Applications for general reimbursement in 2011

02 February 2012

In 2011, we reviewed 21 applications for general reimbursement for 20 different medicinal products. 15 of the applications ended with the granting of general reimbursement or general conditional reimbursement, and the remaining six applications were refused.

If a medicine carries general reimbursement, it means that patients receive reimbursement automatically when they buy medicines at the pharmacy. General conditional reimbursement means that reimbursement is only given automatically to defined groups or patients with specific diseases.

In 18 of the applications, we requested the Reimbursement Committee to make a recommendation. The remaining three applications were determined immediately, and all medicines were granted general reimbursement or general conditional reimbursement.

Recommendations from the Reimbursement Committee

In 2011, 67 % of the applications in which we requested the Reimbursement Committee to make a recommendation were granted general reimbursement. The corresponding figures for 2010 and 2009 were 25 % and 52 %, respectively. These variations can only be ascribed to the specific medicines for which general reimbursement was applied, as neither the criteria for granting general reimbursement nor the practices of the Danish Medicines Agency have changed during the period.

One of the medicines granted general reimbursement in 2011 is Brilique, which is used to prevent atherothrombotic events (e.g. blood clots) in adult patients with acute myocardial infarction (e.g. heart attack). Among other things, the decision was made based on a health economic analysis. It has been several years since a health economic analysis played a decisive role in our reimbursement decision.

Grounds for refusal

In 2011, five of the six applications were refused on the grounds that the price of the medicine was considered disproportionate with its therapeutic value compared to other relevant treatment. In one application it was factors other than the price that led to a refusal, namely the risk that the medicine is abused and the risk that it could be used for other patients than those it is authorised for.

The injection fluid Xiapex is one of the medicines that were refused reimbursement on the grounds that the therapeutic value was disproportionate with its price. Xiapex is used for the treatment of Dupuytren's contracture. Calculations have shown that surgical treatment is less expensive than treatment with Xiapex, when looking at treatment carried out by specialists in the field.

For patients who can only be treated with a medicine that does not carry general reimbursement, the doctor can apply for a single reimbursement grant, which means that the medicine is offered with reimbursement to this specific patient.

All decisions made can be read from this page (in Danish). Decisions on general reimbursement for medicinal products

Table 1: Number of applications for general reimbursement determined in 2005-2011

2005

2006

2007

2008

2009

2010

2011

Total number of applications

-

-

-

38

27

21

21

No. of applications presented to the Reimbursement Committee

19

20

20

29

21

16

18

Applications granted

10

18

(2)

15

(2)

32

(1)

17

(1)

9

(1)

15

*: Includes applications initiated by the Reimbursement Committee without application. Only stated from 2008 and onwards
( ): The figure in parenthesis is the number of reapplications.

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