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information for German doctors

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In Germany, cannabinoid-containing medicines can in principle be prescribed by doctors of all disciplines, regardless of the indication, if they and the patient promise a successful treatment. It should be noted that statutory health insurance companies only cover such a therapy if several requirements according to Social Security Code V (SGB V) are met.

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Due to their broad symptomatic effect profile (learn more: Use of cannabis in medicine), cannabis medicinal products are used in everyday medical practice to control and alleviate various – especially therapy-resistant – complaints. They represent a way out for sick people, especially in the event of therapy failure or contraindications to conventional therapy options. As an alternative to conventional drugs, cannabis can also enable a dose reduction or the complete discontinuation of pain therapy, for example.

 

However, the study situation on medical cannabis does not yet allow a final assessment of the potential effect. This can be attributed, for example, to relatively small test subject collectives and/or short study periods. The range of variation in the measurable results, both within studies and across multiple studies, is high. There is reason to believe that these heterogeneous results are partly due to the fact that some people are non-responders.

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Regulatory Information  

Cannabis therapeutics are prescribed via a Narcotics Ordinance (BtM Ordinance) in accordance with § 9 Narcotics Prescription Ordinance (BtMVV) and must include the following information:

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  • First name, last name and address of the patient

  • date of issue

  • unique drug designation, e.g. B. Cannabis Flos Stratus Indica

  • Prescription amount in grams, milliliters or number of items, e.g. B. 30 grams

  • Instructions for use with single and daily dosage or reference to the written instructions available to the patient, e.g. B. 4 x daily 0.25 g

  • Specification of the dosage form, e.g. B. vaporize and inhale

  • Delivery form, e.g. B. not crushed (in the case of cannabis blossoms, further processing can alternatively be ordered, e.g. according to NRF 22.12.)

  • Name, job title, address and telephone number of the doctor

  • Signature of:the doctor:cannabis therapeutics

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Medicinal cannabis reimbursement

Within the framework of the German statutory health insurance, cannabis therapeutics are reimbursable if a generally recognized service that corresponds to the medical standard is not available or, according to a justified assessment by the treating physicians, is not suitable, taking into account the expected side effects and the clinical picture of the person to be treated. According to Section 31, Paragraph 6 of Book V of the Social Code, the severity of the illness must be proven and all conventional therapy options must have been exhausted or contraindicated in order for reimbursement to be granted.

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Statutory health insurance

German patients submit the application for reimbursement of costs informally directly to their statutory health insurance company before the start of therapy and before the prescription. Treating physicians write a statement accompanying the application, which explains why the disease is serious, that there are no other therapy options and to what extent treatment with cannabis medicinal products promises success.

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In the past, around 60 percent of the applications were approved by the statutory health insurance companies. Rejections were often due to incorrect or incomplete applications. First prescribing doctors are obliged to take part in the non-interventional accompanying study of the Federal Institute for Drugs and Medical Devices (BfArM). The BfArM uses the resulting data anonymously for scientific evaluation and to evaluate the reimbursement of cannabis therapeutics by statutory health insurance companies. Data for the accompanying survey will be documented online at www.seiten-report.de one year after the start of therapy or, if the therapy lasts less than a year, after the end of the therapy. The doctor must inform the patient at the beginning of the therapy about this process and the anonymous data transmission; the BfArM provides a patient letter for this purpose.

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Private health insurance and aid agencies

Private health insurance companies cover the costs for cannabis medicines if they are medically necessary and prescribed by a doctor. Private health insurance companies and aid agencies also usually base their assessment of applications on the legal text from SGB V. Before the start of therapy, comparable requirements are usually made of the patient and doctor.

Self-payers

If the costs are not covered by the health insurance and if there is an indication that complies with the Narcotics Act according to § 13 BtMG, medical cannabis can also be prescribed via private prescriptions and at the expense of the person to be treated.

 

It should be noted that here, too, a certain severity of the disease and resistance to therapy should be documented.

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Indications and areas of application

  • Chronic and neuropathic pain can be relieved by the analgesic and antinociceptive potential of cannabis medicines. This has been observed, for example, in diabetes and HIV-associated or chemotherapy-induced pain, as well as migraine, cluster headache and tumor pain. In addition, anxiety or sleep disorders accompanying chronic and neuropathic pain can be reduced.

  • Nausea and vomiting, especially as a result of chemotherapy or in patients suffering from AIDS, can be alleviated by THC.

  • Spasticity, especially in multiple sclerosis, can be alleviated by drugs containing cannabis by reducing spasticity and decreasing its frequency. Furthermore, positive effects on central nervous pain associated with multiple sclerosis have been achieved in the past.

  • Anorexia and cachexia, as well as related weight loss, for example as a result of HIV disease or cancer, can be alleviated by the appetite-stimulating effect of cannabinoids.

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Symptom relief can also be achieved in some cases for other diseases. This includes:

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  • depressions

  • ADHD

  • epilepsy

  • schizophrenia

  • Parkinson's disease

  • Tourette syndrome

  • sleep disorders

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Dosage and Intake

When dosing medicinal products containing cannabis, the indication is less important than the therapy needs of the person being treated. Drugs containing cannabis should be introduced gradually (sometimes over a period of several weeks) in order to determine the individual dose and reduce the risk of undesirable effects and side effects.

 

The dosage and the most suitable form of application depend on the patient. It may be advisable to test different forms of application in order to achieve the optimum for patients.

 

If unwanted side effects occur, it is advisable to slightly reduce the dose again.

Dosing of cannabis flowers

For inexperienced patients, it is advisable to start with a daily dose of 20 to 50 mg of cannabis flower (for varieties with low THC content, you can start with up to 100 mg).

 

This dose can then be increased in 10 mg increments until the desired effects occur, or decreased in 10 mg increments if side effects occur.

Answers to frequent patient questions

Patient FAQs
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