Foslevodopa–foscarbidopa is recommended as an option for treating advanced levodopa-responsive Parkinson's in adults whose symptoms include severe motor fluctuations and hyperkinesia or dyskinesia, when available medicines are not working well enough, only if:
they cannot have apomorphine or deep brain stimulation, or these treatments no longer control symptoms, and
the company provides foslevodopa–foscarbidopa according to the commercial arrangement.
This recommendation is not intended to affect treatment with foslevodopa–foscarbidopa that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Treatment for advanced levodopa-responsive Parkinson's includes adding apomorphine, deep brain stimulation or levodopa–carbidopa intestinal gel to standard care (such as oral levodopa–carbidopa). Foslevodopa–foscarbidopa is given as a continuous infusion under the skin (subcutaneous).
The company asked for foslevodopa–foscarbidopa to be considered only for people who cannot have apomorphine or deep brain stimulation, or for when these treatments no longer control symptoms. So foslevodopa–foscarbidopa was only considered as an alternative to standard care and levodopa–carbidopa intestinal gel. This does not include everyone who foslevodopa–foscarbidopa is licensed for.
Evidence from a clinical trial suggests that foslevodopa–foscarbidopa improves motor symptoms compared with standard care. But some people in the trial had previously had apomorphine, so it is uncertain how well foslevodopa–foscarbidopa works for people who cannot have apomorphine. An indirect comparison suggests that foslevodopa–foscarbidopa works as well as levodopa–carbidopa intestinal gel, but the results are uncertain.
Even when considering this uncertainty, the most likely cost-effectiveness estimates are within the range that NICE usually considers an acceptable use of NHS resources. So, foslevodopa–foscarbidopa is recommended.