From October 2020, the Danish Medicines Council will use the so-called QALY method when assessing whether new medicinal products should be recommended as standard treatment at Danish hospitals. The new method is introduced to create greater transparency in the decisions of the Medicines Council.
In late November 2019, the Danish Regions decided to change the method used by the Danish Medicines Council in its assessment of whether the effect of new hospital medicines is proportionate with the price and ultimately whether a new medicinal product should be recommended as standard treatment at the Danish hospitals. The new method, which will be implemented as of October 2020, for the Danish Medicines Council to use is the so-called QALY-method.
QALY is an abbreviation for ‘quality-adjusted life years’ and the method is internationally known and already in use in e.g. England, Norway and Sweden. QALY is an indicator which combines both the quality and the quantity of life lived. The method will be used for being able to better compare the effect of a new medicinal product across different diseases, and it is the hope that the QALY-method will create more transparency in the decisions of the Medicines Council. Together with the introduction of the QALY-method, the Danish Medical Council’s processing time will extend from 12 to 16 weeks.
However, the Danish Medicines Council will not use the QALY-method alone, as it will be used in conjunction with the Danish parliament’s current seven general principles for prioritising hospital medicines. Further and where relevant, the Danish Medicines Council may also include the severity of a disease in its assessment of a new medicinal product.
It is to be noted that the QALY-method is not always suited for assessments of medicinal products for rare diseases because of the limited evidence of the effect of these products. For such products, the assessment will instead be made on a more qualitative basis, where it to a greater degree is the purely medical assessment (rather than the statistical (quantitative) assessment) that determines whether the new medicinal product should be recommended.
Consultation period for manual and inclusion of unpublished data
A group consisting of The Organization of Danish Medical Societies, Danish Patients and the Danish Association of the Pharmaceutical Industry (Lif) will provide input to the implementation of the new method, including a new method manual. This manual will subsequently be subject to consultation by interested parties.
Already now, Danish Regions have decided that the Danish Medicines Council is permitted to include relevant unpublished data in its assessments. In this regard, the council is self to decide the criteria for use of such unpublished data.
The Danish Regions has decided that the changes described above shall be evaluated two years following implementation of the QALY method.