Thousands of life-extending drugs could be denied to patients under new guidelines

Thousands of life-extending drugs could be denied to patients under new guidelines which do not always class terminal cancer as ‘severe’, drugs bosses have warned.

A recent decision by watchdog the National Institute for Health and Care Excellence (Nice) to block breast cancer wonder drug Enhertu is just the ‘tip of the iceberg’.

Leading pharmaceutical companies say around 2,000 new cancer drugs are in the pipeline, but warned changes to how they are assessed by regulators mean many are set to be rejected for use on the NHS.

Haran Maheson, of manufacturer Daiichi Sankyo UK, which developed Enhertu, said: ‘In many ways, trastuzumab deruxtecan – or Enhertu – is just the tip of the iceberg.

‘This goes way beyond one company’s individual pipeline for one particular product. It’s an industry-wide issue.’

Thousands of life-extending drugs could be denied to patients under new guidelines, drugs bosses have warned (stock image)

Breast cancer wonder drug Enhertu is given as an intravenous (IV) infusion (stock image)

Breast cancer wonder drug Enhertu is given as an intravenous (IV) infusion (stock image)

Nice introduced new guidelines to determine the cost-effectiveness of medicines for use on the NHS following a review in 2021.

Whereas previous criteria focused on end-of-life treatment for cancer, a new measure – known as a severity modifier rating – was introduced to give more equal weighting for all severe disease. 

It led to Enhertu being refused on cost grounds earlier this year and effectively meant metastatic breast cancer – which has spread with a short life expectancy – was downgraded from being a disease of high to medium severity.

Trials of the drug had found it boosted the time the cancer was held at bay from seven months to over two years – results that were called ‘mind-blowing’ by experts.

The drug is available in Scotland as well as 13 other European countries, the US and Canada.

Baroness Delyth Morgan, of Breast Cancer Now, which has appealed the decision to block Enhertu, warned: ‘For some women it will mean that they will lose their life.’

Dr Sam Roberts, chief executive of Nice, said it was ‘a regrettable case that we hope to resolve’.

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