Three new reimbursement guidelines
The Danish Medicines Agency has issued three new guidelines on reimbursement (in Danish only):
Guideline on application for general reimbursement and general conditional reimbursement
The guideline has been updated to reflect current practice in the area. The guideline now also includes an elaboration of when it is relevant to apply and an encouragement to enclose indirect comparisons if there are no relevant directly comparable clinical studies.
Guideline on periodic reassessment of the reimbursement status of medicines
The new guideline replaces two guidelines in the area. The guideline has been updated to reflect current practice in the area while now also describing new abridged procedures for reassessment in cases where changes in reimbursement status have no adverse effects on the companies.
Guideline on the making of health economic analyses of medicines
The guideline is an update to the old guidelines for making health economic analyses of medicines from 1998. The guideline has been written with assistance from:
- Professor, cand.oecon, PhD, Dorte Gyrd-Hansen
- Professor, cand.scient, MSc Health Econ, Jakob Kjellberg
- Professor, cand.oecon, Kjeld Møller Pedersen
- Professor, cand.oecon, PhD, Lars Holger Ehlers
The new guideline reflects sound health economic practice – at the national and international levels.