Why is a review of reimbursements necessary?

As of 15 November 2010, some cardiovascular products (antihypertensives) will lose their general reimbursement.

Angiotensin II antagonists are characterised by a high degree of class effect, and they are recommended equally in treatment guidelines. The decision to change the reimbursement is based on this class effect combined with the price aspect – the medicinal products which will lose their reimbursement are significantly more expensive than losartan. 

Last year, the Danish Medicines Agency reviewed the reimbursement status of medicinal products for the treatment of cardiovascular products (antihypertensives), including the medicinal products which will now lose their reimbursement. Information in this regard is available in the fact box to the right. The result was that most of the medicinal products will continue to be granted general reimbursement, a few will lose their general reimbursement and reimbursement for other medicinal products will only be granted in special circumstances. It is the latter – the majority of the so-called angiotension II antagonists and renin inhibitor aliskiren – which will now lose their reimbursement. One angiotensin II antagonist, losartan, has been granted general reimbursement.

The Danish parliament (Folketinget) has instructed the Agency to continuously review the reimbursement status of all medicinal products, i.e. whether a medicinal product should be granted general (automatic) reimbursement, reimbursement on special conditions (conditional reimbursement) or not be granted reimbursement at all. In order for a medicinal product to become eligible for general reimbursement, the therapeutic value of the medicinal product must be reasonable relative to its price – this is the overall condition to be met.

The reason for having reassessed the reimbursement for some of the same medicinal products so quickly after the reimbursement change in June 2009 is that the preconditions have changed. Only losartan now meets the condition for general reimbursement. As for the other angiotensin II antagonists and aliskiren, the relationship between their price and their therapeutic value was not reasonable when compared with losartan.

When we approve a medicinal product for the Danish market, we cannot require it to meet a medical need, nor will the price of the medicinal product or other financial considerations be taken into account for the basis of the decision. Instead, the indication, use and price of a medicinal product do form part of the basis for the decision when we decide whether or not a medicinal product should be granted reimbursement. If a medicinal product has not been granted reimbursement, this cannot be interpreted to mean that it is less effective, less safe or of poorer quality than medicinal products with reimbursement. The primary objective of granting public reimbursement for medicinal treatment is to ensure that the patients receive reimbursement for their purchase of important medicine. Additionally, however, we must also ensure that the public funds are used appropriately and encourage the general practitioners to use the medicinal products in a rational way.

The reimbursement change is intended to encourage general practitioners to a rational medicinal treatment, i.e. an equally effective treatment of hypertension and other cardiovascular diseases at a lower cost. It is rational to prescribe the medicinal products that are eligible for general reimbursement. The objective is not to save money, but to provide equally effective treatment at a lower cost.

For further information, please contact Head of Department for Reimbursement Karen Kolenda on tel. +45 4488 9348.