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Ireland is one of slowest countries in Europe for medical reimbursment, it’s ‘a bit of a travesty for patients’

AstraZeneca’s Alex Wilkes warns Ireland needs to speed up access to medicines and expand the breadth of its pharma sector

Alex Wilkes, country head of AstraZeneca at the pharma giant's Blanchardstown base in Dublin. Photograph: Barry Cronin

Dominic Coyle's face
Dominic Coyle
Fri Mar 15 2024 - 05:00

Tall and spare, Alex Wilkes gives no hint of a man who played rugby league and union in his youth but then, as a Wigan man, he could hardly have escaped it.

Wilkes is well travelled since those early years growing up close to a hill from which, on a clear day, he says you could see Ireland across the Irish Sea. He arrived in Dublin to manage AstraZeneca’s Irish commercial operations direct from a second stint in Switzerland. Before that, he had worked in senior commercial positions with rivals Roche, Sanofi, Eli Lilly and Germany’s Merck over the last 20 years.

It’s all a long way from his first job in banking after graduating from University of Leeds in anatomy and physiology.

“I’d already been drawn in towards the business side of things at that point but I missed having the value from working with science,” he recalls. Chasing a career in pharma came about almost by accident on the back of conversations with a neighbour who was an area manager for a pharma company.

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“The way he described the job working in sales, it sounded really good. The amazing thing about this industry is, no matter what job you want to do, you could probably do it in pharma.”

Just five months into his new role, Dublin has yet to intrude on his soft Lancashire accent. But he has already been here long enough to experience some of the frustrations that come with leadership of the Irish operation of a multinational pharmaceuticals group. Market access, and inequity on who can get what medicines loom large on his radar and he also has advice for policymakers weighing the future for foreign direct investment.

Wilkes accepts that, with medicines, pricing is always an issue. “It’s always a challenge,” he says of the trade-off between innovation and reward.

“The time that it gets them to reimburse is possibly a different conversation,” he says, turning to an oft-cited criticism of the Irish reimbursement approval process. “It seems that Ireland is one of the slowest countries in Europe ... and that I think is a bit of a travesty for patients, that it takes so long to get access.”

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“So, typically in NICE [the National Institute for Health and Care Excellence which evaluates value for money within the NHS], it would take 12 months to get reimbursement. Here it’s taking two, sometimes three years.”

Apart from the frustration for patients, such delays have real implications for drug companies who have limited patent life in which to profit from the work in developing sometimes breakthrough therapies.

“We’re bringing out life-changing treatments and you have three years where patients don’t get access to a therapy, where they can in other European markets.

He cites France as an example where companies can get reimbursement for innovative, life-saving treatments, almost from the moment they secure European Medicines Agency approval with accounts between the two sides settled when an eventual final price for the drug is fixed.

Price and access are far from just being an Irish issue. Earlier this month, NICE decided to block access to the NHS for AstraZeneca’s blockbuster breast cancer drug Enhertu over price, with NICE director of medicines evaluation Helen Knight saying: “A key uncertainty in estimating Enhertu’s cost-effectiveness was how much longer people on Enhertu live compared with those receiving standard treatment in the future.”

If I leave this role in four or five years’ time, I would love to be able to say that there is no gap around timelines with patients to be able to get access to treatment

And in the US, AstraZeneca is one of several Big Pharma companies challenging – so far unsuccessfully – the constitutionality of the public health system, Medicare, moving to negotiate lower drug prices as the US battles with surging healthcare costs.

Wilkes notes that the industry is open to looking at innovative models of payment. “Several innovative models that have been tried in the past including ones where you don’t pay for patients that don’t respond to treatment. I think we’re always willing to look at schemes like that because we believe in what our drugs can bring,” he says.

But Ireland’s inability so far to collect patient data is seen as a stumbling block to such innovative solutions.

“I was speaking to an ex-colleague who works in Norway, and the access that they have – every single patient is recorded – and then you can really look. So, for example, 10,000 patients have been treated with this drug, this has been the outcome, this has been the benefit that they’ve seen. And then you can start to have those conversations. I think without that type of data and scale and digitisation, it’s quite hard to be able to do that.”

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The AstraZeneca executive is also uncomfortable with a new feature in the Irish healthcare market where private insurers are agreeing to fund the costs of certain medicines for their customers once they are approved by the European Medicines Agency even as public patients are denied access for several years while wrangling continues over price.

“You can also have three years where actually, in some situations, patients who have private medical care can get access to treatments and therapies three years earlier. And that inequality that’s being driven by the system, that feels like something that should be looked at more closely I think by the Government.

“If I leave this role in four or five years’ time, I would love to be able to say that there is no gap around timelines with patients to be able to get access to treatment. I think that’s super important – I think it’s the right thing to do for patients.”

Despite its global standing, it is only within the last decade that AstraZeneca has had a stand-alone presence in Ireland. Before then, it simply had a local sales and marketing office in Dublin where it was just one arm of the company’s UK operation.

It was the Anglo-Swedish pharma powerhouse’s purchase of American rare disease specialist Alexion that really raised the profile of the Irish business. Alexion had chosen Dublin as the site for a global supply chain operation in 2013. It subsequently acquired part of the Elan Drug Technologies facility in Athlone as a vial filling centre and constructed a biologics manufacturing base in Blanchardstown.

