Early Access Programs
Named Patient Sales (NPS) / Early Access Program or Expended Access Program (EAP)
Early Access Programs / Named Patients Sales / Expended Access Programs are country-specific regulatory tools that allow patients with unmet medical needs to have access to drugs in clinical development before its official launch, providing that it fulfills specific criteria.
EAP or NPS should not be confused with compassionate use, where a drug is supplied by the company for patients as a follow up after a clinical trial or for pure humanitarian reasons. These cases, treatments are free of charge to the patient in contrast to Named Patient Sales projects.
Recent success stories have raised the profiles of EAP, yet many companies remain unaware of the significant advantages and possibilities offered by European EAP programs especially that it is possible to charge for EAP drugs in several European countries.
In addition, even amongst the informed minority, many assume – wrongly that an EAP will be too risky, too complicated or too costly to consider
♦ Pharmacovigilance teams sometimes fear potential safety issues that could be reported during an EAP, especially if the drug is misused by a physician having requested the agent under a named-patient EAP (whereby there is no protocol).
♦ From a regulatory point of view, potential adverse safety results could be considered to endanger the marketing approval of the drug. In addition, regulatory teams in companies sometimes have minimal knowledge and/or experience of EAPs and the country-specific nature of the programs.
♦ EAPs are also assumed to require a significant administrative workload in terms of paperwork, etc. Marketing and commercial teams often do not see how they could benefit from an EAP due to the perception that this is purely a regulatory tool. This is compounded by the fact that promotion of EAPs is prohibited. Last but not least, very few pharma/biotech companies are aware that it is possible to charge for EAP drugs in several European countries. In this case, the key issue is to set the right price, which is close to the price at launch.
♦ Unlike standard clinical trials, the number of patients and sites involved in EAPs are unpredictable (particularly in named-patient EAPs), which makes assessment of adequate drug production and supply difficult.
♦ Pharma/biotech firms with no real presence on the European market, will not yet have developed any distribution channels in Europe. EAPs must be managed on a country-by-country basis, which is challenging for some companies with limited knowledge of the European markets.
In this context, is an EAP worth considering?
The answer is definitely YES.
CarthaGenetics® is your partner to start your successful EAP and prelaunch in Europe. CarthaGenetics® offers an efficient and cost-effective approach to managing global EAP and is aware of local variability within the programs and works within the boundaries of local regulations.
Contact us at : email@example.com