the new therapy, therapeutic advantages and time of approval. Earliest possible approval is determined by quality of the data, quality of the presentation, and interest of the reviewer . . . all competitive factors that can be either controlled or influenced. Obtaining approval to market a new drug is a significant challenge. To get there early and with a competitive data package is a major achievement. Ten percent to 5070 of the time-course to market a new medicine is consumed in regulatory review. The increase in present value of the asset is significant for each month saved in the review process. Strategies should be developed to effect a more rapid review, to assure a more favorable pricing or reimbursement, and to position the new medicine for its optimal competitive opportunity. Strategic considerations will be identified to fulfill the regulatory objective of developing a regulatory dossier capable of receiving expeditious approval for a competitive product in major markets.