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Introduction
01
Legal basis for the prescription of medical cannabis: flowers and extracts can be prescribed.
Cannabis was already used in China more than 4,000 years ago and in the 19th century also in Western medicine for the therapy of various indications.1,2Today, cannabis in pharmacological quality is also available for prescription in Germany. Prescription must consider a whole range of special concerns, including those related to narcotics, medicinal products and statutory foodstuff provisions.3
Cannabis as a medicine
02
Cannabis as a medicine: expansion of prescription and reimbursement capacity in 2017
Since the cannabis plant and all parts of the plant are classified as narcotics, they are subject to the Narcotics Act (BtMG) and the Narcotics Prescription Ordinance (BtMVV). Since 2017, the prescription of medical cannabis has been permitted in Germany, i.e. cannabis flowers and cannabis flower extracts in pharmaceutical quality can be prescribed and qualify for reimbursement as medicines: thus, physicians of all specialties (not dentists) can prescribe cannabis-containing drugs for their patients with serious diseases.3
Excerpt from changes in pharmaceutical legislation (Federal Institute for Drugs and Medical Devices (BfArM): Federal Opium Agency):3
"With the act amending the narcotics law and other regulations, which took effect on 10 March 2017, the law has expanded the possibilities for prescribing cannabis medicines. In the future, physicians will also be able to prescribe medical cannabis flowers or cannabis extract in pharmaceutical quality on a narcotic prescription. In doing so they must comply with drug and narcotics regulations. With the effective date of the act, the Federal Institute for Drugs and Medical Devices (BfArM) has established a cannabis agency. The cannabis agency will manage and control the cultivation of cannabis for medical purposes in Germany."
Conditions for prescription and reimbursement
03
Conditions for prescription and reimbursement of medical cannabis
Patients who are insured by the statutory health insurance plans (GKV) have had a legal right to treatment with medical cannabis and to reimbursement of costs since 2017 according to § 31 paragraph 6 SGB V, under certain conditions.4
Requirements for the prescription of medical cannabis according to § 31 paragraph 6 SGB V are:4
1. “A generally recognized service that meets the medical standard
a) is not available.
or
b) cannot be applied in individual cases according to the justified assessment of the treating participating physician [...]."
2. "There is a not highly unlikely prospect of a noticeable positive effect on the course of the disease or on serious symptoms."
In the case of self-payers and privately insured patients (PKV) other requirements apply to a prescription for medical cannabis: for example, there need not be a serious illness, since medical cannabis is a marketable and prescribable narcotic in Annex III of the BtMG. Thus, if patients have complaints that severely impair them and the physicians are convinced that medical cannabis is therapeutically justified, they may also prescribe it. Since privately insured patients are not entitled to reimbursement by the PKV, they may have to bear the costs of the drug themselves – however, a request for reimbursement to the PKV may make sense.
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Legal provisions: prescription of medical cannabis for persons insured by the statutory health insurance plans (GKV)
When prescribing medical cannabis for patients insured by the SHI, various legal requirements must currently be met: Approval by the responsible SHI of the insured as well as prescription limits.
Approval by the GKV
04
Approval by the GKV
For the assumption of costs according to § 31 para. 6 sentence 2 SGB V, approval before the first prescription must be obtained from the responsible health insurance plan. The corresponding application must be submitted by the patient to the GKV which can subsequently request a medical opinion. Treatment may only be started after approval, otherwise the patient alone must bear the treatment costs.
The approval period of the health insurance plans is also subject to legal requirements, i.e. a decision must be made within specified deadlines:
- three weeks as a rule (§ 13 para. 3a sentence 1 alternative 1 SGB V).
- three days within the framework of Palliative care outpatient/inpatient (§ 31 Para. 6 Sentence 3 SGB V).
- five weeks when the GKV obtains an expert opinion from the Medical Service (§ 13 para. 3a sentence 1 alternative 2 SGB V).
The health insurance company may refuse approval in accordance with § 31 para. 6 sentence 2 SGB V only in justified exceptional cases. In the event of a rejection, an objection can be filed. If the objection is rejected, a cause of action can be filed with the Social Court.
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Prescription quantity limits
The BtMVV specifies the following maximum quantities for the prescription of cannabis-containing medicinal products within 30 days:8,9
- cannabis in the form of dried flowers 100,000 mg
- cannabis extract (based on the THC content) 1,000 mg
- dronabinol 500 mg
Since 01 July 2021, when billing prescriptions according to Annex 10 for the auxiliary tax and additional prescriptions according to §§ 4 and 5 para. 3 AMPreisV, a medical order can only include one prescription at a time. The prescription of various cannabis strains on one prescription is therefore not (no longer) possible. In justified individual cases, deviations from the specified maximum quantity are permitted. This deviation must be marked with the letter "A" in the prescription. There is currently no maximum quantity that can be prescribed for nabilone.5,6
References
Status: 2021
Li’ H-L. An Archaeological and Historical Account of Cannabis in China. Econ. Bot. 1974; 28, 437–448.
Frankhauser M. Cannabis in der westlichen Medizin. In: Grotenhermen F (ed). Cannabis und Cannabinoide. Pharmakologie, Toxikologie und therapeutisches Potential. 2nd edition. Göttingen: Hans Huber 2004:57-71.
BfArM: Änderungen in der Betäubungsmittelgesetzgebung: Änderungen 2017. https://www.bfarm.de/DE/Bundesopiumstelle/Betaeubungsmittel/_artikel.html (last visited on 05 July 2021).
Sozialgesetzbuch, Fünftes Buch (SGB V) Gesetzliche Krankenversicherung § 31 Absatz 6 SGB. https://www.sozialgesetzbuch-sgb.de/sgbv/31.html (last visited on 05 July 2021).
BfArM: Bundesamt für Justiz. Verordnung über das Verschreiben, die Abgabe und den Nachweis des Verbleibs von Betäubungsmitteln (Betäubungsmittel-Verschreibungsverordnung – BtMVV) http://www.gesetze-im-internet.de/btmvv_1998/BJNR008000998.html (last visited on 05 July 2021).
DAP. BtM-Höchstmengen. https://www.deutschesapothekenportal.de/download/public/arbeitshilfen/dap_btm_hoechstmengen.pdf (last visited on 05 July 2021).