Valeurs seuils pour le rapport coût-efficacité en soins de santé - KCE
Valeurs seuils pour le rapport coût-efficacité en soins de santé - KCE
Valeurs seuils pour le rapport coût-efficacité en soins de santé - KCE
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<strong>KCE</strong> reports 100 ICER Thresholds 53<br />
ICERs are used t<strong>en</strong>tatively, as one of differ<strong>en</strong>t criteria. Moreover, the DRC does not<br />
use a formal ICER threshold value wh<strong>en</strong> assessing pharmaceutical products: one<br />
interviewee ev<strong>en</strong> opposes the use of an “absolute” threshold value in the <strong>de</strong>cision<br />
making process, as each pharmaceutical product has its own particularities. nn In answer<br />
to the question whether the committee makes a differ<strong>en</strong>ce betwe<strong>en</strong> outcome measures<br />
(LYG or QALY) used in the ICER, the answer was negative. oo<br />
The perceived therapeutic need and the perceived therapeutic ad<strong>de</strong>d value are the<br />
factual and informal <strong>de</strong>cision criteria used during the <strong>de</strong>liberation. Additional criteria<br />
such as “is it a true innovation” or an adaptation or alternative of already availab<strong>le</strong><br />
product, pp has an impact on the assessm<strong>en</strong>t of medical necessity.<br />
In case of a revision of a product (revision of reimbursem<strong>en</strong>t <strong>de</strong>cision after the product<br />
has be<strong>en</strong> on the market for some time), the committee expects in princip<strong>le</strong> more<br />
information (more real life data both on clinical and cost-effectiv<strong>en</strong>ess) about the<br />
product, since it is th<strong>en</strong> also more feasib<strong>le</strong> for the industry to pres<strong>en</strong>t more and better<br />
data.<br />
It is also recognised by the interviewees that the interpretation of cost-effectiv<strong>en</strong>ess<br />
studies within the <strong>de</strong>cision making process in the committee had to go hand in hand<br />
with a <strong>le</strong>arning process of the members. For examp<strong>le</strong>, it took a gradual process to make<br />
c<strong>le</strong>ar to the members that cost-effectiv<strong>en</strong>ess is not the same as cost-saving. Moreover,<br />
it is not c<strong>le</strong>ar whether all members of the committee truly un<strong>de</strong>rstand the<br />
methodological background of an ICER, but neverthe<strong>le</strong>ss the use of an ICER <strong>le</strong>ads to<br />
expressions as “€80 000 per QALY is high”.<br />
In other words, our respond<strong>en</strong>ts recognise that the <strong>de</strong>cision making process within the<br />
DRC, although being rationalized and substantiated with clinical and economic data,<br />
remains a <strong>de</strong>liberation process of peop<strong>le</strong>, in which differ<strong>en</strong>t formal and informal criteria<br />
are used.<br />
3.6.3.2 Technical Council for Implants<br />
Although the working and <strong>de</strong>cision making procedure of the TCI will be modified in<br />
2009, the curr<strong>en</strong>t process of assessing a technology within TCI is <strong>le</strong>ss formally <strong>de</strong>fined<br />
than in DRC. It is recognized that in the future the need for more objectified criteria in<br />
the <strong>de</strong>cision making process will be nee<strong>de</strong>d. Therefore, it has be<strong>en</strong> <strong>de</strong>ci<strong>de</strong>d to work<br />
more along the lines of the DRC procedures from 2009 onwards, with the<br />
establishm<strong>en</strong>t of the ‘Implants and Medical Devices Reimbursem<strong>en</strong>t Committee’.<br />
The committee makes a differ<strong>en</strong>ce betwe<strong>en</strong> so-cal<strong>le</strong>d ‘me too’ <strong>de</strong>mands or <strong>de</strong>mands for<br />
reimbursem<strong>en</strong>t of ‘new technologies’. Demands for the latter have to be substantiated<br />
by the industry with clinical studies, which are oft<strong>en</strong> not availab<strong>le</strong> for implants and<br />
medical <strong>de</strong>vices. Oft<strong>en</strong> experts from the field are invited and heard by the committee to<br />
substantiate the existing know<strong>le</strong>dge and the information on the clinical effectiv<strong>en</strong>ess of a<br />
new <strong>de</strong>vice.<br />
The members of the TCI say that they consi<strong>de</strong>r cost-effectiv<strong>en</strong>ess as a <strong>de</strong>cision<br />
criterion. Members of the committee report to be aware of the re<strong>le</strong>vance of costeffectiv<strong>en</strong>ess<br />
of implants, but simultaneously state that CEAs or publications are not<br />
assessed on a systematic basis for <strong>de</strong>cisions within the committee.<br />
nn Neverthe<strong>le</strong>ss, we found an examp<strong>le</strong> of a threshold value of 30 000 €/LYG in a motivation docum<strong>en</strong>t for a<br />
reimbursem<strong>en</strong>t <strong>de</strong>cision of the Minister of Social Affairs<br />
(http://www.riziv.fgov.be/inami_prd/SSP/CNS2/Pages/MinisterialDecisionDet.asp?qs_SpcCod=00642119&q<br />
s_EffDat=20071101&qs_MdId=5023).<br />
oo In the evaluation reports prepared by the evaluators of the NIHDI the distinction is neverthe<strong>le</strong>ss<br />
sometimes ma<strong>de</strong> and retained by the Minister of Social Affairs in his motivation for reimbursem<strong>en</strong>t (for<br />
examp<strong>le</strong><br />
http://www.riziv.fgov.be/inami_prd/SSP/CNS2/Pages/MinisterialDecisionDet.asp?qs_SpcCod=00581188&q<br />
s_EffDat=20070301&qs_MdId=6175)<br />
pp 1.5 to 3 years after the initial reimbursem<strong>en</strong>t request and a positive reimbursem<strong>en</strong>t <strong>de</strong>cision for a class I<br />
pharmaceutical product, companies have to submit a revision fi<strong>le</strong>. This fi<strong>le</strong> should contain evid<strong>en</strong>ce on the<br />
effectiv<strong>en</strong>ess and cost-effectiv<strong>en</strong>ess of the product in real life situations.