Cardiovascular diseases (CVDs) are the number one killer in Europe. They cost the EU an estimated €282 billion in 2021, larger than the entire EU budget itself.[1] Sixty million people live with CVDs in the EU, while 13 million new cases are diagnosed annually.[2]
Behind this data are individual stories of suffering and loss, of lives limited and horizons lowered by, for example, heart attack and stroke. These diseases directly affect every community in every country. And they strain our health services which must respond to cardiac emergencies as well as the ongoing care needs of chronic CVD patients.
Cardiovascular health is a priority not just because of the scale of its impact, but because of the scope we see for significant advances in outcomes for patients. We should take inspiration from the past: between 2000 and 2012, the death rate from CVDs fell by 37 percent in the five largest western European countries (France, Germany, the U.K., Spain and Italy).[2] This progress was achieved through a combination of medical innovations, and supported by a mix of health care policies and guidelines that propelled progress and improved patients’ lives.
New treatments can now help prevent strokes or treat pulmonary embolisms. Others can delay kidney disease progression, while at the same time preventing cardiovascular events.
And the research continues. Precision medicines are in development for inherited CVD-risk factors like elevated lipoprotein(a), which affects up to 20 percent of the population.[3] A new class of anti-thrombotics promises to bring better treatments for the prevention of clotting, without increasing the risk of bleeding. New precision cardiology approaches, such as gene therapy in congestive heart failure, are being investigated as potential cures.
Despite progress, this downward trend has reversed and we are seeing an increase in the CVD burden across all major European countries.[4]
Getting the definitions right
This year’s World Heart Day, spearheaded by the World Heart Federation, comes amid the revision of the EU pharmaceutical legislation. The European Commission’s proposal of a narrow definition of unmet medical need, which could hamper innovation is causing deep concern across stakeholders.
Instead, a patient-centered definition of unmet medical need taking the full spectrum of patient needs into consideration, would incentivize more avenues of research addressing the needs of people living with chronic conditions. It would provide a basis for drafting the next chapter in the history of cardiovascular medicines — one that we hope will be written in Europe and benefit people in the EU and beyond. Not only would this inspire advances that help people to live longer, but it would also improve quality of life for those at risk of, and affected by, cardiovascular events.
Unmet medical need criteria currently included in the draft Pharmaceutical Legislation would do a disservice to patients by downplaying the chronic nature of many CVDs, and the importance of patient-reported outcomes and experience.[5] And many of the advances seen in recent decades would fall short of the narrow definition under consideration. This limited approach disregards incremental innovation, which might otherwise reduce pain, slow disease progression, or improve treatment adherence by taking account of patient preferences for how therapies are administered.
At this moment it is unclear how the unmet medical need criteria in the legislation will apply to these and other situations. Policymakers should create a multistakeholder platform with the space to discuss patients’ needs, getting expert views from medical societies, patients and industry to better understand the innovation environment. The European Alliance for Cardiovascular Health (EACH), a multistakeholder network comprised of 17 organizations in the CVD space in Europe, stands ready to inform policymakers about the CVD burden and the pressing needs of patients. [6] EACH not only supports the EU´s endeavor to develop more policies on CVD, it also supports and promotes the idea of an EU Cardiovascular Health Plan to work towards better patients’ health care across the EU and more equal health standards. So far, structured discussions with such stakeholders do not sufficiently take place, and we risk missing those opportunities, and lose in both patient access as well as R&D attractiveness of the EU.
Primary and secondary prevention
As well as driving future innovation, Europe must also make the best possible use of the tools we have now. We must do what works — everywhere.
At the heart of this approach is prevention. Much of the illness and death caused by CVD is preventable — in fact, 9 out of 10 heart attacks can be avoided.[7] Primary prevention can dramatically reduce rates of heart attack, stroke and other CVDs. Secondary prevention, which includes screening and disease management, such as simple blood tests and urine tests, as well as blood pressure and BMI monitoring, has a key role to play in containing the burden of disease. [8]
Joint cardiovascular and diabetes health checks at primary care level, taking an evidence-based approach, would help diagnose and treat CVD before the onset of acute symptoms.[9] By following current treatment guidelines and protocols, health care professionals across Europe can help to prevent complications, improve health outcomes for patients and save health care costs. Also here, a multistakeholder approach is key. Policymakers should not miss out on listening to the CVD multistakeholder alliances that have already formed — at EU and at EU member countries level, as for example EACH. These partnerships are great ways for policymakers to better understand the needs of patients and to get the experts’ views.
Research-driven companies exist to meet the needs of patients in Europe and around the world. We need to create an environment that enables companies to embark on complex and unpredictable trials. That means having the rights incentives and clarity on the regulatory pathway for future treatments.
[1] https://www.escardio.org/The-ESC/Press-Office/Press-releases/Price-tag-on-cardiovascular-disease-in-Europe-higher-than-entire-EU-budget
[2] https://iris.unibocconi.it/retrieve/handle/11565/4023471/115818/Torbica%20EHJ%202019.pdf
[3] https://www.acc.org/Latest-in-Cardiology/Articles/2019/07/02/08/05/Lipoproteina-in-Clinical-Practice
[4] https://www.efpia.eu/about-medicines/use-of-medicines/disease-specific-groups/transforming-the-lives-of-people-living-with-cardiovascular-diseases/cvd-dashboards
[5] https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en
[6] https://www.cardiovascular-alliance.eu/
[7] https://www.ahajournals.org/doi/10.1161/STROKEAHA.119.024154
[8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5331469/
[9] https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/because-we-can-t-afford-not-to-let-s-make-a-joint-health-check-for-cardiovascular-disease-cvd-and-diabetes-happen/
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