The UK's Department of Health (DH) plans to overhaul the appeal process for the National Institute of Health and Clinical Excellence (NICE) by transferring the power to appoint members of the appeal panel from NICE to the government.
Currently, when companies appeal NICE's final appraisal decisions the appeal panel is chaired by a non-executive director of NICE and includes two other non-executive directors of NICE, or one non-executive director of NICE and one NHS representative. The panels also include someone with experience of the relevant industry and someone with experience of patient or carer organisations.
However, in new plans from the DH, secondary legislation will be tabled under the Health and Social Care Act to give the Health Secretary the power to personally approve all appointments to the panel of experts, while the panel's chair must be someone who does not work for NICE.
The move follows pressure from trade body the Association of the British Pharmaceutical Industry (ABPI) on current Health Secretary Andrew Lansley to revise the way NICE decisions can be contested.
“A long standing industry issue is that appeal hearings are non-independent of NICE and the grounds for appeal are limited largely to process,” said the ABPI's CEO Stephen Whitehead in a letter to Lansley in June 2012.
Criticising the layers of process in place for making a decision about a medicine's availability, Whitehead said: “Policy is made a long way from political accountability and the NICE executive appears to have no remit or desire to challenge the decisions of independent academics. There can also be inconsistency in decision making.”
Commenting the DH's new plans, Stephen Whitehead told PMLiVE: “Appeals are an important and integral part of the NICE appraisal process. We are pleased that as of next year, the NICE appeal panels will be made up of more independent members and in particular that an independent member will chair each panel.
"Industry has been calling for a more independent appeals process for many years and we think it will help deliver a more balanced system for the appraisal of medicines.”
NICE chief executive, Sir Andrew Dillon, who has previously voiced his concerns over the uptake of new medicines in England, said of the DH's new plans: “These changes, which we are aware of, underline the independence of the existing appeal process and will enable NICE to draw on a larger pool of qualified and experienced panel members.”
In addition to these changes, the DH is also currently preparing for negotiations with the ABPI concerning the introduction of a value-based pricing scheme to replace the current PPRS arrange that determines the price of a new medicine.
The negotiations are due to begin next month and in a joint statement about the talks the DH and ABPI noted the importance of "rapid and consistent implementation of NICE Technology Appraisal Recommendations throughout the NHS in England".