The Cancer Drugs Fund – A Missed Opportunity for Real-World Data

The Cancer Drugs Fund – A Missed Opportunity for Real-World Data

Last week UK researchers broke the news that the Cancer Drugs Fund in England was a “huge waste of money”, and may have caused patients to suffer needlessly from the side effects of the drugs supplied by this fund.

 

What is the Cancer Drugs Fund?

 

The Cancer Drugs Fund was an addition made the the NHS by the Conservative government following an election pledge that promised cancer drugs would be funded even if the NHS refused to allocate budgets to them. Below is a ‘Vote Conservative’ poster from the 2010 election.

 

The fund ran from 2010 to 2016, costing £1.27 billion. Nearly 100,000 patient received drugs under this scheme.

 

What did the research into the Cancer Drugs Fund look at?

 

Researchers looking at the fund focussed on 29 cancer drugs that were approved for 47 indications.

 

They analysed the value of the Cancer Drugs Fund according to 6 criteria:

 

  • Evidence of drug efficacy
  • Effectiveness in Real-World populations
  • Value according to the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO)
  • Cost effectiveness according to the National Institute for Health and Care Excellence (NICE) thresholds
  • Cost effectiveness according to the Cancer Drugs Fund’s own audit
  • Value delivered to NHS patients

 

What did the research show?

 

These figures are shocking when you think about the amount of money involved, so brace yourself:

 

  • Only 38% of the 47 indications reported a statistically significant overall survival benefit – this average increase in survival was just over 3 months, but across the drugs this varied from around 1 month to more than 15 months
  • 48% and 18% met ASCO and ESMO criteria respectively
  • 55% of the indications had been rejected by NICE because they did not meet cost-effectiveness thresholds
  • 13 were de-listed in 2015 due to insufficient evidence for clinical benefit

 

When quality of life and toxic side-effects caused by the drugs were taken into account, the study found that the majority of drugs failed to show any evidence of meaningful clinical benefit. In real terms that means that people undergoing treatment enabled by the Cancer Drugs Fund may have experienced more harm in the form of side-effects, than benefit to their quality of life.

 

Surely there’s some good news?

 

Whilst these figures seem to demonstrate a huge waste of money, it’s not all doom and gloom. The previous Cancer Drugs Fund is no longer in place, and it will now be re-conditioned and improved to make way for a new Cancer Drugs Fund.

 

The conditional approval piece for the new fund is a managed access approach, meaning the introduction of new medicines into the healthcare system is managed and based on the promise of evidence later.

 

NICE’s usual preference for evidence generation is a large, phase 3, randomised controlled trial with a long follow-up. In oncology this is not a realistic way of collecting data. This is where Real-World Evidence (RWE) comes in.

 

This integration of RWE was what was missing from the original Cancer Drugs Fund. If data had been collected regularly on the drugs supplied by the fund, and the way patients reacted to them, such waste could have been prevented.

 

That said, we’re incredibly glad to see Real-World Evidence being integrated into the Cancer Drugs Fund 2.0. RWE will ensure patients are experiencing benefit, and money is being spent in a cost-effective way.