The introduction of Value-Based Pricing (VBP), anticipated by the end of 2013, will make cost-effectiveness decisions by the National Institute for Health and Clinical Excellence (NICE) “somewhat redundant,” Health Minister Earl Howe said yesterday.
NICE’s clinical effectiveness work will remain “very, very important” but, under the planned VBP scheme, the price paid for a drug by the National Health Service (NHS) would reflect “everyone’s agreed perspective” on its value, he suggested, speaking in London yesterday at the first joint conference to be held by the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA).
The Department of Health is looking for changes to NICE as part of the move to VBP, and the Minister said he envisaged that the Institute’s role would be “expanded and enhanced,” moving it away from Single Technology Assessments (STA) and towards producing a larger range of guidelines in the areas of social care, public health and quality standards.
He also pledged that the government will honour in full the terms of the current Pharmaceutical Price Regulation Scheme (PPRS), which is due to expire at the end of 2013. The industry needs the “predictability and stability of the PPRS,” said Earl Howe, who is Parliamentary Under Secretary of State in the Department of Health.
His assurance was welcomed by Roch Doliveux, global chief executive at UCB Group, who said this was a “key parameter” for UCB when reviewing its decision criteria on where it should be investing. “Whatever you decide to do with the PPRS, first do no harm,” he warned.
The UK is still home to the greatest percentage of pharmaceutical investment in Europe – although Belgium and Switzerland are now investing more per capita, said Dr Doliveux. He urged the UK industry to look beyond its borders and take the lead in international projects such as the Innovative Medicines Initiative (IMI), set up in 2008 by the European Community and the European Federation of Pharmaceutical Industries and Associations (EFPIA) and is due to run to 2017 with the aim of speeding up the discovery and development of new medicines and boosting European biopharma’s global competitiveness.
Two major new initiatives were announced at yesterday’s conference. The first was the launch of two Therapeutic Capability Clusters, which aim to accelerate the development of new medicines and attract investment into the UK through boosting collaboration between academics, clinicians and the life sciences industry, initially in the areas of inflammatory joint disease and inflammatory respiratory disease.
The Clusters programme director, Alasdair Riddell, said the initiative offers industry: - a single point of access to a select group of clinical investigators and their centres; - unified clinical trial approval sign-offs; - reliable trial recruitment rates; - confidence in study timelines; - and high-quality clinical inputs to study design, conduct and analysis.
The aim is to “build the reputation of the UK as the leading place to do first-in-man studies for the global pharmaceutical industry,” said Dr Riddell and, if successful, it will help the industry reduce the high attritition rates of compounds in later-stage studies, he added.
The Cluster initiative is being led by the Office for Strategic Coordination of Health and Research (OSCHR), whose chairman, Professor Sir John Bell, and Dr Riddell told the conference that they aim to develop a growing portfolio of Clusters, expanding them into areas such as neurology, pediatrics, diabetes and cancer, for example.
The Clusters offer the UK “ real opportunity to take a lead globally,” said Sir John.
The conference also saw the launch of a new joint ABPI/Medical Research Council (MRC) Inflammation and Immunology Initiative, which represents a new approach to investment by the MRC and will complement the Therapeutic Capability Clusters programme. It aims to bring together academics and industry at the early planning stages in research to develop a stratified approach to disease, enabling effective clinical trials as well as identifying novel biomarkers, mechanisms and targets.