Amendments 2024 Medicinal Cannabis

1 Overview of the most important legislative changes in 2024

1.1 The MedCang

The most important changes to MedCang:

• Reclassification: Cannabis is removed from the BtMG and classified as a classic prescription drug (Rx) (exception: nabilone).
• Elimination of BTM fees of 4.26€.
• Extension of the validity of prescriptions from 7 days (BtM) to 28 days (Rx) or 3 months for self-payers.
• Distance regulation of 100 meters to schools/kindergartens now also applies to patients.
• Exemption from prescription: The “lack of therapeutic alternatives” in accordance with BtMG § 13 para. 1 does not apply. A specific justification for the cannabis prescription is no longer required.
• Simplified documentation: Medical cannabis is no longer subject to the delivery receipt procedure under the BTMBinHV.

Unchanged regulations on medical cannabis

• Despite the adjustment of the THC limit in road traffic to 3.5 nanograms per milliliter of blood serum, there is no change for cannabis patients in road traffic.
• Cannabis remains a prescription drug.
• It is only available in pharmacies with a prescription.
• Dentists and veterinarians are still not allowed to prescribe medical cannabis.
• The maximum recreational consumption regulation of 25 g does not apply to patients.
• Medical cannabis remains a prescription drug: It must be of the required pharmaceutical quality and be manufactured in accordance with pharmaceutical standards in the pharmacy (including refilling) and tested.
• It is still not possible to cross AUT-IDEM for prescription drugs.

1.2 Decision of the Federal Joint Committee on an amendment to the Medicines Directive Section N § 45

The main amendments to the decision:

• Name of certain specialist names and specialty names, which may now prescribe cannabis drugs without prior approval at the expense of statutory health insurance funds.

Requirements for the qualifications of the prescribing medical person:

The medical qualification requirement is met if, as an alternative, one of the following specialist, focus or additional titles in accordance with (sample) continuing education regulations 2018 (as amended on 25.06.2022) is held by the prescribing contract doctor:

Specialized doctor and specialty designations

• Specialist/general medicine specialist
• Anaesthesiology specialist
• Gynaecology and Obstetrics Specialist with a focus on Gynecological Oncology
• Specialist/specialist in internal medicine
• Neurology specialist
• Psychiatry and Psychotherapy Specialist

Additional names

• geriatrics
• Drug tumour therapy
• palliative care
• sleep medicine
• Special pain management

Unchanged regulations

• The regulatory requirements in accordance with Section 44 also include:
  • A serious illness must be present.
  • A generally recognized service that meets medical standards is not available.
  • There must be a “not entirely remote” prospect of a positive effect.
• Physicians can submit applications voluntarily if there is uncertainty about the fulfilment of the prescription requirements.

2 step by step to prescribing medical cannabis

A) Review of treatment requirements

The serious illness

What does the Federal Joint Committee understand by a “serious illness”? According to Section 12 (3) d Medicines Directive (AM-RL) of the Federal Joint Committee (G-BA): “An illness is serious if it is life-threatening or if it has a lasting effect on the quality of life due to the severity of the health disorder caused by it. ”

What does the G-BA understand by “chronically and seriously ill”? According to Section 2 Paragraph 2 Chronicles Directive of the G-BA on the implementation of the regulations in Section 62 for seriously chronically ill persons: “An illness is seriously chronic if it has been treated by doctors for at least one year, at least once a quarter (long-term treatment) and has one of the following characteristics:

• Care requirement of care level 3, 4 or 5 in accordance with SGB XI
• Degree of disability (GdB) or a degree of damage consequences (GdS) of at least 60% or a reduction in earning capacity (MdE) of at least 60%
• Continuous medical care is required without, according to medical opinion, a life-threatening aggravation, a reduction in life expectancy or a permanent impairment of the quality of life due to the health disorder caused by the illness.

Medical services not available

It must be explained to what extent a generally recognized service that meets medical standards is not available or cannot be used in individual cases according to medical assessment, taking into account the expected side effects and taking into account the state of the disease

Possible reasons for this may include the following:

• Adverse effects that make it impossible to continue treatment
• Lack of patient compliance, which impairs treatment success
• Unreasonable treatment due to individual burdens or risks
• Contraindications that preclude the use of standard therapy
• Existence of allergies or intolerances to the drugs used
• Special patient-specific factors that require adjustment of the treatment plan

Prospect of positive impact

When prescribing cannabinoid drugs at the expense of statutory health insurance, there must be a reasonable prospect of a positive effect on the course of the disease. This assessment should be based on a solid evidence base, with systematic literature reviews being the most significant, followed by randomized controlled trials and finally real world data.

