Anyone who has run an expanded access program (EAP) will know of the challenges that exist with addressing and satisfying the needs of each group or stakeholder involved in the process. And this is true regardless of the therapeutic area or drug type.
Planning an EAP that properly meets the needs of all concerned stakeholders is challenging, but not impossible. When designing EAPs, sponsors are often hesitant to involve external parties such as patient advocacy groups and key opinion leaders (KOLs) in the design process, fearing that there may be conflicts of interest or that feedback received will be inconsistent with the sponsor’s preferred approach. These assumptions have often proven to be untrue in recent years, and now more than ever sponsors are looking to improve collaboration with these key stakeholders.
To design a successful EAP, we must first understand the specific needs of each stakeholder in the process, including identifying any challenges that they may have faced when participating in other EAPs.
When Durbin conducted a research project in 2019, forming this understanding was one of the key objectives. This would then go on to inform the design of our services, in order to provide programs that align, address and satisfy the needs of all involved.
The Expanded Access Research Project
The research project was an analysis of the global EAP landscape with particular focus on the rare disease and specialty drug market.
The research aimed to deconstruct the processes involved when implementing or participating in an EAP. We identified the various stakeholder groups involved, their hopes and desires from such programs, as well as the pain points they faced with the way things were currently being conducted.
The main challenges faced by patients, caregivers and healthcare providers (HCPs) when participating in an EAP all come back to one central issue, a lack of effective communication between key stakeholders in the process.
The Ecosystem of Expanded Access Programs
The concept of “ecosystems” has been frequently overused in pharma as of late; however, when describing the complex network of connected stakeholders involved in an EAP, it is quite fitting. Each stakeholder involved in the EAP process has their own set of individual needs and requirements. Mapping these needs and assessing who each stakeholder will interact with in the process is a crucial part of planning a successful EAP.
The project helped us identify the following stakeholders in the EAP ecosystem: patients, caregivers, physicians, pharmacists, patient advocacy groups, sponsors, payors and regulators. For each, needs were categorised into knowledge and awareness, access and continuity, patient engagement, data and strategy.
Although each required something different, the one similarity was the dependence they had for one another to meet their needs. And these connections were only reinforced when mapping the ecosystem.
For instance, it became clear that to compliantly raise awareness of EAPs among patients suffering from a rare disease, sponsors must first look to build awareness among KOLs and patient advocacy groups. To provide these key stakeholders with information about the drug options available and the support that exists for setting up an EAP, there needs to be clear communication from drug manufacturers and EAP service providers on the availability and scope of any such programs.
Of course, there are often regulatory barriers which limit the outright promotion of EAPs, but with the help of a specialist provider that has experience in the field, effective and compliant awareness building activities can be utilized.
As you would expect in an ecosystem, the needs and involvement of each stakeholder shift and evolve as the EAP program progresses, which is why communication and engagement must never stop. At Durbin we look to technology to help address these needs, in the form of our uniphi EAP portal. uniphi is a central tool that aids in the effective management and roll out of complex EAPs, keeping all necessary stakeholders informed and connected, enabling improved engagement and support.
In this complex area there is clear value in partnering with a provider that not only understands the various stakeholders and their needs, but one that can also support the EAP from design to completion, and then beyond to commercialization of the asset.
And even for those yet to run an EAP, who may be less familiar with the value of interaction between groups, evidence can be found in any recent panel or roundtable discussions involving KOLs and industry experts, where meaningful conversations on specific topics have helped enlighten and share knowledge.
These efforts, along with the identification of key stakeholders and their needs can reduce the assumptions or biases that often hinder effective EAP planning. And it’s with this knowledge and understanding that EAPs can truly reach their full potential in both providing better outcomes for patients and maximising commercial value for the sponsor.