Expanded access programs (EAPs) are growing in popularity throughout North America and Europe. This leaves vast untapped opportunities to provide and establish pharmaceutical supplier relationships in the rest of the world. While the primary goal of an EAP is to bring innovative treatments to patients, sponsors can benefit from the financial incentive of launching a “charged for access” program in new global markets.
Durbin’s experience in delivering EAPs to more than 160 countries gives us unique insight into how patients and manufacturers can gain value through expanded access programs outside of North America and Europe.
In our experience, there are three essential steps to ensure successful EAPs in non-traditional areas:
- Plan strategically to steer success for your expanded access program
- Compliantly raise awareness of your early access program in a new market
- Secure global logistical expertise in the shipping of unlicensed medicines and regulatory teams experienced in early access
1. Plan strategically to steer success for your expanded access program
Sponsors may work under the assumption that newer markets are not financially viable locations for deploying an EAP. We agree there is risk involved in entering a new market, but in our experience, most poor outcomes are preventable. With appropriate planning and forethought, an EAP in Latin America, Asia, or other regions with growing health infrastructure can become an asset to a pharmaceutical distribution program.
For instance, if a manufacturer’s goal is to commercialize a product in a new market, an EAP can be a useful tool to lay the groundwork for future reimbursement and commercial distribution. An EAP is designed to grant patients access to new treatments, therefore, drugs that were once resisted by regulators for commercialization may later gain enthusiasm when regulators see the benefit to patients demonstrated in the program.
Similarly, sponsors that only have experience with product launches in the U.S. and Europe need to invest time creating optimal conditions for aiding eventual reimbursement from these new markets. At Durbin, during our EAP deployment, we simultaneously enable pre-commercial alignment by connecting regulators, payers, and manufacturers and facilitating discussions regarding product commercialization on a global scale. This process sets the groundwork needed for seamless product launch transitions and successful payor negotiations.
An example of this can be found within a global EAP that Durbin delivered in which the inclusion of a smaller Asian market turned out to be a key element of accelerating access and reimbursement in the country. Because of the strategic discussions Durbin facilitated whilst designing the program, a decision was made to include real-world data collection at this location. The sponsor was then able to use this data to support the filing and transition of their product to commercialization.
2. Compliantly raise awareness of your early access program in a new market
One of the most common challenges we encounter is the limited ability to raise awareness of an investigational new drug because of the strong prohibitions on pharmaceutical advertising in many countries. This creates a paradox where only physicians within the country may prescribe an early access drug, but manufacturers cannot proactively inform these physicians about their product.
Existing physicians who are participating in relevant clinical trials can maintain a bi-directional communication pipeline via investigator calls, which companies can use to inform them of upcoming programs in the disease area.
As a point of contact, medical science liaisons (MSLs) often have relationships with physicians in a chosen area. Maintaining established international relationships with MSLs and physicians and using compliant and creative methods to deliver knowledge about early access or applicable trials alleviates this challenge significantly. At Durbin, we have found that EAPs are often a powerful method to improve knowledge of an investigational medicine and increase prescriber confidence before launching a commercial product in new markets.
By increasing prescriber confidence, we also see an increase in appropriate diagnosis as a knock-on effect. Without a therapy, physicians are disincentivized to make certain diagnoses. During and after an EAP, we have observed that appropriate diagnoses increase, as patients have access to the treatment they need. This measurable impact of patient outcomes can serve to increase physician trust, which you can use for future awareness-raising campaigns. Over time, sponsors create a positive feedback loop, creating key opinion leader awareness and product treatment knowledge throughout more countries, ultimately contributing to a huge increase in market preparedness when their drug launches.
Most importantly, raising awareness of a therapy within a disease community via an EAP will result in benefits for everybody involved in that community and beyond, with the potential to globally scale-up the program and help millions more.
3. Secure global logistical expertise in the shipping of unlicensed medicines and regulatory teams experienced in early access
Each country has a unique regulatory framework for early and expanded access programs, which often presents planning and implementation challenges. Durbin has unparalleled global regulatory expertise to help sponsors overcome these barriers and establish EAPs in non-traditional markets.
Our knowledge of the latest country-specific regulations allows us to steer EAPs to success in multiple markets. With strategic experience behind an EAP, patients and providers both benefit.
For example, some countries offer tax benefits to providers, which creates incentives for offering early access drugs to patients. It is essential to use a provider who knows the incentives available in each market and how to best combine those incentives to deliver an EAP that balances patient benefits and stakeholders’ needs.
Each country has specific import and supply chain regulations. A fundamental component of a successful EAP is the ability to streamline shipping and reduce import concerns. Additionally, it is critical to have verified strategies to mitigate risks, such as theft prevention, bona fide checks of institutes to make sure they will be able to pay, and the navigation of financial hurdles such as product affordability and differentiated pricing.
Because we supply to 160 countries, to mitigate risk for our clients as well as streamline shipping, we track all shipments to approved centers, offer alternate shipping routes, hold stock in case of delays, and work with local partners who handle import documentation and destination delivery.
Consider Global Expanded Access Programs
Sponsors should carefully consider the value of using EAPs to expand global access to their products. They can serve as a market access opportunity that your competitors may be overlooking.