How does an early access program work?
Named patient programs are those which provide access of those medicines to the patients and physicians which are not available in their own country. It permits pharmaceuticals and Biotech companies to post permit the medicines or drugs that no longer exist in the market or are not in the clinical trials for a long time. These drugs must be approved in at least one country from which it can be exported to other countries in need. The thriving need has led to the development of an early access program or named patient sales or expended access programs.
These early access programs or named patient sales are authorized country specific regulatory tools that allow patients with unmet medical needs to have drug access before its launch. An EAP has a list of the benefits in pharmaceuticals consulting services; however, it should be dealt with utmost care by adapting following points :
● A regulatory team of EAP assures the level of authentic knowledge they hold before launching any named patient medicine.
● EAP shows major concern for potential safety issues, especially when the drug is ought to be misused under the name of the physician.
● Named patient supply is difficult to estimate in EAP as compared to the typical clinical trials, thus proper assessment of drugs and its production is made in order to meet the demand accordingly.
● Marketing and commercial team prohibits the promotion and set the right price which should match according to the varied countries’ prices (almost close to the right price at the time of launch).
● Furthermore, if one asks for the worthiness of EAP – it always seems to be great in named patient programs.