Over the past two decades, the National Institute for Health and Care Excellence (NICE) has been responsible for deciding who is able to access new medicines, making cost-benefit appraisals of their roll-out and determining the price the NHS will pay for these treatments. Along with Brexit, and the opportunities afforded to the UK by leaving the regulatory orbit of the European Medicines Agency, the current review of NICE procedures – the biggest since the body was established in 1999 – provides a chance to modernise and optimise the process by which medicines and treatments are approved and prices are set.
Since the NHS is such a huge consumer of pharmaceuticals, and has NICE acting as the gatekeeper into a national market of almost 60 million patients in England and Wales, the UK pays some of the most competitive prices for medicines in Europe, providing excellent overall value for money for our healthcare system. However, the model, as it currently stands, has its drawbacks. The UK may have some of the lowest unit costs for medicines in Europe, but patients often have to wait longer for treatment than you see in Germany, Italy, Spain and France. In simple terms, this means patients are often unable to get the treatments they need, resulting in untold human tragedy.
With our life science ecosystem and NHS expertise, the UK remains one of the best, most attractive places in the world for research and medical innovation. With the NHS’s integrated service and partnerships, a host of biotech and pharmaceutical companies like Gilead, as well as top universities, the UK is at the forefront of the global industry. During the Covid-19 pandemic we’ve seen how essential these partnerships have been. The rapid development, manufacture and roll-out of vaccines was only made possible by “triple helix” cooperation between the public sector, academia and the private sector. This kind of rapid scale-up of cutting-edge medical technology and the breaking down of industry silos is clearly a model of best practice that we should look to emulate in the future, and the UK is one of the best-placed countries to do that. In turn, Brexit looks likely to speed up the process by which new medicines are approved by replacing the costly, timeconsuming regulatory approval process in the EU with a more streamlined, pragmatic approach.
We are, however, falling behind in other areas. As a biopharmaceutical company, Gilead invests huge amounts in new research and drug development. When these new medicines are developed – many of which have the potential to extend people’s lives and greatly improve quality of life – the value to the people who take them may not be fully captured by the method NICE uses to calculate the cost and benefits of new treatments. The ongoing review, with recommendations expected in the coming months, provides the opportunity to consider serious reform.
We want to make sure the price we get for these treatments reflects the value they bring to patients and their families. To give a good example, rheumatoid arthritis can be a debilitating illness, but there are drugs called TNF inhibitors that help prevent the kind of inflammation you see with that condition. Although these drugs have been around for a number of years, NICE is only now changing its guidance to allow their use for people with moderate disease. This is despite them being used for these patients in France, Germany, Italy and Spain for a number of years. Until now, NHS patients have had to wait for their condition to deteriorate and become severe before they were able to access TNF inhibitors.
It happens due to current NICE methodology that calculates that it is cheaper for the NHS to treat people who are already disabled than it is to prevent people from becoming disabled. This is a totally false economy. By evolving NICE’s approach to be more flexible, more future-oriented, and more focused on prevention, patients and the NHS will see the benefit.
We’ve got a real chance now, with this NICE review, for the UK to catch up with other European countries in terms of drugs access and pricing. A key area to be addressed is the discount rate. Currently, Gilead offers an innovative, individualised medicine for people with certain blood cancers, known as CAR T-cell therapy. The NHS could see any benefits well into the future, but they pay for the treatment up front. In order to factor in that future effect, NICE applies discount rates to reduce the value of those future years gained. However, this is calculated at a very high rate, so that the 20th life year gained will only be counted as half as valuable as the first – a discount rate that far outweighs the rate applied to other government investments in physical infrastructure, for example. We’d like to see the discount rate equalised, so it’s consistent between the NHS and the rest of what Treasury guidance stipulates, and so people’s future years of life gained through innovative new treatments are properly valued.
Another area that requires reform are modifiers. NICE only has one – the “end of life” modifier. This stipulates that if a new treatment comes along that gives at least an extra three months of life for people with terminal cancer, for example, then because that time is really valuable for people, we are willing to pay more for that than we pay for other things. There are a lot of other instances, though, when patients gain an awful lot from a medicine, not just “end of life”. Current thinking places little value on medicines in comparison with how patients truly benefit from them and this is an area where NICE needs to enhance its understanding and appreciation.
Events of the past 18 months have shone a light on British healthcare innovation that’s come from industry, the NHS and academia working in collaboration. At the heart of that work has been the patient. As we emerge from the pandemic, both Brexit and the NICE review give us an amazing opportunity to build upon this enhanced partnership of industry, the NHS and academia, and evolve the existing methodology to embrace the new ways of working to heighten the value medicines bring to patients. Let’s grab this opportunity to strengthen the NHS for future generations.
Gordon Lundie is senior director of market access and pricing at Gilead Sciences