Breakthrough Clinical Results
Insightec announced FDA approval of its Exablate Neuro platform for staged bilateral pallidothalamic tractotomy in patients with advanced Parkinson's disease. This expands the platform's indication to include both initial and subsequent staged procedures, offering a comprehensive bilateral treatment option for patients with severe motor symptoms unresponsive to medication. The incisionless, MRI-guided focused ultrasound treatment offers a lower risk profile than traditional surgery. A clinical trial across nine centers demonstrated encouraging results supporting the FDA approval. Insightec plans a limited launch in 2025, with efforts to establish reimbursement pathways for broader access. Over 25,000 patients have been treated globally with Insightec's Exablate technology.
Key Highlights
- FDA approves Insightec's Exablate Neuro for staged bilateral treatment of Parkinson's disease.
- Expands treatment options for patients with severe motor symptoms unresponsive to medication.
- Incisionless, MRI-guided focused ultrasound procedure offers lower risk than traditional surgery.
- Limited launch planned for 2025 with efforts to establish reimbursement pathways.
Incidence and Prevalence
Global Epidemiology of Parkinson's Disease
Global Prevalence and Projections
Parkinson's disease (PD) is currently the second most common neurodegenerative disorder, affecting approximately 10 million elderly individuals worldwide. It is also described as the second most prevalent neurodegenerative disease in the world, with projections indicating that 14.2 million PD patients are expected worldwide by 2040.
Prevalence by Region
China
A population-based cross-sectional survey conducted in China found that the overall prevalence of PD in residents aged 65 years and over was 1.86%, with a standardized prevalence of 1.60%. The crude prevalence in men (2.12%) was higher than that in women (1.66%). The standardized prevalence in urban areas (1.98%) was higher than that in rural areas (1.48%).
United States
In the US, age-standardized PD prevalence (per 100,000) was 2,168.18 (±95.64) in White men, 1,036.41 (±86.01) in Blacks, and 1,138.56 (±46.47) in Asians. The prevalence ratio for US Blacks compared to Whites was 0.58 (95% CI = 0.575-0.581), while for Asians, the prevalence ratio was 0.62 (95% CI = 0.617-0.631).
US prevalence by county quartile ranged from 1,175 to 13,800 per 100,000. Prevalence in urban US counties were greater than in rural ones (p < 0.01). Bayesian mapping of PD in the US revealed a concentration in the Midwest and Northeast regions.
Argentina
In Buenos Aires, Argentina (the first study in South America), prevalence was 394/100,000 in the population older than 40 years.
West Africa
The estimated crude prevalence of PD in West Africa varies from 15 to 572 per 100,000 people. The prevalence of parkinsonism in West Africa ranges from 6.0% to 8.3% of neurologic admissions/consultations.
Germany
In Dresden, Germany, 886 PD cases (95% CI: 809-926) were estimated, of which 252 (95% CI: 226-279) suffered from dementia and 216 (95% CI: 191-242) from depression.
Incidence Rates
A meta-analysis of international studies showed rising incidence with age in both men and women. In Buenos Aires, Argentina, crude incidence density was 31.2/100,000 person-years.
In the US, mean county incidence by quartile ranged from 279 to 3,111 per 100,000. The incidence ratio in US Blacks compared to Whites was 0.74 (95% CI = 0.732-0.748), while for Asians, the incidence ratio was 0.69 (95% CI = 0.657-0.723).
Demographic Factors Affecting Epidemiology
Age
Age significantly affects Parkinson's disease prevalence, with rates ranging between 1% and 4% among individuals over the age of 60 and 80 years. The incidence of Parkinson's disease dementia (PDD) increases with age at PD diagnosis, ranging from 0.81 per 1000 person-years among those aged 40-44 to 45.31 per 1000 person-years for those over 80 years.
Dementia rates in PD patients increased by age from 13.8% (≤65 years) to 40.2% (≥76 years) in the Dresden study. Overall, dementia was diagnosed in 69.6% of PD cases.
