Many biotech executives we currently meet report difficulties in securing their next financing round to fund further clinical development and bring their innovative treatments to patients. Surprisingly, many do not know that they could make their therapies available to patients earlier and access reimbursed use as a way to finance. This can be accomplished with reimbursed Early Access Programmes (EAPs) which enable providing patients with promising treatments ahead of formal regulatory approval in areas of high unmet need. This creates a win-win-win situation with patients and healthcare systems accessing innovative treatments earlier and biotech companies achieving early sales to finance their further development.
The Role of Early Access in Biotech Strategy
Early access mechanisms allow biopharmaceutical companies to provide therapies to patients before full marketing authorisation or final reimbursement decisions. While initially intended as compassionate or exceptional access for patients without alternatives, many markets, particularly in Europe, have formalised these programmes with defined pathways and reimbursement structures.
For biotech companies, especially those launching their first product, EAPs offer:
- Early cash flow, often critical in the absence of commercial revenues
- Real-world data to support value demonstration
- Earlier patient access to innovative medicines
However, EAPs differ significantly by country in terms of structure, incentives, and financial viability. Below, we examine how France, probably the most established EAP market, presents unique opportunities for biotech funding.
France: Accès précoce and Accès compassionnel
France offers one of the most robust and financially viable early access frameworks in Europe. The Accès précoce and Accès compassionnel pathways (replacing the former ATU system) allow access to promising therapies targeting diseases with high unmet need ahead of marketing authorisation.
Products under EAP are reimbursed and companies can set their own prices during the programme with rebates applying later. Accès précoce enables early revenue generation through defined patient cohorts and a formalized reimbursement pathway. Accès compassionnel, while also reimbursed, is based on named-patient access and may offer more limited scalability but brings strategic advantages, including early real-world data and a platform for broader market entry, particularly in ultra-rare or life-threatening conditions.
According to the CEPS (Comité économique des produits de santé) 2023 Annual Report, total sales of drugs billed under early access and compassionate access continue to grow strongly, up 44.7% in 2023, compared with plus 60.6% in 2022, reaching €1.6 billion. Many biotechs generate significant EAP sales providing an important contribution to their financing. For example, in their 2023 annual report, PharmaMar Group reported revenues of €29.7 million at year-end for Zepzelca stemming mainly from the French EAP.
Reimbursed early access programs in other EU markets
Many European countries have reimbursed early access programs, e.g. Italy offers two valuable early access pathways: Law 648/96 and the 5% Fund. These are similar to France’s EAP frameworks.
Germany offers some possibilities for reimbursement of individual healing attempts while Spain has several pathways for medicines under exceptional circumstances which can enable reimbursed early access.
There are similar programs in several additional countries such as Netherlands, Switzerland, Nordics, Portugal just to name a few. If you would like to receive a complete overview and further detail, please contact us for further information.
Strategic Implications for Biotechs
For biotechs, leveraging EAPs in France and further EU countries can serve dual purposes: demonstrating the real-world value of their therapies and generating early revenue to fund continued development. However, success depends on careful planning, including alignment with national health authorities, readiness for data collection obligations, and well-designed pricing strategies.
These programmes are not without complexity, but they represent a critical opportunity for biotechs to collect data, enable patient access, and generate early revenues all before formal market access is secured.
As the regulatory and pricing landscape evolves, early access mechanisms may increasingly be viewed not just as clinical bridges, but as financial lifelines for innovative companies bringing high-impact therapies to patients in need.
Why choose Justin Stindt Consultants as your Market Access agency?
- Proven Expertise: With extensive experience in global pricing and reimbursement, including early access programmes, our team offers unparalleled expertise and strategic insights which have received many positive reviews and customer testimonials.
- Tailored Solutions: We understand that each client and market is unique, and we provide customized solutions that address specific needs and challenges for biotechs.
- Comprehensive Support: From initial strategic advice to implementation and beyond, our award-winning team offers end-to-end support to ensure your success.
- In-depth knowledge of regulations: Our agency’s deep understanding of regulations, requirements and processes, including extensive experience with HTA bodies, positions us to effectively support your products.
Partner with Justin Stindt Consultants to leverage our expertise and achieve your market access goals with confidence. Do not hesitate to contact us for any inquiries.
