Kennedy calls for overhaul of NICE processes
pharmafile | July 23, 2009 | News story | Research and Development, Sales and Marketing | NICE, hta
NICE has come under fire over its lack of transparency and its relationship with the industry, following an inquiry by Sir Ian Kennedy into the organisation.
The leading academic called for a major shake-up to the way the cost-effectiveness body operates, though he included pharma in some of his criticism of the current problems.
He said of the relationship between NICE and the industry: “To this outsider, the impression is one of undeclared hostilities, if not war. Pharma sees NICE as a barrier to its ambitions to bring products to patients. NICE sees itself as the guardian of the public purse and of all patients.”
“It does not see itself as the guardian or advocate of particular groups of patients, nor of pharma’s aspirations, to the extent that they may be thought by NICE to be in conflict with NICE’s wider responsibility.”
Kennedy was handpicked by NICE chair Sir Michael Rawlins in February 2009 to undertake an independent study in response to the views expressed by Sir David Cooksey in his Review and Refresh of Bioscience 2015.
In his report of 25 recommendations for change, Kennedy criticises NICE for failing to communicate its job properly.
“It does not seek energetically to communicate and explain what it does, particularly in high profile cases. So, it finds itself regarded as blocking patients’ access to drugs, rather than holding the ring between conflicting demands.”
His proposals call for better communication from NICE in explaining its role to both the public and the industry. He also recommended working closely with pharma to identify how the costs of R&D are distributed in the global market.
Kennedy supported NICE’s continued use of approaches such as the incremental cost effectiveness ratio (ICER) and quality adjusted life year (QALY), but said it should also include other health related benefits in its decision-making. He said to do this NICE should consult other interested parties and research how to assess the social benefits of an intervention, such as whether it allows a patient to return to work.
Other proposals include that NICE should try to understand the behaviour and spending of PCTs, and work to develop an active policy on divestment by the NHS in products that do not offer value for money.
Industry criticised
Pharma came under attack on the way it “creates the abiding impression it does not engage with NICE processes” and the way it prices products to take account of the costs of research, development and marketing.
He said: “But the R&D costs are global, as are the costs of marketing.”
“It is not clear how, in fixing a price for the UK market, the costs of R&D and marketing incurred globally are distributed among the various markets.”
Kennedy also questioned the way pharma expects reward for just the promise of innovation, rather than when it is actually proven. He dismissed claims that a higher price should be charged to the NHS for a product that might later prove to be a major innovation.
He said: “It is not clear to me why pharma should be insulated from the normal winds of commerce.”
“The makers of the Betamax held out the promise of their machine as the future for video-recording. They got it wrong and lost out. There was no question of being able to charge a higher price as insurance against failure. The makers of VHS took the risk. They got it right and profited accordingly. Given that the market for medicines is much more stable and predictable, it seems to me that Pharma should bear this particular risk.”
He concluded that NICE should then only offer incentives for innovation when it is realised.
Response
Rawlins was grateful to Sir Ian for his report on the value of innovation, and for broad confidence he expressed in NICE and its methods.
He said: “Since NICE was established we have regularly consulted on our approach to valuing the benefits of new technologies and we welcome the opportunity to focus on innovation. Sir Ian’s report raises a number of issues that NICE will need to consider.”
NICE’s Board is to set out a formal response at its next public Board meeting in September, which will then be the subject of a three-month consultation.
The ABPI also responded and welcomed Kennedy’s findings. It spokesperson said: “Patients in the UK are missing out on modern treatments. Professor Sir Ian Kennedy has recognised the need for NICE to change – for it to be more transparent, to foster innovation, and to take greater account of wider health benefits.”
More change for NICE
The inquiry has come on the back of the Office of Life Sciences report, which cut NICE out of its planning and then proposed a radical overhaul to the way it appraises medicines.
It suggested and ‘Innovation Pass’, whereby innovative drugs would be accepted for NHS use for a period without having to first go through a NICE appraisal, allowing ‘real-world’ data to build up and demonstrate cost effectiveness. The medicine would then face the usual appraisal process after three years.
The scheme will be piloted 2010/2011 and, if successful, would allow products two further years to prove themselves on the market as well as further dedicated funding to pay for their uptake.
The two reports have not been closely integrated, but Kennedy did comment on the Innovation Pass, recommending that NICE ensure that funding for the purchase of the products subject to the Innovation Pass comes from a specially created fund, and not the NHS.
Related Content
Digital mental health technologies – a valuable tool in supporting people with depression and anxiety
The potential benefits of digital mental health technology for managing depression, anxiety and stress, together …
Combination treatments: Takeda’s Implementation Framework and the broader landscape
Pharmafile talks to Emma Roffe, Oncology Country Head (UK & Ireland) about the combination treatment …
NICE recommends Pfizer’s new once-weekly treatment for haemophilia B on NHS
Walton Oaks, 21st May 2025 – Pfizer Ltd announced today that the National Institute for Health and Care …
