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
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