Possibilities of application

The legal framework in Germany permits the medical use of cannabis products, with funding by statutory health insurance schemes (GKV), private insurance and patients who pay out-of-pocket, with appropriate medical indication.

Types of cannabinoid medication

There are three main categories of medical cannabis products in Germany available on prescription for severely ill patients. These include finished pharmaceutical products, cannabis flowers and cannabis extracts/preparations^1,2. Finished pharmaceutical products can contain synthetic cannabinoids, isolated cannabinoids or a broad spectrum of cannabinoids, terpenes, flavonoids, etc., derived from the plant – see the table below for further details on the three categories. Cannabis flowers and many cannabis extracts/preparations contain a full spectrum of cannabinoids, terpenes, flavonoids, etc.

Differences between cannabinoid-containing products³.

Criteria for prescribing and obtaining insurance coverage

Any established physician, with the exception of veterinarians and dentists, can prescribe products containing cannabinoids for seriously ill patients, if standard treatments are unavailable, have a sub-optimal effect or present intolerable adverse reactions.

Criteria for cannabis prescriptions with insurance coverage at a glance:

1. 1The patient has one or several indications that are considered a serious condition.
   
   
2. 2The patient is treatment-resistant, standard treatment is not available, or there are side effects with standard treatment that negatively affect quality of life.
   
   
3. 3Based on assessment, patient history, published case reports, observational studies, clinical trials, the doctor concludes that there is a possibility that cannabinoids may positively impact the individual outcome, quality of life, or course of disease.

German law does not limit optional cannabis therapy to specific indications or areas of application and leaves the individual therapy decision to the doctor instead.

Large, randomised clinical studies in support of the efficacy and safety of medical cannabis for specific indications are still very limited. This is why claims of ‘no evidence’ or ‘limited evidence’ may not imply that reliable, well-designed studies have found ‘negative evidence’ but rather that there is a lack of scientific data. Doctors are thus highly dependent on their patients’ feedback to evaluate efficacy and adverse reactions as part of a more personalised approach.

In a report based on reviews of the literature the National Academies of Sciences, Engineering and Medicine (USA) has identified indications for which there is ‘substantial evidence’ for the use of medical cannabis. These are primarily chronic pain in adults, chemotherapy-induced nausea and vomiting, and spasticity in multiple sclerosis patients⁴. However, experience by doctors and patients suggest that medical cannabis may be a safe and effective treatment option for a significant number of other indications⁵.

Preliminary results from the observational study in Germany (‘Begleiterhebung’) documenting actual therapeutic use of medical cannabis between 2017-2022 are shown in the figure below. At the time of the interim evaluation in May 2020, there were 10,010 complete data records². Data from the figure predominantly reflect indications for which medical and pharmaceutical cannabis was prescribed at the expense of the statutory health insurance, as this was the only circumstance requiring submission of patient data.

Interim evaluation of actual therapeutic uses of medical cannabis in a German observational study².

70% of the patients receiving cannabinoids for pain management reported improved symptom relief. Spasticity in Multiple sclerosis was rated improved by 79% of the male and 86% of the female patients. For all indications combined, if the therapy was discontinued, in 39% of the cases it was due to an unsatisfying therapeutic effect and in 25% of the cases the result of unwanted adverse reactions. Common unwanted side effects were mild to moderate and included fatigue, dizziness, drowsiness, dry mouth and nausea².

References

1. Johannes Horlemann Norbert Schürmann, med. DGS-PraxisLeitlinie Cannabis in der Schmerzmedizin (2018).

2. Schmidt-Wolf, G. & Cremer-Schaeffer, P. 3 Jahre Cannabis als Medizin – Zwischenergebnisse der Cannabisbegleiterhebung. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz 64, 368 (2021).

3. First Wednesdays, Hanway Associates & The Danish Ministry of Foreign Affairs. European Medical Cannabis Ecosystem Report (2020).

4. The National Academies of Sciences Engineering and Medicine (U.S.) Committee on the health effects of marijuana: an evidence review and research agenda. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington, DC: the National Academies Press (2017).

5. Cannabisbureau.nl. Information for pharmacists and healthcare professionals. (2021).