NICE and the Value of New Medicine

The great and good of the National Institute for Health and Care Excellence are today at their annual conference in Liverpool, so now feels like a good time to look at how the agency has developed since its launch in 1999 and its plans going forward.

NICE says its Health Technology Assessment (HTA) guidances and clinical guidelines help health and social care professionals deliver the best possible care based on the best available evidence and make the best use of their money in the NHS. However, the agency’s efforts to balance clinical and cost effectiveness and the methodology used in its HTAs regularly come under fire, especially by companies who have seen their treatments turned down for use on the National Health Service. One of the reasons for this is often that whilst NICE seek expert clinical and patient opinion, it can sometimes seem as if the patient’s voice is heard as a whisper compared to the weight of academic science taken in to consideration during the process.

It was inevitable that NICE’s quality-adjusted life year (QALY) measures, calculated by estimating the years of life remaining for a patient following a particular treatment and weighting each year with a quality of life score, were going to be controversial. Its committees traditionally use a threshold for recommending treatments of between £20,000 and £30,000 per QALY and there is a debate about whether this represents a reasonable compromise between ensuring a fair price to the NHS (and pharmaceutical companies) and enabling access to new and innovative treatments.

How does Boehringer feel about this?  Well, our group chairman Andreas Barner has already gone on the record to say he admires the agency’s scientific rigour, saying its assessments are, in the main, balanced and intrinsically fair. The process that saw our innovative oncology agent Vargatef (nintedanib) get NICE approval this summer reflects that.

Not even NICE’s biggest supporters would say the system is perfect but I would agree with the sentiments expressed by its chief executive Sir Andrew Dillion earlier this year. He said in a blog that “we obviously can’t just say yes to anything and everything. We don’t have enough money and anyway, not everything is worth having…whether we’ve got the balance right is a question for everyone to reflect on, it’s certainly not a decision just to be left to health economists”.

We are well aware that the demand on the UK’s health and care system continues to grow and are determined to play our part in making sure patients will get access to our innovative treatments at reasonable prices. We are particularly excited about NICE’s new Office for Market Access, an initiative being launched at the Liverpool conference, which will see NICE work with industry to speed up adoption of new medicines by the NHS.

We look forward to continuing our good relationship with NICE and hope its conference is a fruitful one.

What makes a treatment good value for money for the NHS rests on a fine balance of social, political and economic criteria. From my perspective, I can say that Boehringer’s priority is to ensure from the outset that we have the right medicines for the right people at the right price, and this has been reflected in our long list of approvals – which is well above the industry average success rate.

However, one of our core concerns is that as cost pressures increase on the NHS, it is the medicines budget that is the first to be hit. New medicines take decades to research and require billions in investment. As a family owned company, we then have to ensure that our prices reflect our ongoing commitment to long term research and investment.

If the criteria used by NICE to judge the clinical and cost effectiveness of new medicines continue to push downwards on pricing, combined with the low and slow uptake we see in the UK for new medicines, then eventually all companies, including my own, will need to take difficult decisions.

For example, one knock-on effect could be around where clinical trials are sited. If a medicine isn’t going to be used in a country, then you don’t need to have a clinical trial there. This in turn will have an adverse impact on the training and development of our doctors and possibly even patient care.

Another is that patients are today much better informed than 10-20 years ago and will become dissatisfied if they see that medicines which prolong life or improve quality of life are available to patients in other countries sooner than to them in the UK.

What do you think about how NICE works and the criteria it should use to judge new medicines? Please leave a comment and tell me what you think.