Will Europe Discourage the Launch of New Alzheimer's Drugs? - Pharmaceutical Technology

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Will Europe Discourage the Launch of New Alzheimer's Drugs?
The pharmaceutical industry is under pressure to deliver new therapies for Alzheimers disease, but the regulatory bureaucracy in Europe coupled with the demand for lower-priced medicines continues to hinder efforts in innovation.


Pharmaceutical Technology
Volume 36, Issue 11

Mixed signals

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.

Summary

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.

References

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,” http://www.ema.europa.eu, accessed 5 Oct. 2012.

4. A. Palmer, The Telegraph (June 2007), http://www.telegraph.co.uk, accessed 5 Oct. 2012.

5. Alzheimer’s Society website, “The Story so Far,” http://www.alzheimers.org.uk accessed 5 Oct. 2012.

6. EFPIA website, “What Needs to be Done? Time for New Thinking,” http://www.efpia-annualreview.eu, accessed 5 Oct. 2012.


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