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Draft guidance consultation

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1 Recommendations

1.1 Foslevodopa–foscarbidopa is not recommended, within its marketing authorisation, for treating advanced levodopa-responsive Parkinson's disease in adults whose symptoms include severe motor fluctuations and hyperkinesia or dyskinesia, when available treatments are not working well enough.

1.2 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 a continuous infusion under the skin (subcutaneous). For this evaluation, the company asked for it to be considered only for people who cannot have apomorphine or deep brain stimulation, or for when these treatments are no longer controlling symptoms. This does not include everyone who foslevodopa–foscarbidopa is licensed for.

Clinical trial evidence suggests that foslevodopa–foscarbidopa improves motor symptoms compared with oral levodopa–carbidopa. 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. The results from indirect comparisons of foslevodopa–foscarbidopa with levodopa–carbidopa intestinal gel and standard care are uncertain and do not include all the relevant data.

Problems with the design of the company's economic model mean that it is not suitable for decision making. These problems include:

  • a lack of data to inform the large number of health states, including quality of life and cost data

  • uncaptured health effects of advanced Parkinson's

  • how stopping treatment is modelled.

This means that it is not possible to determine a reliable cost-effectiveness estimate or if foslevodopa–foscarbidopa is an acceptable use of NHS resources. So, it is not recommended. There is a high unmet need for treatments that control motor symptoms of advanced Parkinson's, and foslevodopa–foscarbidopa has many potential benefits. So, an improved economic model is needed to make it more suitable for decision making.