From The Times, 21 November 2104. Story by health correspondent Chris Smyth.
Waiting times for cutting-edge drugs will be cut in half under government plans to rip up a “broken” system that has denied many NHS patients life-extending treatments.
Ministers want to bypass traditional clinical trials by using patients as a “test-bed” for promising new drugs, linking their health service data to pharmaceutical company records to discover much more quickly how effective treatments are.
Firms would be paid different prices depending on how well drugs work for individual patients.
Medicines are increasingly being tailored to the genetic make-up of patients. Ministers argue that the system of assessing new treatments is no longer up to the job and that the National Institute for Health and Care Excellence (Nice) needs to catch up.
While charities and drug companies have welcomed the plans, they warn that they will not be a “magic wand” that ends the notorious slowness of the NHS in introducing modern therapies.
There is also likely to be unease about the practicalities, including safety concerns over fast-tracking new treatments, and fear over handing NHS data to drug companies.
Companies take more than a decade to test and get regulatory approval for medicines before submitting them to Nice. Senior sources with the government have gone as far as to say the system is broken.
They are promising to halve the time it takes to get new treatments to NHS patients, arguing that this can cut the £1 billion average cost of developing new drugs, and ease some of the outcry over Nice’s refusal to pay for a string of new cancer therapies.
George Freeman, the life sciences minister, told The Times: “The one-size- fits-all model of blockbuster drug discovery is ending — to be replaced by a new generation of personalised drugs designed around our genetic profile and medical data.
“This will transform the landscape of drug development from the 20th century model to a world in which the NHS becomes a partner in innovation: testing, proving and adopting new drugs and devices in research studies with real patients.
“With accurate data we can then start to measure — and pay by —results and health outcomes.”
Mr Freeman will launch a review today into the role of Nice and the safety regulator, the Medicines and Healthcare Products Regulatory Agency, aiming to produce recommendations for radical change early next year.
He said that patients must “get access to new life-saving drugs years faster than they do now. Not one or two years, but six or seven”, promising that this would save hundreds of lives a year.
Doctors were at present practising “blind medicine”, where they prescribed on the basis of average responses rather than personalised data.
Mr Freeman, a minister in both the Department of Health and the Department for Business, added:
“For too long NHS patients have seen drugs and innovations developed in the UK but not adopted here in our NHS. We are determined to unlock the power of our NHS to be a test-bed for the 21st-century medical innovations we all need, getting NHS patients faster access, reducing the cost of drug development, and boosting our life science sector, which is increasingly central to our ability to generate the revenue to pay for the costs of advanced healthcare in a prosperous and ageing society.”
Aisling Burnand, chief executive of the Association of Medical Research Charities, said: “The vision is right in terms of trying to get promising compounds into patients quicker.
“Patients do want faster access to innovative medicines that are going to enhance their life or even save it. At the moment there are barriers in the way that slow things down.”
But she added: “It is complex. It is not going to be a magic wand waved tomorrow, it’s going to be a ten-year process.”
The present deal on drug pricing runs until 2019 and the government concedes that changes are unlikely to be put in place before that.
Paul Catchpole of the Association of the British Pharmaceutical Industry said that the review could be “transformative”, arguing:
“It must be an end-to-end review that covers all parts of the system from the [lab] bench to the bedside. It’s going to be a key factor that this review includes the role of Nice. We need a fundamental review of Nice.
“We need to make joined up assessment where there is earlier dialogue between manufacturers, regulators and Nice in order that we can get medicines to market quicker. The danger is if we don’t manage to get that then patients won’t benefit.”
Nice itself has acknowledged the need for an overhaul of how the NHS tests new drugs, signalling a willingness to work with pharmaceutical companies to test more targeted treatments, but it has rejected suggestions that its methods are outdated.
Sir Andrew Dillon, chief executive of Nice, said: “The escalating pace of change in medical science offers enormous potential benefits for patients and the economy. This review provides the opportunity to think carefully about how together we can work through the NHS to deliver the greatest benefit.”