New regulation on general conditional reimbursement

On 1 January 2010 a new regulation on general conditional reimbursement came into force. Previously it was only possible for the Danish Medicines Agency to grant general conditional reimbursement for the treatment of specific diseases. With the new regulation the Danish Medicines Agency also has the authority to grant general conditional reimbursement to specific groups of persons.

According to Section 144(1) of the Danish Health Act the Danish Medicines Agency can grant a medicinal product general reimbursement if the product has a safe and valuable therapeutic effect on a well-defined indication including that the price of the product is commensurate with the product's therapeutic value.

If the Danish Medicines Agency, however, determines that the criteria for granting general reimbursement are not fully met, it is possible for the Danish Medicines Agency to grant the product general conditional reimbursement, for example if the Danish Medicines Agency is of the opinion that a patient initially must be treated with a cheaper medicinal product. This is already the case today in relation to treatment of high cholesterol where a number of cholesterol lowering products (eg Atorvastatin or Colestyramin) are granted general conditional reimbursement. A patient can therefore only receive reimbursement to one of these products if treatment with cheaper products (eg Simvastatin or Lovastatin) has shown to be inadequate.

Under the previous regulation on general conditional reimbursement it was only possible to grant general conditional reimbursement for the treatment of specific diseases such as high cholesterol or high blood pressure. With the new regulation it is also possible to grant general conditional reimbursement for the treatment of specific groups of persons, eg persons above the age of 70 years.

According to the remarks to the amendment of the Danish Health Act, the intention is not to change the administration of the regulation on general conditional reimbursement; the intention is only to give the Danish Medicines Agency the authority to target specific groups of persons.