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Cheat Sheet

Deep brain stimulation

10 Minute Read

    Key Takeaways
    • Deep Brain Stimulation (DBS) is the implantation of a device that sends a signal to brain areas responsible for body movement to improve the lives of patients with Parkinson’s, other neurodegenerative diseases, and behavioral and mental health disorders. Innovative treatments in this area are now less-invasive and can also include medical devices such as helmets.
    • The rising prevalence of lifestyle diseases like depression and chronic pain is creating demand for these devices. With increasing investment on R&D activities in the neurological sector, the predicted global neurostimulation revenue in 2022 is around $13 billion
    • DBS devices are disrupting two elements of healthcare: care delivery and generation of clinical evidence.
     

    What is it?

    Deep brain stimulation (DBS) is a rapidly expanding area of research and clinical practice. DBS is the implantation of a device that signals areas responsible for body movement in the brain. Innovative treatments in this area are now less-invasive and can also include medical devices such as helmets and electrode patches.

    Clinical interventions using brain stimulation are an alternative or a complement to pharmacotherapy and psychotherapy. DBS helps in reducing the symptoms in patients with Parkinson’s, epilepsy, other neurodegenerative diseases, and behavioral and mental health disorders. This therapy is generally recommended to patients who do not respond to medicines for at least five years.

    Currently, there are 3 main devices for Parkinson’s:

    • Abbott’s Infinity, involves directional stimulation and can be monitored remotely through Apple iOS devices, where patients can communicate with their physician and make adjustments
    • Medtronic’s Activa and Percept, which can sense and record brain signals and inform clinicians for more precise care
    • Boston Scientific’s Vercise, which also uses directional stimulation, and can allow for clinicians to model brain activity

    Other emerging devices include Deep Transcranial Magnetic Stimulation which entails the utilization of a helmet to improve accuracy, cover a wider area of the brain, and penetrate more deeply through brain tissue to impact the neural activity of specific brain structures associated with depression symptoms.

     

    Why does it matter?

    The field of brain stimulation poses a new way to deliver a moderated amount of electrical stimulation to bodily organs and cells. It's a new in-kind pathway to affect downstream responses in the body and can do so without the side affects that many pharmaceuticals have.

    There is tremendous investment in DBS right now, but this potential is tempered by the novelty of the field. While its current focus is on NDDs, it has prospective impact on a wide swath of therapeutic areas across chronic conditions. These chronic patients' experiences with their diseases and treatments. conditions drive a huge portion of health spending today and have massive impacts on Americans' quality of life. A new procedure to treat these conditions could change the way providers approach entire episodes of care and drastically alter

     

    What makes it disruptive?

    Areas of disruption

    Care delivery

    Although currently, brain stimulation is often complementary to more traditional therapies, it has the potential to replace traditional care for more severe patients.

    Traditionally, care management for chronic patients requires ongoing and consistent follow-up, requiring frequent visits to physician offices. Because relatively few hospitals offer these interventions, some patients would need to travel several hours for visits. Strategies need to be implemented to create cross-continuum care management and to ensure that standardization is possible across health systems.

    Recent innovations allow for physicians to alter settings in brain stimulation devices remotely. However, it is unclear how virtual visits and remote patient monitoring would fit into current clinical practice.

    Cost/payment models

    This therapy is generally recommended to patients who do not respond to medicines for at least five years, after exhausting other treatment options. Brain stimulation can be extremely costly and requires rigorous patient follow-up due to routine adjustment of the level of electrical stimulation and may include many potential safety hazards.

    Clinical evidence

    Clinical trials may be limited in nature to those with extreme and rare diseases, thus affective evidence collection, as there may be a lack of the longitudinal data necessary to substantiate claims. Additionally, deep brain stimulation offers the opportunity to explore novel trial design and the use of RWE where the gold standard randomized clinical trial isn’t as feasible and/or ethical.

    A note on health equity

    Brain stimulation has the potential to support health equity efforts if there is adequate representation in clinical trial data and evidence. However, there are clear racial disparities in treatment for therapeutic areas that brain stimulation is used for. For example, African Americans are less likely to be diagnosed with Parkinson's, are more likely to have delays in diagnosis, and once diagnosed, are undertreated when compared to White patients.

    Adversely, the total cost of the surgery alone (including the implanted device, hospital fees, etc.) can range from $35,000 to $100,000 in the U.S. Insurance coverage and reimbursement can vary but because this procedure has been approved by the FDA, private insurers and Medicare will cover all or a portion of it for those who are eligible. However, the cost can hinder access to treatment for lower income individuals, or the uninsured.

     

    Conversations you should be having

    Sector Conversations

    Payers

    • How can we mitigate against financial risks associated with DBS while supporting patient access?
    • How can we create and implement value-based care contracts to control high cost of care?

    Health systems

    • How are we diagnosing/treating/managing patients with movement disorders today? Could we benefit from establishing or expanding our DBS program to better serve these patients?
    • What strategies can our DBS program implement to overcome patient hesitancy to seek care, and ensure that all patients in our population can access our DBS program?
    • Are there ways to work with payers to prove the value and to help providers integrate these innovations into their care processes to increase the likelihood of uptake?
    • What guidelines can be implemented to create cross-continuum care management? Which standards can be improved upon? (patient identification, outreach, enrollment, and graduation guidelines)

    Manufactures

    • How can we utilize and harmonize representative data across multiple trials, to prove adequate safety and efficacy?
    • If DBS gains more widespread adoption, how does that change the standard of care for PD, and our customers related drug or supply needs for treating these patients?

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