WHAT IS THE CADTH REIMBURSEMENT RECOMMENDATION FOR VYALEV?: 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. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? 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. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? 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. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from a clinical trial demonstrated that Vyalev reduced unpredictable changes in movement symptoms in patients with advanced PD whose movement symptoms were uncontrolled with oral therapy. Vyalev treatment may meet needs identified by patients as important, including reducing fluctuations of motor symptoms and pill burden and by providing a nonsurgical treatment option. Based on CADTH’s assessment of the health economic evidence, uncertainty remains about whether Vyalev represents good value to the health care system at public list prices. A price reduction may be required. Based on public list prices, Vyalev is estimated to have no additional cost to public drug plans over the next 3 years. However, Vyalev may increase public drug plan budgets if its availability results in patients who were not previously on treatment to seek access to Vyalev and/or if Vyalev displaces deep brain stimulation.
WHAT IS ADVANCED PD? PD is a condition in which the brain cells responsible for controlling movement become damaged or die, leading to symptoms such as tremor, stiffness, slow movement, and difficulty with balance and coordination. Advanced PD refers to the later stages of the condition when symptoms become more severe and challenging to manage. It is estimated that more than 100,000 people living in Canada are diagnosed with PD, and approximately 10% to 20% of them with advanced PD. UNMET NEEDS IN ADVANCED PD: Existing treatments for advanced PD (e.g., deep brain stimulation and levodopa-carbidopa intestinal gel) could be difficult to access for some patients because these are typically provided in major urban treatment centres. These treatments can cause surgical complications and are not suitable for some patients due to side effects and other individual factors that would make the treatment unsafe. HOW MUCH DOES VYALEV COST? Treatment with Vyalev is expected to have an annual cost of $62,023 per patient assuming patients will use approximately 1 vial per day.
