DBS in Early Parkinson’s Found to Lower Medication Use, Costs
Deep brain stimulation (DBS) in adults with early Parkinson’s reduces disease-specific medication use and provides significant cost savings, for up to 15 years, relative to standard care, a study shows.
While these savings — just over $100,000 over 15 years — did not outweigh the costs of the surgical treatment, they do provide a partial cost offset. That may be sufficient, the researchers said, to consider DBS a cost-effective approach in this patient population, as previously reported for advanced-stage Parkinson’s.
“Numerous studies have demonstrated that DBS for mid- and advanced-stage PD [Parkinson’s disease] is a cost-effective therapy because of the significant improvement in PD symptoms and quality of life compared to the best medical therapy,” the researchers wrote.
“Therefore, for all stages of PD evaluated thus far … the costs associated with DBS are justified by the benefits the therapy provides, including better motor symptom control, improved quality of life, and reduced complications associated with medical therapy,” they wrote.
These findings, based on a pilot clinical trial, need to be confirmed in a larger Phase 3 trial, according to the researchers.
The study, “Early subthalamic nucleus deep brain stimulation in Parkinson’s disease reduces long-term medication costs,” was published in the journal Clinical Neurology and Neurosurgery.
DBS is an established surgical Parkinson’s treatment that involves implanting thin wires in the brain to stimulate specific regions — most commonly the subthalamic nucleus, involved in motor function — with electric impulses. The amount of stimulation is controlled by a pacemaker-like device placed under the skin, near the collarbone.
These electrical signals are expected to help control Parkinson’s-associated abnormal brain activity, easing disease symptoms.
This approach is typically used to treat people with mid- and advanced-stage Parkinson’s who respond poorly or are no longer responding to standard medications. It has been reported to reduce the need for Parkinson’s medicines and their associated costs.
To date, the safety and preliminary effectiveness of DBS in early stage Parkinson’s have been evaluated only in a single pilot trial (NCT00282152).
That study involved 30 patients, ages 50–75, who had been taking Parkinson’s medications for at least six months, and for up to four years. The participants had no history of uncontrolled movements and showed stable motor symptoms.
To compare the two treatment courses, the participants were randomly assigned to receive DBS plus Parkinson’s medications (15 patients; DBS group), or medication alone (15 patients; control group). Those who completed the two-year trial entered a follow-up study, in which they were evaluated annually for three additional years, for a total assessment of five years.
During follow-up, all patients could use any Parkinson’s treatment, including undergoing DBS for those initially assigned to medication only.
The trial’s main goals were safety measures and changes in levodopa equivalent daily dose — levodopa is one of the main medications used to treat disease symptoms — while secondary goals included changes in disease severity, as assessed with the Unified Parkinson’s Disease Rating Scale.
Previous two-year results showed that adding DBS to standard medication was generally safe and associated with slower progression of rest tremors (tremors in a body part while at rest) relative to medication alone.
Also, five-year data suggested that early treatment with DBS reduces the need for and complexity of Parkinson’s medications, while providing long-term motor benefit as compared with standard medicines.
Now, researchers at Vanderbilt University Medical Center, in Tennessee, where the trial took place, reported five-year results regarding medication costs. They also projected such costs through 15 years to reflect the mean time for Parkinson’s to progress from early to advanced stages — the time when a typical patient may be offered DBS.
Data from motor symptom-targeting medications, collected at each visit, were used to calculate and project medication costs.
The analysis included 28 participants who completed at least one follow-up visit. They had a mean age of 61.1 and had lived with the disease for a mean of 2.1 years at study entry.
The results showed that the mean annual Parkinson’s medication cost had increased from $4,941 at the study’s start to $14,177 after five years for patients receiving standard medication alone. For the DBS group, the costs increased from $4,507 to $6,636.
This represented a 2.4 times lower annual medication cost and a five-year cumulative cost reduction of $28,246 for patients receiving both DBS and standard medication relative to the control group.
Patients originally assigned to medication alone also were five times more likely to have higher medication costs than those in the DBS group.
In addition, annual medication costs at 15 years — using 10% annual cost increases to account for disease progression — were projected to reach $30,371 for the control group and $14,216 for the DBS group.
As such, receiving DBS plus standard medication at an early stage of the disease was estimated to lower cumulative medication costs by $104,958 over 15 years of disease duration, compared with standard care.
These findings highlight that DBS during very early stage Parkinson’s disease “may provide substantial long-term PD [Parkinson’s disease] medication cost savings compared to standard care,” the researchers wrote.
Still, costs associated with DBS “are significant,” they added, with previous U.S.-based studies reporting initial costs of $63,848 for the surgical procedure and additional costs of $26,653 for battery replacement procedures.
“The savings in PD medication cost projected here do not outweigh the costs associated with DBS but do represent a cost offset,” the team wrote, adding that data from Phase 3 trials in patients with mid- and advanced-stage Parkinson’s showed that DBS-associated costs were “justified by the benefits the therapy provides.”
These benefits specifically include better control of motor symptoms, improved quality of life, and reduced complications associated with pharmacological therapy.
The results here “must be confirmed in a larger study,” the researchers wrote, noting that the U.S. Food and Drug Administration has cleared the initiation of a Phase 3, multicenter trial evaluating DBS in early stage Parkinson’s.
Future studies also should collect data related to the use of medications targeting non-motor problems, the researchers said. Additionally, investigators should examine other interventions, such as physical, speech, and occupational therapy, to provide comprehensive information on Parkinson’s-related treatment costs, the team said.
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