UK unveils scheme to fast-track access to drugs for serious conditions

A scheme unveiled Friday by the UK government aims to accelerate access to innovative medicines for serious conditions, allowing doctors to prescribe the drugs after an initial scientific assessment by the Medicines and Healthcare Products Regulatory Agency (MHRA). Under the Early Access to Medicines scheme, which will be funded by pharmaceutical companies and launched in April, drugs deemed suitable for inclusion will be given a "promising innovative medicine" designation, possibly several years before licensing.

To be eligible, drugs must have several years of clinical data indicating they are promising and innovative treatments, which would then be evaluated by the MHRA to assess their benefits and risks. Candidates deemed effective and sufficiently safe would qualify for the fast-track designation. The agency estimated that one or two therapies could be designated under the scheme each year, although some industry experts suggest there could be more.

Health Secretary Jeremy Hunt said "what patients want is sometimes to try medicines that may not be clinically proven to be effective, but are clinically safe." He noted "we are streamlining the process so these medicines can be used much earlier, particularly if they have early promise." Hunt added that the scheme, which is modelled after the FDA's breakthrough therapy designation, would stimulate investment in medical research by shortening the duration of drug development.

Paul Catchpole, director of Value and Access at the Association of the British Pharmaceutical Industry (ABPI), said "the scheme will benefit patients, the NHS and the UK clinical research community." He noted "the collection of additional data and evidence over the period the medicine is available before launch is very welcome," adding that "this has the potential to assist NICE and other health technology assessment bodies...and could, therefore, result in more timely routine access to licensed medicines for NHS patients."

However, he expressed concern that drugmakers would not be reimbursed for providing drugs under the scheme, "which is an issue for some companies." Catchpole noted that the ABPI wants a re-examination of the programme after one year to "potentially review funding options."

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