AstraZeneca boss Pascal Soriot had been focusing on rebuilding the group’s drug pipeline after seeing off an attempted takeover by US rival, Pfizer. When AstraZeneca bought Alexion for $39 billion – €35.6 billion at today’s prices – in 2021, it finally found itself with a manufacturing presence here – one of the last of the top 20 pharma companies worldwide to do so.

“That was when the phenomenal change, for Ireland specifically, occurred – and [Blanchardstown] became a real strategic site,” the AstraZeneca boss said, noting that the company now employs around 1,300 people here, up from 50 a decade ago.

Spare capacity at that Blanchardstown site provided space when the group was considering options later that same year for a $360 million investment in a “next generation” active pharma ingredient (API) manufacturing facility.

Construction work is continuing with an expected commissioning date in 2026. “So, as well as it being Alexion Manufacturing, it’s going to be AstraZeneca Manufacturing and then obviously the commercial side of the organisation as well. It means that Ireland is a really critical place for us as a strategic hub for the business – and I think it’s only going to grow in the future.”

The question for Ireland going forward is ... how does it grow out beyond the manufacturing piece and start to build in those more upstream things like clinical development, market research, R&D

Siting the new plant in Dublin was a controversial decision at the time, not least because Soriot made clear that a post-Brexit plan to increase the rate of corporation tax in the UK had played a part in the decision. It was no unintentional slip as the man credited with restoring the fortunes of the business over the past decade doubling down on those comments 18 months later after the company reported its full year figures for 2022.

“We’ve made a $400 million investment in the state-of-the-art manufacturing facility, which we wanted to make in this country [the UK] and we’ve made in Ireland because the tax rate was discouraging,” Soriot said. “We’re very committed [to the UK], but we need to see also supporting policies for the whole industry.”

It’s a subject Wilkes is wary of pursuing.

“If you look, our manufacturing bases spread globally so we don’t make decisions around one country. I think there was a lot of challenging press around that decision but they made decisions about individual opportunity.

“Strategically Ireland made a lot of sense. Obviously having Alexion as well – that helped I guess influence that decision. Maybe if we hadn’t have had Alexion, the decision might have been different.”

Despite that decision, he says the State needs to be wary of being overtaken.

“It’s an international powerhouse when it comes to manufacturing. I guess the question for Ireland going forward is ... how does it grow out beyond the manufacturing piece and start to build in those more upstream things like clinical development, market research, R&D. They’re areas where I don’t think it does have the big presence and I guess that’s an opportunity to grow and define, that the Government can look at going forward.

“You have some major strengths where you have world-class universities here that do world-class science. But I guess the more you have an ecosystem built around pharmaceuticals, the more likely it is that that investment will continue to grow, and Ireland will be considered a place or destination for investment.

“If it’s just one element of the business, business life cycles change so how you maintain that becomes harder and harder. You’re competing globally now against countries in the Middle East or in China, and their willingness to attract business as well. So, it’s how competitive can you be.”

He says AstraZeneca is beefing up the Irish operation with the addition of research and development roles in the area of precision medicine at the Blanchardstown site.

The plant under construction at the Blanchardstown site will be a small molecule facility – the more traditional basis for medicines. But unlike many of Ireland active pharmaceutical ingredient sites, it will not focus on volume; instead it is designed to deliver small individualised batch runs of the products so that we can scale and get quickly to the market when we’re launching products.

“The main reason it’s been built in that way is, particularly for launches when we’re doing our early development, what we need to be able to do is respond. The unpredictability of a launch means that it’s quite hard to understand exactly how much supply you need. The opportunity here will give us the ability to do small runs of different products from time to time. So, it’s built to give us flexibility – not to be producing just one treatment, large-scale, high volumes.”

He says the site has been designed not just for what AstraZeneca needs now but for its likely requirement in five or 10 years’ time when it hopes to deliver drugs in earlier stages of development or those being acquired by the company.

That’s critical for a company that, alongside a portfolio boasting 13 blockbuster drugs – those with annual sales of more than $1 billion (€913 million) – has invested more than $135 billion in 30 acquisitions of companies focusing primarily on development stage therapies over the past six years.

Finally, now that his company has established a significant physical presence here, what are the prospects for further investment down the line?

“I would love more investment in Ireland, it’s good for me and it’s good for the team here to see that. But I guess when the senior leaders are looking at the decisions, it’s a global marketplace for investment.”

CV

Name: Alex Wilkes

Age: 44

Position: Country manager, AstraZeneca

Family: Married with no children “but we have two cats”.

Outside interests: a “definitely retired” rugby player, he loves sport and has competed in ironman and triathlon. These days, he settles for the gym four or five times and week, cycling and enjoying Dublin’s “fantastic restaurant scene”.

Something you might expect: He’s “super-interested in AI”. “I think it’s going to revolutionise all businesses. When you look at our development, whereas previously, it might have taken six months to identify a molecule that would be successful against a target – that timeline can be significantly shortened.”

Something that might surprise: Wilkes played rugby against Irish coach Andy Farrell’s younger twin brothers, one of whom, Phil, went on to represent Ireland in rugby league.

AstraZeneca