PharmExec Blog

Europe: Into the HTA Fray

Reflector finds some surprising common ground in what should be two very different HTA reports.

Just like with buses, 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 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 HTA, pointing to numerous “inefficiencies and inconsistencies” in the 15 jurisdictions it covered, in Europe, Australia and the US. “The most significant observable impact of the HTA process is imposing restrictions on the use of a particular medicine”, the study comments — and restrictions are often linked to the price of a product, it adds.

As might be expected from a study that industry has paid for — and has energetically promoted across the world — the downsides and potential risks figure prominently. Even its opening page warns that 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.” It then goes on to list a string of inadequacies in the current arrangements. 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”. Overall, it is “difficult to assess whether HTA improves allocation of resources or offers value for money.”
Meanwhile, the European Network for Health Technology Assessment (EUnetHTA) has published its own, rather different 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 coloured by any conspiracy theories, or any fears of HTA turning into a stick that will beat its members into subjection, submission or worse.

So, what does this report conclude? 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 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. In European Union discussions of HTA, relative effectiveness is considered as a separate issue to 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.

And not unlike the industry study, the EUnetHTA report also reveals a wide range of differences in national approach, even within its slightly tighter scope. It remarks, for instance, on the “variation between jurisdictions in the terminology and definitions that are used for similar processes.”

Further potential complications are signaled in “variations in interpretation due to cultural and legislative differences,” and as a result of language barriers, which are an inevitably complicating factor in any European discussion. Another weakness that EUnetHTA acknowledges is that “methods to do the assessment are in general not explicitly reported — on issues as crucial as which endpoints can be used, or the level of evidence required.” It plans to remedy these deficiencies with a series of guidelines. But these are not yet complete, still less in place.

So does this represent a hands-down, two-nil victory for the industry case, then? Not altogether. Because the industry-sponsored study is itself ambivalent, suggesting that it is “generally agreed” that HTA can be valuable. Even the industry’s own spin on the study, in a statement accompanying its release, recognizes that “there are reasons to be optimistic,” optimism that springs from the fact “most HTA systems are still in development or are evolving.”

But industry is evidently determined to intervene more vigorously than it has done so far in the debates over HTA. it is aiming to fill its ammunition belt ready for the fray. And a fray can be expected to gather in intensity over the coming months — certainly in Europe, and probably more widely.

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