Evidence: The unmet need

New regulatory and reimbursement realities coming into force across Europe mean that better evidence of the value of new medicines is required to satisfy a complex network of stakeholders, each with their own priorities.

Innovation is the goal but the term means different things to different people. What is clear is that, in this new health landscape, it is not enough simply to present a new molecule or even a new class of treatment as innovative – there must be clear evidence of the clinical and economic benefit over existing best practice. 

A long-range view
Significant variations in healthcare funding, provision and commissioning across Europe add an additional layer of complexity for biopharma companies to navigate.  

Early planning is needed to make sure clinical trials gather the right data prior to launch, so that companies embark on pricing and reimbursement discussions with the right evidence to support their claims. 

National payer bodies are reluctant to accept data that is not relevant for their particular system, therefore engaging early in discussions with Health Technology Assessment bodies such as the UK's National Institute for Health and Clinical Excellence and France's Haute Autorité de santé is essential in ensuring that clinical studies are designed to collect the evidence needed for reimbursement decisions.

In the longer term, companies are under increasing pressure to prove the value that their medicine brings in terms of real world outcomes and cost effectiveness. Having a long-range view of evidence generation allows for data on the value of a new drug to be collected throughout its life cycle, thus maximising companies' ability to communicate its value on an ongoing basis. 

Change at the heart of Europe
Even within countries, companies must tailor their approach depending on the needs of local payers. National reimbursement is not enough if a regional or local health authority does not have the budget available to fund a new treatment.

For a drug to be considered innovative, companies need to be able to show budget holders how its adoption will help drive improved outcomes as well as save money. The right approach requires people on the ground who understand the nuances of the local landscape and can build meaningful relationships with key players in each of the major markets.  It may involve remodelling of the way services are delivered to ensure that a drug's potential can be realised.  

Individuals with strong ties to the forward-thinking people within healthcare systems, who are open to new ideas and have the power to drive change internally, are therefore much-needed.

National payer bodies are reluctant to accept data that is not relevant to their particular system …

Market access thinking must extend way beyond traditional commercialisation approaches, informing what questions drug development strategies ask; how this value is demonstrated in the real world and how that value is communicated to a range of stakeholders, each with their own priorities.

Companies that do best in European market access will be those that recognise the growing importance of the payer and adopt new ways of working. We live in an evidence-driven value world that necessitates clinical–commercial convergence. It is only through such changes that the industry can align its products with the unmet needs of payers.