The German federal government expects no significant savings from the new priority given to approved cannabis finished pharmaceuticals. This is stated in its response to the Green Party’s written inquiry regarding § 31 Section 6 SGB V. The response also contains clarification for existing patients and previously undisclosed details about Exilby’s approval.
📑 Inhaltsverzeichnis
The government’s answer was published as Bundestag document 21/8148 on September 23, 2026. The Federal Health Ministry submitted it on September 22. We presented the background to these questions in our coverage of the Green Party’s 28 questions on finished pharmaceutical priority in early September. The government answers many of them briefly or with references to other documents.
Finished Pharmaceutical Priority: No Significant Financial Impact
Since July 30, 2026, the new version of § 31 Section 6 SGB V applies. Statutory health insurance now generally only covers cannabis extracts, dronabinol, and nabilone after at least a six-month therapy trial with an approved finished pharmaceutical. This requirement was added through an amendment to the GKV contribution rate stabilization law—essentially a cost-cutting package.
The government’s answer to question 3 is all the more remarkable. Based on product information, the Lauer-Taxe price list, and GKV prescription data, the government assumes no significant financial impact. The questioners had cited an AOK cost comparison showing that a monthly treatment with the finished pharmaceutical Canemes at the recommended daily dose cost €1,372, while the equivalent dronabinol formulation cost €92–117 (Lauer-Taxe, March 2025). The government response does not address this comparison.
The origin of the rule also becomes clearer now. The coalition parties had conveyed the content to the Health Ministry during parliamentary proceedings. The ministry then converted it into a legislative formulation aid. When asked about scientific evidence for exactly six months, the government cites no study of its own. Instead, it references the approval requirements for finished pharmaceuticals, the BfArM’s accompanying survey, and the G-BA’s pharmaceutical directive.
Existing Patients Don’t Need to Switch
For cannabis patients, the government’s answer to questions 8 and 13 is most important. According to the ministry’s assessment, the therapy trial requirement applies only when a cannabis-containing pharmaceutical is prescribed for the first time. Already initiated therapies don’t need to be switched to a finished pharmaceutical. The word „initially“ in the law refers to patients who have not yet received a cannabis pharmaceutical for their particular indication.
However, the phrasing is cautious. The ministry states that the therapy trial „should“ only apply to initial prescriptions. The interpretation of SGB V rests with self-administration bodies. How significant this is became evident during the summer when the KBV retracted its own clarification on off-label prescriptions. In practice, it matters how health insurers and audit bodies apply the rule. The demand for reliable patient care is not new, as earlier appeals from patient networks to health policymakers demonstrate.
Another clarification concerns ineffective treatments. Physicians are not obligated to continue prescribing a drug that doesn’t work or causes intolerance. This would be inappropriate under § 12 SGB V. Whether this permits an earlier switch to a custom formulation than after six months is not explicitly addressed in the response.
Exilby: Approval with Post-Authorization Efficacy Study Requirement
A large portion of the inquiry focused on Exilby, the only approved full-spectrum extract. It has been available since September 1, 2026. We reported on Exilby’s approval for chronic back pain. New information appears in the response to question 26: the BfArM linked Exilby’s approval under § 28 AMG to a condition. The manufacturer must conduct an efficacy study after approval—a post-authorization efficacy study. The reason given was remaining uncertainties regarding efficacy.
The government responds briefly about contact with the manufacturer. At staff and senior levels, there were no discussions with Vertanical or the FUTRUE Group. However, the BfArM informed the ministry four times in writing about progress, most recently on June 8, 2026, regarding completion of the approval process. One report from February 25, 2026, was used to prepare a leadership meeting. According to the government, it had no information about Exilby’s planned price. Our article on Exilby’s price in the AMNOG procedure explains why the reimbursement amount remains open.
The central question posed by the Green Party remains unanswered: how many insured persons are affected by the new regulation? The government has no patient-level data. It plans no formal evaluation with fixed criteria, but says it is monitoring the effects „very closely.“ Whether the rule harms patients or merely structures prescribing pathways can only be assessed through its practical application. The underlying tension itself is longstanding, as our earlier overview of cannabis in law and health demonstrates.
Frequently Asked Questions
What does the finished pharmaceutical priority rule regulate?
Since July 30, 2026, statutory health insurance generally covers cannabis extracts, dronabinol, and nabilone only after at least a six-month therapy trial with an approved cannabis-containing finished pharmaceutical. The basis is § 31 Section 6 SGB V in the version of the GKV contribution rate stabilization law.
Does the therapy trial apply to existing patients?
According to the Health Ministry’s assessment, no. Already initiated therapies need not be switched. However, the interpretation of the law rests with self-administration bodies—health insurers and the medical profession.
Which cannabis finished pharmaceuticals are approved?
At the relevant cutoff date, the government lists Epidyolex, Sativex, Exilby, Efysmo, Lyftenzo, and Canemes. The respective indications can be found in the BfArM’s pharmaceutical information database.
Does the rule save health insurance money?
The government assumes no significant financial impact. It provides no cost estimate in euros. An AOK comparison cited by the questioners even showed substantially higher costs for finished pharmaceuticals with certain active ingredients.
What does the condition mean for Exilby?
The BfArM linked the approval to a requirement for the manufacturer to conduct an efficacy study after approval. Such conditions are standard instruments when questions about efficacy remain unanswered. The approval itself is not affected.
Sources: German Bundestag, Document 21/8148 from September 23, 2026, Government Response to the Written Inquiry of the Alliance 90/The Greens Parliamentary Group (Document 21/7743); Krautinvest, September 28, 2026.
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