Why is this reform needed?
As of 13 July 2009, some cardiovascular medicinal products (‘antihypertensives) will have their reimbursement status changed – some will lose their general reimbursement and some will be eligible for conditional 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.
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 efficient, 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 health insurance funds are used appropriately and encourage the general practitioners to use the medicinal products in a rational way.
On this background, the Danish Medicines Agency has now reviewed the reimbursement status for medicinal products for the treatment of cardiovascular disease (‘antihypertensives’). The result was that most of these medicinal products will continue to be granted general reimbursement, a few will lose their general reimbursement status and reimbursement for other medicinal products will only be granted in special circumstances. These patients will continue to receive reimbursement for the medicinal products in question if the general practitioner writes ‘tilskud’ (reimbursement) on the prescription, thus indicating that the patient is comprised by the condition.
The medicinal products assessed in this respect belong to groups of medicinal product characterised by a high degree of class effect, and the special characteristic for ACE inhibitors and angiotensin II antagonists is that they are recommended equally in treatment guides. The decision to change the reimbursement is essentially based on this class effect combined with the price aspect – the medicinal products concerned are significantly more expensive.
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. As a general rule, it is rational to prescribe the less expensive medicinal products eligible for general reimbursement (without any reimbursement condition), and reserve the more expensive medicinal products with conditional reimbursement for the patients for whom the general practitioner assesses – based on an overall assessment of the patient’s pathological picture – that they can only be treated with these products. The objective is not to save money, but to provide equally efficient treatment at a lower cost.
Danish Medicines Agency, 23 January 2009