Wednesday, 23 April 2014

What price a new cure?

The recent announcement by NICE, the National Institute for Clinical Excellence to deny NHS patients access to the anticancer drug trastuzumab emtansine (called Kadcyla by the manufacturers, Roche) is a result of their cost benefit analysis. It is useful to consider not only the cost of drug discovery, development and clinical trials, but also the price a particular market (or health economy) will stand. The NHS in the UK is facing increasingly tough decisions on how to allocate its annual budget (of just under £100bn), especially when a single drug for a single patient, for one year is just under £100 000: clearly this is why prevention is their byword!  At the same time $800m (approx £480m) is the generally agreed cost of anti-cancer drug development. It is inevitable that some will feel that the NICE decision is harsh, but it has to be seen in the context of other priorities. It also has raises important issues for drug discovery management by the Pharmaceutical sector.

In an earlier Blog I discussed the challenge of making a profit from the sale of
paracetamol, this is the other end of the spectrum. The challenge here is to meet the demands of the UK population whose average lifespan is significantly higher than say that in a developing country (typically by 30 years!) and around 10-15 years more than in the UK when the NHS was established. How might you therefore persuade an investor to back your business plan to develop a new anticancer treatment given the economic climate in the UK and the even greater pressures on healthcare budgets in the majority of the developing countries? It is worth thinking about the cost of typical treatments and the difficulties faced by NICE alongside those facing the drug companies.

For example, a kidney transplant which lasts for about 10 years saves the NHS £24, 000 pa against the comparative cost of renal dialysis. The upfront transplant surgery costs and the post operative care are significantly lower than the annual costs (around £30 000) of renal dialysis. Importantly, this needs to be considered in the context of the 40 000 cases of renal failure diagnosed per year. And that's just one example. The amount spent per capita per year in the UK on health care works out at around £300. Clearly, the system we operate of redistributing tax revenues and National Insurance contributions is under extreme stress, both as a consequence of increasing life expectancy and probably also a result of a long period without a major conflict involving citizens! You will of course be aware of the influence of the last century's two World Wars, which were only separated by 21 years.

On the topic of conflict driven innovation, I am reminded that it is the centenary of the discovery of citrate as an anti clotting agent. A most timely intervention for the start of WWI and the important discoveries made on the biochemistry and physiology of haemoglobin, driven in part by the need to manage the high casualty levels resulting from trench warfare: in particular the valuable practice of blood transfusion. WWII by comparison, presented a major stimulus for antibiotic development on an affordable, large scale in order to combat field infections. Finally, having spent some time working at the Liverpool School of Tropical Medicine, I am still taken aback by the age of some of the drugs used to treat TB and malaria: TB combination therapies were developed 50 years ago and in the case of malaria, quinine based drugs remain in widespread use after nearly 100 years. However, the need for drugs to treat tropical diseases has probably been influenced significantly by our involvement in conflicts in the East illustrating once again that the drivers behind drug development are complex and often surprising! Hopefully, the intensive research efforts to produce artemesin at an affordable price will be successful and the influence of the Bill and Melinda Gates organisation will catalyse further developments.

I wanted to make you think about the economics of drug discovery when you are discussing your business plans. I firmly  believe that taking stock of historical influences and events can be informative. Now you have a think and discussion amongst yourselves about the government's decision to stockpile Tamiflu from around 2006-2010! 

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