There are a lot of horror stories about dealing with the various “big 5” EU country (France, Germany, UK, Spain & Italy) drug approval and reimbursement authorities: NICE is a force to be reckoned with; the German authority seems impenetrable; Spain has been changing their policies to offset economic conditions; Italy may require “pay for performance”; France (and others) set budget limits for certain drugs.
A recent assignment highlighted some key considerations when launching a biopharma product in the EU, and some insights on developing a successful strategy emerged.
1. There may not be one EU strategy
Brand managers often express a need for one, all encompassing EU strategy for their brand. Each country has enough unique requirements that each will need its due course for approval, pricing and access negotiations. A clear overarching EU strategy must allow for each country’s nuances.
2. Strategic choices in patient population
The approved patient population will, of course, be based on the clinical trial design, but consideration of key sub-populations, especially at launch, may be worthwhile. A strategy to launch in a smaller population—where the product benefit is clear—and keep expanding into a larger population over time, as more clinical trial data become available and/or real world experience provides a rationale for expanding patient types, has been very effective. Brands that have a clear long-term strategy may be able to successfully implement this approach. They may start “small” in terms of patient population and price, but over time they continue to advance pricing and access as they add new indications and result in a win-win-win (payer/patient/company) scenario.
3. Be as transparent as possible. Then more so
Many companies approach the negotiations with the approval and pricing authorities (The two functions can be closely aligned or distinct depending on the country) as inevitably contentious. However, there are several examples of companies with very difficult challenges, e.g., a high-priced biologic entering a less expensive tablet market, having very successful outcomes both in terms of price and access. The one thread that seems to connect these success stories is that the companies went into the negotiations with complete transparency on not only their data—going above and beyond requirements—but also their long term clinical development plans. Sharing their vision for the benefits of their product in the target populations and how their clinical program supported that vision, often resulted in favorable pricing and access.
4. Shifting healthcare provider roles and site of patient acquisition
Some of the newer biologics being developed for diseases previously treated with a pill are causing a shift both in site of care and possibly where the patient acquires the drug. Certain countries may require injectables to be administered by a specialist whereas the patient had previously been prescribed a pill by a general practitioner. Similarly, higher cost drugs or drugs requiring special handling may be limited to hospital distribution versus a community pharmacy. These changes require companies to carefully consider how to provide the right support services, education and communication to physicians and patients to ensure that patients have access to their product.
The Sovaldi launch shone a bright light on the ever contentious topics of costs and access for patients. As the industry continues to produce more costly—and highly beneficial— biologics for large potential patient populations (e.g., lipid lowering, certain cancers, HepC), there will be more and more experience to draw from.