DBS in Early Parkinson’s Disease Reduces Long-Term Drug Use and Costs
Deep brain stimulation (DBS) in adults with early-onset Parkinson’s disease reduces the use of disease-specific drugs and provides significant savings, up to 15 years, compared to standard care, study finds.
While these savings – just over $ 100,000 over 15 years – did not offset the costs of surgical treatment, they do provide partial cost compensation. This may be enough, the researchers said, to see DBS as a cost-effective approach in this patient population, as previously reported for advanced Parkinson’s disease.
“Many studies have has shown that DBS for the intermediate and advanced stages of PD [Parkinson’s disease] is a cost-effective therapy due to significant improvement in PD symptoms and quality of life compared to the best medical treatment, ”the researchers wrote.
“Therefore, for all stages of PD evaluated so far… the costs associated with DBS are justified by the benefits therapy provides, including better control of motor symptoms, improved quality of life and reduced complications associated with medical treatment, ”they wrote.
These results, based on a pilot clinical trial, need to be confirmed in a larger Phase 3 trial, the researchers said.
The study, “Early deep brain stimulation of the subthalamic nucleus in Parkinson’s disease reduces long-term drug costs, ”Was published in the journal Clinical Neurology and Neurosurgery.
DBS is an established surgical treatment for Parkinson’s disease that involves implanting thin wires in the brain to stimulate specific regions – most often the subthalamic nucleus, involved in motor function – with electrical impulses. The amount of stimulation is controlled by a device similar to a pacemaker placed under the skin, near the collarbone.
These electrical signals should help control the abnormal brain activity associated with Parkinson’s disease, by reducing the symptoms of the disease.
This approach is typically used to treat people with intermediate or advanced Parkinson’s disease who respond poorly or no longer respond to standard medications. It has been reported to reduce the need for Parkinson’s disease drugs and their associated costs.
To date, the safety and preliminary efficacy of DBS in early-stage Parkinson’s disease has only been evaluated in one pilot trial (NCT00282152).
This study involved 30 patients, aged 50 to 75, who had been taking drugs for Parkinson’s disease for at least six months and up to four years. Participants had no history of uncontrolled movements and exhibited stable motor symptoms.
To compare the two courses of treatment, participants were randomized to receive DBS plus Parkinson’s disease drugs (15 patients; DBS group) or drugs alone (15 patients; control group). Those who completed the two-year trial entered a follow-up study, in which they were assessed annually for an additional three years, for a total assessment of five years.
During follow-up, all patients could use any treatment for Parkinson’s disease, including undergoing DBS for those initially assigned to medication only.
The primary goals of the trial were safety measures and changes in the equivalent daily dose of levodopa – levodopa is one of the primary drugs used to treat symptoms of the disease – while the secondary goals included changes in disease severity, as rated with the Unified Parkinson’s Disease Rating Scale.
Previous results over two years showed that adding DBS to a standard drug was generally safe and associated with slower progression of resting tremors (tremors in a part of the body while resting) compared to the drug alone.
In addition, five-year data suggest that early treatment with DBS reduces the need and complexity of Parkinson’s disease drugs, while providing long-term motor benefit over standard drugs.
Now, researchers at Vanderbilt University Medical Center in Tennessee, where the trial took place, have reported five-year results regarding drug costs. They also projected these costs over 15 years to reflect the average time it takes for Parkinson’s disease to move from early to late stages – the time when a typical patient may be offered DBS.
Drug data targeting motor symptoms, collected at each visit, was used to calculate and project drug costs.
The analysis included 28 participants who made at least one follow-up visit. They had an average age of 61.1 years and had lived with the disease for an average of 2.1 years when entering the study.
The results showed that the average annual cost of Parkinson’s drugs fell from $ 4,941 at the start of the study to $ 14,177 after five years for patients receiving only standard drugs. For the DBS group, costs went from $ 4,507 to $ 6,636.
This represented a 2.4-fold lower annual drug cost and a five-year cumulative cost reduction of $ 28,246 for patients receiving both DBS and standard drugs compared to the control group.
Patients initially assigned to drugs alone were also five times more likely to have higher drug costs than those in the DBS group.
Additionally, annual drug costs at 15 years – using 10% annual cost increases to account for disease progression – were expected 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 illness was estimated to reduce cumulative drug costs by $ 104,958 over 15 years of illness duration, relative to care. standard.
These results highlight that DBS in the very early stage of Parkinson’s disease “may provide substantial long-term PD. [Parkinson’s disease] drug cost savings compared to standard care, ”the researchers wrote.
Still, the costs associated with DBS “are significant,” they added, with earlier US-based studies reporting up-front costs of $ 63,848 for the surgical procedure and additional costs of $ 26,653 for the procedures. battery replacement.
“The drug cost savings for PD projected here do not exceed the costs associated with DBS, but represent a cost offset,” the team wrote, adding that data from Phase 3 trials in patients with DBS. Intermediate and advanced Parkinson’s disease showed that DBS- associated costs were “justified by the benefits of therapy”.
These benefits include better control of motor symptoms, improved quality of life, and reduced complications associated with pharmacological therapy.
The results here “need to be confirmed in a larger study,” the researchers wrote, noting that the United States Food and Drug Administration has cleared the launch of a phase 3 multicenter trial evaluating early stage DBS. Parkinson disease.
Future studies are also expected to collect data related to the use of drugs targeting non-motor problems, the researchers said. Additionally, investigators should look at other interventions, such as physiotherapy, speech therapy, and occupational therapy, to provide comprehensive information on treatment costs related to Parkinson’s disease, the team said.