New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

29 March 2007

As of 23 April 2007, the reimbursement status of lipid lowering medicinal products will be changed. The decision includes all lipid lowering medicinal products with marketing authorisations in Denmark on 15 March 2007. The current and future reimbursement status can be seen in the below table.

Table: Reimbursement status of lipid lowering medicinal products before and after 23 April 2007

Active substance

 

Reimbursement status as of 23 April 2007

Current reimbursement status

Simvastatin

Lovastatin

Pravastatin

 

General reimbursement without restriction

A.

Restricted reimbursement restricted to:

Secondary prevention of ischaemic heart disease, TIA/ischaemic stroke, peripheral arterial insufficiency and diabetic patients (all patient categories with a total cholesterol level above 3.5 mmol/L after lifestyle changes).

The guiding criteria for single reimbursement for primary prevention are based on the presence of risk factors for developing ischaemic heart disease and lipid values above a certain level.

Fluvastatin

Atorvastatin

Rosuvastatin

 

 

 

Restricted reimbursement restricted to:

Patients with hyperlipidemia necessitating treatment for whom therapy with statins eligible for general reimbursement without restriction has proved insufficient or who do not tolerate these medicines.

Cholestyramine

Colestipol

Acipimox

Ezetimibe

B.

No general reimbursement

The guiding criteria for single reimbursement are based on the patient having one of the diagnoses mentioned above and that therapy with statins has proved insufficient or is not tolerated.

Combination of simvastatin and ezetimibe

 

Like B.

Gemfibrozil

Restricted reimbursement restricted to:

Patients with isolated, severely elevated triglycerides or patients with combined hyperlipidemia, possibly combined with statin.

Like A.

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007
The statins simvastatin, pravastatin and lovastatin can now be prescribed without endorsement on the prescription. When prescribing all other lipid-lowering medicinal products, the doctor must make sure that the patient is included in the restriction, and reimbursement is conditional on the doctor endorsing the prescription with ”reimbursement” (”tilskud”).

The new reimbursement status entails an overall relaxation of the reimbursement status of lipid-lowering medicines as they will now all be subject to general reimbursement – with or without restriction. Furthermore, there will be a different distinction between the lipid-lowering medicines.

The overall purpose of the changed reimbursement restriction is to define the condition of a patient suffering from hyperlipidemia requiring medication therapy and to encourage the use of the less expensive statins eligible for general reimbursement where possible, in isolation or combined with one of the other lipid-lowering substances.

In principle, it will no longer be necessary for the doctor to apply for single reimbursement and it is therefore important that the restricted reimbursement is used as intended, i.e. to patients included by the restriction clause.

In the fact box to the right, you will find the letter sent by the Danish Medicines Agency on 16 March 2007 to companies holding marketing authorisations for lipid-lowering medicinal products, which are covered by the decision. In the coming weeks, the Medicines Agency will inform doctors and pharmacies and other stakeholders about the changes to the reimbursement status.

The lipid lowering medicinal products is the first therapeutic group that has been subjected to reimbursement status reassessment.

For further information, please contact the Reimbursement Department, medicintilskud@dkma.dk .

The Danish Medicines Agency, 29 March 2007

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