In Switzerland, only medicines that have been examined by the therapeutic products agency Swissmedic for safety, efficacy and quality and authorised by Swissmedic may be used. However, doctors are free to select the therapy that they believe is most suitable for the patient’s needs, and in this context it is not uncommon for medicines to be prescribed that have been authorised but are administered for conditions for which they are not intended. This is nearly always the case when treating newborn babies, and more than half of children are treated with medicines used “off-label”, or in other words for purposes not listed in the Information for healthcare professionals. About one quarter of adults are treated with medicines used off-label.
There are many reasons why medicines are used off-label. When clinical research involving children is performed, for example, there are some particularly complex ethical aspects that need to be taken into account. For rare diseases it will never be possible to achieve full authorisation for individual indications because the number of patients involved is too small for clinical trials to be carried out.
Unequal treatment in reimbursement
Medicinal products used off-label can be reimbursed if certain strict criteria are met (Art. 71a-d HIO). The medicine must be used to treat a life-threatening disease, and this must be compatible with the objective of protecting health. In addition, use of the medicine must be expected to lead to major therapeutic progress, and there must be no other, comparable medicine available. The decision whether to reimburse the cost of using the medicine lies with the health insurance provider.
Against this background, access to and reimbursement of medicines used off-label are not always equal for everyone. Depending on the insurance provider, some patients may be treated unequally, as is also the case if decisions differ.