Singing in Harmony

Will EUnetHTA succeed in harmonizing the value assessment of medicines across the European Union?



Health Technology Assessment emerged from the need of national healthcare systems to rationalize its spending on new medicines but, with 77 HTA organizations spread across 29 countries, European HTA is incredibly fragmented.

The European network for Health Technology Assessment (EUnetHTA) was established to help streamline HTA, in its own words, to “create an effective and sustainable network for HTA across Europe”. Working closely with the European Medicines Agency (EMA), the network has sought to facilitate efficient use of resources, optimize knowledge sharing and promote good practice.

On paper, this all sounds like good news, especially for pharma – desperate for a clear steer on HTA requirements across the continent – and for patients desperate for access to innovative new medicines.

“The current fragmented approach to HTA decision making across Europe is inefficient, and the inefficiencies are even more extreme when you consider that many aspects of the evaluation process are common across HTA bodies,” says Preeti Patel, CEO of pricing consultancy, Global Pricing Innovations. This sentiment is shared by independent global market access consultant Neil Grubert: “There’s a willingness from national governments, payers, regulators and the industry. There is also political will at the EU level because of the enormous duplication of effort, which increases as HTA expands.”

However, as with so many good ideas, there are obstacles, not least the need for any harmonized system to encompass the radically different healthcare systems and policy agendas of the countries represented in EUnetHTA. Given the sheer complexity, is pan-European harmony possible? If it is possible, is it workable, given that EUnetHTA is only attempting to foster voluntary collaboration?

The national prerogative

Perhaps the biggest barrier to harmonization is decisions on pricing and reimbursement – that HTA exists to support – are seen as a national prerogative. “It is difficult to see this changing,” says Grubert. “The European Commission has been reasonably explicit in saying that will remain as it is. Even though there is pressure for more pan-European harmonization, we’re seeing an increase in regional and even local HTA activity.” For instance, Spain and Italy have multiple regional HTA agencies represented within EUnetHTA. “Regional and local bodies in the UK often conduct HTA in the absence of an appraisal by the National Institute for Health and Care Excellence (NICE),” he says.

“In addition to NICE’s judgments, these reinforce geographic inequalities in access – the so-called ‘postcode lottery.’” NHS England is trying to tackle such variations by establishing four new Regional Medicines Optimization Committees to cooperate on the evaluation of drugs not appraised by NICE. One committee will be designated to review a drug on behalf of all four. “It remains to be seen how this new system will work in practice,” says Grubert. Geographic inequalities in access of any kind are a major headache for pharma and patients and, to help eradicate them, EUnetHTA has undertaken a series of programs, starting with the two-year Joint Action 1 (JA1) which ran until 2012. The organization’s own report on JA2, which finished last year, pointed to its success in changing the way information on the benefits and risks of a medicine in the European public assessment report (EPAR) is presented. “This has resulted in improvements to the report structure,” it says, adding that JA2 also fostered the development and use of patient registries for data collection, and created a framework to allow the timely provision of information from the regulatory benefit-risk assessment in the effectiveness assessments of medicines.

A big bat

EMA and EUnetHTA have identified more areas of importance including more “structured interactions” on marketing authorization applications (such as pre-submission dialogue at the time of concluding the regulatory assessment), as well as improved regulatory reports to support HTA (for instance, the inclusion of patient-reported outcomes).

Joint Action 3, co-funded by the European Commission, is now in play and will run until 2020. Its focus is on increasing the use, quality and efficiency of joint HTA work at the European level. This renewed emphasis on joint working could have a significant knock-on effect, encouraging HTA authorities to re-use information from other bodies’ assessments.

“Some of the smaller EU member states in central and eastern Europe are more open to [sharing],” says Grubert.” Whereas in larger markets, there is relatively little use of either joint reports or other agencies’ assessments.”

Among JA3’s ambitious goals is a push to bring together data requirements for both benefit/risk and value assessments in a single development plan. There is certainly some way to go here as broader regulatory harmonization has been underway for the last two decades. “There is a whole new set of data requirements and hurdles, and companies can discover too late that the design of their trials doesn’t meet these requirements,” warns Grubert.

