Drug or Device? The Future of Treating Parkinson’s Disease

Much like its evil twin Alzheimer’s disease, Parkinson’s disease (PD) is a neurodegenerative disorder that destroys the quality of life and human productivity of more than 1 million U.S. patients and their caregivers. An additional 6 million to 9 million patients outside of the United States also are affected.¹  The disease leads to shaking (tremors) and difficulty with walking, movement and coordination. Approximately 60,000 additional patients are newly diagnosed each year. PD begins between the ages of 40 and 70 years, with peak age onset in the seventh decade.²

Why It’s Important 
Costs vary, but sources estimate the combined direct and indirect cost of this incredibly debilitating disease—including treatment, social security payments and lost income from inability to work—is estimated to be nearly $25 billion per year in the United States.⁴ Pharmaceutical costs also are high with medication costs for a Parkinson’s patient, averaging $2,500 a year.

The Opportunity for Medtech: Deep-Brain Stimulation
An estimated 30,000 people worldwide have had deep-brain stimulation (DBS).⁵  In DBS, a neurosurgeon surgically implants a battery-operated neurostimulator similar to a heart pacemaker to deliver electrical stimulation to parts of the brain that control movement. The electrical impulses block abnormal nerve signals that cause tremor and PD symptoms. 

Prior to the procedure, a neurosurgeon uses magnetic resonance imaging or computed tomography scans to identify and locate the exact area in the brain where electrical nerve signals produce PD symptoms. The DBS device is configured from three components: the lead, the extension, and the neurostimulator. The lead, similar to pacemaker leads, is a thin, insulated wire that is implanted in the brain. Analogous to a shunt, the extension is passed under the skin of the head, neck, and shoulder, connecting the lead to the neurostimulator. And like a pacemaker, the neurostimulator usually is implanted under the skin near the collarbone.

Previous surgeries for PD damaged healthy brain tissue by destroying nerve cells. DBS blocks electrical signals from targeted areas in the brain, preserves brain tissue, and can be reversed if necessary. Without additional surgery, the neurostimulator can be adjusted to meet the needs of the patient.

The PD Opportunity: Drug, Device, Diagnostics or All Three?
According to industry trade group Pharmaceutical Research and Manufacturers of America, U.S. biopharmaceutical research companies currently are developing 37 new medicines to treat PD.⁶ Because the disease results from the loss of dopamine-producing brain cells, the treatments in the R&D pipeline include:

• Gene therapy that targeting segments of the brain that controls movement;
• Medication that targets a brain receptor degeneration; and
• New delivery mechanisms of currently approved medications, which may require device co-development, of an intranasal formulation and an intestinal gel.

DBS device data is showing significant changes in clinical studies. In a clinical study published in the New England Journal of Medicine, a six-month study of patients younger than 75 with severe motor complications of PD demonstrated that neurostimulation of the subthalamic nucleus was more effective than medical management alone.⁷  When compared to the medication-only arm of the study, the greatest improvements occurred in activities of daily living, stigma of the disease, and emotional well-being. Chart 2 shows a snapshot of findings from the study.

Early diagnosis of PD will be important as new treatments are developed to stop or reverse the disease. It is estimated that Parkinson’s patients lose up to 80 percent of dopamine-producing cells in their brains before symptoms of the disease appear.⁹ Results from special imaging tests of the brain suggest that dopamine may decline as much as 10 percent per year in people with PD. Early diagnosis and treatment are important to help minimize dopamine loss in the brain and maintain motor function.
Currently, healthcare providers diagnose patients based on symptoms and whether those symptoms improve once treatment begins. One imaging agent has been approved to measure levels of dopamine in the brain to help confirm a diagnosis of Parkinson’s.

Will Devices or Drugs Result in Lower Costs?
Absolutely. Reducing symptoms and arresting the loss of dopamine will help Parkinson’s patients achieve an improved quality of life and return to the workforce. Entrepreneurs are making PD patient treatment a reality by improving outcomes with a substantial impact on reducing healthcare costs.

How is your company planning to assist the healthcare system in improving efficiencies and lower costs? What systems in your medical specialty can you improve to meet the needs of this evolving collaboration between physicians and the hospital? There is profit in providing improved financial outcomes in healthcare. How will you identify those opportunities? 


References

1. www.pdf.org/en/parkinson_statistics
2. www.movementdisorders.org/disorders/parkinson.php
3. http://aje.oxfordjournals.org/content/157/11/1015.full.pdf+html
4. www.pdf.org/en/parkinson_statistics
5. www.pdf.org/en/surgical_treatments
6. www.phrma.org
7. www.nejm.org/doi/pdf/10.1056/NEJMoa060281
8. Ibid
9. www.phrma.org
10. Neurotech Insights, Volume 10.1, April 2014

Editor’s note: Readers are invited to submit market data and trend questions to Maria Shepherd. Periodically, selected questions will be presented in this column, with answers from Maria. Send your questions to [email protected].

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Maria Shepherd has 20 years of leadership experience in medical device/life-science marketing in small startups and top-tier companies. After her industry career—including her role as vice president of marketing for Oridion Medical, where she helped boost the company valuation prior to its acquisition by Covidien; director of marketing for Philips Medical; and senior management roles at Boston Scientific Inc.—she founded Data Decision Group. Data Decision Group (www.ddecisiongroup.com) provides whitespace research and critical data to support medical device product development. The firm performs market research, evaluates new technologies and provides marketing services and human factors usability testing. Shepherd has taught marketing and product development courses and recently was appointed to the board of the MSBiV Medtech Investment Committee. She can be reached at (617) 548-9892 or via email (listed above).