Copeia GmbH is conducting a survey on the course of medicinal cannabis therapy, where important information from the perspective of the patients is being collected. Currently, this data is urgently needed for the evaluation and assessment of prescribed medicinal cannabis therapies in Germany.

The nationwide survey on the course of medicinal cannabis therapy started on January 17 and is ending on April 30, 2022.

Under the guidance of Dr. André Ihlenfeld and Dr. Knud Gastmeier, information will be collected from patients regarding their therapy and prescribed cannabis medications. Thereby the following information will be compiled:

• Afflictions, indications as well as symptoms

• The course of the symptom development during the treatment

• Side effects and impact on the quality of life

• Drug concentration, delivery system and daily dosage of the cannabis medicine

• Duration and course of dosage

• Age and sex

• Benefactor of the therapy (self-payer or cost coverage by the statuary health insurance)

Copeia GmbH. develops digital health applications to support patients and physicians during a personalized therapy with cannabinoid containing medicine.

The impetus for this patient survey emerged from public discussions about the published interim results of the accompanying inquiry of the German Federal Institute for Drugs and Medical Devices (German: BfArM), which was launched in 2017 and ends on March 31, 2022.

All physicians, that prescribe cannabis to patients with statutory health insurance reimbursements, are obliged to anonymously and digitally provide information about the cannabis therapy. When looking at the data collected, it becomes apparent that, despite this obligation, not all patients whose therapy is reimbursed by the statutory health insurance are recorded.

As part of the accompanying survey, data from patients undergoing treatment with dronabinol, a semi-synthetic cannabis derivative, was primarily collected. These figures show a discrepancy between the prescription figures for medicinal cannabis published by the GKV umbrella organization, which present a significantly higher proportion of patients receiving therapy with cannabis flowers and extracts.

Consequently, fewer data is available for the course of therapy with cannabis flowers and extracts. Furthermore, the accompanying survey includes little information on the course of symptoms or the dosing of the prescribed cannabis medications. In addition, only data from patients with statutory health insurance is recorded - data from self-paying or privately insured patients is not considered.

Ratio of cannabis medicine prescriptions.

In comparison: GKV (Statutory health insurances), BfArM survey, Copeia survey

Strong network of partners

To reach as many patients as possible, Copeia's survey is supported by a network of associations and companies. This network includes patient organizations, medical professionals, pharmacies, and manufacturers and wholesalers of medicinal cannabis. Through the VCA (Verband der Cannabis versorgenden Apotheken {“association of pharmacies supplying cannabis”}), the survey is supported by more than 50 cannabis-specialized pharmacies throughout Germany.

Through this network, patients are made aware of the survey and receive informational flyers with a QR code linked directly to the survey. Via an interactive chatbot protocol, patients are guided through an approximately 6-minute questionnaire.

The data collected is then statistically validated and published. Through this survey, Copeia significantly contributes to the existing evidence on medicinal cannabis therapy by considering the following:

• Indication-specific patterns

• Coherence between the progression of symptoms and dosage

• Severity of side effects during the therapy
  
  

“The possibilities of clinical data collection have developed enormously in recent years but are still insufficiently used. Patient-focused applications, such as Copeia's interactive chatbot protocol, allow us to collect authentic data from patients and present it transparently. These can be utilized in clinical decision-making processes and thus support personalized therapy, which plays a major role in the prescription of cannabis medicines in particular.”

Dr. André Ihlenfeld, Anesthesiologist, Copeia Medical Director

Background

In March 2017, the possibilities for the treatment of patients with cannabis-based medicines significantly expanded: since then, the costs of the therapy can, under certain circumstances, be reimbursed by the statutory health insurance. Concrete indications for a treatment were not specified but were tied to certain conditions.

Since then, patients have been able to apply for reimbursement of the cannabis therapy from their health insurance with the help of their attending physician. The health insurance subsequently decides on the application according to certain guidelines. Once approved, a therapy with medicinal cannabis can be covered by the health insurance. Currently, about 1/3 of these applications are rejected and the complexity of the application process discourages many physicians from prescribing a cannabis therapy.

Furthermore, data is collected by the German regulator in a non-interventional accompanying survey, which covers the use of these cannabis medicines. The data collection period ends on March 31st, 2022, and includes just patients treated with medicinal cannabis at the expense of the statutory health insurance. Since the results of the accompanying survey will, among other things, be the basis for the Federal Joint Committee to regulate the assumption of treatment costs in the context of a therapy with medicinal cannabis products according to the Social Code (SGB) V, the results are being eagerly awaited.

However, the interim results published suggest that these results alone cannot provide sufficient insights into medicinal cannabis treatments.

About Copeia

Copeia GmbH develops digital health applications that focus on the improvement of therapy with cannabinoid containing medicines for all parties.

Due to the inadequacy of studies focused on indication-specific prescriptions of cannabis medicines, there is a great need for evidence generation. To close this data gap, Copeia is developing digital workflow solutions to collect patient data and generate evidence to support individualized cannabis therapies.

Copeia combines competences from international cannabinoid research scientists and knowledge gained from experience gathered through cooperation with physicians and patients as well as pharmacies, manufacturers and wholesalers of medicinal cannabis.

If you would like to know more about the survey, simply contact us by email and we will get back to you as soon as possible. We look forward to hearing from you.

Your Copeia team