How will NICE fare in a post-Brexit world?

NICE has a global reputation as a pioneering HTA – but is that influence at risk now that the UK has left the EU? Experts from ICON give us their views on the past, present and future of NICE’s standing on the world stage.

This article appears in our digital magazine, Deep Dive: Market Access 2021. Read below for a preview:

One of the earliest and most pronounced impacts of the UK’s vote to leave the European Union was the loss of the European Medicines Agency (EMA). Long headquartered in London, the EU drug regulator is now severed from the country both physically and systematically, with its base now in Amsterdam and the UK now assessing drugs through its own regulatory agency, MHRA.

This leaves the UK’s drug pricing watchdog, the National Institute for Health and Care Excellence (NICE), in an uncertain position. Once a leading voice in health technology assessment (HTA) in both Europe and the wider world, the body now finds itself unable to work as closely with the EMA – and by extension countries in the EU – as it did in the past.

Emmanuel Lacharme, previously a technical analyst at NICE and now senior consultant, global health economics and outcomes research at ICON, is confident that NICE’s existing reputation will help it maintain its global standing in the immediate future – but notes that there is still a risk the body will become “isolated” as a result of Brexit, particularly as companies are no longer able to rely on the EU’s centralised approval system for the UK.

“There will be uncertain times, but also new opportunities,” he says.

“I believe that NICE will try to do as much as possible to support our industry, by offering early engagements and a streamlined MHRA and NICE parallel approval process. Practically though, there are risks of additional processes and requirements (and expense) for pharmaceutical companies. This additional effort could lead to poorer patient access.

“It is also possible that companies may prefer to enter the EU market through the EMA process and avoid additional processes involving the MHRA and NICE. It’s important to remember that the UK market represents only 2.5% of global pharmaceutical sales, while the entire European market represents more than 20%.”

Caroline Delaitre-Bonnin, senior principal, global health economics and outcomes research at ICON, notes that this could lead to companies no longer seeing the UK as an early launch market.

“The UK has traditionally been an early launch market for pharmaceuticals partly because UK prices are often used as a reference price for other countries, and also because NICE assessments are held in high esteem. Brexit could change this.

“It’s difficult to say whether NICE will maintain the same leadership position in Europe that it has in past years.”

But uncertainty goes both ways, and at the moment it is also too early to say that NICE won’t be able to maintain – or perhaps even strengthen – its influence under the right circumstances.

Lacharme points out that NICE does, at the very least, have a very strong foundation to build upon.

“NICE has always been a great reference in HTA for cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) of new medicines,” he says. “For example, its 2013 guide to the methods of technology appraisal is still a valid reference to understand the key principles of cost effectiveness within an HTA context, and NICE decision support unit documents are a useful resource for any health economist needing technical or educational support.

“While NICE’s first target is the UK NHS, this information can also be useful for other EU health services – especially when a country has not developed its own guidance – and even the US, where evaluation from the institute for clinical and economic review becoming more important, using NICE principles of CEA/CUA.”

With NICE having had a significant influence on the development of other HTA authorities’ methodologies over the last 20 years, Manpreet Sidhu – ICON’s executive principal, global health economics and outcomes research – says the agency’s influence has a good chance of remaining robust over the coming years.

“NICE is still considered to offer a transparent and clear methodological framework for regulators and companies, and so whilst the intricacies of working in a post-Brexit world are ironed out it would seem unlikely that pharma companies/regulators would move away from continuing to engage with NICE.”

Sidhu says it will be important for NICE to continue to lead discussions on methodological perspectives within HTA bodies if it wants to maintain its reputation.

“Being a flagship HTA, where other HTA bodies look to NICE methodologies as a signpost, has been great for the agency,” she says.

“To continue on that trajectory NICE needs to continue engaging with other HTA bodies on joint commissioning of advice and guidance, and utilising cohesive methodologies.”

In fact, NICE has not stopped working with global agencies on collaborative methodologies – one example being the Orbis Project, a joint programme involving the US, Canada, Switzerland, Singapore and Brazil that aims to review and approve promising cancer treatments months ahead of the EU.

“NICE is conscious of its key role in HTA,” says Lacharme, “and it wants to be sure that the UK remains a destination of choice for the life sciences sector. It is still working collaboratively with global health system partners, and more particularly with the MHRA, to design a streamlined process for licensing and evaluating new medicines.”

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