Foslevodopa-Foscarbidopa (Vyalev)

Key Messages

• CADTH recommends that Vyalev should be reimbursed by public drug plans for the treatment of motor fluctuations in patients with advanced levodopa-responsive Parkinson disease (PD) who do not have satisfactory control of severe, debilitating motor fluctuations and hyperkinesia or dyskinesia despite optimized treatment with available combinations of medicinal products for PD if certain conditions are met.
• Vyalev should only be covered to treat patients with advanced PD who have unpredictable changes in movement symptoms and severe limitations in being able to perform daily activities while receiving optimized oral therapy. Patients should have previously shown improvement in their symptoms when they received levodopa treatment and should not have severe psychosis or severe dementia. Patients or caregivers should be able to understand how to use the drug infusion system correctly.
• Vyalev should only be reimbursed if prescribed by neurologists who are specialized in managing movement disorders or with expertise in managing advanced PD. Its cost should not be more than other treatments that are reimbursed for the treatment of advanced PD. Vyalev may lead to more patients seeking treatment; this adds uncertainty in the budget impact which should be addressed.