Pharmacy Daily | First new PBS listing for ALS drug in 20 yrs

RADICAVA IV infusion (edaravone, Teva Pharma) is now listed on the Pharmaceutical Benefits Scheme (PBS) for eligible adults with amyotrophic lateral sclerosis (ALS), representing the first new PBS-listed molecule for the treatment of ALS in over 20 years.

Teva noted that pharmacists will play a key role in counselling patients and caregivers about Radicava's administration schedule, monitoring for potential side effects, and supporting adherence to treatment, particularly as part of a multidisciplinary approach to ALS care.

Radicava is indicated in Australia for adults with a diagnosis of ALS, the most common type of motor neurone disease, who are independent in activities of daily living with normal respiratory function and where treatment is initiated within two years of disease onset.

ALS symptoms can progress rapidly, decreasing function and quality of life, with a median survival time of around 3.5 years from the onset of symptoms.

Early treatment with the drug can help slow disease progression and reduce decline in quality of life.

A six-month clinical trial in eligible people with ALS showed a 33% reduction in functional decline versus placebo and a 34% reduction in decline in quality of life versus placebo.

The main adverse events include contusion, gait disturbance, headache, eczema and dermatitis contact.

"ALS is a rapidly progressing disease, placing a substantial physical, emotional, and financial burden on individuals and their families," said Professor Matthew Kiernan, CEO and Institute Director at Neuroscience Research Australia.

"Early symptoms can be subtle and ALS is difficult to diagnose," Professor Kiernan explained.

"If healthcare professionals suspect ALS or MND, it is important to refer to a neurologist who can diagnose MND to meet the individual's needs as early as possible, including the commencement of protective treatment, to keep patients in the milder form of the disease for longer periods," he concluded.

Radicava is listed on the PBS as a Section 100 item. KB