Leela Barham explores how different HTA approaches could affect market access in different EU countries
When it comes to Europe and health technology assessments (HTAs), one thing is clear, “The only consistent trend is ‘more,’ as in more countries are adopting more HTA approaches at a national and regional level,” says Steven Flostrand, pricing and market access director at Creativ-Ceutical.
The increase in HTAs has led to a variety of initiatives at the European level: from industry, through the European Federation of Pharmaceutical Industries and Association’s (EFPIA) principles for HTAs; from the European Commission, through its ongoing collaborative work via EUnetHTA; from the industry and the Commission together, through the High Level Pharmaceutical Forum (HLPF).
But these initiatives operate at a high level and, given the reserved responsibility for healthcare expenditure, EU member states still drive the use of HTAs.
“HTA is maturing in Europe, with some commonalities in the scientific and clinical elements across Europe, but key differences in the ‘brand’ of HTA adopted in specific countries,” says Alicia Granados, senior director global HTA strategy-GMA at Genzyme. (For more on HTAs, see ‘HTAs go global: What it means for market access’, ‘Market access and HTAs: the role of ISPOR ’, and ‘Market access: How to meet both marketing authorisation and HTA needs’.)
Value for money
In the wake of the global financial crisis, all EU countries face tough times.
In healthcare, this translates into an ever greater focus on value for money. (For more on value for money, see ‘Mal’s Musings: Are HTAs about excellence or economics?’.)
“Companies all have to respond to the focus on price and cost cutting in healthcare systems,” Granados notes.
HTA is meeting this need by assessing the costs and benefits of new medicines and, in some cases, such as Sweden, older medicines, too.
But Granados is keen to stress that HTA can be a multi-method type of analysis, with different sorts of appraisals.
“In some countries,” she says, “it won’t necessarily look at cost-effectiveness but will help respond to the desire of payers to really focus on key concepts, including understanding the quality of the evidence base for a new medicine and the benefit for the patient compared to what healthcare systems currently use.”
These concepts, Granados argues, are vital, and companies will always need to demonstrate “the benefits of a new medicine, not just as a new mechanism of action but a kind of superiority, whether that’s a better safety profile, clinical benefit, or quality of life for patients.”
But the need to consider value for money doesn’t mean a uniform approach to HTA.
Different approaches to HTAs
Big differences exist is the way different countries approach HTAs, and more change is on the way.
“Italy and Spain are advancing in regional approaches,” Flostrand says, “but depending on how you define HTA, it can also be seen in Germany, Sweden, Poland, the UK, and elsewhere.”
For example, IQWiG, the German agency, considers HTA in the context of the efficient frontier, while the English agency NICE uses cost per quality-adjusted life year.
NICE’s approach could change, though, as it is likely to start providing a new assessment of value that includes further adjustments to account for innovation, burden of illness (severity and unmet need), and social perspectives (the impact on carers and the ability of patients to work).
These changes come under proposals for a shift to value-based pricing (VBP). (For more on value-based pricing, see ‘ADD LINK TO APRIL VBP STORY’ and ‘Is value-based pricing an aid to market access?’.)
This is “inspired but not without its challenges,” Granados says. “Key questions remain about how to really measure and interpret value.”
Given the uncertainties, companies may end up adopting one strategy for all of Europe, keeping to a pricing corridor, for example.
But companies also need to work hard to ensure access within the local dynamics of specific countries.
That can mean taking time to negotiate not only a national HTA but also regional or local versions.
“There is a real diversity in the quality of the undertakings, the impact, the ambitions,” Flostrand notes.
Granados highlights a growing trend toward decentralization in healthcare systems, and with that comes the use of HTA at even lower levels.
“HTA is not just about the national agencies, but even some hospitals now do or use HTA,” she says.
Granados also highlights that HTA is a “global issue, given the capacity of both HTA doers (the researchers who complete the analysis) and HTA users (the agencies that take the decisions) to network.”
Looking ahead, Flostrand sees a growing paradox
“HTA appraisal may over time reduce the importance of proving value at launch,” he says.
“It is very costly and difficult to prove effectiveness at launch, not to mention raising ethical issues related to the use of non-approved medicines. We may see a real strengthening of real-world data requirements in the future, where the launch is just the starting point for further study to demonstrate such effectiveness.”
Granados also anticipates increasing flexibility across Europe, with HTAs helping inform a more sophisticated approach to decision making about access and reimbursement.
“Countries are now adopting ‘yes, but’ approaches, where the ‘but’ requires companies to undertake further evidence gathering to show benefit,” she says.
For more on market access and HTAs, join the sector’s key players atSales & Marketing Excellence Australia on September 14-15 in Sydney,3rd Annual Market Access Canada on November 1-3 and eMarketing Canada on November 8-9, 2011 in Toronto, and Marketing Europe in November in Berlin.
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