Business of Cannabis
Last month, the German government passed a controversial cost-saving law that saw tens of thousands of patients denied access medical cannabis to flower reimbursed through statutory health insurance (GKV).
In the weeks since, a chaotic tug-of-war between physicians, health funds, patient groups and the cannabis industry has thrown the framework into further disarray.
Fissures have now opened between the country’s statutory-insurance physicians and the health funds, after an August move to soften the most contested provision, the mandatory six-month finished-medicine trial, which was itself reversed.
The question of how roughly 65,000 cannabis patients are actually treated now rests with a ministry that has yet to rule.
Weeks of chaos
The Statutory Health Insurance Contribution Rate Stabilisation Act (GKV-Beitragssatzstabilisierungsgesetz), a broad financial bill designed to reduce the country’s ballooning insurance deficit, officially took effect on July 30.
This removed dried flower from statutory reimbursement imposed a six-month finished-medicine trial before extracts like dronabinol or nabilone could be prescribed.
Amid a flood of queries from doctors, the KBV and the GKV-Spitzenverband issued a joint interpretation on August 06 that softened the rule.
In their statement, they suggested that the mandatory six-month trial would apply only to indications for which a finished medicine was actually licensed, and patients already on extracts would be spared. Industry and pharmaceutical bodies welcomed the move.
“The clarification provides legal certainty for physicians and, above all, for patients,” Philip Schetter, CEO of Cantourage Group SE, said in a press release. Continuity of treatment is an essential component of reliable medical care.”
On closer examination, though, the KBV changed its position once again. This week, it said that it now believed a cannabis finished medicine must be tried first in every case, even when it is not approved for the patient’s condition, which would mean prescribing ‘off-label’ medicines.
In practice, this means starting most patients on a product not licensed for their illness, which insurers normally reimburse only in exceptional cases. The four finished cannabis medicines approved for specific indications include Sativex for MS spasticity, Epidyolex for certain epilepsies, Canemes for chemotherapy nausea, and Exilby for chronic back pain.
Two exceptions still hold. Patients already on flower or extracts are unaffected. And if the finished medicine doesn’t work, or the patient can’t tolerate it, the doctor can switch straight to an extract, without seeing out the full six months or having to try a second finished product.
