Authors' objectives: The objective of this systematic review and economic evaluation was to assess the effectiveness/efficacy, safety, and cost-effectiveness of Deep Brain Stimulation (DBS) for treatment of patients with advanced Parkinson’s disease (PD).

Authors' results and conclusions: Part A: Systematic review Efficacy/ effectiveness There were thirteen systematic reviews retrieved on effectiveness of deep brain stimulation for advanced parkinson’s disease. Evidence demonstrated that: 1. Deep brain stimulation has shown positive and negative outcomes in Parkinson's disease patients, particularly in addressing non-motor symptoms. Positive outcomes include improved motor function and sleep quality, reduced medication dependence, pain relief, mood improvements, and weight gain. Negative outcomes include slight worsening of cardiovascular symptoms, mixed effects in speech, voice, and language, cognitive decline, and increased apathy post-operatively. Careful monitoring is necessary to ensure long-term cognitive health and avoid adverse effects. 2. Deep brain stimulation has been shown to improve motor symptoms in Parkinson's disease patients, with positive outcomes including reductions in UPDRS Part III scores, balance and gait metrics, and reduced off-time. DBS also shows moderate-to-high effectiveness in alleviating PD-associated postural abnormalities, with better outcomes in younger patients and those with lower preoperative motor disability scores. However, DBS-treated patients may experience cognitive decline, balance and fall risk, and heterogeneity in gait outcomes. DBS does not significantly alter the incidence rates of Parkinson's Disease–Mild Cognitive Impairment (PD-MCI) or Parkinson’s Disease Dementia (PDD), suggesting no protective effect against long-term cognitive decline. Additionally, the best stimulation parameters and target sites for specific symptoms remain unclear, suggesting the need for individualized therapy. 3. STN-DBS significantly improves quality of life (QoL) in Parkinson’s disease, particularly for patients with poorer preoperative QoL, greater motor response to dopamine challenges, lower baseline dyskinesia, and higher daily "OFF" time. While sex and education do not influence outcomes, older age may result in smaller gains in specific domains like stigma and mobility. Higher Hoehn and Yahr stages and poor initial QoL often predict greater improvements, though reliance on social support is associated with poorer mental health outcomes. The relationship between baseline levodopa equivalent dosage (LED) and QoL is inconsistent, and psychological factors like anxiety, apathy, and depression generally do not impact QoL changes. These findings highlight the need for individualized patient selection and expectation management in DBS therapy. Safety DBS devices have been approved by the U.S. Food and Drug Administration (FDA) and registered with the Medical Device Authority (MDA). However, their use is associated with specific risks that require careful monitoring and management, particularly concerning the potential for suicidal behavior. Common serious adverse events (SAEs) include infections, intracranial hemorrhage, and seizures, which are typical of DBS procedures but can be managed without long-term consequence. The safety of DBS also depends on timely interventions, such as regular monitoring for complications like DBS-withdrawal syndrome, which can occur if battery failure happens. In summary, while DBS offers significant benefits in managing PD symptoms, it requires rigorous patient selection, surgical expertise, pre- and postsurgical care to minimize risks and ensure optimal outcomes. Organisational issues Organisational issues in implementing DBS for PD include regulatory compliance (e.g., FDA PMA for devices), clear patient selection, and delivery in specialised centers. Effective care requires interdisciplinary collaboration and structured post-surgical follow-up. Resource management and education improve access and outcomes. STN is the preferred target for motor symptoms, while GPi may be used for dyskinesias. Standardised protocols and expert consensus ensure ongoing refinement and safety. Economic implication Three systematic reviews on cost-effectiveness study retrieved on deep brain stimulation for Parkinson’s Disease. The reviews have demonstrated that DBS to be cost-effective for PD, particularly over longer time horizons. Conclusion Based on the above review, evidence demonstrated that Deep Brain Stimulation (DBS) is effective in improving motor and non-motor symptoms in Parkinson's Disease, particularly in reducing off-time and enhancing quality of life. It also helps alleviate pain, improve cardiovascular health, and enhance sleep quality. DBS is approved by US FDA, MDA and have CE mark. However, it is associated with potential risks and complications such as, infections, suicide, dislocation of device and haemorrage. Economic evaluations of high-income countries showed that Deep Brain Stimulation (DBS) is a cost-effective treatment for Parkinson's disease, especially compared to best medical therapy (BMT). Although initial costs are high, they decrease over time, improving cost-effectiveness beyond the first few years. Deep brain stimulation consistently provides more quality-adjusted life years (QALYs) at costs below GDP thresholds in high-income countries, supporting its use as a valuable long-term treatment option. An extrapolated cost utility analysis from Ministry of Health perspective showed that DBS treatment for Parkinson’s Disease involves a substantial initial investment. Although DBS plus BMT reduces long-term medication needs and yields some improvement in QALYs, it results in higher overall healthcare costs compared to BMT alone over a 5-year horizon. The resulting ICER reflects a high incremental cost for a relatively small QALY gain, suggesting that DBS plus BMT is unlikely to be cost-effective within this timeframe.

Authors' methods: Part A: Systematic Review A comprehensive search was conducted on the following databases without any restriction on publication language and publication status. The Ovid interface: Ovid MEDLINE(R) and Epub Ahead of Print, In-Process, In-DataReview & Other Non-Indexed Citations, Daily and Versions <1946 to July 11, 2024> HTA Full-Text Journals. Searches were also run in PubMed. Google was used to search for additional web-based materials and information. Additional articles were identified from reviewing the references of retrieved articles. Last search was conducted on 22 November 2024. The tools used to assess the risk of bias and methodological quality of the articles retrieved is the ROBIS checklist. All full text articles were then graded based on guidelines from the US/Canadian Preventive Services Task Force. Part B: Economic evaluation An extrapolated cost-utility analysis of Deep Brain Stimulation (DBS) combined with best medical therapy (BMT) compared to BMT alone for the treatment of advanced Parkinson's disease. The analysis was conducted from a Ministry of Health perspective over a 5-year time horizon, utilizing a 3% discount rate.

Project Status: Completed

URL for project: https://www.moh.gov.my/index.php/database_stores/store_view_page/30/427

Year Published: 2024

URL for published report: https://www.moh.gov.my/index.php/database_stores/store_view_page/30/427

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Malaysia

Organisation Name: Malaysian Health Technology Assessment

Contact Address: Malaysian Health Technology Assessment Section, Ministry of Health Malaysia, Federal Government Administrative Centre, Level 4, Block E1, Parcel E, 62590 Putrajaya Malaysia Tel: +603 8883 1229

Contact Name: htamalaysia@moh.gov.my

Contact Email: htamalaysia@moh.gov.my

Copyright: Malaysian Health Technology Assessment Section (MaHTAS)