This is why the EMA’s involvement is crucial, he says. “As a pan-European body, [the EMA] could have a broader role in co-ordinating multiHTA activity, which is consistent with greater EU alignment of data requirements.” However, there are areas where HTA harmonization is problematic. “It’s easier in clinical domains, where things are arguably more clear-cut. Once you venture beyond that, it’s more difficult to reach concessions. I don’t see much prospect of that.”

Blitzing bureaucracy

“Bureaucracy is a predictable part of the policy process,” says Patel. “Back in 2013, when the permanent secretariat for European cooperation on HTA was being discussed, bureaucracy was one of the key hurdles identified. It is going to need a unified implementation team, where transparency, empowerment, and flexibility are the driving values to overcome the likely red tape ahead.”

In the meantime, HTA is likely to get more complicated, says Grubert. “The movement to adaptive pathways will present more challenges, since HTA will need to be more extended than at present, for example, with more post-marketing research or gathering of real-world evidence. It’s interesting to consider how that might work at a pan-European level – how easy would it be to implement? The simple logistics of the process are difficult if you’re trying to apply it for all new drugs. What we could see is a growing gulf between transformative innovation and the rest of the product pipeline. [In the UK] the Accelerated Access Review (AAR) has offered interesting ideas about what could be done to provide fast access to transformative technologies,” he says.

Brexit complications

Given the Brexit vote, the UK will need to carefully consider its relationship and alignment with the European regulators and the HTA network, says Patel. “A scenario such as that seen with Norway and Iceland, would probably be the most convenient path. The alternative post-Brexit EU environment, where UK membership is fully terminated, is likely to have significant detrimental impact on timely access to innovative and new medicines for British citizens.” Whatever happens on the political front, there is an increasing focus on genuine innovation in healthcare plus a will to accelerate access to drugs that make a significant difference to patients’ lives. However, cost remains a big issue. “The role of cost-effectiveness in HTA is well-established in north-west Europe and is gathering momentum in France, but there is resistance from other countries,” says Grubert. “If that is addressed, it could be crucial in advancing the harmonization agenda, particularly if the HTA network wants more convergence on clinical views. There is also the question of cost-effectiveness and budget impact, and how to embrace a longer-term perspective. The challenge is how to provide funding and access for drugs that are recommended by HTA bodies.” Given the complex nature of the HTA landscape, are the issues insurmountable? “One of the founding principles of the European Union is to build a common future; an EU-wide HTA decision-making network is a natural extension of that,” says Patel. “There are surely challenges ahead in its implementation, such as harmonizing evaluations, however, EU policy is a progressive process. The ultimate goal following JA3 would be an EU Directive governing HTA harmonization. That would be real progress. There is a long journey ahead.” “The alternative postBrexit EU environment, where UK membership is fully terminated, is likely to have significant detrimental impact on timely access to innovative and new medicines for British citizens.” 

Whatever happens on the political front, there is an increasing focus on genuine innovation in healthcare plus a will to accelerate access to drugs that make a significant difference to patients’ lives. However, cost remains a big issue. “The role of cost-effectiveness in HTA is well-established in north-west Europe and is gathering momentum in France, but there is resistance from other countries,” says Grubert. “If that is addressed, it could be crucial in advancing the harmonization agenda, particularly if the HTA network wants more convergence on clinical views. There is also the question of cost-effectiveness and budget impact, and how to embrace a longer-term perspective. The challenge is how to provide funding and access for drugs that are recommended by HTA bodies.” Given the complex nature of the HTA landscape, are the issues insurmountable? “One of the founding principles of the European Union is to build a common future; an EU-wide HTA decision-making network is a natural extension of that,” says Patel. “There are surely challenges ahead in its implementation, such as harmonizing evaluations, however, EU policy is a progressive process. The ultimate goal following JA3 would be an EU Directive governing HTA harmonization. That would be real progress. There is a long journey ahead.


This article is extracted from Trends in Market Access magazine. To download the magazine, click here.

 


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