We know innovative medical technologies are essential to addressing the unmet needs of patients and health systems. In fact, no other industry brings as many innovations to market in Europe as the medical technology sector. However, we also know that payers and manufacturers sometimes face a dilemma when it comes to patient access to promising innovations.
Payers want value for money, but defining value is not easy. They often face uncertainty about the clinical and economic outcomes that new technologies will deliver and, as more is known about an innovation through further clinical studies and real-world use, the perceived value of medical technologies can and often does change over time.
This makes it difficult to evaluate the likely return on investment. It’s a Catch 22: more evidence is needed if products are to be reimbursed, but evidence can only be gathered if patients have access.
Showing the value that is directly linked to a medical technology is often not straight forward either. Procedures in which medical technologies are used are multi-factorial, and clinical trials are generally complex and expensive to set up and it is often unclear if and how they inform decision making of the payers. Next to that we deal with relatively short product lifecycles for medical technologies.
All this creates uncertainty for manufacturers too. How can they generate the data required by payers and health authorities if the product is not funded? What is the incentive to invest in solving patients’ unmet need, if they cannot expect their innovation to reach the patient? The challenges and unpredictability that this creates, can stifle innovation. Ultimately, this slows down patient access to potentially life-changing or even lifesaving technologies.
But don’t be discouraged – we have good news. Several payers across Europe are seeking novel approaches to solve this conundrum. Their solution is to create Value-Based Access Programmes (VBAPs). These can offer funding with the aim of introducing medical technologies with promising outcomes into the market in a controlled way, until evidence about their value is fully available. They take a value-based approach – going beyond cost/price to consider the wider value of new technologies.
Based on our research, we believe well-designed VBAPs can have a positive impact for patients, payers, health systems and industry. The trouble is that these new tools are not widely used in Europe yet
To address this need, MedTech Europe and ValueConnected have been working closely together for several months to create a taxonomy (or classification) of existing mechanisms in Europe that allow early funding for medtech innovations.
As we looked more deeply at this issue, the scope of our work evolved. We began to consider the key success factors of each of six identified sub-types of VBAP from the perspective of payers and the industry.
The result is something that goes beyond a descriptive taxonomy of existing VBAPs – we have produced a Guidance document that we hope will serve as a bridge between stakeholders, fuelling a two-way dialogue on how payers and industry can work together to reduce the various uncertainties they face. (A guidance document and two-page summary of this work are now available.)
Based on literature analysis and interviews with payers and industry leaders, the research highlights 27 existing VBAPs across 23 European countries that offer opportunities for manufacturers and payers to work together towards bringing medical innovations to patients.
In this project we aimed to address the needs of both parties – payers and manufacturers – to overcome uncertainties. We found that the first steps are being taken, and the willingness is there on both sides. Payers and industry should continue to build two-way open communication to develop these VBAPs further.
Ultimately, we hope it will help create new ways to ensure access for patients to medtech innovations in a sustainable way.