Prof. Josef Hecken, impartial chairman of the G-BA, clarified: “In order to avoid misunderstandings, no specific medical conditions are mentioned, as the approval requirement is not limited to specific diseases. ”

The requirement for an evidence-based prescription applies to all cases — regardless of whether they are made with or without prior approval. It is therefore advisable to always keep up to date with the latest scientific evidence on the effectiveness of cannabis.

What is the state of evidence on the effectiveness of medical cannabis?

The assessment of the evidence on the effectiveness of medical cannabis is complex. The availability of evidence often depends on the incidence of the disease, not necessarily on the effectiveness of the cannabinoids themselves.

The following effects are currently attributed to THC:

• antiemetic
• analgesic
• antispasmodic
• Appetizing

→ Symptomatic effects in diseases that have these pathological dimensions can therefore be supported argumentatively.

According to a systematic review by Bilbao and Spanagel (2022), medical cannabinoids are attributed an overall positive therapeutic effect (medium level of evidence) in:

• epilepsy
• chronic pain
• spasticity
• loss of appetite
• Parkinson's disease
• sleep disorders
• Substance use disorders (SUDs)
• Tourette syndrome

Key indications based on German practice data include:

• Neurological and psychiatric disorders
• Oncological diseases
• Infectious diseases
• geriatric disorders
• Digestive system disorders

B) The patient's health insurance

The prescription requirements discussed apply to GKV patients.

PKV patients generally do not require approval for treatment with medical cannabis.

In principle, the costs of therapy are covered in accordance with the model PKV condition (MB/KK 2009) when medically necessary.

However, the decision to cover the costs of private health insurance is also an individual decision and depends on the tariff and suitability of the treatment method.

C) Review of possible applications

Infobox: Financial audit and recourse

In order to minimize risks associated with financial audits and claims for recourse, doctors should:

Review the applicable regulatory requirements carefully before making any prescription.

comprehensively document the main points of the cannabinoid therapy decision for each patient, and

If there is any uncertainty, submit a voluntary application for approval early on.

D) Submitting an application to health insurance

The application for reimbursement of cannabinoid therapy is generally submitted by the patient.

The application should include the following documents:

• Completed medical questionnaire on cannabinoids in accordance with Section 31 (6) SGB V. The corresponding questionnaire can be found on the website of the Federal Medical Service (MD Bund).
• Supporting literature, where appropriate, which strengthens the assessment of therapeutic effectiveness.

Deadlines for processing the application:

• Health insurance decision: Within 2 weeks
• When involving the medical service: 4 weeks in total.

Exceptions with shortened deadlines:

• General outpatient palliative care: Decision within 3 days.
• Prescriptions following hospital treatment: Decision within 3 days.

E) Fill out the prescription

Since April 1, 2024, cannabinoid drugs are no longer subject to the Narcotics Act. This means that they are prescribed by electronic prescription, just like other conventional prescription drugs (Rx).

An exception is the synthetic cannabinoid nabilone, which is still subject to the Narcotics Act.

Since these are highway medicines, the following information must be included on the prescription:

• Description of [quantity unit] Name of application (NRF information), in accordance with written instructions [type of application; dosage, time of use, frequency; duration of treatment]

example:

Oily cannabis oil resin solution, PZN [30 mL; 25 mg/mL THC] for oral use (NRF 22.11). According to written instructions: [0.1 mL per day, gradually increasing according to titration scheme; 2x daily; for 1 month].

Which cannabinoid drugs can be prescribed?

• dronabinol
  • 2.5, 5 or 10 mg dronabinol capsules (NRF 22.7)
  • Dronabinol drops 25 mg/ml (2.5%) oily solution (NRF 22.8)
  • Dronabinol ethanol solution 10 mg/ml for inhalation (NRF 22.16)
• Cannabis oil resin “cannabis extract”
  • Oily cannabis oil resin solution 25 mg/ml dronabinol (NRF 22.11)
• Dried cannabis flowers
  • Cannabis flowers for inhalation after evaporation (NRF 22.12)
  • Cannabis flowers in single doses for inhalation after evaporation (NRF 22.13)
  • Cannabis flowers for tea preparation (NRF 22.14)
  • Single-dose cannabis flowers for tea preparation (NRF 22.15)
• More
  • Ready-to-use drug for treating spasticity in multiple sclerosis: Sativex (THC:CBD) oromucosal spray
  • Nabilone/Canemes (synthetic drug, also narcotic)

literature

• Bilbao A, Spanagel R. Medical cannabinoids: a pharmacology-based systematic review and meta-analysis for all relevant medical indications. BMC Med. 2022; 20 (1) :259.

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