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Regulation: what should be considered? (7/7)

With the new legal situation, the previous procedure is no longer applicable. So far, seriously ill patients who were supposed to receive medicinal cannabis in narrow exceptional cases, needed an exception permit from the Federal Opium Agency at the Federal Institute for Drugs and Medical Devices (BfArM). The patients paid for the therapy themselves.

The cannabis-containing drugs that were already prescribable and approved can continue to be prescribed in Germany. The law states that patients with a serious illness are entitled to a supply of cannabis "in the form of dried flowers or extracts of standardized quality and to a supply of drugs containing the active ingredients dronabinol or nabilone".

The drugs Sativex® and Canemes® fall under the new law if they are prescribed outside of the areas of application specified for them.

Indications are not mentioned

The law does not specify for which indications cannabis may be prescribed as medicine. Literally it says: Cannabis flowers and extracts can then be prescribed,

  • if "a generally recognized service corresponding to the medical standard is not available in individual cases" or
  • if this service "cannot be used in individual cases according to the justified assessment of the treating contract doctor, weighing the expected side effects and taking into account the state of illness of the insured person".

Therapy with cannabis is therefore also possible if a patient has not yet been treated with all the theoretically available measures.

Maximum amounts are specified

The amount of medicinal cannabis that can be prescribed is regulated by law. According to the Narcotics Prescription Ordinance (BtMVV), Section 2, Paragraph 1, doctors must comply with fixed maximum quantities. Within 30 days you can prescribe up to 100,000 milligrams (i.e. 100 grams) of cannabis in the form of dried flowers or, alternatively, up to 1,000 milligrams of cannabis extract (based on the Delta-9-THC content) for a patient.

Exceptions are possible in justified individual cases if a patient is under continuous treatment and the required safety of narcotics traffic is observed. Such an exception is indicated on the recipe with the letter A.

The law sets the maximum amount for medical cannabis, but not the maximum active ingredient content. This can vary greatly due to the different cannabis strains. Therefore, both the amount and the cannabis strain must be recorded on the recipe.

Cannabis strains from abroad

Currently, doctors can prescribe their patients 13 different types of cannabis, all of which have to be imported from abroad. They come from controlled cultivation, meet pharmaceutical quality requirements and are standardized with regard to the proportion of the most important cannabinoids.

However, they differ in their composition of active ingredients and thus also in their effect. The newly established cannabis agency of the Federal Institute for Drugs and Medical Devices (BfArM) is currently in the process of introducing state-monitored cannabis cultivation in Germany. Until then, cannabis flowers and extracts for medicinal purposes will be introduced.

An accompanying study documents the therapy

Every therapy with medicinal cannabis must be documented for an accompanying study. This is for scientific purposes only.

The doctor informs the patient about the data collection before the first prescription. If this has agreed, the doctor transmits anonymised treatment data to the Federal Institute for Drugs and Medical Devices (BfArM).

If a doctor or patient refuses to participate in the accompanying research, the respective health insurance company will not reimburse the costs. The aim of the accompanying survey by the Federal Opium Office at the BfArM is to find out more about the effects of cannabis as a medicine.

The patient data that the doctor passes on includes, for example, the age, gender and diagnosis of the patient. Furthermore, previous treatments play a role as well as the reasons why medicinal cannabis was selected for therapy. In addition, the accompanying study asks what dose cannabis is administered, to what extent it is tolerated and whether it changes the quality of life.

The accompanying survey is planned for a period of five years after the law comes into force. When the results are available and evaluated, a decision will be made as to whether or to what extent cannabis should remain a health insurance benefit as a medicine.

Approval by the health insurance company

Before starting cannabis therapy, the responsible health insurance company must approve the assumption of costs. In these cases, the health insurance company usually consults the medical service of the health insurance companies (MDK) to get a professional assessment of the indication.

A decision has to be made within three weeks, if an assessment is carried out by the MDK, within five weeks. The health insurance company can only reject an application in justified exceptional cases.

If cannabis therapy is to take place within the framework of specialized outpatient palliative care (SAPV according to § 37 b SGB V), the approval period is only three days.

If the therapy is prescribed for a person with statutory health insurance on a private prescription, approval by the statutory health insurance companies is not required, as these costs are not covered.

The correct recipe

The following information is required for the recipe check:

  • Date of issue: The prescription must be presented to the pharmacy within seven days of the date of issue.
  • Specification of the flower variety: The cannabis variety must be mentioned explicitly, as the varieties differ in their active ingredient content. A pure drug regulation stating the THC content is not permitted.
  • Dosage information: If the instructions for use were only marked on the prescription with the words "According to written instructions", the instructions from the pharmacy must also be available in writing. The reason for this is the obligation to label the primary packaging. If there is no additional written instruction, the recipe must not be made until it has been clarified.
  • Doctor's stamp: In principle, every doctor can prescribe narcotics - except for dentists and veterinarians who are not authorized to prescribe cannabis as medicine.
  • Quantity / maximum quantities: The statutory maximum quantities must be complied with.

Rejection rate

Since the change in the law in March 2017, around 16,000 applications for reimbursement of cannabis therapy have been received by the statutory health insurance companies in Germany. (Status: February 2018) Of these, more than 60 percent have been approved.

The comparatively high rejection rate of around 40 percent results from the fact that applications for cannabis therapies were sometimes also made for banal diagnoses, that effective therapy alternatives were available or that applications were sometimes incomplete.

Currently, the law only mentions serious diseases as an indication for medicinal cannabis. Naming these diseases in the medium term and after further research would be desirable.

That would create more clarity and security for everyone involved - for the prescribing and assessing doctors, for the patients and for the health insurance companies who have to bear the costs of the cannabis therapy.

Cannabis therapy costs

Cannabis therapy is comparatively expensive. For example, cancer patients are usually prescribed three grams of cannabis flowers per day, which they obtain from a pharmacy.

Cannabis flowers cost around 22 euros per gram. The monthly costs of a therapy are between 300 and 2,200 euros. An alternative opiate therapy, on the other hand, would be much cheaper.

However, finished medicinal products containing cannabis and dronabinol formulations are also less expensive. The average monthly costs for dronabinol are between 70 and 500 euros, for Sativex® between 31 and 373 euros and for Canemes® between 1,026 and 2,052 euros.

It should be carefully checked in advance whether the prescribed cannabis therapy is to be classified as necessary for the patient, as appropriate in the indication and as comparatively economical.