Interim Results of the Survey Accompanying the Prescription of Cannabis-Based Medicines in Germany Regarding Dronabinol

Doctors who prescribe cannabis-based medicines paid for by the statutory sickness funds are obliged to participate via an online portal of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM, the Federal Institute for Drugs and Medical Devices) in a non-interventional accompanying survey, which is running until 31 March 2022. Data per patient and prescribed cannabis-based medicine are collected in the context of the companion survey at a maximum of twice a year during the treatment. The first survey is undertaken after a treatment duration of one year or—if the treatment with the selected cannabis-based medication is stopped before one year is up—immediate after treatment cessation. For health insurance members who are in treatment after 31 December 2021, a further survey questionnaire will have to be completed by 31 March 2022 at the latest, independently of whether data on the same insurance scheme members were collected before (1). The history and the legal prerequisites can be found in the interim evaluations published in 2019 (2, 3). The companion survey cannot replace randomized controlled trials. On 11 May 2020, the date of data export, 10 010 data sets were available. The Table compares cannabis-based medications where case numbers were sufficient. The number of 6485 patients who were treated with dronabinol enables subgroup analysis. We present a selection.

Table

Comparison of cannabis-based medicines in the companion survey where case numbers were high enough

Patients with pain

4858 patients were treated with dronabinol primarily for pain, 684 of these had neoplasms. The medical specialty that was most often recorded in the companion survey was anesthesiology, at 60% (general medicine 12%, internal medicine 7%). In 29% of cases the therapeutic outcome regarding pain was recorded as “notably improved,” in 39% as “moderately improved,” and in 31% as “unchanged.” In the subgroup of patients with tumor disease these values differed only slightly (28%, 42%, and 27%). The reasons for stopping treatment or treatment cessation after less than a year (37%) were unsatisfactory effectiveness in 47%, adverse effects in 26.7%, interactions in 0.1%, and death in 12.7%.

Treating spasticity

Altogether 476 patients were given dronabinol to treat spasticity. The medical specialty recorded most often in the companion survey was neurology, at 34%, followed by anesthesiology (24%). The therapeutic outcome was recorded as “notably improved” in 39% of cases, “moderately improved” in 40%, and “unchanged” in 20%. In 113 patients with multiple sclerosis as the initial main diagnosis and concomitant spasticity, the therapeutic outcome was assessed as “notably improved” in 41%, “moderately improved” in 43%, “unchanged” in 15%, and “notably worsened” in one patient. The reasons for treatment cessation (27.7%) were insufficient effectiveness in 40.9%, adverse defects in 30.3%, and death in 8.3%.

Cancer patients

1473 of patients last treated with dronabinol had malignant neoplasms. The medical specialty most often recorded in the companion survey was anesthesiology, at 46% (general medicine 20%, internal medicine 24%). In 44% of cases the additional label “special analgesic treatment” was recorded, and in 68%, “palliative medicine.” The median age of the patients was 64, and 46% were male. In the subgroup of patients with an oncological disorder, symptoms other than pain were treated often (684 cases, 46%): in 427 cases (29%) anorexia/wasting, in 21 cases (1%) spasticity, and in 341 cases (23%) other symptoms, according to the free text fields most commonly nausea/vomiting (218 cases, 15% and sleeping problems, restlessness, tension, fatigue, loss of appetite, and combinations of symptoms. In 127 cases, the ICD-10 code Z51.5 (palliative treatment) was additionally recorded. The median value for duration of illness was 21 months and for duration of therapy 2 months (in 38% one month and less). In 839 cases (57%), treatment was stopped after less than a year, in 18% of these because of unsatisfactory effectiveness, in 11% because of side effects, and in no case because of drug interactions. In 482 cases (58%), death was named as the reason for treatment cessation. The rate of side effects was 38%, fatigue and increased appetite were mentioned most often (11% each), followed by dizziness (7%). The Figure shows the therapeutic outcomes.

Figure

Assessment of the therapeutic success of dronabinol by the doctor in patients with neoplasms as their main diagnosis (percentage)

Patients aged 75 or older

Of the 6485 patients treated with dronabinol, 1515 were at least 75 years old and 63% were female. The most commonly named medical specialty in the companion survey was anesthesiology (54%) (general medicine 16%, internal medicine 13%). 52 patients (3%) had had an exemption license, and 64 had previously been treated with another cannabis-based medicine, mostly (40 cases) with nabiximols. For the most commonly treated symptom “pain,” the therapeutic outcome was recorded as “notably improved” in 21.9%, as “moderately improved” in 36.1%, and as “unchanged” in 39.1%. A moderate deterioration was recorded in 25 patients (2.2%) and in 8 patients a notable deterioration was documented. The rate of side effects in this age group was reported as 51%, most common were dizziness (16%), fatigue (15%), somnolence (7%), nausea (7%) and vertigo (6%) (4, 5). The reasons for treatment cessation (52.8%) were unsatisfactory effectiveness in 37.9% of cases, adverse effects in 24.0%, and death in 27%.

Patients treated with cannabis-based medicines are usually chronically ill patients in whom several previous attempts at pharmacotherapy have not yielded the desired effect. A comparison of the effectiveness of cannabis-based medicines by age group is possible if case numbers are large enough.

Dr. med. Gabriele Schmidt-Wolf, Dr. med. Peter Cremer-Schaeffer

Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Conflict of interest statement
The authors declare that no conflict of interest exists.

Manuscript received on 12 October 2020, revised version accepted on 18 January 2021

Translated from the original German by Birte Twisselmann, PhD.

Cite this as:
Schmidt-Wolf G, Cremer-Schaeffer P: Interim results of the survey accompanying the prescription of cannabis-based medicines in Germany regarding dronabinol.
Dtsch Arztebl Int 2021; 118: 177– 8. DOI: 10.3238/arztebl.m2021.0125

References

1. Verordnung über die Begleiterhebung nach § 31 Absatz 6 des Fünften Buches Sozialgesetzbuch (Cannabis-Begleiterhebungs-Verordnung–CanBV) vom 23. März 2017 (BGBl I S. 520).

2. Schmidt-Wolf G, Cremer-Schaeffer P: Begleiterhebung zur Anwendung von Cannabisarzneimitteln in Deutschland–Zwischenauswertung. Bundesgesundheitsbl 2019; 62: 845–54

3. Cremer-Schaeffer P, Schmidt-Wolf G, Broich K: Cannabisarzneimittel in der Schmerztherapie–Zwischenauswertung der Cannabisbegleiterhebung hinsichtlich der primär behandelten Symptomatik Schmerz. Schmerz 2019; 33: 415–23

4. Sativex Fachinformation. 2015. www.fachinfo.de/suche/fi/013156 (last accessed on 15 September 2020).

5. Canemes Fachinformation. 2019. www.fachinfo.de/suche/fi/021517 (last accessed on 15 September 2020).