Title: Foslevodopa-foscarbidopa for treating Parkinson’s disease with motor symptoms [ID3876]
Funder: Department of Health and Social Care

Abstract: Parkinson's disease is a progressive chronic disorder of the central nervous system. It is caused by a loss of cells in the brain that are responsible for producing dopamine, which helps to control and coordinate body movements. In the early stages of Parkinson’s disease, the 3 main symptoms are shaking (tremor), slowness of movement (bradykinesia) and muscle stiffness (rigidity). These develop gradually, in no particular order. [1] Other physical symptoms that can occur early on include balance problems, nerve pain and sleep disturbances. People with advanced Parkinson’s disease have more complex symptoms that significantly impact daily living, including anxiety, depression and dementia. [2] Pharmacological treatment may also be less effective in later stages. Advanced Parkinson’s disease has a severe negative impact on the quality of life of patients, their families and carers._x000D_ _x000D_ There are around 145,000 people living with Parkinson’s disease in the UK.[3] Men are more likely to develop Parkinson's disease than women, and the risk of developing the disease increases sharply with age. [3] It is estimated that around 34% of people have complex disease. [4] In 2018 there were 6,505 deaths due to Parkinson’s disease in England and Wales. [5]_x000D_ _x000D_ NICE guideline [NG71] recommends levodopa as the first-line treatment for people in the early stages of Parkinson’s disease whose motor symptoms impact their quality of life. However, people having long-term levodopa treatment develop motor complications. These include motor fluctuations, where the patient switches between being able to move (‘on’ phase) and being immobile (‘off’ phase), and involuntary movements (dyskinesias). Dopamine agonists, monoamine oxidase Type B (MAO-B) inhibitors or catechol O methyl transferase (COMT) inhibitors are offered as an addon to levodopa for people who have developed dyskinesia or motor fluctuations despite optimal therapy. If the dyskinesia remains uncontrolled, amantadine can be considered. Best medical therapy for people with advanced Parkinson’s disease may include intermittent apomorphine injection and/or continuous apomorphine infusion. Surgery (for example, deep brain stimulation) can be considered in people whose disease has not responded adequately to best medical therapy. An NHS England Clinical Commissioning Policy recommends that levodopa-carbidopa intestinal gel can be considered in certain people with advanced levodopa-responsive Parkinson’s disease, with severe motor fluctuations that have not responded to available medications. [4]_x000D_ _x000D_ References_x000D_ 1. NHS (2019) Parkinson’s disease symptoms. Accessed January 2021_x000D_ 2. Parkinson’s UK. Advanced Parkinson’s. Accessed January 2021_x000D_ 3. Parkinson’s UK (2018). The Incidence and Prevalence of Parkinson’s in the UK. Accessed April 2021_x000D_ 4. Parkinson’s UK. 2019 Audit Summary Report. Accessed April 2021._x000D_ 5. Office for National Statistics (2019). Deaths from Parkinson's Disease, England and Wales, 2001 to 2018. Accessed January 2021

Lay abstract: To appraise the clinical and cost effectiveness of foslevodopa-foscarbidopa subcutaneous infusion within its marketing authorisation for treating Parkinson’s disease with uncontrolled motor symptoms.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: NEUROLOGICAL