Belgian Government Introduces New Cost-Containment Measures for Medicines

Belgian public health insurer INAMI/RIZIV has today summarised the cost-containment measures that will affect the pharmaceutical industry during 2012. The principal changes will happen during April and May 2012 and will consist of an increasing recourse to generic substitution, additional price cuts on reimbursable medicines, and the creation of a new reimbursement category.

Mandatory INN Substitution

Incentives for the prescription of drugs under the generic name prescription system have seen the number of international non-proprietary name (INN, called DCI in Belgium) prescriptions increase by 7% year-on-year (y/y) during 2009 in Belgium. The government now aims to use this successful growth to oblige pharmacists to deliver a medicine that belongs to the group of cheapest alternatives when physicians prescribe it under its DCI. The dispensing of the cheapest medicines scheme began on 1 March 2012, and will become mandatory on 1 April 2012. Pharmacists cannot substitute when it is mentioned on the prescription that substitution is contraindicated. INN substitution will be mandatory for antibiotics and antimycotic agents covering acute care as of 1 May 2012.

Reimbursement Price Cut

Meanwhile, the reimbursement base of pharmaceuticals of category A (reimbursed at 100%) will decrease by 41% (instead of 31%). After four years of reimbursement, a complementary cut of 7% (instead of 5.5%) is applied. This measure will come into effect on 1 April 2012.

Adjustable 1.95% Price Cut on Pharmaceuticals

During 2012, the government will ask the industry to contribute to cost-containment efforts via new price cuts. Pharmaceutical firms can opt for:

A linear 1.95% price cut on their whole portfolio; or an adjustable decrease in price on part of their products, as long as price cuts correspond to 1.95% of their 2010 turnover. The price cuts will be applied on 1 April 2012.

New Reimbursement Category: F (Fa/Fb)

The government has also decided to set up a new reimbursement category: Fa/Fb as of 1 April 2012. For medicines reimbursed under category F, the sum of the statutory health insurance's reimbursement and of the "ticket modérateur" (patient co-payments) can be inferior to the public price applied.

Biosimilars Prescription

The Belgian government has also proposed to encourage the use of biosimilars by including the latter in physicians' prescription targets. It is estimated that by 2015–16, about 10 new biosimilars will be launched in Belgium, according to the Belgian generics association, Febelgen.

Outlook and Implications

Belgium is stepping up its cost-containment efforts in the pharmaceutical sector despite a drug spending growth reported at 2.8% y/y during 2010. Medicines represent a significant share (17.6%) of the public health insurance's spending and therefore represent a target of choice for the government in this period of austerity. During 2012, Belgium aims to reduce its deficit to 2.8% of GDP, down from 4.2% last year. As such, spending on pharmaceuticals does not escape the rule and will be subject to significant pressure during 2012. Apart from reimbursement and price cuts, measures which have been common in Belgium since 2009, the government is aiming to encourage and develop generic and biosimilars substitution through mandatory INN prescription/dispensing, and physician's targets.