Europe in HTA Gridlock - Pharmaceutical Executive


Europe in HTA Gridlock

Pharmaceutical Executive

Issues Galore

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, since the European Union alone operates in more than 20 official languages. These variations, it continues artlessly, "may lead to confusion on whether jurisdictions are actually doing the same thing," adding, equally ingenuously, "in order to develop common methodology it will be essential to be clear about the wording and the content of definitions."

Another weakness that EUnetHTA acknowledges in its own conclusions 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.

In the background, too, there is "confusion" and "a debate ongoing on whether a benefit/risk assessment (the balance between doing more good than harm) is part of a relative effectiveness assessment." As EUnetHTA observes, some authorities advocate leaving benefit/risk assessment strictly to the registration procedure, while others want it to be included in the relative effectiveness assessment.

Another area of divergence is that "whether the weighting of the intended and unintended effects is part of the assessment or is explicitly limited to the appraisal phase." And while "in many jurisdictions the definition for the choice of comparator is similar to 'usual care,' the choice of comparator may differ between jurisdictions, as usual care can differ between jurisdictions."

So although EUnetHTA champions the development of a shared methodology, it openly recognizes that "our results also show that there are still a number of issues to be dealt with before it can be introduced."

A hands-down, two-to-zero victory for the industry case, then? Not really. 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." The industry's optimism springs from the fact "most HTA systems are still in development or are evolving."

Industry is evidently determined to intervene more vigorously than it has done so far in the debates over HTA. Part of the industry reticence until now has been the consequence of its own lack of information on the issues that matter to it. On the principle that you don't go into a gunfight waving a weapon if you have no ammunition, industry has limited itself largely to consultations, interspersed with communicating a sense of unease through muttering imprecise warnings. This is clearly about to change. The industry says that its study "sets the foundation for a regular exercise, which will receive continuous support from the four trade associations."

This, it believes, will "allow consistent assessments of the impact of HTA to be efficiently captured over time." It will make it possible in this complex environment to "take into account the impact of current reforms and cross-border activities on access to innovative medicines and the move towards truly patient-centred healthcare systems." In other words, industry 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. European governments have clearly indicated their readiness to get pharmaceutical spending in a tighter grip—and many of them are already doing so. HTA will play a central role in the debates over drug pricing and reimbursement and drug access, and industry naturally wants to ensure it has answers for all the questions that will arise. But the EUnetHTA initiative is also rumbling forward too. So if you are waiting hopefully at the HTA bus stop, you can be sure that there will be a whole lot of new reports coming along soon.

Reflector is Pharm Exec Europe's anonymous columnist, a commentator so close to the action in Europe that his identity must remain secret.


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