Sex Differences
Males had a higher incidence of PD in all age groups, but this difference was only statistically significant for those in the age range 60-69 and 70-79 (p < 0.05). The male to female ratio in the Buenos Aires study was 1.31.
Men exhibited statistically significantly greater motor and non-motor impact of PD, more severe motor signs, worse PD-specific health-related quality of life, and more depressive symptoms. Women had slower fast gait speed compared to men.
In terms of survival rates, patients who were female (HR 0.74; 95% CI, 0.73-0.75) had a lower adjusted risk of death than white men. Dementia was most often diagnosed in women (71.5%).
Geographic and Racial Variations
Urban residence was identified as an independent risk factor for PD in the Chinese study. Similarly, prevalence and incidence in urban US counties were greater than in rural ones (p < 0.01).
Regarding racial differences, patients who were Hispanic (HR 0.72; 95% CI, 0.65-0.80) or Asian (HR 0.86; 95% CI, 0.82-0.91) had a lower adjusted risk of death than white men. Dementia was most often diagnosed in African American patients (78.2%).
Patients living in urban high industrial metal emission areas had a slightly higher adjusted risk of death (HR 1.19; 95% CI, 1.10-1.29).
Mortality Trends
Globally, PD mortality rates increased significantly between 1994 and 2019, with rates rising from 1.76 per 100,000 in 1994 to 5.67 per 100,000 in 2019. Regional survival rates for PD were similar across the United States, with thirty-five percent of patients with PD living more than 6 years according to a study of Medicare beneficiaries.
Economic Burden
Economic Burden of Parkinson's Disease in the USA and Europe
United States Economic Burden
The total economic burden of Parkinson's disease (PD) in the US was estimated at $51.9 billion in 2017. This substantial figure includes $25.4 billion in direct medical costs and $26.5 billion in indirect and non-medical costs. Breaking down the indirect costs further reveals $14.2 billion for patient and caregiver burden combined, while non-medical costs account for $7.5 billion. Additionally, $4.8 billion is attributed to disability income received by patients.
The Medicare program bears the largest share of excess medical costs, primarily because most PD patients are over age 65. Another source indicates that disease-related costs exceed $10 billion, not including medications, out-of-pocket expenses, or societal costs.
Currently, PD affects nearly 1 million people in the US. Looking ahead, the projected prevalence will be more than 1.6 million with the total economic burden surpassing $79 billion by 2037.
European Economic Burden
In Luxembourg, the total mean cost of care for PD was estimated at €22,673 per patient per year in 2016, with long-term care accounting for the highest costs (69%).
A broader study across six European countries found that total mean costs per patient ranged from €2,620 to €9,820 over a 6-month period. In these European countries, direct costs totaled about 60% to 70% of total costs, while indirect costs represented about 30% to 40%.
The major expenditure categories identified in European countries were inpatient care, long-term care, and medication. In Germany, mean drug costs per day and patient were €5.78 compared to €3.92 in Norway. Dopamine agonists caused 44% of total drug costs in both Germany and Norway. Drug expenses were found to rise with increasing severity and duration of the disease.
Comparative Analysis and Global Context
When comparing the US and European economic burdens, the US shows significantly higher total costs, though the distribution between direct and indirect costs appears somewhat similar. In the US, direct medical costs account for approximately 49% of the total burden, while in European countries, direct costs represent 60-70% of total expenditures.
PD is the second most common neurodegenerative disorder with increasing prevalence worldwide. The current projection is more than 12 million patients with PD worldwide by 2040, with more than 20% of patients remaining undiagnosed. Environmental pollution and an aging population are driving rising PD cases worldwide.
Cost Factors
Several factors are associated with higher costs across regions, including being male, married, employed, presence of wearing off phenomenon, cognitive impairment, depression/anxiety, reduced activities of daily living, and increasing disease stage. Surgical interventions, though performed on only a small percentage of patients, significantly increase hospitalization costs.
Drug used in other indications
Lack of Information on Exablate Neuro Clinical Trials
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