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WHY SET 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 direct and indirect 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 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. These programs provide access for patients who otherwise would not be able to participate in clinical trials and allow companies to engage with physicians, providing early, hands-on experience with potentially life-saving medicines.
WHY SET 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 direct and indirect 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 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. These programs provide access for patients who otherwise would not be able to participate in clinical trials and allow companies to engage with physicians, providing early, hands-on experience with potentially life-saving medicines.
For patients with life-threatening illnesses, license 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 after a 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 a controlled relationship with your real markets, as well as to manage data reporting and processing in order to better understand the targeted markets’ needs and gain loyalty pre-launch. Take advantage of EAPs as a pre-marketing tool!
For patients with life-threatening illnesses, license 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 after a 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 a controlled relationship with your real markets, as well as to manage data reporting and processing in order to better understand the targeted markets’ needs and gain loyalty pre-launch. Take advantage of EAPs as a pre-marketing tool!
EAPs offer real marketing rewards
♦ EAPs create an important opportunity for your company to test your product in “real life”, for the physicians to gain experience and for the patients to benefit from your product 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.
♦ Equally, besides providing the patients with access to a potentially life-saving medicine, there is also the opportunity for feedback and building relationship with patient advocacy groups and associations.
♦ In some countries / cases EAPs can be reimbursed, creating early revenues, but whether or not a drug is made available free of charge, market penetration can be maximized through an EAP, which can then translate into a successful launch and increased post-approval usage. Even for non-profit EAP’s, patient recruitment is generally faster and these patients will continue to be treated under reimbursement as soon as your product is officially commercialized.
For detailed information, please contact us at: eap@carthagenetics.com
EAPs offer real marketing rewards
♦ EAPs create an important opportunity for your company to test your product in “real life”, for the physicians to gain experience and for the patients to benefit from your product 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.
♦ Equally, besides providing the patients with access to a potentially life-saving medicine, there is also the opportunity for feedback and building relationship with patient advocacy groups and associations.
♦ In some countries / cases EAPs can be reimbursed, creating early revenues, but whether or not a drug is made available free of charge, market penetration can be maximized through an EAP, which can then translate into a successful launch and increased post-approval usage. Even for non-profit EAP’s, patient recruitment is generally faster and these patients will continue to be treated under reimbursement as soon as your product is officially commercialized.
For detailed information, please contact us at : eap@carthagenetics.com