Working with HTAs: It’s Your Move
European HTA bodies have signaled that they want greater and earlier dialogue with pharma but is their call being answered?
In June last year, the heads of European health technology assessment (HTA) bodies came together at a meeting facilitated by EUnetHTA (European Network for Health Technology Assessment) and the European Commission’s Directorate General for Health and Food Safety.
A key focus of the event was the creation of earlier and more engaging dialogue between pharma and HTA bodies. This is not surprising. As critical gatekeepers for new medicine seeking access to national markets, HTAs are playing central roles in moves to tighten control over drug spending across Europe. As part of this, bodies are going further than ever before to understand the budgetary impact of new products, which requires greater cooperation with the companies developing them.
So, with a renewed spirit of openness and collaboration permeating access discussions, are both sides actually listening to one other’s point of view? “We’ve had a pretty good experience over the last year as a result of early dialogue,” says Niklas Hedberg, chair of EUnetHTA’s executive board.
“We’ve seen evidence of pharma listening more closely to the calls from HTAs, to the point where we can now see the mutual benefits for both sides from interaction.”
Stefan Holmstrom, Astellas’ Global Head of HTA strategy, has also noticed a change, citing a technical meeting between EUnetHTA and EFPIA in Paris in December. “[It was] a good experience; the meeting was extremely collaborative and open with everyone asking questions, listening and taking advice.”
Yet, relations were not always so rosy in the past and many have long memories, he points out. “At that meeting, some of the HTAs said they were surprised to see pharma companies engaged and listening. They said their first encounters with pharma tended to be around companies marching in with fixed phase-III programs being unwilling to change them. It was interesting to hear how things have changed.”
While some solid output have already been achieved – including recent discussions between EUnetHTA and EFPIA around joint assessments of clinical evidence – there are many other factors at play. The result is inevitably uneven.
“While we are seeing calls for more dialogue, it’s not necessarily evenly distributed,” says Holmstrom. “The reality is that some HTA bodies – those in France and Germany excepted – don’t have much capacity. So there are real insufficiency issues from their side; but where they don’t have the capacity, they’re seeing how they can work together.”
He mentions the BeNeLuxA initiative, a joint collaboration between Belgium, the Netherlands, Luxembourg, Austria and Ireland on pharmaceutical policy with the aim of more sustainable and affordable access to drugs] come into play.
Capacity aside, are all European HTAs equally keen to engage pharma early and proactively? “There is a great deal of variation between HTA bodies in different countries and settings, but I would say there is a strong agreement about keeping neutral while going about building a new system to benefit all parties,” says Hedberg, who is also Chief Pharmacist with Swedish HTA body, TLV. “There is a mutual understanding about that.”
A key output for EUnetHTA is influence. “We want to be able to show that HTAs can really influence what’s happening in pharma. It’s a balancing act; we need to stay neutral and independent, but we also need to be open to discussion and interaction for the benefit of both parties, as well as healthcare providers and patients.”
The current regulatory environment is also a key driver, adds Holmstrom, with regulatory agencies doubling down on efforts around the ‘patient experience’. So, how does this fit with the idea of greater dialogue?
“There are huge movements right now, specifically within the FDA but also with the EMA, where you have an active push for more open dialogue with the pharma companies. This is specifically early on to make sure that we collect information about patients and the patient experience in a meaningful way.
“This has all been part of a general push for more open dialogue and more engagement with the pharma companies. It’s partly to do with practical, pragmatic issues around working more efficiently and better together,” says Holmstrom.
Power is shifting, he adds. “Around five to ten years ago, the regulators were king. Whatever they told us to do, we were required to listen and nod.” More recently, he has witnessed a sea change towards far greater openness, all of which has coincided with the rising influence of HTAs.
“I believe there has been a little bit of a struggle between regulatory and HTA agencies as both try to take advantage of this openness,” says Holstrom. “Many pharma companies have done a lot of internal growing up, but there are still people in the industry who don’t understand how important it is to engage and listen to HTA bodies. They listen to us, so why shouldn’t we listen to them?”
In spite of this caveat, progress is the watchword, believes Hedberg, who says there is plenty of evidence to suggest that pharma is more inclined than ever to engage with HTA bodies. “If we can start the interaction with an early dialogue – especially at a time when there is a lot going on within the EMA – it will be very beneficial, because this can potentially influence their development power and ensure better outcomes all round.”