The industry evaluates HTA

The controversies regarding NICE have impacted other emerging European HTA bodies, which are immediately viewed with suspicion by both patients and the pharmaceutical industry. This negativity has not gone unnoticed; for example, from its statements, Germany's Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) HTA seems keen to distance itself from any direct comparisons with its UK counterpart (7). IQWiG admits to cooperating with NICE and other European HTA bodies, but stresses the differences between methodologies and that inter-agency discussions examine to what extent methods might be compatible (9). France's Haute Autorité de Santé (HAS) has also stated that differences remain in methodologies between European HTA bodies (10).

At present, HAS is struggling to justify its role because it has been caught up in France's domestic controversy regarding Servier's Mediator (benfluorex) drug, which may have caused the deaths of as many as 2000 people (10). The scandal has implicated both Servier's representatives and the French health authorities. In 2010, HAS issued a press release to defend itself, but the agency has been accused of contributing to the errors that led to Mediator staying on the French market (11). One critic of the Mediator situation recently wrote in the Lancet that a French government report appeared to omit details of HAS's contribution to decision-making regarding the drug (12).

The authors of the study noted that although there were many reports on the workings of HTA bodies in different countries and how they were evolving, there was relatively little public domain information on the impact of their decisions. In particular, little had been published about whether the outcome of HTA related to the assessment of the value of the medicine, the type of HTA, or whether decisions really did result in a superior allocation of scarce health resources (5). A major conclusion of the study was that although HTA was supposed to improve access to innovative treatments, there was little evidence that current HTA processes were speeding up access. Furthermore, the study authors stated that recommendations from HTA bodies were not always implemented by pricing and reimbursement authorities. In general, the link between HTA and pricing and reimbursement was far from clear, and decisions over the same product varied greatly between systems and countries.

The authors acknowledged that the remit of the HTA bodies was different in countries surveyed, but were concerned that these bodies were reaching very different decisions over the same products. They suggested that the lack of consistency pointed to inefficiencies in HTA processes and weaknesses in their methodology. In particular, they were unimpressed at the differing data requirements to reach decisions. The study revealed that most HTA systems considered data from published randomised clinical trials as the preferred evidence for evaluation, but countries varied on consideration of other information (5). Clearly, divergent opinions were found as to whether HTA should include a full assessment of societal value.

At one extreme were bodies such as NICE, which only take into account the impact of a technology on public healthcare resources. At the other extreme, only the HTA systems in Sweden and the Netherlands were found to consistently consider societal value for cost-effectiveness analysis (4). Some other countries did have provisions to allow societal value to be considered, but guidance appeared vague. In Poland, for example, HTA guidelines stress that the first consideration for any analysis should be that of the healthcare system, but adopting a social perspective may be justified in some cases, such as where the health effects of a particular technology impact members of society other than the patient (4). Not surprisingly, however, the study authors found few examples of non-healthcare costs or benefits having been taken into consideration in evaluations, even where the HTA system allowed for their inclusion. In the Netherlands and Sweden, where a societal perspective is used, the societal information considered is not described in the final evaluation report. The pharmaceutical industry continues to believe that societal value is an important component of any HTA to efficiently allocate available resources. In line with this thinking, the industry has been in favour of involving patients more in HTA bodies (13).

Summary

Despite their unpopularity with pharmaceutical companies and, in many cases, with patient groups and physicians as well, HTA is an established part of healthcare systems worldwide. To date, HTAs in different countries have evolved in isolation to each other, which makes analysis of their impact difficult. The recently published international analysis of HTA processes suggests that the pharmaceutical industry will be less passive in how it approaches HTA decision-making. Publications of this nature will better enable companies to challenge the approaches being used by HTA bodies.