Threats and Opportunities in Cardiovascular Health - Pharmaceutical Technology

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Threats and Opportunities in Cardiovascular Health
With the cardiovascular disease burden in Europe increasing, policymakers, regulators and other healthcare stakeholders are seeking to raise awareness and lessen the threat. There are also opportunities for pharma companies. The cardiovascular therapeutic area comprises 15% of the total pharmaceutical market and this looks set to grow in the coming years.

Pharmaceutical Technology Europe
Volume 23, Issue 11

The EMA has also been collaborating with the European Heart Network (EHN) with respect to World Heart Day. The EHN is an alliance of heart foundations and nongovernmental organisations throughout Europe, with member organisations in 26 countries. Using advocacy, networking, education and patient support, the EHN seeks to play a leading role in the prevention and reduction of cardiovascular diseases. The EHN believes that 80% of current cases of cardiovascular disease can be prevented and that even small reductions in incidence and mortality will result in large health gains and reductions in direct and indirect healthcare costs (5). With this in mind, EHN and the European Society of Cardiology created a joint project called EuroHeart. The project involves partners in 21 countries in the EU and the European Economic Area, and receives funding from the European Commission Public Health Programme. The first EuroHeart ran from April 2007 to March and focused on five core areas, including the impact of cardiovascular disease on women and the implementation and adaptation of European guidelines on disease prevention to national situations. EuroHeart II is now underway and will analyse the current situation regarding cardiovascular disease in the EU with the goal of developing a long-term strategy. In particular, the EHN is keen to develop measures for less-advantaged groups.

The fight against cardiovascular disease now has a high political profile thanks to the EHN and European Society of Cardiology. These two organisations manage the Secretariat for the Members of the European Parliament (MEP) Heart Group. This forum is made up of MEPs who have an interest in promoting measures to tackle the threat of cardiovascular disease. Several of the members have a medical background, although there is no restriction on the MEPs who can become involved. The group has been heavily involved in raising the profile of World Heart Day at a political level to influence EU health policy. In March 2011, the MEP Heart Group held a meeting to examine how e-healthcare initiatives could be tailored for cardiovascular disease. Its October 2011 meeting examined how learnings from the United Nations Summit on NonCommunicable Diseases could be applied to the group's own objectives.

Opportunities for the pharma industry?

For the pharmaceutical industry, cardiovascular disease is an important commercial target for treatments and diagnostic tools. Typically, the cardiovascular therapeutic area comprises around 15% of the total pharmaceutical market (6), and Europe's political, regulatory and medical emphasis on improving the outlook for cardiovascular health should create further opportunities for companies to market products in this therapeutic area. Despite the expected demand, however, pharma companies are concerned that cost pressures and cautious regulatory approaches will stand in the way of innovative therapies. It is also unlikely that the EMA's ongoing Multaq review will add to the industry's confidence.

At the 2010 European Society of Cardiology's annual meeting, the organisation's president, Roberto Ferrari, was cited as implying that cardiology had become a victim of its own success (7). Although noting that therapeutic advances in cardiovascular medicine had increased average life spans by about 7–10 years, he also added that regulatory demands were increasing, particularly regarding the required size of clinical trials; large-scale trials inevitably drive up the expense of the development programme. One fear expressed was that companies might choose to reduce investment in the cardiovascular area and preferentially focus on therapy sectors seen as more profitable, such as oncology.

But it's not all bad news on the regulatory front regarding pharmaceutical innovation in this therapy area. Since 2006, the European Federation of Pharmaceutical Industry Associations (EFPIA) has been working with the EMA to develop reliable biomarkers for cardiovascular drug development and in 2009, a workshop was held to discuss the possibilities (8). As biomarkers represent substitutes for clinically meaningful endpoints, their regulatory acceptance would revolutionise cardiovascular drug development by shortening development times. Potential candidates fall into three areas: laboratory markers, physiological parameters and imaging biomarkers. Current thinking is that a cluster of biomarkers will be needed to make progress, as well as collaboration between the pharmaceutical industry and EMA. Fortunately, it does appear that both sides are eager to cooperate and this bodes well for the development of new cardiovascular therapies in line with public health objectives.


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