Healthy Skepticism Library item: 15991

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Publication type: news

Taylor L.
Cutting-edge drugs to be fast-tracked, bypassing NICE
Pharma Times 2009 Jul 15
http://www.pharmatimes.com/uknews/article.aspx?id=16224

Full text:

The UK government has announced plans to allow highly innovative drugs to be made available on the NHS for a limited period without going through appraisal by the National Institute for Health and Clinical Excellence (NICE).

This new initiative, called the Innovation Pass, will be made available for drugs to treat small patient populations – such as late-stage cancers – which have the potential to deliver improved patient outcomes but where a lack of cost-effectiveness data is limiting market access, under proposals announced yesterday.

The three-year initiative, which will be piloted with a budget of £25 million in 2010-11 and consulted on until November, aims to give earlier access to innovative drugs to patients with the greatest need. It is a major plank of the Office of Life Sciences (OLS) Blueprint, a package of measures announced yesterday by the Minister for Science and Innovation Lord Drayson and Lord Darzi, Health Minister for Quality and Innovation, which seeks to put innovation at the heart of healthcare delivery, ensure faster patient access to cutting-edge treatments and transform the UK environment for life sciences companies.

“The UK life sciences have everything going for them – world-class facilities, talented scientists and entrepreneurial flair,” said Lord Drayson. “And we are changing how industry, academia, government and the NHS work together to create jobs and ensure a bright future for this country,’ he added.

Lord Darzi said that placing innovation at the heart of health care delivery will help to create a pioneering NHS, and is essential for the Service to be able to meet current economic challenges.

The Blueprint outlines action points in four categories: the NHS as an innovation champion; building a more integrated life sciences industry; providing greater access to finance and stimulating investment; and marketing UK life sciences.

Key actions on what Lord Drayson described as the Blueprint’s “to do” list agreed across government and with industry, academia and the NHS, also include: – a review by NHS chief executive David Nicholson of the system of levers and incentives, including Payment by Results, to accelerate the uptake of new medicines; – reinforcement, in the next NHS Operating Framework, of the need for greater emphasis on research and clinical trials; – the formation of a UK Life Sciences Super Cluster to coordinate work across industry, higher education and the NHS, and to boost international recognition of UK life sciences; and – launch by the Technology Strategy Board of an £18 million Regenerative Medicine programme of investment to support key areas of commercial R&D and the development of R&D partnerships, supported by additional funding of £3.5 million from the Research Councils.

In a joint statement, health care industry groups welcomed the Blueprint as “an excellent basis for firmly securing the future of the life sciences sector and re-establishing the UK’s global competitive position.”

Richard Barker, director general of the Association of the British Pharmaceutical Industry (ABPI), said: “In January we warned the Prime Minister that the life sciences industry in the UK needed a shot in the arm – Gordon Brown has clearly heeded that warning. The OLS Blueprint charts a course of action which is both sound and welcome.”

Mr Brown forecast that the Blueprint “will ensure the life sciences and biotech sector continues to be one of Britain’s leading industries. Harnessing innovation, speeding up access to cutting-edge medicines and technologies and creating high value jobs, the strategy will not only improve the health and well being of patients, but drive economic growth too.”

Leading drugmaker Pfizer called for the Blueprint’s initiatives to be implemented in full measure and stressed the need for “continued commitment to improve and deliver on the suite of proposals as to the future of health technology appraisal and the role of NICE.”

NICE said it welcomed the Innovation Pass, which chief executive Andrew Dillon described as “an opportunity for data to be gathered on potentially important new treatments.”

He added that the access which drugmakers have to the Institute as it appraises their products is being extended. “Later this year, we will begin asking pharmaceutical and other life sciences companies, whose products we are evaluating, to make technical staff available to engage with our advisory Appraisal Committees. They will be able to respond to requests from committee chairs to clarify the data they have submitted and to point out any error of fact in the presentation of their data. We believe that this will give companies more confidence in the way NICE handles the evaluation of their products,” said Mr Dillon.