gms | German Medical Science

28th Annual Meeting of the German Drug Utilisation Research Group (GAA)

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

11.11. - 12.11.2021, digital

Cannabis-Report 2020 – An analysis of prescriptions of cannabinoid-based medicinal products based on data of the Mobil health insurance from 2017 until October 2019

Meeting Abstract

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Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 28. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. sine loco [digital], 11.-12.11.2021. Düsseldorf: German Medical Science GMS Publishing House; 2021. Doc21gaa06

doi: 10.3205/21gaa06, urn:nbn:de:0183-21gaa061

Published: November 10, 2021

© 2021 Glaeske et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

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Background: Cannabinoid-based medicinal products have been available within the statutory health insurance in Germany on legal base of §31 (6) SGB V since March 2017. Finished medicinal products as Sativex® (INN: Nabiximols) or Canemes® (INN: Nabilon) as well as imported FDA-approved medicinal products with the active substance Dronabinol (Marinol® capsules or Syndros® solution) might be prescribed in Off-Label-Use. Furthermore, magistral preparations according to the New Prescription Formulatory (NRF) containing Dronabinol, Cannabis-Extracts or dried Cannabis blossoms in No-Label-Use are prescribable and reimbursable [1]. In absence of a precise definition of indications for cannabis-based therapies, different perspectives were established within patients, medical doctors, Medical Service of the Health Funds (MD former MDK) and statutory health insurances. In consequence, social courts have judged over 100 times if the statutory health insurances have to pay for therapies with cannabinoid-based medicinal products [2]. The spend of cannabinoid-based medicinal products in social health insurance increased from 26,679,826 € in the year 2017 to 154,219,207 € in the year 2020, which means a growth of 578% [3]. This leads to the following research questions, how cannabinoid-based medicinal products are used in the statutory health insurance according § 31 (6) SGB V, especially the engrossed indications, the pharmaceutical forms and dosages as well as the medical specialist groups, who prescribe these medicinal products.

Materials and Methods: The analysis is based on the statutory health insurance claims data of “Mobil Krankenkasse”, formerly known as BKK Mobil Oil. 1,076,381 people were insured in the year 2017, representing a market share of 1.5% of the statutory health insurance of Germany. Two filters were used to detect the relevant patients, on the one hand an application on cost coverage and on the other hand the billing of prescriptions with fitting medications. 956 patients received prescriptions of cannabinoid-based medicinal products between January 2017 and October 2019 and 783 obtained an assumption of costs based on § 31 (6) SGB V. The requests for cost coverage were analysed due to the indications. Besides, all relevant prescriptions of narcotic drugs were visually analysed for two subgroups, especially patients receiving cannabinoid-based medicinal products within “Specialised Palliative Outpatient Care (SAPV)” (n=66) or individual high-cost cases (n=62) [4].

Results: More than 50% of the spend of cannabinoid-based medicinal products were required by only 8% of insured people with a cost coverage. 51% were prescribed by general practitioners. In the SAPV subgroup, 86% of the CAM were prescribed by specialist physicians, while mainly Dronabinol Solution NRF was used and at nearly 100% cost coverage. Many of the SAPV patients suffered from oncological diseases. In the subgroup of high cost patients, which are defined with cost of more than 15,000 € in each case, mainly younger men received CAM as dried cannabis blossoms in high amounts for a long period. In the case of regular cost coverage of cannabinoid-based medicinal products, patients documented in the applications as diagnosis 27% chronic pain syndrome, 7% back pain, 6% spasticity and 5% polyneuropathy.

Conclusion: The results provide an indication that cannabinoid-based medicinal products are used in SAPV responsibly. Within coverage of prescription due to § 31 (6) SGB V, especially in the subgroup of high cost cases, there seem to be indicators of overuse and misuse of cannabinoid-based medicinal products. Apparently, cannabinoid-based medicinal products are used contrary to § 13 (1) narcotic law (BtmG) not as a last line therapy. The amounts of prescribed cannabis blossoms and the dosages are higher than in the statutory program of the Netherlands [5], which means that these amounts are no longer justifiable for medicinal purposes [6], [7]. In singular cases of the high cost subgroup patients used 3g to 20g Cannabis blossoms per day. Further analysis will be possible with so-called “Z-Datasegments”, which have been mandatory for billing since July 2021.


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