Epidyolex, the first CBD-based drug to be reimbursed in France

Available in France since 2018 through temporary, name-specific authorizations for use (ATU) before obtain its European marketing authorization (MA) On September 19, 2019, Epidyolex, a high-potency pharmaceutical CBD oil, was approved and granted reimbursement status in France. This marks a first for a cannabis-based medication—a milestone that the Sativex, on hold since 2014.

An executive order issued Friday morning The Official Journal has added Epidyolex to the list of drugs eligible for reimbursement to social security beneficiaries for three indications:

• adjuvant treatment of epileptic seizures associated with Bourneville tuberous sclerosis (BTS) in patients 2 years of age and older with drug-resistant epilepsy
• in combination with clobazam for the treatment of epileptic seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in patients 2 years of age and older

«The announcement that Epidyolex will be covered by insurance in France is both positive and historic, as it is the first and only cannabidiol-based medication to be covered.», Franck Cousserans, Managing Director for France at Jazz Pharmaceuticals—an Irish pharmaceutical company that has r—said in a press release,acquired the British company GW Pharmaceuticals in May 2021. He was instrumental in the development of Epidyolex, which also had its marketing authorization in the United States, and Sativex.

Epidyolex must be prescribed by a doctor and is subject to an annual initial hospital prescription. It is an oral solution of cannabidiol (100 mg/ml) available in a 100-ml bottle, accompanied by two 1-ml syringes, two 5-ml syringes, and two adapters per bottle. The price will be €1,066.74 (including tax), with health insurance covering 65 % starting December 20, 2022.

The Lennox-Gastaut and Dravet syndromes are severe forms of epilepsy that typically manifest during early childhood or childhood. People with these conditions experience several types of seizures, most commonly atonic, tonic, and atypical absence seizures, which can be difficult to treat because they are resistant (refractory) to many types of anticonvulsant medications. Furthermore, certain anticonvulsant medications may actually worsen the seizures.

« The crises have had a major impact on daily life, by virtue of not only their recurrence but also the complications they can cause; seizures can occur at any time and significantly impair the quality of life not only for patients but also for those around them »," explains Prof. Rima Nabbout, a pediatric neurologist, coordinator of the Reference Center for Rare Epilepsies (CReER), and head of the CReER site at Necker-Enfants malades Hospital.

The use of CBD to treat epilepsy has been studied as early as the 1980s by Raphaël Mechoulam and his team. It wasn't until the 2010s that Charlotte Figi so that the effects of CBD on epilepsy can once again take center stage in public and media discourse.