OR WAIT 15 SECS
Nathan Jessop is a columnist for Pharmaceutical Technology Europe.
Despite the fact that Europe's population is ageing rapidly, the region is astonishingly still underprepared for dealing with the health-related effect of this demographic trend.
By 2025, more than 20% of the European population will be 65 or older, with a particularly rapid increase in the number of people over 80. By 2050, the number of people aged 65 and above is expected to grow by 70% and the number of people aged over 80 by 170% (1).
Nathan Jessop ((Spotlight image) Stockbyte/GettyImages)
In 2004, the US National Center for Health Statistics reported that 80% of the elderly population (adults aged 65 years and older) took at least one prescription drug in the prior month. Its survey revealed that around half of the individuals in the same age group reported taking three or more prescription drugs and that this statistic represented an increase of nearly 50% over the prior 5–10 years (2). The issue of polypharmacy is also of particular concern in the elderly, who, compared with younger individuals, tend to have more disease conditions for which medicines are required (3). While pan-European figures are hard to come by, these insights into trends in healthcare usage by the elderly studied elsewhere in the world should be considered relevant for the future of healthcare in Europe.
The European Commission's (EC) official position is to actively support Member States in their efforts to promote healthy ageing through dedicated initiatives to improve the health of older people. An ageing population in good health will also mean less strain on health systems and fewer people retiring from work due to ill health. At present, the European Innovation Partnership on Active and Healthy Ageing aims to ensure that the average European citizen has two more active and healthy years to live by 2020 (4). The EC have termed ageing as an opportunity for the region rather than a hindrance. The Partnerships Steering Group was set up in May 2011, and is made up of more than 30 stakeholders representing the health and ageing area, including Member States and regions, organisations representing older patients, nurses, carers and doctors, hospital representatives, academics, industry and venture capitalists organisations. It has already announced that in 2012, it will launch calls for involvement of stakeholders beyond those that participated in the Steering Group to implement together the priorities and actions identified in a Strategic Implementation Plan that it adopted at a meeting in November 2011 (4).
While those behind the initiative push the project forward, their optimism sits in contrast to the current realities because funding and resourcing healthcare systems through societies with smaller workforces is becoming extremely difficult. Most governments have no choice but to make cutbacks in the current, uncertain economic environment, which affects the ability to deliver effective healthcare services for the growing elderly population. For example, the EU recently and dramatically revised its growth forecast for the Eurozone in 2012, from 1.8% to a mere 0.5% (5). Such financial predictions will do little to convince nervous politicians to provide additional investment for initiatives to boost healthcare systems that are already underfunded.
The ominous situation in Greece illustrates the difficulties that can arise in the current economic climate. As a result of the economic meltdown, doctors' wages in the public system have been cut in line with those of other government workers, and hospitals are at risk of being merged and face regular shortages of materials. Even patients who should be entitled to reduced or free medication often cannot find pharmacists to provide them and are instead asked to pay the cost up front and then seek reimbursement.
While the elderly account for high drug consumption, they remain underrepresented in clinical trials. A number of European geriatricians have gone as far as to launch a charter against ageism in clinical trials, highlighting that practical issues in involving elderly people in clinical trials are not the only reason for such observations. These views are the result of their involvement in the European-wide PREDICT consortium for "Increasing the Participation of the Elderly In Clinical Trials" (6). Coordinated from the Medical Economics & Research Centre, Sheffield, UK, the PREDICT initiative began in February 2008 and has received support from the EU and FP7 Health research (the Seventh Framework Programme of the EU for the funding of research and technological development in Europe). The aim of PREDICT is to investigate reasons for the exclusion of the elderly in clinical trials and to provide solutions for this problem. Those behind PREDICT highlight that an analogous problem occurred in the paediatric population, but research in this domain has considerably improved and therefore offers an example of what can be achieved.
Several key European geriatricians state that they have often found themselves in a situation where they were unable to offer patients the best course of treatment with the weight of scientific evidence behind them because of insufficient evidence from clinical trials (6). The group has also carried out extensive reviews of medical literature for conditions prevalent in elderly people to back their opinions. In 2010, PREDICT researchers reported findings from interviews with health professionals in nine countries, as well as from more than 50 focus groups with elderly people and their carers. More recently, it published some of its conclusions in a peer-reviewed paper in the Archives of Internal Medicine, focusing primarily on the extent of exclusion of older individuals in ongoing clinical trials regarding heart failure (7).
