Limited coverage drugs – levodopa-carbidopa intestinal gel

levodopa-carbidopa

20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate intestinal gel

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 benefits of using levodopa/carbidopa intestinal gel treatment outweigh the risks associated with the insertion and long-term use of the percutaneous endoscopic gastrostomy-jejunostomy (PEG-J) tube required for administration 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

The patient continues to benefit from the treatment, including significant reduction in the time spent in the off state and/or in ongoing, bothersome levodopa-induced dyskinesias, along with an improvement in the severity of the disability in the off state.