News regarding the Danish Medicines Council - conditional recommendations to be used as of 2022
The board of the Danish Regions has decided that as of 1 January 2022, and for a limited period, the Danish Medicines Council can issue conditional recommendations regarding medicinal products.
The conditional recommendation will be in force while additional data on the effect of the medicine are being collected. Once all the data have been collected, the Danish Medicines Council will follow up on the recommendations in order to assess whether there is a basis for recommending the medicine as the standard treatment. A similar process is known from the issuing of marketing authorisations, where medicines agencies can also issue conditional authorisations while gathering additional data. We have seen this in use for instance with the approval of the corona vaccines.
The Danish Medicines Council can issue the conditional recommendations if the following conditions are met:
- the Danish Medicines Council will not recommend the medicine as a possible standard treatment because there is too much uncertainty about the effect, safety and/or costs;
- the medicinal product is potentially likely to be cost-effective at the offered price;
- additional data are likely to resolve the clinical uncertainties;
- the price of the medicine reflects the uncertainty about the scope of its effect; and
- the pharmaceutical company will be financing the collection of data (for instance through additional clinical trials or registration in clinical practice in Denmark).
According to the Danish Regions, using conditional recommendations reflects the developing trend of medicines increasingly being marketed even though their effect and safety are very uncertain. This is happening because of the increasing use of accelerated approval procedures and more medicines being targeted at limited groups of patients, with clinical trials being based on a smaller study population, among other things.
With conditional recommendations, innovative medicines can come into use faster, especially for smaller patient groups, and with these recommendations Danish hospitals may possibly get to use cost-effective and innovative medicinal products at an earlier stage than what we have previously seen.
Read the Danish Regions’ memorandum on conditional recommendations (in Danish).