Limited coverage criteria– foslevodopa/foscarbidopa

Generic name

foslevodopa/foscarbidopa

Strength & form

foslevodopa 240 mg/mL / 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