First cannabis-based medicine reimbursed for patients with rare epilepsy

Pharma News: The first-ever cannabis-based medicine authorised by the Therapeutic Goods Administration (TGA) has received approval for treating seizures associated with Lennox-Gastaut syndrome in patients aged 2 years and older. This monumental decision paves the way for enhanced treatment options and improved quality of life for individuals battling this rare and drug-resistant form of epilepsy.

Effective from June 1, 2023, Epidyolex will be included in the Pharmaceutical Benefits Scheme (PBS), ensuring greater accessibility and affordability for patients in need. The listing on PBS is backed by evidence from two pivotal clinical trials that demonstrated when the cannabis-based medicine is used in combination with other antiseizure medications, it significantly reduced the frequency of drop seizures, including atonic, tonic, and tonic-clonic seizures, compared to a placebo in patients diagnosed with Lennox-Gastaut syndrome.

Among the notable findings of the trials, the most common adverse reactions reported were somnolence, decreased appetite, diarrhea, pyrexia, fatigue, and vomiting. However, the benefits of Epidyolex far outweighed these side effects, offering hope to those burdened by the devastating symptoms associated with Lennox-Gastaut syndrome, such as recurring and prolonged seizures, cognitive impairments, and intellectual challenges.

Esteemed experts in the field have expressed their excitement and anticipation for the PBS listing of Epidyolex. Laureate Professor Ingrid Scheffer, a renowned paediatric neurologist, epileptologist, and clinical researcher at Austin Health and the University of Melbourne, acknowledged the significance of this milestone, stating, “Epidyolex is pharmaceutical-grade and the only cannabis-based medicine with demonstrated efficacy in refractory childhood epilepsies such as Lennox-Gastaut syndrome and Dravet syndrome.”

Graeme Shears, CEO of the Epilepsy Foundation, also welcomed this new treatment option and emphasised the positive impact it would have on Australians grappling with epilepsy. Highlighting the challenges of Lennox-Gastaut syndrome, Mr Shears stated, “Lennox-Gastaut syndrome is one of the most severe and difficult to treat forms of childhood-onset epilepsy. The availability of Epidyolex on the PBS is an important milestone for patients and their families who are affected by this complex and life-long form of epilepsy.”

Chiesi Australia, a partner of Jazz Pharmaceuticals, the company responsible for manufacturing Epidyolex, expressed their enthusiasm for this achievement. Chris Rossidis, the General Manager of Chiesi Australia, affirmed their commitment to ensuring affordable and timely access to Epidyolex for Australian patients suffering from Lennox-Gastaut syndrome.

Epidyolex has also been approved and registered in the United States and Europe, solidifying its position as a globally recognised treatment for refractory childhood epilepsies like Lennox-Gastaut syndrome and Dravet syndrome.

As medical advancements continue to revolutionise the field, the approval of this cannabis-based medicine signifies a turning point in epilepsy management, underscoring the power of innovation and dedication to transforming lives. With Epidyolex now accessible through the PBS, Australians living with Lennox-Gastaut syndrome can look forward to a brighter future.

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