The technology appraisal system currently applied by the National Institute for Health and Care Excellence (NICE) is not fit for purpose for today’s medicine, and a more radical reform of NICE methods and processes is needed than that proposed in the Institute’s consultation on value-based pricing (VBP), says the Association of the British Pharmaceutical Industry (ABPI).
In its response to the consultation, the industry group calls for NICE to approve more new innovative medicines in the context of the Pharmaceutical Price Regulation Scheme (PPRS) agreement, and says that a new mandate from government may be necessary for achieving this.
The new PPRS sees the industry underwriting growth in the UK branded drugs bill over agreed levels during 2014-18, and this provides a new context to progress a more ambitious set of proposals for VBA, the ABPI tells the consultation.
“This includes explicit opportunities for NICE to adopt a more ‘pro-innovation’ perspective in its decision-making processes for technology appraisals of new medicines; rebalancing its approach to dealing with reasonable uncertainty in the evidence base for new medicines so that NHS patients do not lose out; and providing further discretion to Appraisal Committees to approve medicines for use beyond any fixed upper threshold limit when this might be deemed appropriate,” the Association proposes.
It also stresses that, under the new system, patients must not be worse off than before. For example, while NICE is proposing that existing end-of-life (EoL) criteria will be excluded from its Methods Guide, “uncertainty regarding the way all factors highlighted in the consultation will be aggregated raises concerns over the possibility that exclusion of the EoL criteria could result in a lower acceptance rate of life-extending EoL treatments,” says the ABPI.
It also finds the consultation’s proposal for VBA to be incomplete, insufficiently detailed and too restrictive, warning that, as it stands, the proposal would not only “fail to resolve the underlying access problems faced by medicines coming through the pipeline” but could also “lead NICE to approve interventions that the public would not choose to pay for.”
• NICE needs to develop an approach to assessing a medicine’s value that takes into account not just “an often narrow clinical definition of benefit,” but which also “recognises the real experience of patients, who often benefit in unforeseen ways as a result of having been given new medicines,” a group of cancer charities has urged, in a letter published in The Times on June 20.