A well-run early access program (expanded access, named patient supply, compassionate use, managed access program), in addition to providing a promising medicine to patients with no other options, can provide long-term positive corporate benefits from; generating goodwill amongst future prescribers, gaining early market share, to the generation of data from the first patients to be treated outside the confines of a clinical trial.
But early access programs don’t always go the way you anticipated. Issues can arise from both operational considerations (Are physicians initial enquiries not being responded to in a timely manner?, Are physicians not being adequately supported through the regulatory process? Is product not being shipped in a timely manner?), and also from an expectation point of view i.e., is uptake not as high as anticipated? Forecasting uptake in the early access setting is notoriously difficult as it depends on a broad range of factors, some of which are intangible; awareness of the product, perception of benefit of the product, whether there are existing products on the market for the indication, the level of unmet need and of course the price of the product, if you are charging for access. If you are not receiving demand prior to putting a program in place, there is little chance of demand becoming apparent just because you have put a program in place. Vendors should be advising companies of potential barriers to uptake during the initial program discussions, so expectations are set early on, prior to a program being launched.
A poorly advised, or poorly run program can have significant long-term negative impacts on patient and physician experience and perception of your company, as well as being a wasted investment of both time and resource.
But, what should you do if you find yourself in this situation? The first step is to hold a detailed, honest review with your vendor to discuss issues and agree approaches to address them. A fundamental value of a vendor should be the provision of trusted honest advice, based upon extensive experience of the early access environment. At the same time, their advice should also address the specific nuances of the disease area in which you operate and aim to provide you with a solution tailored to your needs. Operational issues should be straight forward to resolve, and should be detailed in a comprehensive documentation, including Service Level Agreement, Regulatory Plan, Storage and Logistics Plan, Quality Technical Agreement and Communications Plan. Where uptake is lower than expected, then some compliant communications activities to ensure physicians and patients seeking access to a product are aware that a route of early access exists, can be implemented.
Business relationships are like all relationships; some work better than others. If attempts to resolve issues with your vendor fail, then the next step should be to consider transitioning your program to another vendor. This is not as daunting as it sounds (and if done properly should see a smooth transition for physicians and patients already registered on the program) and is often the only way to save or reinvigorate an underperforming access program.
Getting into an early access program is easy. Getting out of one is trickier, but still feasible, and sometimes it is the best option. Inceptua has a ‘Program Transition Toolkit’ which is based on experience of transitioning ongoing early access programs in a seamless manner, to minimize costs to you and disruption to your physicians and patients. Please contact us for more information.
Stuart Bell, Vice President, Inceptua Early Access
Stuart Bell, VP, Inceptua Early Access
Stuart Bell has more than 20 years of healthcare consulting experience, with the last 10 years focused on early access. Stuart has been involved in over 100 early access programs. Stuart is responsible for Inceptua’s consulting activities, including: strategy and policy, feasibility analyses, real-world evidence development and communications. He pioneered the development of global corporate strategies on early access, the concept of detailed Feasibility Analyses for early access, and developed the first early access-specific EDC for real-world data collection.
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