Europe in HTA Gridlock

Aug 01, 2011

Much like a bus stop, you wait for ages for an international review of health technology assessment to come along ... then two turn up at once.

One emerged in mid-July in the shape of a study written by Charles River Associates and sponsored by some of the big beasts among the world's drug industry associations: EFPIA, EuropaBio, Medicines Australia, and PhRMA. This was unsurprisingly critical of many aspects of the current arrangements for health technology assessment (HTA), pointing to numerous "inefficiencies and inconsistencies" in the 15 jurisdictions it covered, in Europe, Australia, and the United States. "The most significant observable impact of the HTA process is imposing restrictions on the use of a particular medicine," the study comments.

Senior industry figures have repeatedly underlined their concerns that HTA may prove a dangerous weapon rather than a valuable tool if it falls into the wrong hands or is operated carelessly. Glaxo- SmithKline CEO Andrew Witty said recently that the industry is "in an awkward position as countries are doing it in different ways." He is apprehensive that these national systems will become increasingly demanding in the information they seek for their national validation. "This will lead to fragmentation of the assessment of relative and clinical effectiveness, and that will be unsustainable," in Witty's view. EFPIA complained earlier this year that the challenge of diverse national requirements "is further compounded by lack of alignment among HTAs, and between HTAs and regulators, about what value is and, more specifically, how it can be appropriately assessed."

So, as might be expected from a study that industry has paid dearly for, potential risks figure prominently. A "poorly designed or managed HTA process runs the risk of denying patients appropriate access to medical technologies, inefficiently allocating resources, constraining clinical freedom, and sending distorted signals to medical technology providers," the study warns on its opening page.

It then goes on to list a string of inadequacies in the current arrangements. "Methodologies greatly vary across systems," and the economic aspects are often "subject to intense academic discussions," it says. "The range of evidence accepted by different HTA varies across countries," and "there is little evidence of societal value being taken into account in assessments examined." On top of that, "mechanisms to account for uncertainty are currently fairly limited," and industry has little recourse to any "independent appeal process."

Not only are the mechanisms inconsistent, but—worse still, the study suggests—so too are the outcomes: "HTA processes lead to different results in terms of recommendations for coverage, including potential restrictions for the same products." And "little evidence can be found that HTA on average resulted in higher rewards for higher value medicines."

Significantly, the industry report fails to even consider a contrarian view: that disarray in HTA approaches and methodology can actually benefit companies by allowing several "bites at the apple" and the opportunity to rectify a single bad judgment elsewhere.

No Ringing Endorsement

Meanwhile, the European Network for Health Technology Assessment (EUnetHTA) has published its own report. It trumped the industry-backed study by analyzing 26 European jurisdictions, Australia, Canada, the US, and New Zealand. This is very definitely not an industry-inspired report. EUnetHTA is a very different type of organization, bringing together at European level a host of national health insurance organizations, academia, government agencies and health ministries, and national and regional health authorities. Its views, therefore, are not colored by any conspiracy theories, or any fears of HTA turning into a stick that will beat its members into submission, or worse.

And what does it conclude? "This review has indicated that although the reimbursement processes differ between jurisdictions, the methodology that is used for the comparative analysis is rather similar," it says. It concludes that there is sufficient common ground for the development of a shared methodology for relative effectiveness assessment of pharmaceuticals.

A contrary view to the industry study? Not altogether. For a start, the EUnetHTA report does not constitute (and nor was it intended to be) a straight rebuttal of the industry-sponsored study. Its range of reference is more restricted, since relative effectiveness assessment does not cover the entire field of HTA—notably omitting cost and economic considerations. In European Union discussions of HTA, relative effectiveness is considered as a separate issue from cost-effectiveness, so since cost-effectiveness is excluded, the EUnetHTA study's findings are accordingly limited in one of the areas that is of most interest to the pharmaceutical industry.