Significant relief for many stakeholders in the cannabis industry and among patients. Physicians may continue to prescribe cannabis extracts at the expense of statutory health insurance for indications for which no finished cannabis-based medicine is approved. The minimum six-month waiting period for finished medicinal products is eliminated. This is likely to be the final word on the reimbursement of cannabis-based medicines under the statutory health insurance system. Several licensed wholesalers and importers with manufacturing licenses have developed and launched their own extracts. A chronology follows.
On March 20, 2026, the Finance Commission on Health submitted its first report with recommendations for the Statutory Health Insurance (SHI) Contribution Stabilization Act to the Federal Ministry of Health (BMG). Based on a questionable calculation by the AOK ( a major German health insurance provider), the commission had projected that it would be more economical to prescribe cannabis flower extracts or finished medicinal products instead. Despite considerable doubts about this calculation, the Federal Ministry of Health (BMG) incorporated the proposal to completely eliminate reimbursement for cannabis flowers at the expense of statutory health insurance into the first draft of the bill, presented on April 29, 2026. Subsequently, the medicinal cannabis industry lobbied vehemently for relief for existing patients using cannabis flowers. However, instead, the regulations were tightened. On July 6, amendments were published that also restricted the prescription of cannabis extracts: “Contractual medical care must initially be provided with an approved cannabis-containing finished medicinal product within the framework of a six-month therapeutic trial.”
In Germany, Sativex (multiple sclerosis), Epidyolex (epilepsy), and Canemes (synthetic cannabinoids, for chemotherapy-induced nausea) as well as Exilby (chronic back pain) are approved. However, Exilby is not yet available in German pharmacies. Price negotiations are currently underway. The German Hemp Association (DHV), among others, criticized the subsequent amendments , partly due to six-figure party donations from Exilby’s manufacturer, Vertanical, in the run-up to the last federal election. The Pharmaceutical Journal discussed whether political influence had played a role. Melanie Dolfen, owner of the district pharmacy, called for a parliamentary review. Despite the criticism, the Federal Law on the Stabilization of Tobacco Products (BStG), including the amended wording, came into effect on July 30th.
As the National Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) clarified in a statement yesterday, Thursday, the minimum six-month priority for finished medicinal products applies only to the approved indication. Essentially, this means that off-label prescriptions of finished medicinal products and no-label prescriptions of extracts are treated equally as soon as no finished medicinal product is approved for a given indication. The new regulations for prescribing cannabis have led to “numerous inquiries, particularly from physicians.” The joint statement explicitly reads: “According to the joint interpretation of the KBV and the GKV-Spitzenverband, physicians can immediately prescribe an extract or another cannabis-containing medicinal product for the initial treatment of patients with severe pain or other indications for which no approved finished medicinal products are available.” This wording deviates from a strict interpretation of the wording of the law in favor of patients. And the KBV and GKV go even further: “Patients who have previously been treated with cannabis in the form of extracts or prescriptions also retain their entitlement to it.” According to this wording, doctors may continue to prescribe an extract to their existing patients at the expense of the GKV, even if a finished medicinal product is approved for the present indication.
According to Gamsi, gross sales of cannabis flowers, both processed and unprocessed, reached almost €31 million in the first quarter of 2026. The pharmaceuticals Canemes, Epidyolex, and Sative accounted for a total of €9.7 million during this period. Sales of cannabinoid-containing substances or finished medicinal products, either prepared or in their original state, accounted for approximately €20.5 million. Assuming that some of the former flower patients are now switching to extracts – and potentially gaining new patients – this should also be reflected in Gamsi’s figures from the third quarter of this year onward.
Continue at: https://krautinvest.de/vorrang-fuer-cannabis-fertigarzneimittel-nur-noch-bei-zugelassenen-indikationen/
The text above is owned by the site above referred.
Here is only a small part of the article, for more please follow the link
Also see:
Manostaxx – Industrial Management Consulting