The EMA has also taken account of the demographic implications of ageing. In October 2011, it issued an invitation for expressions of interest in an EMA workshop on medicines for older people (8). The provisional dates stated for the workshop are March 22–23, 2012. The workshop will feature a presentation and discussion of the EMA geriatric medicines strategy and related activities, so that gaps in the strategy can be identified. The EMA hopes that a presentation of its strategy in this field will provide opportunity for the identification of synergy areas between stakeholders. It will also seek input on the regulatory mechanisms it is developing to boost geriatric medicine. The sessions currently planned focus on themes that match the EC's European Year of Active Ageing initiative, namely healthy ageing and medicines, demonstrating safety and efficacy in the older population, geriatric pharmacovigilance, and the role of regulatory agencies in providing information to the older population.
For the pharmaceutical industry, a renewed focus on the elderly population offers a tremendous research and commercial opportunity. The work of the PREDICT group and the EMA should also help companies to trial their drugs in this underserved section of the population.
It is predicted that the Alzheimer's disease drug market will nearly triple over the next 10 years, increasing from €4 billion in 2010 to €10.6 billion in 2020 in the major markets of the US, France, Germany, Italy, Spain, the UK and Japan (9). At present the market is dominated by symptomatic therapies that only provide modest effects on cognitive and functional decline but there is a need for more effective drugs. To date, governments have been unwilling to fund expensive new therapies. For example, the UK's National Institute for Clinical Excellence (NICE) caused considerable patient anger in 2007 when it ruled that Aricept and similar drugs should be restricted to people whose dementia had progressed from mild to the moderate, but has not yet reached severe (10). The pharmaceutical industry must find natural allies among patient organisations and clinicians who are dissatisfied with the availability of treatments for elderly section of the population. If governments have publicly stated that they will back initiatives to improve healthcare for the elderly, then their commitment to reimbursing new therapies will be expected.
Companies are aware that pricing will remain important and in the US market, which is becoming more cost conscious, many firms are attempting to become more proactive. For example, Pfizer recently signed a five-year agreement with the US healthcare insurer Humana to investigate treatment costs for the elderly in chronic pain, cardiovascular disease and Alzheimer's disease. The two companies will look at products in relation to healthcare resources and reducing costs (11). The Pharmaceutical Research and Manufacturers of America (PhRMA) industry body has highlighted the cost of failing to treat chronic diseases, estimated it to be as much as 75 cents of every dollar spent on healthcare in the US (12).
Europe faces serious challenges in sustaining its healthcare systems to deliver high quality services to the elderly. Initiatives are being launched at a European level and have received high profile backing from the EC, the EMA and key geriatricians. Such an approach has led to improvements in addressing the gaps seen in paediatric medicine and is seen as a potential model for making improvements with respect to the elderly. Sadly, the ongoing economic difficulties in Europe may hinder investment in additional healthcare services for the elderly as politicians look to implement cutbacks. However, the elderly also represent a growing proportion of the voting population and will therefore not accept their long-term healthcare needs being ignored. For the pharmaceutical industry the demographic trends present opportunities to launch new therapies in these disease areas.
1. EC, "Elderly" (2011). http://ec.europa.eu, accessed Nov. 11, 2011.
2. D.M. Qato et al., J. Gerontol. B. Psychol. Sci. Soc. Sci. 64 Suppl. 1, i86–93 (2009).
3. P.A. Rochon et al., "Drug prescribing for older adults," UpToDate (2011). www.uptodate.com, accessed Nov. 11, 2011.
4. EC, "European Innovation Partnership agrees on actions to turn ageing into an opportunity," Press Release (2011). http://ec.europa.eu, accessed Nov. 11, 2011.
5. BBC News, "Eurozone's growth has stalled, says EU," (2011). www.bbc.co.uk, accessed Nov. 11, 2011.
6. PREDICT, "Increasing the participation of the elderly in clinical trials," (2011). www.predicteu.org, accessed Nov. 11, 2011.
7. A. Cherubini, Arch Intern Med.171(6), 550–556 (2011).
8. EMA, "EMA workshop on medicines for older people," (2011). www.ema.europa.eu, accessed Nov. 11, 2011.
9. Decision Resources, "The Alzheimer's disease drug market will nearly triple over the next ten years," (2011). http://decisionresources.com, accessed Nov. 11, 2011.
10. A. Palmer, "It's not Nice… but the alternative is worse." (Daily Telegraph, 2007). www.telegraph.co.uk, accessed Nov. 11, 2011.
11. Inpharm, "Pfizer has signed a five-year research pact with US healthcare insurer Humana," (2011). www.inpharm.com, accessed Nov. 11, 2011.
12. G. Forrer, "Treating chronic disease could help forestall onset of Alzheimer's disease," (PhRMA, 2011). www.phrma.org, accessed Nov. 11, 2011.