Cancer drug gains first early UK access grant
pharmafile | September 17, 2014 | News story | Research and Development, Sales and Marketing | Cancer, NICE, UK, keytruda, oncology, pin, promising
A new type of cell therapy for cancer has become the first to be deemed by the UK government as ‘promising’ and has been added to a new scheme to get medicines to patients faster.
Northwest Biotherapeutics’ experimental DCVax-L is currently undergoing trials for a type of brain tumour called glioblastoma multiforme, and this week the drug become the first to be given the ‘Promising Innovative Medicine’ (PIN) tag.
The scheme, first established in April this year, is designed to speed up the time it takes to get to the UK market and will now be assessed, via the UK drugs body the MHRA, which allows access to new drugs months or even years before they are officially licensed for sale.
Typically the types of drugs being given this designation are for diseases with an unmet medical need.
This mimics similar programmes in the US, notably the FDA’s ‘breakthrough designation’ programme that can see a new drug be authorised more quickly, such as was the case with the early approval this month of Merck’s new PD-1 melanoma drug Keytruda.
The UK is looking to follow in the FDA’s footsteps and react to criticism that it is slow to adopt new drugs. The programme, known as the Early Access to Medicines Scheme (EMAS), also helps harbour a more pro-innovation environment for further pharma investment.
Northwest Biotherapeutics’ drug is predicted by analysts at EvaluatePharma to be worth around $2 billion in peak sales by 2020.
The Department of Health says in a statement: “This early boost to a drug’s potential is expected to be beneficial to companies, especially small and medium-sized enterprises, who can struggle to attract capital during drug development from investors.”
NW Bio will now continue to develop the medicine and, if proven in trials, it will be eligible to apply for the second step of the EAMS. Should it pass through these two phases successfully, it will then go through formal medicines licensing.
The new life sciences minister, George Freeman MP, says: “Making Britain the best place in the world for science, research and development is a central part of our long term economic plan. We want to make Britain the best place in the world to design and deliver 21st Century healthcare technologies which is central to our life science strategy.
“This scheme is helping to secure a better future for people and proves that our country is leading the world in Life Sciences. I hope more companies – big and small – and medical charities, will nominate products to be part of this scheme.”
Linda Powers, chief executive of Northwest Biotherapeutics, adds: “We are most grateful to the MHRA and Minister Freeman for spearheading this new Early Access to Medicines Scheme (EAMS). It strikes a very practical balance between clinical benefits and risks, through careful scientific evaluations, and will be of great help to doctors and patients in opening up new treatment options.”
NICE
EAMS is currently funded by the pharma industry, although a number of industry groups such as the BioIndustry Association (BIA) do not think it should bear all of the costs.
The BIA tells Pharmafile that when it comes to a NICE appraisal, things should also be sped up here too. A NICE appraisal can take anything from nine months to a year, depending on whether the watchdog is minded to find it cost-effective from the start, which could slow down the entire EAMS process.
But the recent government response on how EAMS will be run, explains: “Medicines which have been developed through the Early Access Medicines Scheme will, following granting of a marketing authorisation, be appraised by NICE for routine use on the basis of the evidence collected in the earlier stages of the scheme.”
The BIA tells Pharmafile that this should also see the NICE process quickened under EMAS: “We understand the thinking is that with NICE, having earlier knowledge of the product and access to evidence from the earlier stages of the EAMS process, this will speed up the NICE appraisal at the point of marketing authorisation.”
Ben Adams
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