[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"news-article-germany-s-new-cannabis-medicine-exilby-launches-amid-reimbursement-shake-up-3df6483a":3},{"data":4},{"_id":5,"slug":6,"articleType":7,"body":8,"createdAt":15,"dek":16,"entities":17,"headline":29,"imageAlt":30,"imageUrl":31,"keyFacts":32,"language":49,"publishedAt":50,"seo":51,"sources":54,"summary":59,"updatedAt":60},"6a9097bbaeddfad21a39f9d2","germany-s-new-cannabis-medicine-exilby-launches-amid-reimbursement-shake-up-3df6483a","regulation",[9,10,11,12,13,14],"The imminent launch of Exilby, an oral cannabis extract developed by German company Vertanical for chronic lower back pain, comes just days after dried cannabis flowers were removed from Germany's national health reimbursement programme under BStabG regulations. This timing gives the new pharmaceutical a significant regulatory advantage in its domestic market, according to the Branchenverband Cannabiswirtschaft (BvCW), which represents Germany's cannabis businesses.","Michael Greif, Managing Director of the BvCW, said the new rules create an artificial market protection for finished pharmaceuticals like Exilby while systematically disadvantaging extemporaneous preparations, also known as specials. He noted that finished cannabis pharmaceuticals such as Sativex typically cost around €350 or more per standard pack, leading to monthly treatment costs between $350 and $1,000-plus depending on dosage.","An estimated 800,000 patients secure medical cannabis in Germany, with most being self-payers. Around 250,000 successfully obtain statutory health insurance (GKV) reimbursement, and of those, about 65,000 were on cannabis flowers—the group that lost coverage on 30 July 2026. Benchmark medical flower prices range from €4 to €6.50 per gram, meaning a typical patient using 20g to 30g per month pays up to €180, cheaper than cannabis clubs or the black market.","The shift from flowers to extracts such as Sativex or Epidiolex is often clinically unsuitable for patients with acute breakthrough pain because extracts have a delayed onset of action. Dr Greif described this as a social disparity, saying patients who depend on rapid-acting flower inhalation are pushed into the out-of-pocket market, and those unable to afford private flower prescriptions face a stark dilemma between home cultivation exceeding the legal 50g threshold or turning back to the illicit market.","The new BStabG regulations require a mandatory six-month trial with authorised finished pharmaceuticals before GKV reimbursement can be granted for specials, granting Exilby an immediate regulatory fast-track. However, Dr Greif said this creates a severe mismatch with established medical guidelines and remains highly disputed, with the BvCW working on a request for clarification to the Federal Ministry of Health regarding potential off-label prescribing during the trial period.","Exilby, also known as VER-01, contains over 100 compounds, compared to the single or dual compound CBD\u002FTHC combinations of other approved cannabis medicines. In clinical trials it was found to alleviate pain more effectively than opioids and improve sleep. Business of Cannabis has approached Vertanical for comment and is yet to receive a response.","2026-08-27T20:02:03.632Z","Vertanical's Exilby oral extract debuts weeks after dried cannabis flowers lost national health reimbursement, giving the new pharmaceutical a regulatory edge but raising patient access concerns.",{"brands":18,"products":22,"markets":23,"organizations":25},[19,20,21],"Exilby","Sativex","Epidiolex",[19,20,21],[24],"Germany",[26,27,28],"Branchenverband Cannabiswirtschaft (BvCW)","Federal Ministry of Health","Vertanical","Germany's New Cannabis Medicine Exilby Launches Amid Reimbursement Shake-Up","Exilby oral extract packaging for chronic lower back pain in Germany","",[33,37,40,43,46],{"claim":34,"sourceUrl":35,"_id":36},"Vertanical's Exilby oral extract for chronic lower back pain is set to debut in Germany within weeks, making it the first new European cannabis-based pharmaceutical in over five years.","https:\u002F\u002Fbusinessofcannabis.com\u002Fis-it-an-open-goal-for-germanys-new-cannabis-medicine\u002F","6a9097bbe81f0249cd72d374",{"claim":38,"sourceUrl":35,"_id":39},"Dried cannabis flowers were removed from Germany's national health reimbursement programme under BStabG regulations on 30 July 2026.","6a9097bbe81f0249cd72d375",{"claim":41,"sourceUrl":35,"_id":42},"The BStabG regulations require a mandatory six-month trial with authorised finished pharmaceuticals before GKV reimbursement can be granted for specials.","6a9097bbe81f0249cd72d376",{"claim":44,"sourceUrl":35,"_id":45},"An estimated 800,000 patients secure medical cannabis in Germany, with about 250,000 obtaining GKV reimbursement and roughly 65,000 of those previously on cannabis flowers.","6a9097bbe81f0249cd72d377",{"claim":47,"sourceUrl":35,"_id":48},"Exilby (VER-01) contains over 100 compounds and in clinical trials was found to alleviate pain more effectively than opioids and improve sleep.","6a9097bbe81f0249cd72d378","en","2026-08-28T05:26:14.544Z",{"title":52,"description":53},"Germany's Exilby Launch Amid Cannabis Reimbursement Shift","Vertanical's Exilby oral extract debuts in Germany weeks after dried cannabis flowers lost national health reimbursement, raising patient access concerns.",[55],{"name":56,"url":35,"trustTier":57,"_id":58},"Business of Cannabis","trade","6a9097bbe81f0249cd72d373","German company Vertanical is set to launch Exilby, the first new European cannabis-based pharmaceutical in over five years, for chronic lower back pain. The launch follows the removal of dried cannabis flowers from Germany's national health reimbursement programme under BStabG regulations, creating a regulatory advantage for finished pharmaceuticals like Exilby. Industry representatives warn the shift may increase costs and push patients toward the black market.","2026-08-28T05:26:14.616Z"]