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
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).
Despite the difficulties that individual HTA bodies might face, there is growing cooperation between counterparts in different
countries, but this is a concern for pharmaceutical companies. Recently, a number of international industry representatives
commissioned consulting firm Charles River Associates to conduct a comparative assessment of the role and impact of HTAs in
different parts of the world. Key industry bodies that backed the report included the European Federation of Pharmaceutical
Industries and Associations (EFPIA), the Pharmaceutical Research and Manufacturers of America Medicines Australia and EuropaBio
(4). EFPIA has stated that it hopes the report will form the foundation of future, regular exercises to monitor HTA (13).
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).
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.