Health technology assessments

Based on an interview with Annette Bus

An unnecessary rein on medical innovations, or a wise insurance for patients' protection?

The press says it’s a miracle cure, so why can’t I (or - as relevant - my brother, mother, child) have it now?
The answer is not simple: although a new technology or treatment may have been the subject of successful studies, it must go through a Health Technology Assessment (HTA) before clinical use because, in many EU countries, medical insurers will not reimburse for procedures that have not had an HTA. We asked Dr Matthias Perleth, of the Department of Medicine at the AOK Federal Association, (AOK-Bundesverband, Stabsbereich Medizin) to explain how an HTA system works and its potential.

‘Depending on the country, an HTA is initiated by different institutions. In Germany, for example, this it is the role of the joint federal committee - comprised of doctors’, hospitals, medical insurers’ and patients’ representatives - which completes an application for the inclusion of a new technology,’ Dr Perleth explained. ‘Following various discussions in different committees, a recommendation is then made. So, initially, the HTA is a tool for health politics - used to assess whether the costs of a procedure are likely to be covered. In essence, an HTA is a data review.’

Is an HTA on for new procedures? And is it always based on existing data?
‘This hasn’t really been resolved. On the one hand, new technologies should be assessed as early as possible, for the potential benefit of patients. However, to carry out HTAs we need clinical studies. A good example is Kyphoplasty, which helps to repair and stabilise vertebrae affected by fractures. Because this procedure carries certain risks, the firm marketing it has imposed very limiting conditions as to who is allowed to carry it out, and also stipulates that it should only be used to treat new, recent fractures. However, because kyphoplasty is so attractive it’s being used for other indications, such as for older osteoporotic fractures, but the results are not as good as those achieved with new fractures - which we hardly ever get to see.’

Couldn’t a preliminary HTA be carried out, and then reassessed in a few years?
‘That’s something we could think about. Despite the dilemma about available data, the HTA should support decision-making, especially when a procedure is still new. If the statutory medical insurers do not reimburse for a procedure its use will be very limited, then hardly any data can be gathered. That’s why differentiated decision models are increasingly discussed. Initially, a procedure can be financed within the framework of certain test trials, before a final decision about its use is made. This allows us to prevent unjustified expansions of indication at an early stage.

‘How all this is being handled in detail depends on the decision-making structures in any particular healthcare system. In Switzerland, for example, there is a very differentiated range of decision-making options. Sometimes a procedure may only be allowed in certain hospitals, or a clinical study has to be carried out over a certain period of time before another evaluation is made. In Germany we have the added problem that everything is currently in a state of flow, due to the introduction of DRGs and the revision of the OPS-Code. HTA procedures must be further developed and data generated at an early stage, so that information can be updated constantly - something already occurring in other countries, at the National Horizon Scanning Centre in the UK, for example (see box). This centre produces and regularly updates dossiers when studies on certain technologies are published, and that’s mostly three to five years away from them being introduced to the market.

‘The classic HTA is a retrospective assessment, as existing data is being analysed. If carried out during the development of an innovation, an HTA can be completed at a much earlier stage. We can establish reciprocity between the institution carrying out the HTA and the institution developing the new technology, be it a university or a company, and use this reciprocity. There was a joint project, with the university and industry in Hanover, in which scientists at the university went to look at projects developed by companies, then gave their feedback. In this way we can ensure we have a user evaluation, as well as clinical evaluation on which to base an HTA. But quite often today’s available data is just too bad for a meaningful HTA. The second, important point of doing HTAs during the development of innovations is that you can answer the question: Is this actually potentially meaningful technology? at a very early stage of development.

Does industry play along with this?
‘Not really; they tend to want to keep things close to their chests. This is where a market economy-based way of thinking conflicts with scientific requirements. In Germany, the term innovation brake is used a lot - as soon as yet another great innovation has failed approval by the federal committee, and the statutory insurers decide against financing a new procedure, these bodies are automatically accused of being against innovations and of not giving enough consideration to patients. Typically, however, these tend to be technologies for which there have never been any meaningful clinical trials. This is why we need to improve communication, particularly as HTAs carried out as new procedures are being developed, give companies more reassurance about the innovations they are bringing in to the market.’