NICE bows to industry pressure
pharmafile | August 21, 2012 | News story | Sales and Marketing | ABPI, NICE, QALY, VBP
NICE has bowed to industry pressure and will allow independent advisors to sit on its appeals board.
An appeal can be lodged by a pharma company – and other interested stakeholders – if its treatment has not been recommended by NICE. This is then taken to an appeals board that can reverse this decision, maintain the original recommendation or make other changes.
But in a recent letter to the health secretary Andrew Lansley, the ABPI’s chief executive Stephen Whitehead said that a ‘long-standing industry issue’ was that NICE’s appeal hearings were populated by members of the watchdog.
This he feels was increasing the likelihood of NICE’s original decision to be upheld, and asked the government to ensure that independent members were allowed to sit on the panels.
The government and NICE have now bowed to pressure and from 2013, Whitehead will get his wish of an independent appeals panel.
He told InPharm: “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.”
The Department of Health confirmed that the changes would go ahead, and said it would be enacted through secondary legislation in April next year.
ABPI wants more concessions
But the ABPI isn’t stopping there; in his letter to Lansley he bemoaned the ‘negative view’ of Britain that was being created by NICE’s decisions not to fund new drugs, adding that this public disavowal “will do nothing to support growth and investment [in the UK].”
NICE is a ‘key issue’ for his members, he said, and that British-headquartered companies were particularly impacted due to the global reach and influence of the watchdog.
He said there are four issues that need to be addressed in order to appease the industry. The first is to broaden the ‘narrow definition’ of QALY – the complex formula NICE uses to assess the cost effectiveness of drugs.
The second is that NICE is too far removed from any political accountability and that this was leading to ‘inconsistency in decision-making’.
Third, Whitehead feels that NICE’s negative decisions often come as a result of comparing a new drug to a generic comparator, or simply to no treatment at all. He says that this practice risks ‘killing innovation’ by not duly rewarding the industry for its R&D costs.
The fourth and final point was managing uncertainty in the evidence base – Whitehead said that good evidence “will never be perfect at launch” and that this should be recognised by NICE and the academics it uses to assess drugs.
Too often, he argues, academic purity can over-ride pragmatism in allowing drugs through.
Whitehead also added that he wants NICE International’s position to be re-considered, amidst concerns that it was having a detrimental affect on pricing – rounding off a full-house of grievances against NICE and its offshoot.
Whitehead said he has already met with Sir Andrew Dillon, chief executive of NICE to discuss some of these issues, but further debate will be ongoing with the government about the issues he has raised.
New drug pricing scheme
This comes just one week before the ABPI and the government start new drug pricing negotiations that could see the end of the PPRS.
The ABPI will hope that it is a good omen that the government has already decided to uphold one of its grievances against NICE.
The government is looking to create a new Value-Based Pricing system by 2014 that will allow it to decide the cost of drugs based on new definitions of value.
The ABPI is looking to water this down considerably, and wants to see an evolution of the old PPRS system, rather than the revolution coming from VBP.
Ben Adams
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