Changed reimbursement for cardiovascular medicinal products – background and importance

12 July 2010, Updated 25 October 2010

What will be changed?

The reimbursement status of certain medicinal products for the treatment of cardiovascular diseases will be changed as of 15 November 2010. The change comprises medicinal products in ATC group C09 (most angiotensin II antagonists and the renin inhibitor aliskiren).

The table below lists the medicinal products changing reimbursement status along with the new reimbursement status. As can be seen from the table, the new reimbursement status of the medicinal products concerned means that most of the medicinal products will lose their general reimbursement.

All other cardiovascular medicinal products will maintain their current reimbursement status, and the vast majority of them will be granted general reimbursement.

Reimbursement status as of 15 November 2010 for the medicinal products for cardiovascular disease in ATC group C09 for which the reimbursement will be changed .

Medicinal product group
(C09)

Active substance
and combinations

Reimbursement status

Angiotensin II
antagonists
(C09C and C09D)

losartan
losartan and
hydrochlorothiazide*
-----------
Exceptions:
Cozaar® oral suspension

General reimbursement


No general reimbursement

eprosartan
valsartan
irbesartan
candesartan
telmisartan
olmesartan

Eprosartan and
hydrochlorothiazide
valsartan and
hydrochlorothiazide
irbesartan and
hydrochlorothiazide
candesartan and
hydrochlorothiazide
telmisartan and
hydrochlorothiazide
olmesartan and
hydrochlorothiazide
valsartan and amlodipine
valsartan, amlodipine
and hydrochlorothiazide

No general reimbursement

Renin inhibitor (C09X)

aliskiren
aliskiren and
hydrochlorothiazide

No general reimbursement

* Medicinal products containing losartan were granted general reimbursement on 19 April 2010. See link in the fact box at the right.

When do the changes become effective?

The above-mentioned reimbursement changes will become effective on 15 November 2010. Within the next five months, general practitioners and their patients who are treated with the medicinal products losing their general reimbursement must therefore decide upon the patient's future treatment if the patient is to continue to receive reimbursement.

The general practitioner may change the treatment to one of the following products:

  • the less expensive medicinal product losartan, which is eligible for reimbursement
  • a less expensive ACE inhibitor which is eligible for reimbursement
  • another medicinal product which is eligible for reimbursement.

If, in the opinion of the general practitioner, special reasons exist for not changing the treatment, he or she may apply to the Danish Medicines Agency for single reimbursement.

What is the medical background for these changes?

This change of the reimbursement status of the majority of the angiotensin II antagonists and aliskiren is based on a medical recommendation from the Reimbursement Committee. The Committee's recommendation has been submitted for consultation with a number of relevant scientific societies and other stakeholders, whose consultation responses are also available at our website (in Danish only). The Committee's recommendation is available via the fact box to the right.

When the reimbursement status is changed for most of the single substance products concerned, the overall reason is that they belong to a group of medicinal products with a high degree of class effect. The angiotensin II antagonists are thus characterised by a relatively narrow spectrum of use and a high degree of uniformity, and the medicinal products are recommended equally in a number of national and international guidelines, cf. the list below.

The reason why the reimbursement for the angiotensin II antagonists is eliminated is that the class effect within this group is so comprehensive that most patients can be treated with the less expensive losartan, which is eligible for reimbursement, or possibly with one of the ACE inhibitors which are eligible for general reimbursement. If there is an exceptional reason for continuing the treatment with one of the expensive angiotensin II antagonists or aliskiren, the doctor may apply for single reimbursement.

Why is the Danish Medicines Agency making reimbursement changes?

The Danish Parliament has charged the Agency with the task of reassessing the reimbursement status of all medicinal products on an ongoing basis. The aim of the reassessment procedure is to 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. In other words, we must assess whether the current reimbursement status has contributed to a rational use of the medicinal products in practice. One of the criteria that must be met in order for a medicinal product to become eligible for general reimbursement is that the therapeutic value of the medicinal product must be reasonable relative to its price.

The Agency has now reviewed the reimbursement status of cardiovascular medicinal products with this aim in view – partly through the comprehensive review, which became effective on 13 July 2009, and partly through this ad hoc review of the angiotensin II antagonists and aliskiren following the major decrease in the price of losartan. Many people have considered the reimbursement changes to be a cost-cutting measure, but that is not the case. The reimbursement change is intended to prompt a rational medicinal treatment, i.e. an equally effective treatment at a lower cost. It is rational to prescribe the less expensive medicinal products that are eligible for general reimbursement and only prescribe the more expensive medicinal products in situations where the cheaper ones, for some reason, cannot be used. In such well-founded, special cases, the general practitioner may apply for single reimbursement.

Why change the reimbursement when there is undertreatment?

It is a fact that there is a significant undertreatment of hypertension patients in Denmark. It is estimated that approximately 300,000 more persons in Denmark ought to be treated for hypertension, and that many of the people currently treated have not reached their treatment target. We assess that last year's changes to the reimbursement status and future changes will not make the undertreatment any worse. Partly because the changes go hand in hand with the current treatment recommendations and are also in accordance with rational pharmacotherapy, and partly because the undertreatment has existed for many years, where all hypertension products have been eligible for general unconditional reimbursement.

The increased focus on hypertension patients in connection with the reimbursement changes and the resulting consideration of choice of treatment may, in our opinion, contribute to diminishing the undertreatment at all levels, if anything.

What are the financial implications of the change?

For the individual patient, the expenses will be the same or lower after the change. The expenses will be the same if the patient is treated with a medicinal product which does not lose the general reimbursement. If the patient is switched from an expensive medicinal product which loses its reimbursement to a less expensive medicinal product eligible for reimbursement, the expenses will be lower.

For each patient who switches from a treatment with an expensive angiotensin II antagonist to losartan or an inexpensive ACE inhibitor, the average annual savings (for region and patient) will exceed DKK 2,000.

A corollary of the change of product is one or more additional consultations with a general practitioner and possibly a blood sample test, but for patients who are to switch to another medicinal product, it would be natural to do this in connection with the patient's routine visits with his or her general practitioner over the coming months before the change becomes effective. The expenses for the additional consultations and blood samples will only need to be paid once, and as they are significantly lower than the medicinal expenses saved, and as the treatment is often lifelong, we find that the additional expenses resulting from such a switch would be regained quickly.

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

 National and international treatment guidelines etc.