Early Access Programs: Keys to Success

Early Access Programs (EAPs) offer the healthcare industry two major advantages—providing patients with a high unmet medical need access to innovative medicines before commercialization and allowing pharmaceutical companies to generate KOL engagement that can accelerate reimbursement while leveraging evidence to support both P&R and market access. However, despite these significant benefits, EAPs still remain a mystery for the industry due to their complexity. 

Continue reading to discover Alira Health’s top five recommendations to building a successful EAP. 

Would you like to learn more about EAPs? Check out this episode of Alira Health’s podcast, Transformation Talks, where we discussed the benefits and challenges of implementing EAPs from both the industry and payer perspectives, and recommendations for their effective design and implementation in Europe.

1. Build your strategy around clear goals and objectives

EAPs are different in each country—from the name to the requirements—and companies need to weigh their opportunities and costs to identify which programs are the best fit for their treatment. In France, for example, setting up an EAP is essential to clinical validation as well as demonstrating unmet need that can be leveraged during reimbursement negotiations.  

Additionally, engaging with commissioners, in the UK for example, and payers as early as possible allows agencies to see what drugs are in development and plan their budgets more efficiently. 

Outline your EAP as part of your Phase III evidence gap and plan and identify why you want that scheme for each market, and where the opportunities and benefits are. Then you can create your EAP based on your strategy in each country.

2. Acknowledge challenges and trade-offs

Addressing both market access and pricing challenges before your EAP is implemented is essential and identifying what concessions you are willing to make will help you plan your EAP. One of the biggest pricing challenges, for example, is that Germany sets the highest price in Europe, so if you implement an EAP in a different country before you set the price in Germany, you could be driving your revenue down.  

Similarly in the UK, where early access is free for patients and hospitals, the challenge becomes how to incentivize a quicker evaluation to get to commercialization when you’re addressing the unmet need for free. “A risk analysis is important because maybe authorities don’t want to reimburse the treatment, but what’s important is the patient gets the therapy because there’s a need,” states Nerea. At that point, looking at the clinical validation and data you’ll collect, may be the deciding factor—if you can leverage that data in other countries for earlier access, it may be worth it. 

3. Prioritize patient engagement

Putting patient access at the center of your EAP will help you generate and collect the right data. Such a real-world setting provides payers with a more complete picture of how the product will perform in the market.  

EAPs also allow you to reach patients with real unmet needs who may be excluded from trials or patients who may fall outside official patient organizations.

Patients themselves can often drive early uptake of these medications as they spread the word with their patient and support groups. Engaging patients as early on as possible provides the best opportunity for a successful EAP. 

4. Leverage real-world data (RWD) collection

RWD demonstrates to payers the real-world potential of your treatment and can supplement your clinical trial results. Understanding all aspects of RWD and its impact to your EAP is essential. “You have to understand RWD—if you can use it or not, how it will affect your business,” says Nerea.  

Particularly with rare diseases or where there’s a high unmet need, EAPs can use RWD to inform more than just clinical validation. Developing messaging with input from patients and testing that messaging with your EAP can play a big role in your overall launch strategy. 

5. Keep up with regulations and trends

Staying up to date on each country’s EAP requirements is necessary as the landscape is changing, and EAP implementation is growing. “France has a new law, a change in the EAP system as part of the 2021 Social Security Finance Bill (PLFSS 2021), and we anticipate Germany will also implement new regulations in the overall pricing and reimbursement system soon,” says Nerea. “Staying up to date and considering these new regulations in your strategy is essential.” 

EAPs are a way to provide medicines as quickly as possible to patients with rare diseases or diseases with no treatment—an option that is sometimes lifesaving. Being proactive, planning your company strategy, understanding the collection of RWD collection requirements, and making the most out of your product are the keys to a successful EAP. 

About Alira Health 

The complexity of launching EAPs can be addressed by relying on a trusted partner with strong expertise at the global level. Alira Health can help biopharmaceutical companies shape their market access strategies by supporting the ideation, design, and implementation of EAPs.