Access to medicines
‘One-size-fits-all’ approach will not work for drug evaluation and funding
Chair of accelerated access review tells conference why most promising and innovative medicines need to be fast tracked through approval process.
Courtesy of Guy’s & St Thomas’ NHS Foundation Trust
Evaluation and funding of the most promising and innovative medicines require a separate approach to other drugs, according to the chair of the government-commissioned Accelerated Access Review.
Speaking at the Association of the British Pharmaceutical Industry (ABPI) conference in London on 21 April 2016, Sir Hugh Taylor, chair of the review and of Guy’s & St Thomas’ NHS Foundation Trust, said: “A one-size-fits-all system of reimbursement and value isn’t going to work for our future.”
The review, which was expected to be published in spring 2016 but has been delayed until after the UK referendum on EU membership, will recommend alternative options for fast tracking the most promising medicines and technologies, he said.
“What we are going to be proposing is that there is a more systematic attempt to identify the most promising products – the really transformative medicines and other technologies,” he said.
The review will also outline how key players in the government can work together to monitor, support and promote the progress of these technologies and “forms of conditional licensing” to allow patients to access the products while they continue to be evaluated. “That is going to demand a more flexible system of reimbursement,” he added.
Whatever the financial position of the NHS, Sir Hugh added that the uptake of the most exciting new developments “should be a given”, and the focus needs to be on driving out medicines and other technologies that are outdated. “We will have some things to say about how to do that,” he added.
He told the conference it was essential for the NHS to engage at an early stage with pharmaceutical companies developing new products and for companies to be part of the research and evaluation process within the NHS, allowing the NHS to be at the forefront of adopting new medicines. “Right from the moment that something is given conditional approval or approval, the company [should have] confidence that the drug will be adopted at scale because the NHS in its totality is ready and waiting for the medicine – is expecting it and will welcome it,” he said.
The launch of lung cancer drug osimertinib (Tagrisso) was cited as a recent example of how the UK is failing to adopt innovative medicines quickly. Mene Pangalos, executive vice president of innovative medicines and early development at Astra Zeneca, which manufactures Tagrisso, told the conference that the usual time between the first human trials and product launch is seven to nine years, but Astra Zeneca reduced this to just over 2.5 years.
He said the drug was available to patients in the United States 5 hours 37 minutes after regulatory approval. Osimertinib is now also available to patients in France, Germany, the Netherlands, Austria and Scandinavia. In the UK, only patients seeking private healthcare have access to the medicine. “On the NHS, we are now 79 days post approval and lung cancer patients cannot get this drug,” he said. “There is something wrong there – for a drug that was invented in the UK not being accessible to UK patients.”
Mike Thompson, chief executive of the ABPI, added: “The uptake of new medicines is so slow in some therapy areas that some companies are now discussing excluding the UK from their clinical trial roster, because the standard of care is now behind that of other developed countries.”
Carole Longson, director of the National Institute for Health and Care Excellence (NICE) Centre for Health Technology Evaluation, said part of the reason why NICE may take more time than expected to approve a new drug is that the value proposition put forward by industry at market entry isn’t necessary backed up by the evidence needed to support it. “We have to go back to industry and ask them for more information.”
Longson acknowledged that more flexible reimbursement options were required for innovative products such as gene therapies. “Companies are coming to us with proposals which at the moment the [NHS] system itself isn’t able to accommodate,” Longson said.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20201068
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