Cannabis as medicine: BfArM publishes final report on the accompanying survey

07.07.2022 10:29

On July 6, 22, the Federal Institute for Drugs and Medical Devices (BfArM) published the final report for the accompanying survey on the use of cannabis medicinal products. Since 2017, anonymized data on around 21,000 treatments with cannabis flowers and extracts as well as with dronabinol, nabilone and Sativex® have been included in the evaluation.

More than 75 % of the treatments evaluated were due to chronic pain. Other commonly treated symptoms included spasticity (9.6 %) and anorexia/wasting (5.1 %). In relation to all cannabis medicines, the people treated are on average 57 years old and the majority are female. A special feature is the treatment with cannabis flowers. Here the average age was 45.5 years and more than two thirds of those treated were male. Based on the THC content, these patients are treated with a much higher dose and are three times more likely to report a euphoric effect.

The form of accompanying survey that the BfArM was commissioned to carry out by the legislature is not a clinical study to test the effectiveness and safety of a drug. Rather, it is anonymized treatment data that provides information about possible areas of application, side effects and limitations of therapy with cannabis medicines. The results of the accompanying survey serve as a basis for the Federal Joint Committee (G-BA) for further regulations on the supply of cannabis medicines to patients and for details on reimbursement in the statutory health insurance system.

In 2017, the legal options were created for cannabis medicines to be prescribed and reimbursed, even if these medicines are not approved as finished medicines to treat the existing symptoms. This means that patients for whom no other medication is available for their treatment and for whom treatment with cannabis medicine has a chance of success should not be left to self-therapy or self-cultivation of cannabis. This new regulation should secure the supply and create incentives for research into cannabis medicinal products in order to achieve the approval of finished medicinal products under pharmaceutical law in the medium term, so that safe and effective medicinal products are available to patients.

The final report on the accompanying survey is published at: https://www.bfarm.de/cannabis-begleiteraufnahme