Cannabisprescription

Since March 2017, it has been possible to prescribe cannabis medicines at the expense of the statutory health insurance. Together with the amendment of the law, the Federal Institute for Drugs and Medical Devices (BfArM) was commissioned by the legislator to collect data on the use of cannabis medicinal products. After five years, in 2022, they are to be evaluated.

By means of the accompanying survey, treatment data on the use of cannabis medicines in off-label use are to be collected anonymously. The documentation of the course of therapy, dose adjustments, side effects, change of cannabis medication or reasons for discontinuation of therapy are to improve the hitherto very thin data situation. After the five-year survey phase, the results are to form the basis, among other things, for the Federal Joint Committee to decide on the future assumption of treatment costs by the statutory health insurance.

The patients concerned must be informed before the start of the therapy that data on their therapy must be passed on anonymously. For this purpose, there is an information sheet from the BfArM which must be handed out to the patient by the attending physician.

If a therapy with cannabis medicinal products approved by the statutory health insurance is started, the participation of the treating physician in the accompanying survey is obligatory . The regulation affects ALL medicinal cannabis products - the finished extracts Sativex and Canemes, the active ingredients dronabinol and nabilone and cannabis flowers, provided they are used outside the approved indication.

Only for the finished medicinal products Sativex® and Canemes®do approved indications exist. If Sativex and Canemes are used according to the approved indications, the data collection forms do not need to be completed.

The approved indications are currently only:

• Sativex® for severe spasticity due to multiple sclerosis where other antispastic medicines have not been effective or have not been sufficiently effective.
• Canemes® capsules for chemotherapy-induced emesis and nausea when there has been an inadequate response to other antiemetic treatments.

The accompanying survey is only obligatory for insured persons of a statutory health insurance. The data do not have to be collected for insured persons of a private health insurance. The accompanying survey asks for data that are also asked for and documented during the medical history.

The scientific accompanying survey is filled out online. The address at which the physician logs in with his or her data is www.begleiterhebung.de. The sole purpose of the login is to grant access to the documents only to authorized persons. The transmission of the data is anonymous. Neither the patient nor the transmitting physician can be identified. For the login, the individual narcotics number(BtM number) of the prescribing physician and certain letters of the first and last name are required.

1. https://www.bfarm.de/DE/Bundesopiumstelle/Cannabis/_node.html