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For the first time ever, NICE has approved a treatment for advanced Parkinson’s disease.
Foslevodopa–foscarbidopa (Produodopa), manufactured by Abbvie, is delivered by an infusion pump and can be refilled at home, allowing patients to manage their symptoms “more reliably and effectively.”
The device is small and completely portable, and delivers the medication over a 24-hour period. NICE predicts around 900 patients will benefit from this new treatment.
How does foslevodopa–foscarbidopa work?
Foslevodopa is turned into the chemical dopamine, which is used to transmit messages between the parts of the brain and nerves that control movement.
Taking foslevodopa with foscarbidopa increases the availability of foslevodopa in the brain.
Standard treatment for advanced Parkinson’s disease is oral treatment with levodopa and carbidopa, but other medicines may be added as the disease progresses.
Non-oral treatments that may be used in advanced Parkinson’s that is responsive to levodopa include:
- apomorphine (a drug given as an injection to act like dopamine to stimulate nerve cells)
- deep brain stimulation through surgery
- levodopa–carbidopa intestinal gel.
Foslevodopa–foscarbidopa is to be considered only for people who cannot have any of the above treatments, or for when these treatments no longer control symptoms.
Foslevodopa-foscarbidopa reduced dyskinesia and “off” time
In a clinical trial involving 141 participants with advanced Parkinson’s disease, roughly half (n=74) were randomly assigned to receive continuous subcutaneous infusion of foslevodopa-foscarbidopa plus oral placebo capsules, while the other half (n=67) received oral encapsulated immediate-release levodopa-carbidopa plus continuous subcutaneous infusion of placebo solution.
Compared with levodopa-carbidopa, foslevodopa-foscarbidopa showed a significantly greater increase in time without troublesome dyskinesia and a significantly greater reduction in “off” time (when Parkinson’s motor and/or non-motor symptoms happen between medication doses).
Adverse events (most of which were non-serious and mild-moderate in severity) were reported in 85% (63) of 74 patients in the foslevodopa-foscarbidopa group versus 63% (42) of 67 in the levodopa-carbidopa group.
Incidences of serious adverse events were similar between the groups, with six (8%) incidences of adverse events in the foslevodopa-foscarbidopa group compared to four (6%) in the levodopa-carbidopa group.
Treatment helps patients with Parkinson’s to manage symptoms “reliably and effectively”
This is the first technology appraisal from NICE to look at a treatment for Parkinson’s. NICE has previously published clinical guidelines and medtech innovation briefings on Parkinson’s.
Helen Knight, director of medicines evaluation at NICE, said: “Foslevodopa–foscarbidopa represents an important new treatment for people with advanced Parkinson’s, providing an easy-to-use option that can help them manage their symptoms more reliably and effectively.
“This is the first time NICE has approved a treatment for Parkinson’s and comes after NICE was able to work with the company to address the issues that had initially prevented a positive recommendation.
“We are determined to get the best care to patients fast and ensure value for the taxpayer.”