What does the removal of reimbursement mean for affected patients?
It is entirely legitimate for a solidarity-based healthcare system to review which treatments it can afford to fund. What came as a genuine shock, however, was the exclusion of cannabis flower without any transition period or protection for existing patients. Previously approved treatments were no longer covered almost overnight.
Those affected are people with serious illnesses for whom standard treatments are unavailable, unsuitable or have already failed. Many have been through years of treatment. Because cannabis flower cannot simply be replaced with another medicine, patients are often left with only three options: paying for their treatment themselves, switching to a different therapy or, in the worst case, having their treatment interrupted.
Will the reform actually save the statutory health insurance system money and what would have been a more targeted approach?
It could quickly prove to be a false economy. The projected savings focus primarily on expenditure that statutory health insurers will no longer cover. But patients will still need treatment: removing one option from reimbursement does not remove the underlying illness or the need for care. In practice, the reform is therefore more likely to shift costs to other treatments or directly to patients than to deliver sustainable savings.
A more targeted approach would have been to update the reimbursement rates for pharmacy-compounded cannabis preparations under the Hilfstaxe. This is the pricing framework used to calculate statutory reimbursement for compounded medicines, but the applicable rates were set years ago and no longer reflect current cannabis market prices. Updating them could have delivered meaningful savings within the existing system without excluding an entire treatment option. At a minimum, there should have been a transition period allowing patients to move to a suitable alternative under medical supervision.
Why is Cansativa continuing to take such a clear public position?
As a pharmaceutical company, we have to look at this honestly from two perspectives. The first is our own commercial exposure. These changes do not have a major direct impact on Cansativa. The statutory health insurance segment represents a comparatively small part of the market and has grown only modestly. (Federal Ministry of Health, 8 October 2025) We are therefore not speaking out to protect our own commercial interests. But we do feel a clear responsibility rooted in the early days of our company. Before 2017, seriously ill patients fought hard to secure access to medical cannabis. Their need was ultimately recognised leading to the law we have to today and now those same patients are being left in the lurch.
This is also about the coherence of a market in which we have been investing for the long term since 2017. Inconsistent regulation makes the market unpredictable and ultimately harms everyone, with patients paying the highest price. We used our channels to engage with policymakers before the decision was taken, and we will continue to do so. We also expressly welcome the initiatives being led by patients, associations and other parts of the industry.
What is your assessment of the conflicting guidance on the six-month treatment trial?
Under the new rules, patients starting cannabis treatment must generally first try an finished medicinal cannabis product for six months before statutory health insurance will cover a cannabis extract. The central unresolved question is whether doctors must prescribe such a product even when it is not authorised for the patient’s condition – in other words, whether it must be used off label.
It was already problematic that this fundamental question was only addressed after the law had entered into force. Initially, both the National Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds took the view that an finished medicinal cannabis product should only take priority within its approved indication. Shortly afterwards, the KBV reversed its position and stated that the requirement also applies to off-label use, while the health insurance funds’ association continues to disagree. (ApoAdhoc, 18 August 2026)
This leaves doctors unsure whether they can prescribe an extract directly or must first put their patient on a different medicine for up to six months. Leaving doctors and patients to navigate this uncertainty is unacceptable.
The principle that finished medicinal cannabis product should be considered first is not new. Even under the previous rules, doctors had to check whether a suitable finished product was available and explain why cannabis flower or an extract was needed instead. What is new is the rigid six-month requirement. It places unnecessary restrictions on doctors’ ability to choose the most appropriate treatment, particularly as only three finished cannabis products are available for narrowly defined conditions: Canemes for chemotherapy-induced nausea and vomiting, Sativex for spasticity associated with multiple sclerosis and Epidyolex for certain severe forms of epilepsy.
Why can cannabis flower not simply be replaced with other formulations?
With medical cannabis, the route of administration matters. Oral extracts and authorised medicinal products typically take effect much more slowly than inhaled treatments. For people experiencing sudden peaks in pain, it can be important for the medicine to work quickly.
Inhalable extracts may offer an additional option in the future, but they are not yet widely available. Their regulatory classification and reimbursement status also need to be clarified. It is therefore not realistic to assume that all patients can simply be moved to another formulation.
What needs to happen now?
We need clear and binding guidance on the priority given to finished medicinal products. The Federal Joint Committee has announced that it will amend the Pharmaceuticals Directive. (Tagesspiegel Background, 31 July 2026) This process should resolve outstanding questions, including whether inhalable extracts are eligible for reimbursement and whether the six-month trial requirement also applies to palliative care. In palliative settings in particular, requiring a six-month treatment trial is completely detached from clinical reality.
The decision on cannabis flower has been made, but the future structure of patient care has not yet been settled. Policymakers and the healthcare system’s self-governing bodies can still limit the consequences. We will continue to support this process with healthcare supply data, direct engagement with policymakers and our public channels.
Seeing so many patients and other stakeholders speak up gives me confidence that these unresolved issues will not simply be allowed to drift.
Thank you for sharing your perspective.
From the editorial team:
Do you have any questions, suggestions or ideas for topics for the Cannabis Briefing?
If so, please feel free to email us at briefing@cansativa.de.
This edition was written by:
Nicole Borges Steeb
External Affairs Manager
Cansativa Group