Hi all!
I would like to ask you for some help.
Do you know if any of the EU5 countries allow reimbursement of drugs outside its registered indication (off-label)? And what are the procedures?
I only found information that it is possible in Germany and that there is an expert group within G-BA responsible for assessing off-label use, but I didn’t find information for other countries.
In Poland, drugs can be also reimbursed outside their indication. Please see Off-label - Agency for Health Technology Assessment and Tariff System
There is a Medicines Repurposing Programme in the UK.
You can find more informations here: NHS England » Medicines Repurposing Programme – Eligibility and prioritisation criteria
Quite recently, I came across an interesting article summarizing access to off-label medicines in Europe.
Paving the Path for Sustainable and Responsible Off-Label Use of Pharmaceutical Products in Europe in: European Journal of Health Law - Ahead of print (brill.com)
Check out Table 2: Reimbursement situation of off-label prescription in the selected countries.
Check this report: Study on off-label use of medicinal products in the European Union (https://www.nivel.nl/sites/default/files/bestanden/Report_OFF_LABEL_Nivel-RIVM-EPHA.pdf)
In Switzerland, Off-label use has to be reimbursed if it is indicated for a life-threatening disease, a substantial benefit can be expected, and no other effective and approved treatment is available. The treating physician has to issue an upfront reimbursement request, and the patient’s health insurer decides on a case-by-case basis.