At Medicines for Europe’s annual conference earlier this year, the association’s value added medicines sector chair and Pharmanovia CEO, James Burt, set out a stark message for the region – suggesting that it was falling behind other global markets by not harnessing the potential of reformulated medicines.
Recent European legislative efforts to recognize the value of repurposed medicines, set out in directive Article 84 of the EU’s new proposed pharmaceutical package, include a period of data exclusivity protection for new indications, but crucially offer no reward for reformulated drugs.
With that legislation continuing to make its way through the European system – a process that is expected to last throughout next year – Burt indicated in an interview with Generics Bulletin that the value added medicines industry is continuing to put pressure on legislators to broaden Article 84’s scope.
“We are asking permanent representatives from quite a few countries whether we can get that expanded to include change in posology or change in formulation,” Burt indicated. “And what’s super important about that is that Europe is missing out a massive opportunity if it doesn’t do that.”
Holding up the US hybrid 505(b)(2) approval pathway as a template for Europe to aspire to, Burt observed that while the US market for value added medicines was currently “much bigger, as you’d expect,” the scale of the challenge for Europe was even bigger than some might realize.
“The whole value added medicine market globally is the equivalent of about France in terms of medicine spend,” he outlined. “But the vast majority of that is not Europe. It’s sort of 80% outside of Europe, or more, 85%.”
Outlining some of the particular challenges for European developers, he said that “what you see with approvals of things in this sort of space, because of the issue that the pathway is not clear, you typically have to do Phase III. You typically have complicated price recognition, or getting treated like a generic after you’ve invested. It’s just static. There’s no one really getting approvals through.” Whereas “the US is bigger and growing at quite a pace, as there’s an incentive.”
Ultimately, Burt warned, in Europe “we’re 40 years behind them and the gap is growing. Without this legislation we won’t ever catch up. And it’s not just the US, it’s Japan, it’s China, it’s Brazil, it’s Mexico, it’s everywhere.”
VAMs ‘Save Health Systems A Lot Of Money’
Setting out the many benefits that would come with recognizing changes in formulation and posology as well as just new indications, Burt said “it’s going to allow improvements to utility. Good examples there are things like methotrexate pre-filled syringes, that held people off anti-TNFs and saved billions for the European health system. Innovations like that can have a big impact on holding patients lower down rungs in the treatment ladder at great savings.”
“Or it can be an efficacy gain,” he outlined. “There’s a great breast cancer medicine where they’ve reformulated and got a 50% efficacy gain – same INN – and things like that really should be afforded a protection.”
But “if they don’t get that, there’s no incentive for people to invest millions in trials to go make them happen. So it’s a self-defeating prophecy.”
And the benefits of value added medicines went wider, he explained, with certain innovations around existing molecules able to “actually take a load off busy hospitals, busy primary care surgeries. It’s things that may be a bit like that methotrexate, for example, that allow more home administration. It can be things like fixed-dose combinations, getting better adherence, so you’ve got less problems. So people are less likely to go back to their physician.”
“All of these things save health systems a lot of money,” he emphasized. “It’s not about adding to costs, it’s about being more efficient. But if Europe doesn’t facilitate that change in Article 84 to have posology and formulation, no-one’s going to develop for it.”
So “the legislation is part of it,” he said. But it was also about “engaging with HTAs [Health Technology Assessments]. So price reimbursement bodies.”
“We fully want us to be held to pharmacoeconomic cases,” he acknowledged. “No one’s trying to get free pricing here. It’s about incentives through the system. Once something’s effectively approved as a value-add, you then go talk to the HTAs.” But compared to the US system, “there’s no mechanism to get it recognized.”
“Europe’s falling behind and actually more often than not, costing itself more money than it needs to.”
“A lot of the bigger Indian formulators are giving up on Europe now.”
Moreover, he suggested, the latest industry data suggested that “a lot of the bigger Indian formulators are giving up on Europe now. It’s been talked about for so long. They’d rather focus on other geographies like the US or China for value added medicines. So I think there’s a big issue there.”
And value added medicines, he suggested, offered Europe “a massive of opportunity for domestic formulations – places like Barcelona, like northern Italy, like Germany, have some fantastic formulation specialists: give them a chance. It’s about growing home industry.”
Another topic that arose during Medicines for Europe’s annual conference this year was the need for developers to have a more meaningful dialogue with regulators and payers earlier in the development process. Asked if there was any optimism on this front, Burt said “I think there’s hope.”
“There’s certainly recognition that the European Medicines Agency and price bodies need to get involved at the clinical trial design stage. And I think I’m understanding scientific advice is sort of being conjoined with engagement with payers now. I think that’s all part of the package. So it’ll remain to be seen what comes out. But that’s certainly a stated aim.”
Sector Group Sets Out 2025 Priorities
“One of the things I’ve just done with the Medicines for Europe value added medicines sector group is agree the priorities for 2025,” Burt revealed. “We feel that we’re getting toward the end of the legislation activity. We want to be seeing more of the HTAs, particularly through national associations who are the experts for their market.”
And “what you can see at a local level is different archetypes,” he said. This included “some quite visionary HTA bodies, particularly in the Nordics and places like that, which are prepared to look at these types of products, look at the full impact to healthcare systems and use that to inform a health economic case.” Meanwhile, he said, a new package of laws coming through in Spain also held promise for value added medicines.
However, conversely “other recalcitrant markets are just purely concerned about cost of drug budget, not patient output or in the round. And I think they’re the ones we need to go and talk to say, look, you’re missing a trick. You’re not looking at how you can help your health system, how you can help your patients – and how you can actually, in the round, help your cost, but not myopically just focusing on one thing, price.”
“I fully expect that there’s going to be thought leaders and recalcitrants, and it is a bit of a game of divide and conquer,” Burt acknowledged. “We’re not trying to change everywhere. Price is a national competence obviously. But what we do want is a proper dialogue so people can understand, through the national associations. And we’re building up a resource bank to help with those dialogues.”
“I want to be involved in some discussions to really try and illustrate what we’re talking about,” he indicated. “I think quite often pricing and reimbursement bodies just get freaked out and think they’re going to be disadvantaged. But when you actually look at the cases, quite often it’s the opposite. And I want to have a forum where we can get that across.”
