The National Institute for Health and Care Excellence (NICE) and NHS England have released details of their consultation on arranging funding for medicines.
The changes, which will come into force from April 1 this year, will see the introduction of a £100,000 Quality-adjusted life year (QALY) threshold for medicines evaluated via NICE’s Highly Specialised Technologies (HST) programme.
The programme assesses treatments for very rare conditions; this threshold will effectively stop the flow of new medicines reaching patients with very rare and complex diseases.
Many treatments for very rare conditions that are currently funded by NHS England have costs per QALY in excess of £500,000 including the three medicines that have been approved by NICE’s HST process to date.
Steve Bates is the CEO of The BioIndustry Association (BIA), trade association for enterprises in UK bioscience. He said:
The proposals will damage the UK. They will build a Hadrian’s Wall for English patients.
“The decision by NICE and NHS England to implement this new policy in just two and half weeks’ time sends an immediate, stark, negative signal to the global life science investors and companies that the UK needs to attract in the Brexit era.”
“The changes announced will limit patient access to novel, breakthrough potentially life-saving medicines, especially for rare diseases – an area of research the UK government has prioritised in the 100,000 Genome project.”
“In addition, the proposals will damage the UK. They will build a Hadrian’s Wall for English patients who will no longer be able to access innovative new treatments that will continue to be available in Scotland.”
“The UK government now needs to act fast to turn this lose-lose situation into a win-win for rare disease NHS patients, the UK life science sector and the EU.”
“They need to see the big picture and reconsider this initial NICE and NHS England policy in the context of the UK’s upcoming life science strategy.”
Background
It is widely acknowledged in the industry that QALY thresholds are not appropriate for evaluating medicines for very rare diseases, due to the small patient populations, often limited data and uncertainty in the figures produced.
Life sciences companies have been working with government to put together an industrial strategy to ensure the life sciences sector in the UK can continue to thrive following Brexit.
However, the recent NICE/NHS England decision leaves these companies reconsidering whether they will continue to engage with the process, as they do not believe that the government is supporting the industry to bring treatments to the patients that would benefit from them.
