Enhancing Prescription Drug Innovation and Adoption
ABSTRACT The adoption and use of a new drug would ideally be guided by its innovation and cost-effectiveness. However, information about the relative efficacy and safety of a drug is typically incomplete even well after market entry, and various other forces create a marketplace in which most new drugs are little better than their older counterparts. Five proposed mechanisms are considered for promoting innovation and reducing the use of therapies ultimately found to offer poor value or have unacceptable risks. These changes range from increasing the evidence required for U.S. Food and Drug Administration approval to modifying the structure of drug reimbursement. Despite the challenges of policy implementation, the United States has a long history of successfully improving the societal value and safe use of prescription medicines.
Clinical Therapeutics 03/2013; DOI:10.1016/j.clinthera.2013.02.023 · 2.59 Impact Factor
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ABSTRACT: Background When a new drug is launched onto the market, information about the new manufactured product is contained in its monograph and evaluation report published by national drug agencies. Health professionals need to be able to determine rapidly and easily whether the new manufactured product is potentially useful for their practice. There is therefore a need to identify the best way to group together and visualize the main items of information describing the nature and potential impact of the new drug. The objective of this study was to identify these items of information and to bring them together in a model that could serve as the standard for presenting the main features of new manufactured product. Methods We developed a preliminary conceptual model of pharmaceutical innovations, based on the knowledge of the authors. We then refined this model, using a random sample of 40 new manufactured drugs recently approved by the national drug regulatory authorities in France and covering a broad spectrum of innovations and therapeutic areas. Finally, we used another sample of 20 new manufactured drugs to determine whether the model was sufficiently comprehensive. Results The results of our modeling led to three sub models described as conceptual maps representingi) the medical context for use of the new drug (indications, type of effect, therapeutical arsenal for the same indications), ii) the nature of the novelty of the new drug (new molecule, new mechanism of action, new combination, new dosage, etc.), and iii) the impact of the drug in terms of efficacy, safety and ease of use, compared with other drugs with the same indications. Conclusions Our model can help to standardize information about new drugs released onto the market. It is potentially useful to the pharmaceutical industry, medical journals, editors of drug databases and medical software, and national or international drug regulation agencies, as a means of describing the main properties of new pharmaceutical products. It could also used as a guide for the writing of comprehensive and objective texts summarizing the nature and interest of new manufactured product.BMC Medical Informatics and Decision Making 01/2013; 13(1):10. DOI:10.1186/1472-6947-13-10 · 1.50 Impact Factor
Journal of clinical epidemiology 08/2013; 66(8):812-6. DOI:10.1016/j.jclinepi.2013.04.002 · 5.48 Impact Factor