Limited Coverage Drugs – levodopa-carbidopa

levidopa-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:

1. 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.
2. 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)
3. The patient has received an adequate trial of maximally tolerated doses of levodopa, with demonstrated clinical response.
4. 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.
5. Deep Brain Stimulation (DBS) is contraindicated or the patient is on the DBS waitlist for more than 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.

First approval: 1 year

Renewal: 1 year