Few topics are more taboo in Brussels than theEU getting involved indrug pricing.
Yet that’s exactly what the European Commission is doing.
The Commission is putting the finishing touches on a plan to improve cooperation between governments on a key element of drug-pricing decisions: the so-called health technology assessment (HTA). There’s unusual momentum for a more integrated approach, though there’s no guarantee countries will sign off.
DG SANTE, the Commission’s health department, will introduce a proposal to coordinate how countries measure the value of new medicines in the coming weeks. HTA is vital for policymakers to decide how much their health systems are willing to pay for a drug. While EU countries all rely on the European Medicines Agency to determine whether a drug is safe, they’re pretty much on their own when it comes to deciding how much it’s worth.
Few policy decisions are more fraught. National HTA bodies have to effectively decide the value of a life. It’s their job to weigh quality of life versus longevity; spending a lot of money to save a single child with a rare disease versus treating many older people with chronic illnesses for the same amount or less; and other zero-sum calculations.
So far, cooperation on the European level has been halting.
Virtually no one wants Brussels to make those decisions instead of national governments. However, DG Santé is likely to propose a way to reduce duplication of the data analyses that underpin those decisions — which could give countries a better understanding of the potential value of a drug ahead of price negotiations with pharma.
A headline-grabbing study highlighted frustration and confusion regarding Europe’s current lack of centralized value determination. Most new cancer drugs approved by the EMA in recent years offered little evidence that they prolong or improve quality of life, especially compared with existing treatments, researchers wrote in the British Medical Journal. NGOs said this was evidence of a broken system, with the EMA allowing expensive new drugs to enter the market with little proven benefit.
But the EMA doesn’t focus on how well a drug works compared to its cost. So once a drug is approved for sale in Europe, it’s up to national governments to decide what a drug is worth — and whether it makes sense for its health system to bear that cost. Working together on HTA — by sharing economic and scientific data on the efficacy of new drugs — might make that process easier for governments and drugmakers alike.
So far, cooperation on the European level has been halting. A voluntary network known as EUnetHTA is in its third multiyear iteration, but countries have been slow to take up the results of the joint assessments and in some cases still ran their own. Funding ends in 2020.
Germany is the fiercest, most powerful opponent of further alignment on HTA.
As for what comes next, the Commission is considering options, from a variation of the status quo to larger changes that could come uncomfortably close to encroaching on national governments’ responsibilities. One mild option includes intensifying existing efforts to merge methods and data sharing. At the other extreme lies an option in which countries make shared determinations about the clinical, economic and ethical benefits of new medicines or medical devices.
No one is expecting the Commission to go for the latter. EU Commissioner for Health Vytenis Andriukaitis plans to propose that countries opt in to HTA at a European level, and when they do, they will have to accept the results of those assessments.
For smaller countries, the more cooperation, the better. They don’t have their own infrastructure to do the type of complex analysis behind HTA, so they’re already fairly dependent on the findings of bigger countries like France, Germany and the U.K.
They’ll need one of those bigger countries to take a leadership role, and France is game to help. It hopes to manage the increased coordination by participating early.
“We could continue alone,” said Chantal Bélorgey, head of the HTA division at France’s High Authority for Health (HAS). “But we do think that, like what’s happened for marketing authorizations [at the EMA], the future is cooperation.”
Cooperation is particularly valuable when it involves products that fulfill an unmet need, like drugs for rare or complex genetic therapies, Bélorgey said. But, she added, it shouldn’t go as far as putting a euro figure on a treatment’s value.
NGOs responded to a headline-grabbing study on the price of cancer drugs by arguing this was evidence
of a broken system. But the EMA doesn’t take cost into consideration when approving a drug for sale in Europe | British Medical Journal
Germany is the fiercest, most powerful opponent of further alignment on HTA. Berlin sees even non-binding guidance as a potential intrusion on national decision-making. Germany is fiercely protective of its unique HTA structure, where the health system funds the whole process, and doesn’t collect fees from drugmakers for assessing their products. That makes it more independent, said Jürgen Windeler, head of Germany’s HTA body, the Institute for Quality and Efficiency in Health Care (IQWiG).
Windeler sees two key drivers for harmonization. One is the smaller member countries looking for help. For them, Germany is open to lining up methodologies and exchanging results — minus rules about using those results.
The other driver, Windeler said, is the pharmaceutical industry. He noted that while drugmakers want cooperation on HTA, which could save them time and money meeting different requirements, they don’t want countries working together on other elements that can affect the bottom line, like market access and pricing.
Indeed, pharma is rooting for the Commission to push bolder proposals.
“We see a lot of duplication within member states,” said Tina Taube of the European drug lobby EFPIA. She pointed to clinical efficacy assessment, a measure of how well a treatment achieves its aim, as a key area for cooperation.
And since sometimes the demands from the EMA and HTA bodies to green-light a drug overlap, the EU’s drug agency and EUnetHTA are intensifying coordination on early talks with drugmakers about what sorts of data are needed for both the safety and value assessments so the industry can design clinical trials that satisfy both.
Several national diplomats believe 2018 is the make-or-break year.
A German diplomat close to the file acknowledged that the political tide is against them, especially now that Brexit means a once powerful opponent of increased HTA cooperation, the U.K., doesn’t have much influence.
Several national diplomats believe 2018 is the make-or-break year. Without European Parliament and Council agreement on the Commission’s proposal by the end of the year, HTA could move to the back burner as attention turns to May 2019’s European Parliament elections. Commission leadership changes follow a few months later.
For HTA cooperation to work, countries have to trust each other, and that may be hard to come by when you’re working with all EU countries at once from the beginning, said Kris Boers, health attaché at Belgium’s Permanent Representation to the EU.
“There are difficulties,” he said, “but it’s the way forward.”
CORRECTION: An earlier version of this article misstated the funding source for Germany’s HTA system. It’s funded through fees paid by users of the health system.
This article is part of the spring policy primer.