The reference price system and socioeconomic differences in ... - KCE

KCE Reports 126 Reference Price System 23
With regard to the revision frequency, the reference price level was initially reviewed
every six months (on 1 January and on 1 July) by the administration of the National
Institute for Health and Disability Insurance (INAMI/RIZIV). Since 1 May 2009, the
revision frequency of the reference price level and reference groups has increased to
four times a year (on 1 January, 1 April, 1 July and 1 October). 42
2.4.4 The security margin
Concerned about the additional cost borne by patients, the Belgian legislator introduced
a legal upper-limit on the reference supplement (modification of §3, article 35ter of the
Law of 23 December 2009 44 ) in effect on 1 April 2010. This so-called ‘security margin’
aims to exclude from the reimbursement list all drugs for which the reference
supplement is more than 25% of the reimbursement basis (with a maximum of €10.80).
The security margin is meant to encourage pharmaceutical companies to decrease their
prices and to grant patients a new financial protection.
2.4.5 Exemptions
As the scope of the Belgian RPS was progressively enlarged, exemptions were specified
simultaneously to limit, in some cases, the reach of the extensions.
Firstly, with regard to the enlargement in July 2005 which extends the cluster definition
to all pharmaceuticals with the same active ingredient, independently of dosage and
administration form, two types of exemptions were allowed:
• Injectable pharmaceuticals for which the reimbursed cheaper alternative does
not have the injectable form, does not enter the RPS;
• Pharmaceuticals, whose administration form is accepted to be a significant
therapeutic added value compared with the cheaper alternative, can obtain an
exception status by the DRC. The exemption request procedure is defined in
article 55bis, §2bis of the Royal Decree of 21 December 2001 38 (introduced
by the Royal Decree of 16 June 2005 37 and modified by the Royal Decree of
19 January 2010).
Secondly, with regard to the introduction of art. 35quater that entitled the DRC to
specify a list of drugs with similar and/or analogous indications and mechanisms of action
to drugs already in the RPS, the following exemption was specified:
• Pharmaceuticals with proven significant therapeutic added value linked with
convenience of drug use, safety and/or effectiveness can obtain an exception
status. This exemption request procedure is defined in article 55ter, al. 7-13
of the Royal Decree of 21 December 2001 38 (introduced by the Royal
Decree of 22 December 2005). 39
Lastly, in January 2010 drugs for which the principal active ingredient(s) is/are variants of
the principal active ingredient(s) of drugs already in the RPS moved from article
35quater of the Coordinated Law (case-by-case application) to art. 35ter (‘by full right’
application). As a result of this enlargement, the above exemption request was
appended in the art. 55bis, §2ter (introduced by the Royal Decree of 19 January 2010 45 ).
2.4.6 Measures for physicians, pharmacists and patients
Like in many other countries that have implemented a RPS, the Belgian Minister of
Social Affairs has progressively recognized the important role of physicians’,
pharmacists’ and patients’ behaviour in the demand and consumption of low cost drugs.
He/she consequently introduced a set of measures for these three groups to increase
the efficiency of the RPS and to boost the share of low cost drugs consumption.