The imminent launch of the first new European cannabis-based pharmaceutical for over five years could not have been better timed, it seems.
German company Vertanical’s Exilby pill for chronic lower back pain is set to debut in its domestic market within weeks.
This comes just days after dried cannabis flowers – a popular patient alternative – were removed from the country’s national health reimbursement programme under the BStabG regulations.
Whilst this will deliver a significant advantage to Vertanical, it is doubtful whether it will deliver the cost-savings sought by the government, and it may force many patients into the ‘black market’.
In an email exchange with Business of Cannabis, Michael Greif, MSc, Managing Director of the Branchenverband Cannabiswirtschaft (BvCW), which represents Germany’s cannabis businesses, acknowledged the opportunity it presents to Vertanical whist highlighting its concerns over the regulatory environment in which Exilby will debut.
He said: “Enshrining an absolute statutory priority for finished pharmaceuticals creates a big regulatory advantage for products like Exilby/VER-01 while systematically disadvantaging extemporaneous preparations (specials).
“This artificial market protection shields expensive finished products from cost-effective, personalised compounding alternatives.”
This elevated price of pharmaceutical cannabis medicine is an area of concern. He continued: “While exact final list pricing for Exilby remains subject to statutory pricing mechanisms, finished pharmaceuticals (Fertigarzneimittel) systematically operate in a considerably higher pricing tier than individualised compound formulas or raw flowers.
“Established finished cannabis pharmaceuticals such as Sativex range around €350-plus per standard pack, often leading to monthly treatment costs ranging between $350 and $1,000-plus depending on the required daily dosage.
“While the regulatory framework promotes finished pharmaceuticals under the guise of cost control, this assumption is health-economically flawed.
“Individualised compounding formulas (specials) are frequently far more economical for statutory health insurers over long-term treatment cycles.”
Cannabis pricing
An estimated 800,000 patients secure medical cannabis in Germany, with most of these being self-payers. An estimated 250,000 successfully obtain GKV reimbursement, which requires meeting strict criteria – serious illness, failure of standard therapies, etc.
And, of those reimbursed, about 65,000 were on cannabis flowers – the group that lost coverage under the BStabG on 30 July 2026.
The benchmark medical flower prices are between €4 to €6.50 per gram. For a typical patient using 20g to 30g per month, that equates to up to €180 a month, which is cheaper than the nation’s cannabis clubs, or the black market.
Some of these patients who can no longer access flowers will shift to extracts such as Sativex or Epidiolex however, because extracts have a delayed onset of action, this shift is often clinically unsuitable for patients with acute breakthrough pain.
Dr Greif highlighted this describing it as a ‘social disparity’: “Patients who clinically depend on rapid-acting flower inhalation are pushed into the out-of-pocket market.
“Since many chronic GKV patients live on limited financial resources, self-funding creates severe supply gaps.
“Those unable to afford private flower prescriptions face a stark dilemma: attempting home cultivation – often exceeding the legal 50g threshold – or turning back to the illicit market.”
Six-month trial dispute
The new BStabG regulations explicitly favours authorised finished pharmaceuticals by requiring a mandatory six-month trial with them before GKV reimbursement can be granted for specials.
On paper, this grants Exilby an immediate regulatory fast-track within the GKV system.
However, this has been met with resistance, Dr Greif said: “Forcing a mandatory 6-month trial period under BStabG creates a severe mismatch with established medical guidelines, potentially locking patients into ineffective, costly treatments for months.
“It remains highly disputed whether the new legislation forces physicians into off-label prescribing during the mandatory trial period — creating significant legal uncertainty and administrative resistance among prescribers.
“We are currently working on a request for clarification to the Federal Ministry of Health.” He explained. “For patients suffering from acute breakthrough symptoms who rely on the rapid onset of inhaled cannabis flower, finished oral preparations are clinically non-interchangeable, regardless of regulatory preference.”
Business of Cannabis has approached Vertanical for input into these developments and is yet to receive a response.
VER-01 contains over 100 compounds, compared to the single or dual compound CBD/THC combinations of other approved cannabis medicines.
In clinical trials it was found to able to alleviate pain more effectively than opioids, and also improve sleep.