Cerebral palsy affects an estimated 764,000 people in the United States, according to United Cerebral Palsy, with approximately 8,000 babies and 1,200 to 1,500 preschool-age children diagnosed with the condition each year. Caused by damage to one or more areas of the developing brain, cerebral palsy is characterized by an inability to control motor function fully, particularly muscle control and coordination.
The most common form of cerebral palsy involves spasticity - tight, stiff muscles that make coordinated movement (especially of the arms and legs) difficult or uncontrollable. Up to 80 percent of children with cerebral palsy develop spasticity, which can be painful and limit functional ability for the patient, and tax the patient's family physically, emotionally, and financially.
Medtronic ITB Therapy, which uses the company's SynchroMed(R) implantable infusion system to deliver a muscle relaxant directly to the fluid-filled area surrounding the spinal cord, can effectively reduce severe spasticity with fewer side-effects than oral medication. By reducing spasticity, ITB Therapy may also improve function, quality of life, and ease of care.
Despite the treatment's well-demonstrated clinical efficacy, ITB Therapy remains underused - in large part because of concerns about the cost of the pump and the surgery to implant it.
"The cost of ITB Therapy should not prevent pediatric patients with spastici ty of cerebral origin from receiving this clinically effective treatment," explained Dr. Terence Edgar of the Medical College of Wisconsin's Department of Neurology and senior author of the study. "Specifically, we found that the projected improvement in quality of life justifies the estimated five-year treatment cost based on well-established guidelines for cost-effectiveness."
Dr. Edgar and colleagues, including a team of health economists from United BioSource Corp. in Bethesda, Md., "used mathematical modeling and computer simulation to estimate the incremental cost per quality-adjusted life-year for identical cohorts of children treated with intrathecal baclofen or alternative therapy during a five-year episode of treatment," according to the study abstract. "On average, intrathecal baclofen therapy increased the five-year cost of treatment by $49,000 relative to alternative treatment. However, this was accompanied by an average gain of 1.2 quality-adjusted life-years. The net result was an incremental cost-effectiveness ratio of $42,000 per quality-adjusted life-year, a figure well (below) the $50,000 to $100,000 range that is widely accepted as offering good value for money."
Supported by Medtronic, this analysis of ITB Therapy's cost-effectiveness is the first in the context of the U.S. healthcare system.
"Cost-effectiveness is an important consideration in today's healthcare environment," said Dr. Richard E. Kuntz, M.D., senior vice president of Medtronic, Inc., and president of the company's Neurological business. "This study supports the cost-effectiveness of Medtronic ITB Therapy, an effective treatment for severe spasticity that has the potential to restore functional ability and a better quality of life to thousands of people every year."
Medtronic ITB Therapy is indicated for the management of severe spasticity of cerebral and spinal origin, including stroke, cerebral palsy, brain injury, spinal cord injury, and multiple sc lerosis. It uses Medtronic's SynchroMed Implantable Infusion System, which consists of a programmable drug pump connected to a thin tube, or catheter, to deliver precise amounts of a muscle relaxant called Lioresal(R) Intrathecal (baclofen injection) directly to the intrathecal space - the fluid-filled area surrounding the spinal cord, the drug's site of action. By targeting the spinal cord, ITB Therapy reduces spasticity with smaller amounts of medication than would be required orally. Intrathecal infusion, which bypasses the body's blood-brain barrier, also minimizes systemic side-effects.
ITB Therapy drug side effects are usually temporary and manageable by adjusting the dose. The most common side effects include loose muscles, drowsiness, nausea/vomiting, headache, and dizziness. Abrupt discontinuation of intrathecal baclofen, regardless of the cause, can result in high fever, altered mental status, returned spasticity, and muscle rigidity, and in rare cases has been fatal. Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms.
Children should be of sufficient body mass to accommodate the pump. The safety and efficacy of ITB Therapy in pediatric patients below the age of four have not been established.
More information about ITB Therapy is available online at www.spasticity.com or by calling toll-free 1-800-856-3823. Other pharmaceutical treatments for spasticity include oral and injectable medications.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
Lioresal(R) is a registered trademark of Novartis Pharmaceuticals Corporation.
Jeff Warren, 763-505-2696
Joe McGrath, 763-505-0291