Enhancing Prescription Drug Innovation and Adoption
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.
[Show abstract] [Hide abstract] 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.0Comments 3Citations
- "...s and physicians with better information, including the results of studies comparing effectiveness . Other authors  have highlighted problems due to a lack of information concerning the value of ..."They also tend to focus on comparisons of the efficacy of the new manufactured product with other drugs for a given indication; aspects relating to safety or ease of use are described in less detail and may even be completely ignored. Improvements in drug labelling have been proposed, to provide patients and physicians with better information, including the results of studies comparing effectiveness . Other authors  have highlighted problems due to a lack of information concerning the value of the innovation brought by the new drug after entry into the market.
[Show abstract] [Hide abstract] ABSTRACT: New drugs often substitute others cheaper and with a risk-benefit balance better established. Our aim was to analyse the diffusion of new drugs during the first months of use, examining the differences between family physicians and specialists. Prescription data were obtained of cefditoren, duloxetine, etoricoxib, ezetimibe, levocetirizine, olmesartan, pregabalin and tiotropium 36 months after their launching. We obtained the monthly number of prescriptions per doctor and the number prescribers of each drug by specialty. After discarding those with less than 10 prescriptions during this period, physicians were defined as adopters if the number of prescriptions was over the 25th percentile for each drug and level (primary or secondary care). The diffusion of each drug was studied by determining the number of adopter family physicians throughout the study period. Among the group of adopters, we compared the month of the first prescription by family physicians to that of other specialists using the Kaplan-Meier method. The adoption of the drugs in primary care follows an exponential diffusion curve that reaches a plateau at month 6 to 23. Tiotropium was the most rapidly and widely adopted drug. Cefditoren spread at a slower rate and was the least adopted. The diffusion of etoricoxib was initially slowed down due to administrative requirements for its prescription. The median time of adoption in the case of family physicians was 4-6 months. For each of the drugs, physicians of a specialty other than family physicians adopted it first. The number of adopters of a new drug increases quickly in the first months and reaches a plateau. The number of adopter family physicians varies considerably for different drugs. The adoption of new drugs is faster in specialists. The time of adoption should be considered to promote rational prescribing by providing timely information about new drugs and independent medical education.0Comments 10Citations
- "..., based on data showing that it often takes 5 to 10 years to identify significant adverse effects . This is in great contrast with the adoption rate in our study. ..."Older drugs are generally safer owing to their longer track record. Even, to wait 7 years before using a new drug has been advocated, based on data showing that it often takes 5 to 10 years to identify significant adverse effects . This is in great contrast with the adoption rate in our study.
- [Show abstract] [Hide abstract] ABSTRACT: Efforts by the Food and Drug Administration (FDA) to ensure the safety of prescription medicines historically have focused on the requirements for therapies to gain market approval. However, many safety risks are discovered only after a medication reaches the market.1 During the past decade, reports by the Institute of Medicine2 and calls from policy experts have provided momentum to improve the US drug regulation system. One major step in this direction was achieved in 2007 when Congress passed the FDA Amendments Act (FDAAA).3 Although the FDA has frequently sought to avoid a focus on postmarketing regulation by emphasizing that it “does not regulate the practice of medicine,” the FDAAA language suggests increasing involvement of the agency in shaping clinical practice to ensure safe medication use.0Comments 11Citations
- [Show abstract] [Hide abstract] ABSTRACT: "Off-label use" occurs when the use of a medication or device deviates from what is mentioned in its US Food and Drug Administration (FDA) product label. Off-label use is common, legal, and an important source of innovation; however, it can be costly, and strong evidence of the efficacy and safety of such use may be lacking.(1) Given the contradictory and unresolved expectations of major stakeholders, off-label use remains problematic. It requires a new policy paradigm that can successfully balance the need for innovation against the imperatives of evidence-based practice and finite health-care resources.0Comments 15Citations
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- [Show abstract] [Hide abstract] ABSTRACT: Huseyin Naci and colleagues find that raising evidence standards for market entry of new drugs could have numerous benefits, including providing incentives for development in therapeutic areas with few treatment options.0Comments 12Citations