EAP – For which product
Is your product eligible ?
To be eligible for an EAP, your drug candidate must fulfil several criteria.
Firstly, regulation states that the treatment is available to “patients with a chronically or seriously debilitating disease, or a life threatening disease, and who cannot be treated satisfactorily by an authorized medicinal product.” These programs are not only designed for rare diseases but also for severe conditions affecting large populations. “Patients who cannot be treated satisfactorily” means those who are left without treatment options, or those whose disease does not respond to or relapses with available treatments, and/or those for whom current therapy is contraindicated or inadequate.
Your drug candidate must either be the subject of an application for marketing authorization or must be undergoing clinical trials. Typically, EAPs involve products in Phase III (although planning during Phase II). Sufficient safety and efficacy information are required to demonstrate a positive benefit/risk ratio and permit use of the drug in a minimally controlled out-patient setting.
Named Patient Sales say not interfere with or replace clinical trials, although safety data may be collected during EAPs, these programs are not substitutes for clinical trials. Therefore, patients should always be considered for inclusion in clinical trials before being offered a drug through an EAP.
You have to set the right price, which will be close to the price at launch