When money speaks – the truth is silent.
-- Russian Proverb
I’ve just returned from Moscow where I was proud to participate in the first ISPOR conference (co-sponsored by the Ministry of Health) on HTA ever held in the Rodina. And it was a very worthwhile experience.
The meeting featured a cast of international HTA all-stars. Some useful take-aways:
Luigi Migliorini (the WHO’s Special Representative to the Russian Federation) noted that the conference was taking place at the same time as the World Health Assembly – which he referred to as “the Duma of the WHO.” Whether he was making a somewhat forced local reference or trying to make some type of political statement is up for debate.
Hans Severens (Erasmus University) spoke about “the possibilities and the impossibilities of HTA.” His main point (which became a mantra of all of the day’s presentations) is that, when it comes to HTA, “all decision-making must be made in a local context.” He also firmly stated that economic concerns are only one of many petals on the HTA flower – another point reinforced throughout the course of the program. Countries “shouldn’t just adopt NICE findings” but should assemble all available information and put all data into a local context.
If all politics is local – so to must HTA designs and decisions.
Severens said that, “all HTA research is biased.” This reinforces the point made by NICE’s Sir Michael Rawlins that HTA “is not based on empirical research, there is no empirical research anywhere in the world, it is really based on the collective judgment of the health economists. There is no known piece of work which tells you what the threshold should be. It is elusive."
Jérôme Boehm (Health and Consumer Directorate, European Commission) discussed the EC’s work towards developing protocols to share HTA data through a common database – but that “HTA must be a national decision.” He also added that there should be “no interference between market authorization and HTA.”
Wim Goettsch (Deputy Secretary, Medicinal Products Reimbursement Committee, the Netherlands) also affirmed that HTA decisions should be taken at the local level and that it needs to be as much about relative effectiveness (what we in the US refer to as comparative clinical effectiveness). He also pointed to an EU-wide database of HTA studies (www.eunethta.eu) that is becoming the “go-to” source for existing reports and information.
EUNETHTA, describes itself as “focusing on scientific cooperation in HTA in Europe, thirty four government appointed organisations from the EU Member States, Accession Countries and EEA work together to help developing reliable, timely, transparent and transferable information to contribute to HTAs in European countries.”
(Is PCORI aware of this? If not, they should spend some of their hundreds of millions of dollars doing so – rather than reinventing the wheel.)
And speaking of PCORI, Steve Pearson (Institute for Clinical and Economic Review), reinforced (and seemed to be bemoan) the fact that it cannot use any of its time or resources to address cost issues.
The US needs to learn from the successes as well as the failures of the European HTA experience. HTA isn’t easy. It isn’t foolproof. The science is in its early days and it is imprecise and cost containment is only one of many factors (and, according to all the speakers, not the most important). There isn’t a one-size-fits-all methodology. As Mark Twain quipped, “For every complex problem there is usually one simple answer – and it is usually wrong.” That’s an adage we should keep in mind. Alas – there is no universal Michael Moore-like “SiCKO” solution.
HTA cannot make political decisions – or make them any easier. A lesson we must learn as we debate the future of IPAB here at home.
Mira Pavlovic (Deputy Director, HAS) also spoke to the growing importance of EUNETHTA as well as the issues of HTA relative to choosing the best endpoints and comparators. She also addressed one of the 800 pound HTA gorillas – pharmacovigilance. She ended her talk by asking the big question – “Can we think prospectively.”
She also said that , since l’affaire Mediator, new conflict of interest rules have forced her agency to use physicians who have “sheep grazing around their offices.” Baa humbug.
Laura Sampietro-Colom (Hospital Clinic Barcelona and immediate Past-President of Healthcare Technology Assessment International – HTAi) discussed the importance of international cooperation and data sharing and the organizations own HTA database. She mentioned that AHRQ is a member of HTAi. (Hopefully Carolyn Clancy has shared her password with Joe Selby over at PCORI.)
According to conference organizer Vitaly Omelyanovskiy (Director, Research Center for Clinical and Economic Evaluation and Pharmacoeconomics, Russian National Research Medical University), HTA is the “near abroad” meaning that, while still a foreign concept – it’s not too foreign. Russia’s initial goal, accordingly, is to begin studying international (meaning European) HTA information and experiences so that a more “Russian-style” program can de developed.
The US has much to learn from this thoughtful Russian model because, as Leslie Levin (Head, Medical Advisory Secretariat, Health Quality Ontario) so elegantly put it, “Nobody can do it alone.”