People with diabetes need access to life-changing medicines (Guest blog)
Data from the EFPIA Patients Waiting to Access Innovative Therapies (W.A.I.T.) Indicator Survey reveal major disparities in how long people with diabetes must wait to access the latest medicines. Reviewing the data, the headline figure that jumps out is the average time it takes before a new treatment is available: 647 days.
However, the range is wide. In Switzerland, people with diabetes wait 102 days while those in Poland wait 1,626 days after a product has been approved by the European Medicines Agency (EMA). On top of that, no country offers all 17 new diabetes treatments approved between 2014 and 2022, according to an analysis of W.A.I.T data conducted for the EFPIA Diabetes Platform.
All 17 new treatments examined in this study have been scientifically proven to deliver better outcomes and completed regulatory approval, but are not reaching the people who need them.
The EU average availability is 56% of new products.
Access is hampered by reimbursement mechanisms, some of which prioritise price over value. In some countries, the reimbursement process only begins when a certain number of other EU Member States have granted reimbursement. Allowing the reimbursement process to run in parallel, or immediately after EMA approval, can accelerate time to access and increase availability.
This is a serious problem for people with diabetes, health systems and wider society given the higher costs associated with managing complications. The scale of Europe’s diabetes challenge is growing. And, while industry has delivered new tools that can help to reduce the burden on individuals and economies, their benefits will not be realised if those products stay on the shelf. In the meantime, people with diabetes are at risk of silently developing irreversible health issues.
Focus on preventing complications
When we, the EFPIA Diabetes Platform, commissioned the analysis, we expected the data to show some inequities from one country to the next. But the extent of the problem is much worse than we had feared.
The numbers are stark, especially in the context of a diabetes pandemic. We know that every five seconds, someone dies from a diabetes-related complication. We know that 61 million people in Europe are living with the disease ‒ taken together, this is greater than the population of Italy. And we know the impact that complications have on people’s quality of life. Just consider the human and economic costs of blindness, amputation, stroke or kidney failure to understand the toll this disease can take unless it is actively managed.
We also know that a century of scientific research and sustained industry commitment have delivered the novel treatment options needed to prevent complications. This, in turn, has the potential to dramatically reduce the burden on people’s lives as well as the overall cost of care. 75% of diabetes-related spending is absorbed by managing complications that can be prevented by medicines. Yet only 6% to 11% of overall diabetes spending goes to diabetes medication.
Understanding the barriers
The question is why are so many people waiting so long? The answer, of course, is complex: it can vary due to the differences in how health systems are organised. There are several root causes behind the delays and lack of availability that we are seeing across Europe. These include the speed of national pricing and reimbursement processes, insufficient healthcare systems readiness, and siloed budgeting.
Let’s take siloed budgeting, for example. Imagine a new medication costs more than current treatments but delivers better results for people with diabetes and prevents costly complications. You might expect the new treatment to be funded in a timely manner.
The problem is that the payment might come from this year’s primary care budget, while the savings will benefit future hospital and social care budgets by reducing hospitalisation or care needs. The incentives are misaligned, leading to siloed management of diabetes that does not benefit people nor the overall health system. That is why we advocate integrated budgeting and management in diabetes care as a key element of delivering better outcomes and greater efficiency.
We need to give the best available treatment as early as possible, in line with the recommendations of scientific societies, based on scientific evidence. This is our best chance to prevent irreversible complications which often manifest when the window of prevention has closed. However, it is impossible to do this if new treatments are not available to people with diabetes.
Uniting the diabetes community
Ending undue delays in access to optimal treatment is a task for the entire diabetes community. EFPIA members are committed to playing their part.
Industry is committed to filing pricing and reimbursement applications in all EU countries no later than two years after EU market authorisation, where national systems allow. We support the creation of a European Access Portal where companies can provide information on the timing and processing of pricing and reimbursement applications in EU countries ‒ including the reasons for any delay.
This can provide up-to-date insights to help the diabetes community track progress on our collective efforts to reduce health inequality, as well as a means of monitoring the relative attractiveness of Europe’s regulatory framework compared to other regions.
Industry is also working on a conceptual framework for equity-based tiered pricing (EBTP) to ensure ability to pay is considered in the value-based prices of new medicines, anchored in a principle of solidarity between countries. We believe novel payment and pricing models, used appropriately, can accelerate access and address uncertainty for payers, while providing sufficient incentives for innovation.
No time to wait
The mission for all concerned with diabetes care must be to translate scientific evidence into policy and clinical practice. We are facing a rising tide of non-communicable diseases: cancer, cardiovascular disease, dementia, diabetes, and others. The burden of these conditions will depend on our capacity to prevent or limit the damaging impact of complications.
From a European policy perspective, an overarching approach is needed. This must include an integrated life sciences strategy encompassing diagnostics, devices, digital health and medicines. It should be data-driven and outcomes-focused, while ensuring that the EU provides an innovation-friendly environment. And it should reflect the European Parliament’s motion for a resolution calling for ambitious patient outcomes targets backed by national diabetes plans and effective data collection, monitoring and action to improve self-management.
We know this is complex. If it were easy, it would have been solved by now. However, we can reduce delays and inequalities by accelerating cooperation between stakeholders.
People with diabetes cannot afford to wait. In the five minutes it took you to read this blog post, 60 people have died as a result of diabetes. It is time to urgently embrace EU-level solutions that are accompanied by clear treatment targets and implementation milestones to improve outcomes for people living with diabetes across Europe.