Companies need to understand early where drug fits in UK system to avoid uptake frustration, says NICE CEO

by Thomas Meek at the BIA and MHRA conference
LONDON, 6 July (APM) - Pharma companies need to have early conversations with UK health bodies about where their product fits into the country’s health system to avoid disappointment about lack of uptake, the chief executive of NICE has said.
“I hear so much from companies saying how disappointed they are that their particular product hasn't done whatever it's doing in Germany or France or Japan or the U.S.,” said Sir Andrew Dillon at a conference on Tuesday.
“I can entirely understand that disappointment, but I do think sometimes companies fail to recognise that this healthcare system is different from those healthcare systems.”

Budget constraints

Dillon, who has led England’s health technology assessment (HTA) body NICE for 20 years, said the UK healthcare system works in a “difficult context” where delivering innovation sits uncomfortably between the ambition of all stakeholders for patients to have access to new products and budget constraints on the National Health Service (NHS).
“Reconciling that and doing that in a way that delivers on the ambition for delivering innovative products and innovative practice in the system is enormously difficult,” said Dillon during a session at a joint conference of the UK’s BioIndustry Association (BIA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in London.
These fiscal challenges have contributed to a perceived lack of uptake for new drugs in the UK, with Dillon saying that NICE, NHS England and other partners need to look across the system to identify constraints so that they can seek opportunities to “encourage and incentivise” the system to make sure that products are taken up as quickly as possible.

Where a product should sit

One of the ways to do this is for NICE and NHS England to have a conversation with pharma companies to try and reach agreement before a product is available for use in the system about what its realistic prospects might be in comparison to other markets.
“We need to recognise the fact that the UK is a particular place to do business if you are a life sciences organisation because of the issues around the way it's structured, the way it’s funded, its traditions in adopting new technologies - some of which stem from that conservative culture, some which stem from the complex mechanisms for decision-making in the system.
“But we can do better than we do at the moment by starting out with a clear recognition and agreement between the company and the healthcare system about where the product should sit in the market, given its particular characteristics, given the other things that are available and given what else is coming down in the development path.”

Pathway redesign

NICE has however attempted to address this through some redesigns of its evaluation pathway in order to engage companies much earlier in the HTA process and give them chances to speak with NHS England, said Dillon.
“I think that opportunity will enable us to have a number of very useful conversations, and one of them will be 'where should this product sit in the system and what can we do collectively - the company, NICE in its guidance and NHS England - to send a clear signal to the system that that's where the product should sit'?”

'Tough place’

Biogen’s UK director for public policy and government affairs Sam Graham said in the same session that the UK can be a “tough place” to bring medicines to market, in particular for rare diseases, where it “languishes behind” European countries.
To address this there needs to be “creative thinking”, he said. “We can’t do what we have always done earlier; I think we need to try and do different things.”
He welcomed the publication in 2016 of the Accelerated Access Review, which set out ways for the UK to speed up access to new medicines, including the launch of the Accelerated Access Collaborative (AAC) (APMHE 55447). This group was set up to identify a small number of breakthrough therapies each year to receive extra support for early access.
“I think it will work if it picks innovations that address wider system issues,” said Graham, adding that there needs to be acceptance that some of the innovations picked by the AAC are going to be budget-increasing, at least in the short term.



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