The Danish Medicines Council amends their process and methods guide

A recent amendment to the Danish Medicines Council's process and methods guide clarifies the categories, which the Council invokes when assessing the added clinical value of new medicines.

The Medicines Council assesses new hospital medicines and several medicines within the same therapeutic area. The Council's assessments aim at determining whether the value of a particular medicine is proportionate to the costs and whether it should be recommended as a standard treatment.

According to the amended guide, new medicines and their value will be categorised in one of the following categories:

  1. High added clinical value
  2. moderate added clinical value
  3. Low added clinical value
  4. Added clinical value of unknown extent
  5. No documented added clinical value
  6. Negative value
  7. The total value cannot be categorised

The introduction of the more precisely defined categories aims at providing clarity on the assessment of new medicines and their effect as compared to the products already on the market.

The Medicines Council will hold an information meeting on 10 December 2018 in order to discuss the new categories and the other amendments introduced in the new process and methods guide.

The amended guide enters into force on 1 January 2019. Read the amended guidehere (Danish only)
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, September 2018 Issue (Thomson Reuters).

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