How does NICE decide whether to approve a new treatment?

NICE is charged with looking at the cost-effectiveness of drugs and deciding whether they should be made available routinely on the NHS in England and Wales. They do this by looking at how well drugs work using a measure called a Quality Adjusted Life Year, or QALY, which takes into account both length and quality of life. They then measure this against the cost of the drug to get a ‘cost per QALY’ which essentially determines the cost of the drug per year of healthy, good quality life.

A drug which comes in at £20,000-£30,000 per QALY would normally be considered to be cost-effective but with costs per QALY higher than that, very strong evidence is required to show that making the drug available constitutes effective use of NHS resources.

Why has Kadycla been rejected?

Since its inception, we have seen very few new breast cancer medicines approved by NICE. In some cases this has simply been because they do not offer significant benefits to patients, or have severe side effects, but more recently, a number of very promising new drugs have been rejected as their cost has simply been too high for the NHS to afford.

But Kadcyla is a hugely exciting drug that can bring real benefit to women and their families. It is used to treat HER2-positive secondary breast cancer and clinical trials have shown that it can give women six extra months of life on average compared to the existing treatment given at this stage. Most importantly, it is good quality life, with significantly reduced side effects.

That’s because Kadcyla combines a powerful chemotherapy with the drug Herceptin, which targets the treatment to breast cancer cells, reducing the effects of the chemotherapy on the rest of the body. But with a cost per QALY of over £165,000, it’s easy to see why NICE was simply unable to approve it.

But I heard the pharmaceutical company offered a discount?

Roche, the pharmaceutical company which developed Kadcyla, did offer a price reduction to NICE. However, despite NICE applying all the flexibility they could to go beyond their normal cost-effectiveness thresholds, the price reduction offered by Roche simply did not bring the drug down to a price which could realistically be approved by NICE.

So what now?

For us here at Breakthrough, the rejection of Kadcyla by NICE is a red flag, indicating that the current system is just not fit for purpose. We believe all cancer patients should be able to access the best possible treatment but for this to happen within the confines of the NHS budget, prices set by the pharmaceutical industry for impressive, life-extending drugs such as Kadcyla must come down.

Whilst some of the drugs rejected by NICE, including Kadcyla, are available on the Cancer Drugs Fund (CDF) in England, this is a short-term sticking plaster, and doesn’t provide the long-term, sustainable UK-wide solution that we need. The Government promised to fix this problem but they just haven’t done that. And that’s why we’re going to be calling on them to think again, and to work together with NICE and the pharmaceutical industry to find a way to make these drugs available to women who need them, across the whole of the UK, in a way which is sustainable for the NHS in the long term.

It’s impossible to put a price on life’s precious moments. But it’s not impossible to put a fair price on drugs.

What does this mean for patients in the rest of the UK?

The NICE decision also applies to Wales and, while the Cancer Drugs Fund only exists in England, patients in Wales may be able to access Kadcyla through an individual funding request submitted by their doctor.

In Scotland, the Scottish Medicines Consortium (SMC) carries out a similar role to NICE and Kadcyla is being assessed by them at the moment. We expect to hear in the autumn whether it has been approved for routine use in Scotland so watch this space for more. In the meantime, patients in Scotland may also be able to access Kadcyla through an individual funding request.


Read the article on the NICE website