A new drug development pathway including faster uptake of cost-effective medicines, conditional licensing of new drugs at the end of Phase II trials, and earlier engagement by the National Institute of Clinical Excellence in the development process were among the recommendations in a comprehensive review of UK health research funding published yesterday.
While the review by Sir David Cooksey, chairman of the Clinical Research Collaboration Industry Reference Group, addressed the design and institutional arrangements for publicly funded health research in the UK, it extended not only to the interface between public and private research but to the particular conditions affecting the pharmaceutical industry, the country’s largest single investor in health research.
The Cooksey Review followed on from Chancellor Gordon Brown’s announcement in the 2006 Budget of a single, ring-fenced fund for health research backed by the Medical Research Council and the National Health Service R&D Programme. Accordingly, one of Sir David’s key recommendations was establishing an Office for Strategic Co-ordination of Health Research to serve as an umbrella agency for the MRC and a consolidated version of the new National Institute of Health Research.
The OSCHR concept was taken up in yesterday’s pre-budget report by Chancellor Brown, who said the new initiative would bring together the research capabilities of UK universities, institutes and pharmaceutical companies with the “unique resources” of the NHS under the leadership of Professor John Bell, president of the Academy of Medical Sciences.
£1 billion budget
The OSCHR would have a pooled budget of more than £1 billion per year and would operate a fast-track procedure for priority research, the Chancellor confirmed. One of the proposals in the Cooksey Review is that the new Office should be “responsible for communicating the UK’s health priorities to improve market signalling to the pharmaceuticals and biosciences sectors.”
Research projects considered by the OSCHR to address an unmet national health need would be classified as ‘UK Priority Health Research Projects' conferring “institutional and procedural advantages.” Ideally, these might include faster approval for clinical trials in the NHS and an expedited route through NICE approval, Sir David suggested.
Taking the lead from the USA
The Cooksey Review’s specific recommendations on improving the UK climate for pharmaceutical R&D took their cue from the Critical Path Initiative launched by the US Food and Drug Administration in March 2004. Sir David started from the premise that the current model for drug development was “unsustainable in the long term.”
As pharmaceuticals were increasingly targeted at smaller populations, “the reality is that they will either not repay the investment needed to develop them, or they will be too expensive for health systems to afford,” he commented. At the same time, there were concerns that regulations for healthcare product development had become too complex and onerous, while for some categories of medicines health technology assessment came too late in the development cycle.
“If the NHS’ HTA programme and NICE were involved earlier in the testing of a drug, and were able to influence the questions asked, the outcome measures, and the design of studies,” Sir David said, “NICE might be more comfortable with making interim judgements on new medicines, which would allow limited early adoption of those thought to be cost-effective.” He admitted this would call for cultural change in industry, such as allowing HTA bodies more involvement in designing efficacy studies and aligning marketing strategies more closely with NHS objectives.
Other recommendations for alternative drug development models offering benefits to healthcare funders, taxpayers and patients, as well as pharmaceutical companies and their shareholders, include:
- More rapid discrimination between drug candidates at earlier stages of development, raising the chances of success and reducing development times/costs, with a knock-on effect on affordability;
- Conditional licensing of new drugs – “under strict controls” – at an earlier stage of development, such as the end of Phase II trials; More rapid uptake of new drugs regarded as cost-effective. This would require “processes and approaches which enable NICE to discriminate faster between these and less cost-effective drugs;"
- Using the NHS National Programme for Information Technology to assess more rapidly efficacy and any emerging side-effects over longer periods; and
- Streamlining the processes for setting up and costing clinical trials, while drawing on the NPFIT to identify appropriate patients for trials.
These initiatives would need to be backed up by programmes to encourage the development of novel drug-discovery technologies, such as identifying new biomarkers that could substitute for proof of efficacy and/or safety in clinical studies. Here Sir David envisaged a key role for the OSCHR and the Translational Medicine Funding Board proposed in the review.
A shot in the arm for health research
More generally, he wanted to see a more positive attitude to innovation in the NHS, one that looked beyond immediate cost pressures to the full potential for efficiency gains. The Review recommended a more systematic approach to adopting new technologies and ideas, applying across the whole of the NHS and based on clearly mapped-out processes.
The Cooksey report was warmly welcomed by the research-based industry, with the ABPI calling it a “shot in the arm” for health research and commending its focus on ring-fenced R&D funding, a unified UK research strategy and bolstering translational research to “bring the fruits of bioscience to patients.” The BioIndustry Association said the recommendations for a new drug development pathway could have a “dramatic impact” in reducing costs.
But there were reservations in other quarters about the research budget announced by Chancellor Brown for the OSCHR. The combined value of research funding for the MRC and the NHS in 2007-08 was originally expected to be £1.3 billion, pointed out the British Medical Association. By Peter Mansell