Clinical Clarity
The government says it is keen to increase the transparency of how NICE appraises new technologies, but will it be enough to overcome media scepticism of how decisions are made? Jolyon Kimble investigates
As the Medical Devices Agency (MDA) and Medicines Control Agency (MCA) prepare to merge into a new body, the Medicines and Healthcare Products Regulatory Agency (MHRA), in April, it may be time to take a fresh look at how new technologies are appraised before they are approved for use in the National Health Service. The National Institute of Clinical Excellence (NICE) lists technologies as medicines (for example, drugs); medical devices (for example, hearing aids or inhalers); diagnostic techniques (for example, tests used to determine cancer cells); surgical procedures (for example, removal of wisdom teeth) and health promotion activities (for example, the role of diet in managing diabetes). All these areas fall within its appraisal remit.
The speed of technological development ensures that people will be aware of, and consequently expect to receive, the latest (and often most expensive) new clinical products. However, evaluating both the safety and cost effectiveness of state of the art treatment is an extensive, and consequently drawn-out, process. Health minister Lord Hunt is clear about the challenges. "The technology is complex. We have moved from engineering to electronic and now we are in the what-you-might-call the bio age of life sciences. That complexity and the growing importance of bio products is one of the reasons why we decided to merge MDA and MCA to create MHRA", he says.
The Department of Health (DoH) pledged in March 2002 to clarify the scope of NICE's duties, following a commitment made in the Pharmaceutical Industry Competitiveness Task Force (PICTF) report 2001 to review the timings of appraisals of new drugs and other new technologies. It said at that time new technologies should be appraised at time of launch "when the need for guidance is most acute", but allowed for "special circumstances" in which some delay might be appropriate. It further proposed that the Technologies Advisory Committee should give explicit advice on this point for each topic they consider.
Now the aims have evolved. In July last year the Commons Health Select Committee called for a "full-scale review" of how NICE worked and demanded greater transparency in its consultation exercises. The Health committee came to its conclusions after the institute was criticised by charities and patient groups, which accused it of banning or limiting the use of some drugs because they would cost the NHS too much money. Sandra Gidley, Liberal Democrat MP and a member of the committee, argued that: "NICE must be clearer about how it takes decisions on the affordability of new treatments and the effect of that on the wider NHS."
Consequently last December the DoH broadened and refined that framework to include new targets which are anticipated to improve public consultation. The department has set up a web-based system to help members of the public suggest topics for NICE to appraise, which went live in December, and is looking to broaden the membership of the Technologies Advisory Group which advises ministers on the selection of topics. This committee will now include members from all NICE's stakeholders. The DoH is further looking to simplify the process for consulting stakeholders on proposed topics, by combining what are at present separate consultations by health departments and by NICE respectively. The department is also committed to clarifying the criteria for selecting topics, especially around determining when a topic should be considered as a guideline and when as an appraisal. Ministers have also now decided to look at the timing for each topic on its merits, on advice from the companies concerned and from the Technologies Advisory Group.
Explaining the evolving thinking behind the push for improved consultation at the NICE annual conference last December, Lord Hunt said "NICE is already making a major impact on standards of healthcare in this country, by ensuring speedy and equitable access to treatments which work. These changes will strengthen the process and make it easier for everyone to be involved.
"It is clearly important for an effective NICE appraisal process that there is greater involvement by patients and stakeholders and also that there is a better understanding of how decisions are made."
There is no doubt that NICE and the DoH are making the right noises about their determination to improve the transparency of their decision making. Last year's pledges and the imminent appearance of the MHRA are testament to that. There was also much that was encouraging in the select committee report last year. Although there were extensive criticisms, MPs were generally supportive of the Institute's aims. However, constant reports in the media questioning the motives behind NICE's decisions have undermined its reputation, and it's important not just that the reforms to NICE's consultation process work, but that they are seen to work.
