The UK’s cost-effectiveness watchdog the National Institute for Health and Clinical Excellence (NICE) will have primary responsibility for assessing medicines for value-based pricing (VBP) when the new system is introduced in 2014.
The announcement marks a broadening of responsibility for NICE “beyond its current drug evaluation processes”, said the UK Department of Health (DH).
VBP will replace the 55-year-old Pharmaceutical Price Regulation Scheme (PPRS), which allows drugmakers to set their own prices within the constraints of a profit cap, with terms up for renegotiation every five years.
The new system – first unveiled in 2010 – will see government-set pricing based on new definitions of value, although the criteria for these assessments remain sketchy and there are concerns it is being adopted as a means of dramatically reducing the NHS drugs bill.
Earlier this year, the House of Commons Health Committee criticised the lack of detail on the plans and said the inactivity was having a detrimental effect on the pharma industry, patient groups and clinicians. The DH says it has responded to the concerns raised “in full”.
“We are delighted to announce the central role NICE will take in assessing the value of new medicines,” said Health Minister Lord Howe in a statement. “This will allow us to draw on NICE’s world-leading expertise as we develop the VBP scheme,” he added.
NICE will now “plan how it will undertake its role in assessing the value of new medicines”, said the DH. Time is fairly short, however, given that VBP is due to come into force on January 1 next year, and given there have been no pilot schemes to trial the system there are concerns it will not be ready in time.
It has already been suggested that VBP will only apply to new medicines at the outset, with existing drugs continuing to be priced in accordance with the PPRS for an interim period.
The move also comes as NICE is seeing its workload further extended by the addition of social care into its scope of responsibilities, as well as its current remit on the NHS and public health.