My thoughts on mixing HTA with regulation? The writing’s on my wall…

  • Posted on 17.08.2011

My thoughts on mixing HTA with regulation? The writing’s on my wall…


Victoria Malakhova

Former Eucomed Director Economic Affairs

My tmixing HTA with regulation

Not too long ago, I was invited to a friend’s 40th birthday party. As many other guests I came up with my best wishes and cheers stressing the benefits of getting “settled, mature, wise, stable, change-resistant and risk and-averse…” That was then, but it did make me think when today I was once again reading through the WHO report “Health Technology Assessment of Medical Devices” how ambiguous this whole age perception is.

Health Technology Assessment (or HTA) is basically a procedure whereby a healthcare  technology (be it a medical device, medicine, vaccine or intervention) is evaluated for its effects  and potential impact. The results of that evaluation should be used by policymakers so that they can make informed decisions on creating appropriate policy frameworks in healthcare. It is important that HTA is used as a tool for ensuring faster uptake of new cost effective technologies and not merely as a short term cost-cutting mechanism. The latter would have detrimental effects on people’s access to new and improved technologies.

The birth of HTA dates back to around 1970 and although turning 40 in humans usually means that they become less inclined to look for changes, HTA still seems to be dwelling in its adolescence, continuously undergoing new developments. Discussions currently revolve around HTA goals, timing, perspectives and challenges, particularly in the field of medical devices. One of the hot issues revolves around the difference in HTA methodology for drugs and devices. Given that HTA bodies have more experience in assessing the former, instinctively one would be inclined to apply those same parameters when assessing devices. But medical devices are fundamentally different from pharmaceuticals in their development, approval processes, application and overall characteristics of the technology life cycle.

The WHO report outlines the purpose, approach and definition of HTA for medical devices, integrating it in the WHO “framework for evidence-informed policy making”.  A large part of the report talks about the interfaces between HTA, Health Technology Regulation (HTR) and Health Technology Management (HTM). The authors not only acknowledge the importance of all three activities (HTR, HTA, and HTM) for optimal healthcare delivery, but also highlights on which activity we should focus at any given point in a technology’s lifecycle. It provides differentiation points between HTR, HTA and HTM based on their characteristics (Perspective, Requirements and Role) and their dimension (Perspective, Orientation, Method, Criteria and Outcome).

It is of key importance that these three activities are kept separate. Strengthening the link between HTA and regulation, the report says, would result in “a very superficial use of HTA not conducive to evidence-informed decision -making”. In a time when discussions are taking place to link the evidence requirements for regulatory approval with those needed for HTA (see the report published in Clinica by the Belgian Health Care Knowledge Centre, KCE), this warning should be taken very seriously.

Lastly, the WHO report recognizes that, often, the performance of a medical device is dependent on the skilful handling by the user. The authors point out that an innovation is becoming an invention only after it gets integrated in the process and “adapted by the market”.

I am sure many more discussion on HTA will follow. One of the conclusions from the WHO report will be written on the wall in my office, however: “HTA cannot support innovation if it is amalgamated with regulation”. It might be considered immature to write on the walls but I do not mind. After all the age perception is relative as we already established…

– Victoria Malakhova, Director Economic Affairs, Eucomed

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