The announcement of NHS England’s £20m cap on costs of new drugs is the strongest signal yet that directions in cancer research need to change. Whether other countries will make similar decisions is hard to know, none have such centralisation as we have with the NHS.
Why, I hear you ask, does cancer research need to change direction?
Research is dominated by the pharmaceutical industry in its ceaseless search for new agents which can be patented and whose revenues will then fund the next generation of drugs. They also fund our pension schemes, we must not forget that. Socially we have a dichotomous relationship with them, we want their profits but we recognise that we are funding them. This hidden agenda has been present throughout the increasingly tense relationship between pharma and its demand for higher and higher prices, and healthcare systems which somehow or another have to be funded by consumers.
Now NHS England is calling a halt.
The £20m cap means a drug which costs £5,000 for a treatment will only get funding for 4,000 treatments. A course of eight treatments means that only 500 patients can get funded. This might work with a rare condition, it won’t where there are high volumes of patients. The signal to pharma is ‘drop your prices’. It is quite unequivocal. There will, of course, be plenty of occasions when the value of a drug is perceived to be so high that the cost beyond £20m will be carried; even so ‘drop your price’ will still be the message.
Research now has to focus on ‘value’, not clinical benefit. Pharma-led research has been driven by outcomes such as Overall Survival, and various surrogates for it like Progression Free Survival. Patients will tell you that survival with heavy side-effects is not necessarily good value. Spending all the time gained from treatment taking yet more pills, travelling to and from hospital or confined to home is not good quality of life. It is that quality which needs measurement and independent reporting. At the end of the day only patients can tell the regulators what represents good value.
There is another impact on research. There is now a real need for academic researchers to push pharma to look again at drugs which have not entered standard clinical practice. A drug which failed against the Overall Survival outcome for one cancer may have real value in another cancer. A drug licensed for one condition may have value in another for which it is not explicitly licensed. The value for pharma could be an extended exclusive patent period.
There are also drugs available to generic manufacturers, who are familiar with small scale proof of equivalence studies but rarely undertake exploratory studies. There should be the opportunity for academic researchers to work with them to open up new treatment opportunities, perhaps in rarer conditions where there are indications a drug might add value. A core issue here is preserving some income exclusivity for a company or companies which invest in this way. This is a regulatory challenge.
There is a huge resource out there which is largely unexploited. The £20m cap is a strong signal that we must start thinking outside the box