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Regulatory bureaucracy in Europe coupled with the demand for lower-priced medicines continues to hinder efforts in innovation for Alzheimer's disease.
In September 2012, the first global World Alzheimer’s Month was held, representing an international campaign to raise awareness and challenge stigma concerning the disease.
Alzheimer’s disease has a heavy social and financial impact in Europe, particularly because of the rapidly ageing population. EU-funded research has shown that the current rate of ageing in the EU is economically unsustainable and that improving healthcare efficiency would have a greater impact than increasing per capita income (1). This research predicted that nearly 25% of the EU population will be over age 65 by 2030, which represents an increase from 17% calculated in 2005. Despite such officially backed studies, there are few data reflecting the current regional situation for Alzheimer’s disease. In 2011, the Alzheimer Europe’s European Collaboration on Dementia (EuroCoDe) project published its estimates for the economic impact of dementia in Europe in 2008 (2). EuroCoDe estimated the cost of illness of dementia to be €160 billion for 27 EU member states and €177 billion for Europe as a whole (2). The study authors concluded that the estimated cost of illness was higher than described in previous studies and that there was considerable variation in costs and the nature of such costs between different European regions. In northern Europe, direct costs contributed to a large extent to overall estimates, while in southern Europe, the cost of informal care was the major cost component.
These data are already outdated and campaigners believe that the impact of the disease is being underestimated and that European governments must allocate more resources to tackle the disease. There is also pressure on the pharmaceutical industry to deliver new therapies. Although there are several drugs in the industry pipeline, companies often complain that excessive regulatory bureaucracy hinders their efforts in innovation. European patient groups are also highly active in the Alzheimer’s disease field and are scrutinising approaches being taken by regulators.
The World Alzheimer’s Day campaign was coordinated by Alzheimer’s Disease International, an umbrella organisation of Alzheimer associations worldwide, but also received the backing of many other organisations, including the EMA, which was keen to highlight its role in the authorisation of medicines to treat dementia. The EMA has attempted to counteract external criticism concerning bureaucracy and its perceived slow decision making by highlighting changes in its regulatory processes, such as the qualification of innovative development methods to encourage the development of new drugs for this disease area. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued five qualification opinions on biomarkers for Alzheimer’s disease that may enable the diagnosis of the disease before patients show signs of dementia (3). This qualification process is a new procedure whereby applicants can obtain scientific advice on new methodologies for regulatory clinical trials, offering companies greater confidence early in the research and development process that they are employing methods that will be considered robust by regulatory agencies when they reach the review stage. Pharmaceutical companies were able to comment on the EMA’s qualification procedure as it was developed; it will be interesting to see what happens when they submit a novel Alzheimer’s disease therapy for approval using the provisions.
Although the pharmaceutical industry and patients must be encouraged by the stance that regulators are taking towards new research efforts, there is concern that Europe’s pricing environment may still stifle the uptake of new treatments. Regulatory approval is an important step in the lifecycle for a product, but pricing is a distinct area influenced by different government bodies, which may take a very different approach in their decision-making. Although European regulators examine the safety and efficacy of a new drug from a scientific and ethical perspective, decisions by bodies involved in pricing inevitably relate to whether the government “believes” they can fund such treatments. At present in Europe, each country takes a very different attitude to pricing and uses very different systems. Although companies may receive regulatory approval that applies to the EU as a whole, they must then negotiate with pricing bodies in different countries, sometimes at a regional level within a country, as a separate exercise. Much to the annoyance of companies, negative decisions in one country regarding pricing can influence pricing decisions in other countries.
The health technology assessment (HTA) experience with current Alzheimer’s therapies in the UK, based on decisions by the National Institute for Health and Clinical Excellence (NICE), will not have given companies and patients much confidence that future drugs will be welcomed onto the European market (4). Backed by patient groups, the manufacturers of Aricept (donepezil; Pfizer/Eisai), Reminyl (galantamine; Ortho-McNeil Neurologics) and Exelon (rivastigmine tartrate; Novartis) have struggled against NICE. In March 2005, NICE controversially decided that these drugs were not cost effective, leading to a backlash from manufacturers, patient groups and some politicians in the form of “The Hands off dementia drugs” campaign (5). The campaign appeared to have some impact and in 2006 NICE recommended that these drugs be made available to people in the moderate stages of Alzheimer’s disease. Campaigners continued to challenge NICE to widen patient access to the drugs, with the most high-profile challenge occurring when Eisai, the manufacturer of Aricept, launched a judicial review of regarding the negative decision in January 2007. The High Court ruled that NICE had breached disability and race discrimination law, and the body was ordered to make changes to its guidance, but this did not actually reverse its decision. It was, however, concluded that there should be a review of the NICE guidance on drug treatments for Alzheimer’s disease, which took place in 2010 with evidence being submitted by manufacturers and patient organisations. In January 2011, NICE confirmed that Aricept, Exelon and Reminyl would all be available from the National Health Service (NHS) for people in the early to moderate stages of Alzheimer’s disease.
Although this move was welcomed by campaigners, it illustrates the challenge facing companies developing new therapies in Europe. With the current economic crisis, governments are keener than ever to drive down healthcare costs and becausesome Alzheimer’s drugs are already being funded, they may be reluctant to fund others unless the cost-effectiveness data are overwhelmingly compelling. Although it has a huge influence on funding of treatments, HTA is still an evolving process in many European countries and frequently receives criticism from companies and patient groups about opaque decision making (6). Many countries are consulting NICE to develop their HTA processes, which may trouble companies hoping to launch new Alzheimer’s disease therapies in Europe.
The campaign to raise awareness of Alzheimer’s disease and encourage the allocation of more healthcare resources has received considerable support from the pharmaceutical industry, patient groups and government bodies. There is a desire for the pharmaceutical companies to develop new therapies in this area, but the prevailing attitude to pricing among European governments could stand in the way of the next generation of Alzheimer’s disease drugs reaching patients.
1. EC website, “The current rate of ageing in the European Union is economically unsustainable, according to researchers,” http://ec.europa.eu, accessed 5 Oct. 2012.
2. A. Wimo et al., Int. J. Geriatr. Psychiatry 26 (8) 825–832 (2011).
3. EMA website, “World Alzheimer’s Month: September 2012,” www.ema.europa.eu, accessed 5 Oct. 2012.
4. A. Palmer, The Telegraph (June 2007), www.telegraph.co.uk, accessed 5 Oct. 2012.
5. Alzheimer’s Society website, “The Story so Far,” www.alzheimers.org.uk accessed 5 Oct. 2012.
6. EFPIA website, “What Needs to be Done? Time for New Thinking,” www.efpia-annualreview.eu, accessed 5 Oct. 2012.