The 55-year-old man diagnosed with prostate cancer should have been relieved to learn that his disease was limited to a small portion of his gland and was entirely treatable. According to his urologist, available options would likely eradicate his cancer and ensure him a long and healthy life. However, the permanent sexual dysfunction and incontinence that often accompany standard whole gland treatment made survival feel ominous.
This same feeling of foreboding overwhelms a 60-year-old woman diagnosed with essential tremor — a condition marked by uncontrollable shaking that affects more than 10 million Americans. Facing a future with tremors that impact everyday activities like eating, bathing and working, she has learned that pharmacological treatments are not free of troubling side effects, although they may reduce the severity of the condition.
When considering treatments that can save their lives — but involve profound changes to their daily routines — millions of Americans have confronted the same frustrating reality: Why are there no better options?
In these cases, and for many others, there are better options. Scientists and researchers have developed new, advanced therapies that can tackle many cancers and common diseases while significantly limiting the side effects associated with standard therapies. However, absent more robust opportunities for clinical trials, more widespread reimbursement by private insurers and Medicare, and greater support from policymakers, these technologies sit on a shelf, largely unavailable to those who need them.
Focused ultrasound — a noninvasive therapeutic technology that uses focused beams of ultrasound to precisely and accurately target areas deep in the body without damaging surrounding tissue — is one such solution. Focused ultrasound does not expose the patient to radiation or incisions, and it can produce a variety of therapeutic effects including the destruction of cancerous tissues, more pronounced and localized drug delivery, enhancement of radiation therapy effects, and stimulation of a stronger immune response.
While therapeutic focused ultrasound is FDA-approved for use in the United States for the treatment of essential tremor, Parkinson’s tremor, prostate diseases, uterine fibroids, and painful bone metastases, it also has shown promise with a wide range of other conditions. In many other countries, it is used commonly to treat Parkinson’s disease, neuropathic pain, and tumors of the breast, liver, kidney, pancreas, and bone.
As an FDA-approved treatment for prostate disease, focused ultrasound has been shown to have better outcomes for incontinence and erectile dysfunction than other treatment modalities, while providing equivalent cancer control. But, the technology is available only in several dozen locations around the country. With no coverage determination by Medicare and little to no commercial insurance coverage, patients are required to pay “out of pocket.” Even so, some 3,000 patients with prostate disease have been able to access this treatment in the U.S. since 2015.
Focused ultrasound is valuable technology that should be more readily available to Americans when needed. However, many patients are unaware that focused ultrasound may be a treatment option for them, and even when they are aware, they have difficulty locating a treatment center or covering the costs of treatment. Focused ultrasound has the potential to improve lives, but remains frustratingly out of reach for many. It also offers measurable savings to the health care economic system via lower procedure costs, fewer complications and reduced rates of secondary treatments. Perhaps most importantly, focused ultrasound gets patients back to their lives and back to work more quickly.
As Congress works towards improving our nation’s health care during this session, it seems like an ideal time for legislators of both parties to support adoption of better reimbursement options for innovative treatments like focused ultrasound that are underutilized but recognizably needed. Patients deserve hope for a better future, and that means providing them with the widest range of choices for getting there.
Jessica Foley, PhD, is the Chief Scientific Officer of the Focused Ultrasound Foundation. Mark Carol, MD is the CEO of Sonacare.