| dc.description.abstract | INTRODUCTION – Drug rediscovery (DR) provides opportunities for new treatments and patient benefit. However, due to the barriers and the lack of an incentive in the rediscovery process, DR often does not lead to an extension of indications or market authorization. Hence, the patient does not have access to the rediscovered drug, or only off-label with possible safety issues involved. On the other hand, cases of DR that did register and now benefit from regulatory exclusivity are also part of a public debate as there is a perception of low efforts and high prices asked. For a balanced discussion on this topic, it is important to have better insights in the landscape of DR. This will support policymakers to improve the conditions for DR with patient benefit as a focus.
AIM: To examine the efforts needed and barriers of different routes to get drug rediscovery to the patient.
METHODS – 29 experts from different actors were interviewed about specific costs and barriers of DR through one of the following routes: registration, delivered compounding, magistral formulas or off-label use.
RESULTS – Costs of DR fluctuate heavily between projects and routes and must be seen as indicative. Costs of off-label use are almost nihil, while the development of the production of magistral formulas and delivered compounding could reach up to € 10.000 and € 25.000, respectively. Registration of rediscovered drugs is found most expensive, ranging from € 300.000, if no clinical research is needed, to several millions of euros if additional clinical studies are required. One of the barriers to drug rediscovery is the lack of a business case for DR due to the inability to ask a higher price than a generic already on the market. Another barrier is that medical professionals do not value the registration of DR and do not see registration as a necessary goal of DR.
CONCLUSIONS – Paying a fair price for DR is essential for sustainable DR activities and the status-quo causes therapeutic chances to be missed. Registration should be reconsidered as the golden standard of DR, because most of the found barriers are due to the registration process. Also, registering DR can lead to significant regulatory exclusivity, while the costs have shown to be too low to justify such reward. The most important aspect remains that the product itself is of high quality. Under those circumstances, many patients could clinically benefit from wider application and research of medicinal products once on the market. Registration should not always be the desired result of drug rediscovery. | |
