The National Institute for Health and Care Excellence (NICE) has rejected a government proposal that its assessment of new medicines should include the evaluation of their “wider societal benefit.”
Wider societal benefit (WSB) is a measure of the impact of a treatment on the extent to which people living with an illness or disease “produce” or “consume” resources. However, in its proposals on how the new elements of value-based assessment (VBA) should be incorporated into its methods of technology appraisal, presented to its Board last week, the Institute says that the conceptual framework for WSB which has emerged from work commissioned by the Department of Health “cannot comfortably be integrated into the methodology of a NICE technology appraisal.”
On average, people are at their most productive when they are young to middle-aged, even when taking account of caring and other unpaid roles, it says. Also, WSB is a consequence of the difference between consumption and production, so for some patients their conditions will mean that they have to receive more from society than they are able to give back.
NICE’s report to the Board sets out its concerns explicitly, pointing out that any approach to WSB will “inevitably take age into account to some degree. However broadly the concept is drawn, our age has an impact on what we are able to contribute and what we take from society.”
“Nevertheless, it would be quite wrong for NICE to use the simple fact of the age distribution of people with particular conditions as the basis for deciding whether or not the NHS should offer new treatments,” the Institute tells the Board. It adds: “regardless of the way the proposals in this paper are incorporated into the appraisal process, NICE will not allow age itself to tip the balance of a recommendation against the use of a treatment.”
The Department has explored WSBs by developing “an analytical framework that translates the health benefit of an intervention to the people being treated into a net monetary impact on society,” says NICE. But some members of its Methods Working Party, drawn up to review and advise on the implementation of the WSB and “burden of illness” elements of VBA, “found it conceptually difficult to reconcile the suggested approach to WSB with the equity position normally adopted by the NHS, and some were uncomfortable with the theoretical economic argument that underpins the concept,” it adds.
The Institute has put forward an alternative approach, of “wider societal impact” (WSI). This does not rely on calculations of production and consumption, assessing instead the shortfall of people’s ability to contribute to society as a result of their disease or condition, and taking into account the impact of a condition itself on people’s ability to interact in and contribute to wider society.
The main reason for incorporating WSI into a technology appraisal “is to provide a mechanism for the Appraisal Committee to consider a wider range of potential benefits of new technologies and, in doing so, to give preference to technologies developed for conditions that have the potential to restore the ability of individuals to contribute to society,” says NICE.
The public consultation on incorporation of the new elements of VBA into NICE processes is set to begin in February and last for three months.
– PharmaTimes will be holding a meeting to discuss PPRS and Value Assessment: A Revolution for Medicines Access? on February 26, 2.30pm-6pm. at The Royal Institution in London. Sepakers will include Meindert Boysen, NICE’s programme director, technology appraisals, Dr Cathleen Schulte, policy manager for medicines pricing and value at the Department of Health, and Eric Low, chief executive of Myeloma UK.
