Available in France since 2018 through nominative temporary authorizations for use (ATU) before obtaining its European marketing authorization (AMM) on September 19, 2019, Epidyolex, a high-dose pharmaceutical CBD oil, comes to obtain its price and reimbursement in France. A first for a cannabis-based drug that Sativex, blocked since 2014, had not been able to win.
A decree published Friday morning in the Official Journal includes Epidyolex on the list of medicines reimbursable by social security in three indications:
- adjuvant treatment of epileptic seizures associated with tuberous sclerosis (TBS) in patients 2 years of age and older with drug-resistant epilepsy
- in combination with clobazam for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in patients 2 years of age and older
“The announcement of the reimbursement of Epidyolex in France is both positive and historic because it is the first and only cannabidiol-based medicine to be reimbursed”, rejoiced in a press release Franck Cousserans, the general manager of Jazz Pharmaceuticals, an Irish laboratory which bought the British GW Pharmaceuticals in May 2021. The latter is behind the development of Epidyolex, which also had its marketing authorization in the United States, and Sativex.
Epidyolex must be prescribed by secure prescription and is subject to an initial annual 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 bottle adapters. Its price will be €1,066.74 including tax, with coverage by health insurance of 65% from December 20, 2022.
The Lennox-Gastaut and Dravet syndrome are severe forms of epilepsy that usually manifest during infancy or childhood. Affected individuals have 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. Some anticonvulsant medications can also exacerbate seizures.
” The consequences of crises on daily life are major, by their repetition but also the accidents they can cause; crises happen at any time and considerably degrade the quality of life of patients but also of those around them explains Prof. Rima Nabbout, neuropediatrician, 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 was studied in the 1980s by Raphaël Mechoulam and his team. It was not until the 2010s and Charlotte Figi that the effect of CBD on epilepsy came back publicly and in the media to center stage.