Witty: Industry must step up to help create new value system
This article was originally published in Scrip
The pharmaceutical industry must commit to "real innovation" and open mindedness if it is to become a thought leader in the debate about delivering and defining value for payers, said Andrew Witty, president of the European pharmaceutical industry federation, EFPIA, at its annual meeting this week.
Mr Witty, also CEO of GlaxoSmithKline, said that the pricing system was changing from one that involved individual countries negotiating individual prices, to one that was "more focused on the value generated".
It is crucial that the industry is engaged in the dialogue about the type of information requested about a drug and about how this information is used to determine whether it will be reimbursed. "There is no point in having a system which requests information that is impossible to generate." There must be a balanced discussion between companies, purchasers, governments and patients, he said.
In Europe, there has been a "Darwinian process of letting a thousand flowers bloom" in terms of finding the right approach to value and price. Some processes are more complex – like that of NICE, the health technology assessment (HTA) body in England and Wales – while others use a more simplistic approach, such as price referencing.
Being part of the discussions is important, but equally, industry must actually deserve to be at the table, said Mr Witty. "We must be committed to innovation that makes a difference. We should not be an industry that thinks a molecule with a one atom difference to a previous molecule deserves a new patent … We must be committed to real innovation to improve patient wellbeing, reduce morbidity and extend life."
Additionally, companies must also be open minded and less defensive about price and agreeing on value. Industry must make payers understand it and also understand that industry is "in it for the same reasons" – ie the best outcomes for patients and healthcare systems.
But governments too have to change their mindset and be willing to reconsider older mechanisms aimed at containing cost and sometimes volume, he said. "As we move to thoughtful health technology assessments, these older mechanisms are becoming redundant." Complex HTA decisions based on relative effectiveness and complex processes should not be "trumped by a decision to reference the three lowest prices in Europe", he warned.
Mr Witty also cautioned against any new system to define value that was so complex that it was overloaded with "unintended consequences" that might prevent or delay innovation.
changing value
It was also important to recognise that a drug's value often increased or decreased in clinical settings after authorisation, said Richard Barker, director general of the UK industry association, the ABPI.
Thomas Löngrenn, executive director of the European Medicines Agency, acknowledged that a drug's value was not clear at the time of approval as evidence was often lacking at that stage. Regulators focused on safety following authorisation, but HTA bodies needed to think about how they would follow up on value, he said.
"Thomas is right … things sometimes become more valuable and useful, we need to generate mechanisms to recognise that," said Professor Sir Michael Rawlins, chairman of the UK National Institute of Health and Clinical Excellence. However, he acknowledged that at the moment there were not enough resources to do this.
Already support is gathering for discussions on a common methodology for assessing relative effectiveness at the European level (scripnews.com, 24 June 2010).