Healthcare Business Today

How to Build a Business Case for Medical Devices Awaiting Reimbursement

When does it make sense to invest in a medical technology that had not yet been approved by the US Food & Drug Administration?  In 2015, Houston Methodist dealt with this question and ultimately chose to invest in new medical technology used to treat prostate disease, High Intensity Focused Ultrasound (HIFU). HIFU was new in the U.S. and largely unknown by urologists across the country, but prevalent and in demand in Europe and parts of Asia.

Concentrated sound waves are used to destroy targeted tissue in the prostate during HIFU. Using advanced ultrasound imagery during the outpatient procedure, urologists are able to avoid damaging healthy tissue and nerve bundles that control urinary continence and sexual function, and preserve patients’ quality of life. This makes it an appealing option for eligible patients.

New Medical Technology

New Medical Technology Gives Urologists a More Precise Method to Target Diagnosed Areas of the Prostate

We asked Dr. Cary Robertson, M.D. from Duke University Medical Center three questions on the latest development of a new medical technology that gives urologists a more precise method for treating prostate cancer.

Q1: Can you start by explaining why High Intensity Focused Ultrasound (HIFU) is an important option for treating the prostate?

A: More often than not, men with prostate cancer are offered standard choices for treatment including active surveillance, radiation therapy or surgery.

Active surveillance is especially difficult for patients who have been told they have cancer, even if it’s contained within the prostate.  Urologists will typically monitor a patient with low grade disease since this prostate cancer is slow growing and may not progress.  Some patients may prefer to seek treatment, however, and not risk waiting.

If a patient is diagnosed early, with intermediate or high risk prostate cancer confined to the prostate, most urologists recommend radical surgery or radiation therapy. Radical prostatectomy involves removing the entire prostate whereas radiation therapy treats the whole gland in place, but both treatments may cause side effects, including urinary incontinence and erectile dysfunction.

There is a new treatment urologists in the U.S. are beginning to use to treat selected cases of prostate cancer.  It’s called High Intensity Focused Ultrasound (HIFU) and it is FDA approved (October 2015) for prostate tissue ablation. HIFU bridges the gap between active surveillance and radical treatments, allowing patients to maintain their quality of life with minimal morbidity and potentially fewer side effects. This is particularly true if only a focal area of the prostate is ablated.

HIFU: a more Precise Method to Target Diagnosed Areas of the Prostate

We asked Dr. Cary Robertson, M.D. from Duke University Medical Center three questions on the latest development of a new medical technology that gives urologists a more precise method for treating prostate cancer.

Q1: Can you start by explaining why High Intensity Focused Ultrasound (HIFU) is an important option for treating the prostate?

A: More often than not, men with prostate cancer are offered standard choices for treatment including active surveillance, radiation therapy or surgery.

Active surveillance is especially difficult for patients who have been told they have cancer, even if it’s contained within the prostate. Urologists will typically monitor a patient with low grade disease since this prostate cancer is slow growing and may not progress. Some patients may prefer to seek treatment, however, and not risk waiting. If a patient is diagnosed early, with intermediate or high risk prostate cancer confined to the prostate, most urologists recommend radical surgery or radiation therapy. Radical prostatectomy involves removing the entire prostate whereas radiation therapy treats the whole gland in place, but both treatments may cause side effects, including urinary incontinence and erectile dysfunction. There is a new treatment urologists in the U.S. are beginning to use to treat selected cases of prostate cancer. It’s called High Intensity Focused Ultrasound (HIFU) and it is FDA approved (October 2015) for prostate tissue ablation. HIFU bridges the gap between active surveillance and radical treatments, allowing patients to maintain their quality of life with minimal morbidity and potentially fewer side effects. This is particularly true if only a focal area of the prostate is ablated.

Q2: How does Focal HIFU work?

A: HIFU uses a minimally-invasive probe placed in the rectum, a natural orifice. There are no incisions or needles required. It can target only a part of the prostate without damaging other surrounding structures.

These structures include neurovascular bundles that bring nerve and blood to produce an erection, and the urinary sphincter muscle, which controls the release of urine from the bladder. HIFU preserves the patient’s quality of life with diminished side effects of urinary incontinence and erectile dysfunction and lower overall complication rates. It is an ambulatory procedure with a rapid recovery with less time away from work and leisure activities. Similar to a breast lumpectomy, where the surgeon removes only the part of the breast containing cancerous tissue, urologists can use Focal HIFU to target the exact location of a suspicious area within the prostate, destroy it, sparing the remainder of the gland.