Why is a review of reimbursements necessary?

As of 15 November 2010, a number of medicinal products for the treatment of heartburn, sour eructations and ulcers (‘drugs for acid-related disorders’) will lose their general reimbursement.

These medicinal products are of several different types. The so-called proton pump inhibitors – omeprazole, lansoprazole, pantoprazole, rabeprazole and esomeprazole – are characterised by a high degree of class effect, and they are recommended equally in treatment guidelines. Against this background, the medicinal products omeprazole, lansoprazole and pantoprazole will maintain general reimbursement, whereas rabeprazole and esomeprazole will lose their reimbursement. The decision is based on the class effect in combination with the price aspect – rabeprazole and esomeprazole are considerably more expensive without providing a better therapeutic effect.

All the other drugs for acid-related disorders – the group of antacids and the so-called H2 receptor antagonists as well as the medicinal products misoprostol and sucralfate – are less effective and cost more than omeprazole, lansoprazole and pantoprazole and will therefore also lose their reimbursement.

These changes are a consequence of the fact that the Danish parliament (Folketinget) has instructed the Danish Medicines 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. This condition has not been met for the medicinal products losing their general reimbursement.

We must also assess whether the current reimbursement status has contributed to a rational use of the medicinal products in practice. In this assessment, we must incorporate experience from everyday clinical practice and the actual use of the medicinal products and assess whether the conditions on which the original reimbursement decisions were made remain valid or whether they have changed over time.

When we approve a medicinal product for the Danish market, we cannot demand that it must meet a medical need, nor will the price of the medicinal product or other financial considerations be taken into consideration 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. a cheaper and equally effective – in some cases more effective – treatment of heartburn, sour eructations, ulcers and similar disorders. 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.