The Department of Health has launched a 10-week consultation over plans for an Innovation Pass that would allow patients with rare diseases access to new drugs on the NHS before they have been cleared by the cost watchdog.

The appraisal of treatments for rare illnesses has always been a bit of a headache for the National Institute for Health and Clinical Excellence because small patient numbers means that the evidence needed to make a full assessment of their use on the NHS soon after their launch is often lacking.

But the new scheme hopes to address this problem by allowing patients access to selected, highly innovative, licensed drugs for a period of three years on the NHS, to give drug manufacturers sufficient time to gather a reasonable amount of clinically meaningful data before NICE carries out its cost-effectiveness test.

“Where there is a high risk that a NICE appraisal of a new treatment at the point of its first use in the NHS might underestimate its benefits, providing the opportunity to gather more evidence and making the treatment available before undertaking an appraisal is the right thing to do,” said the Institute’s chief executive Andrew Dillon, explaining the initiative.

Plans for the Innovation Pass were first laid out in the Office of Life Sciences Blueprint in the summer, forming a key strand of a package of measures designed to put innovation at the heart of healthcare delivery to create a pioneering NHS.

The first year of the three-year pilot scheme, which is being run in conjunction with NICE, will be funded by a ring-fenced budget of £25 million, and funding for subsequent years will be discussed during the consultation, the DH said.

Positive response
According to Health Minister Mike O’Brien, the Innovation Pass pilot will help collect the essential data needed to demonstrate “exciting new innovative drugs…which would not otherwise be available to patients, are making a big difference to their lives”, while Science and Innovation Minister Lord Drayson said the scheme would help “secure patient and economic benefit”.

In addition, Clive Dix, chairman of the BioIndustry Association said the Innovation Pass “signals to the investment community that the government understand and supports the innovative life science sector in the UK”, and the Association of the British Pharmaceutical Industry also welcomed the move, with its Director-General Richard Barker hailing the scheme as “a very positive step for patients, clinicians, the
life science industry and the NHS”.