Limited Coverage Drugs – foslevodopa/foscarbidopa

Generic name

foslevodopa/foscarbidopa

Strength & form

foslevodopa 240 mg/mL and foscarbidopa 12 mg/mL solution for subcutaneous infusion

Initial

For the management of severe cases of advanced idiopathic Parkinson’s Disease (PD) when requested by a neurologist practicing at a movement disorder clinic AND all criteria below are met:

• The patient has not been able to achieve satisfactory control of severe, debilitating motor fluctuations and hyper-/dyskinesia despite optimized treatment with available combinations of PD treatments including maximally tolerated doses of levodopa in combination with carbidopa, a catechol-O-methyl transferase (COMT) inhibitor, a dopamine agonist, a monoamine oxidase (MAO-B) inhibitor, and amantadine, if not contraindicated

AND

• The patient experiences severe disability associated with at least 25% of the waking day in the off state and/or ongoing, bothersome levodopa-induced dyskinesias, despite having tried frequent dosing of levodopa (at least five doses per day)

AND

• The patient has received an adequate trial of maximally tolerated doses of levodopa, with demonstrated clinical response

AND

• The patient or caregiver are able to demonstrate correct understanding and use of the delivery system AND the patient does not have severe psychosis or dementia

AND

• Deep Brain Stimulation (DBS) is contraindicated, or the patient is on the DBS waitlist

1 year

Renewal