The ABPI has expressed major concerns that NICE is “failing to recognise the progressive and iterative nature of medical discovery,” after it has not endorsed several new drugs.
The UK pharma group, which usually does not discuss NICE decision on specific drugs, said that several “desperately needed medicines” have been rejected by NICE recently.
This includes InterMune’s Esbriet (pirfenidone), licensed for idiopathic pulmonary fibrosis (IPF), which was given a provisional no from NICE earlier this week. The watchdog says that Esbriet had “a modest but measurable effect on slowing the decline in lung function”, but that it was uncertain whether this benefit persisted over time because the clinical trials were short in duration.
The ABPI says this provisional rejection by NICE “reiterates that medicine evaluation processes need to take into greater account levels of unmet need, which includes considering whether there are other treatments available”. NICE could change its mind, however, and recommend that drug if more data is given to the watchdog, or the drug is offered at a lower price.
But the ABPI says that this illustrates the need for more pragmatic approaches to dealing with the uncertainty in the evidence base, which often exists when a medicine is launched such that patients with no other alternatives do not lose out.
The pharma group said that through increased use of cheaper, generic and off-label medicines as comparators, coupled with a lack of pragmatism in dealing with the available evidence, it is “becoming increasingly difficult to get new medicines through the current NICE system”.
Stephen Whitehead, chief executive of the ABPI, said: “These medicines could make a real difference to many thousands of people. Often the first steps in developing new and more advanced treatments are small ones and these gradual improvements over many years have transformed many once terminal diseases in to conditions which can be easily managed through regular medication.
“This is the very nature of scientific innovation and NICE must understand that their continued rejection of new medicines could be standing in the way of breakthroughs in battling disease. We will continue to work with NICE to address these issues.”
This comes as the ABPI is debating a new drug pricing scheme - Value Based Pricing - with the UK Government. VBP could replace the current PPRS pricing scheme by January 2014, and could see the UK Government set drug prices at launch based on new definitions of value.
Currently, its role within this system remains uncertain and the previous health secretary Andrew Lansley made it clear that he would like to see the watchdog’s HTA status downgraded. But new health secretary Jeremy Hunt has not made it clear what NICE’s place will be in the future, or how health technology assessment will work under a VBP system.
The Health Select Committee of MPs is also reviewing NICE's role, and is asking for written submissions on the work of NICE.