Why setting up an EAP ?
Early access programs in Europe: a regulatory tool with pre-marketing impact
As the pharmaceutical industry is rapidly changing, it is becoming more and more likely that your company will receive requests for access to its drug candidate. At the same time, the increased transparency of clinical research and accessibility of powerful social media tools have led to a more informed and vocal population of patients.
For companies as yours, with drugs in development which may generate early demand, managed access programs offer a way to meet the patients needs on a global basis in a regulated, ethical and transparent manner. Managed access programs provide access for patients who otherwise would not be able to participate in company-sponsored clinical trials and allow sponsors to engage with physicians, providing early, hands-on experience to potentially life-saving medicines.
For patients with life-threatening illnesses, licence approval or commercial launch of an innovative new drug may come too late. In some cases, such as those involving the EU registration and approval process, a drug may not clear reimbursement hurdles in an individual country until well after centralized approval is granted. In countries where a formal launch is not feasible, a patient may not have any other opportunity to receive the drug other than through such a program.
In all of these scenarios, managed access programs provide an effective route to your innovative drugs prior to approval or launch, potentially providing patients who have run out of therapeutic options with an important lifeline.
EAP will allow you to keep control of relationships with your real markets, as well as manage data reporting and processing in order to better understand your clients’ needs and gain their loyalty pre-launch. Take advantage of EAPs as a pre-marketing tool !
EAPs offer real marketing rewards
♦ EAPs are a good way of testing your product in “real life” and convincing prescribers and patients of your product efficacy before launch. One advantage is that “real life” data are obtained, reflecting a more clinically and ethnically diverse population than often encountered in clinical trials. This information gained pre-launch can also shape post-launch marketing messages. “Early Adopters” or brand advocates can be identified as a wider group of physicians gain experience with the drug, and physician loyalty may be developed. Furthermore, key opinion leaders often play a major role in discussions with regulatory agencies.
♦ Equally with respect to patients, as well as providing them with access to a potentially life saving medicine, there is the opportunity for feedback, the development of patient loyalty and building relationship with patient advocacy groups and associations.
♦ There is the potential for early revenues in countries where EAPs can be designed as “for-profit” programs, but whether or not a drug is made available free of charge, market penetration can be maximized pre-launch through an EAP, which can then translate into a successful launch and increased post-approval usage. Even when EAPs run at a loss or neutral returns in stand-alone financial terms, long-term benefits make them an attractive choice for your company. Even for non profit EAP’s, patient recruitment is generally faster and these patients will be automatically translated into sales as soon as your product will be officially commercialized.
CarthaGenetics® is your partner of choice to start your successful EAP and prelaunch in Europe. CarthaGenetics® offers an efficient and cost-effective approach to managing European & Mediterranean EAPs. We are fully aware of local variability within the programs and we always work within the boundaries of local regulations.
Please contact us at : firstname.lastname@example.org