Magnetic Resonance-Guided Focused Ultrasound Neurosurgery for Treatment-Refractory Obsessive-Compulsive Disorder: A Health Technology Assessment

Abstract

Background: Obsessive-compulsive disorder (OCD) is a debilitating neuropsychiatric illness characterized by obsessions and compulsions that are distressing, impair function, and are time-consuming, especially in severe cases. Up to 40% of people with OCD have treatment-refractory OCD and experience inadequate response to multiple trials and combinations of treatments. Neurosurgery is an important treatment option for people with severe, treatment-refractory OCD but is typically invasive. Magnetic resonance-guided focused ultrasound (MRgFUS) is a noninvasive technology that is used to perform neurosurgery. We conducted a health technology assessment of MRgFUS neurosurgery for people with severe, treatment-refractory OCD, which included an evaluation of effectiveness, safety, the budget impact of publicly funding MRgFUS neurosurgery, and patient preferences and values.

Methods: We performed a systematic literature search of the clinical evidence published since 2013. We assessed the risk of bias of each included study using the Joanna Briggs Institute's Critical Appraisal Checklist for Case Series, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic literature search of the economic evidence. We estimated the 5-year budget impact of publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario. Owing to a lack of comparative clinical evidence, we did not conduct a primary economic evaluation. To contextualize the value of MRgFUS neurosurgery, we spoke to people with treatment-refractory OCD who underwent the procedure, as well as those on the waitlist.

Results: We included 2 studies in the clinical evidence review. In these small case series, MRgFUS neurosurgery led to improvements in OCD symptoms, quality of life, and patient functioning, as well as treatment response for many but not all patients (GRADE: Very low). In a minority of cases, the procedure could not be successfully performed due to skull factors (GRADE: Very low). MRgFUS neurosurgery was also found to have a favourable safety profile (GRADE: Very low). No cases of re-treatment were reported (GRADE: Very low). No studies compared MRgFUS neurosurgery with other neurosurgeries.Due to the lack of comparative clinical evidence, the cost-effectiveness of MRgFUS neurosurgery could not be determined. Our budget impact analysis found that publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario would cost an additional $1.9 million over 5 years.Patients reported the negative impacts that OCD had on their day-to-day activities, work and school, social life and family relationships, and mental health. The 6 participants who underwent MRgFUS neurosurgery commented on the positive impact that it had on their OCD symptoms, mental health, and quality of life.

Conclusions: MRgFUS neurosurgery may be an effective and generally safe treatment option for severe, treatment-refractory OCD, but the evidence is very uncertain. The cost-effectiveness of MRgFUS neurosurgery could not be determined given the lack of comparative clinical evidence. Publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario would result in an additional cost of $1.9 million over 5 years. Patients and care partners emphasized the negative impact of OCD in their lives and highlighted the importance of having access to MRgFUS neurosurgery as a treatment option for treatment-refractory OCD.

Figure 1:. PRISMA Flow Diagram - Clinical Systematic Review

Figure 2:. PRISMA Flow Diagram - Economic Systematic Review

Figure 3:. Schematic Model of Budget Impact

Figure 4:. Schematic Model of Costs Included in Budget Impact Analysis