First and only prostate cancer spacing device available for use in the U.S. clinically proven to preserve patient quality of life following radiation therapy
BEDFORD, Mass.–(BUSINESS WIRE)–Augmenix, Inc., a medical technology company that develops, manufactures and sells proprietary absorbable hydrogels that separate and protect organs at risk during radiotherapy, announced today that the American Medical Association (AMA) established a new Current Procedural Terminology (CPT®) code, 55874, for periprostatic implantation of biodegradable material, under which SpaceOAR hydrogel will be typically billed.1 The code, which goes into effect January 1, 2018, will enable both hospitals and physicians to receive payment, when medically necessary, for the SpaceOAR hydrogel procedure, where Medicare coverage is available.
Also, the Centers for Medicare and Medicaid Services (CMS) promulgated their 2018 Medicare Hospital Outpatient Prospective Payment System (HOPPS) rule through which the payment rate for the new code (55874) will provide for a national average Medicare reimbursement rate of $3,706 in the outpatient department and a national average rate of $1,757 when performed in an ambulatory service center (ASC).2 Additionally, CMS’ 2018 Medicare Physician Fee Schedule (MPFS) will provide for a Medicare reimbursement rate of $3,797 when the procedure is performed in a physician’s office.3
“CMS’ decision represents a significant step forward for the thousands of patients undergoing prostate cancer radiation therapy, as well as the physicians who treat them,” said John Pedersen, President and CEO of Augmenix. “Patients covered by Medicare will now have greater access to the SpaceOAR hydrogel procedure, which has been shown to reduce risks associated with prostate cancer radiation therapy, including rectal bleeding, incontinence, pain and loss of sexual function. We look forward to private insurers initiating adequate reimbursement in the coming months.”
Treating prostate cancer with radiation therapy can cause unintended injury to adjacent healthy tissue, often leading to impairment of bowel, urinary and sexual function, negatively affecting patient health and quality of life (QOL). With SpaceOAR hydrogel, physicians place a hydrogel barrier to separate the prostate from the anterior rectal wall, reducing the risk of radiation exposure and these adverse side effects.
Earlier this year, Augmenix announced three-year post-treatment results from a prospective, randomized, multi-center clinical trial showing that patients treated with SpaceOAR hydrogel technology prior to prostate cancer radiotherapy demonstrated rectal (bowel), urinary and sexual benefit through three years of follow-up. Overall patient wellness at three years was assessed by analyzing the percent of patients with clinically significant declines in all three QOL areas, including bowel, urinary and sexual function. A total of 20 percent (1 in 5 patients) of men in the control arm had clinically significant declines in all three QOL areas compared to only 2.5 percent (1 in 40 patients) of men in the SpaceOAR hydrogel arm (p=0.002).4
Additionally, overall patient wellness at the 5-year mark has also been assessed. Patients treated with SpaceOAR hydrogel had significantly less problems with bowel urgency at 63 months post-treatment, compared to patients who did not receive SpaceOAR hydrogel (0 percent vs. 14 percent, p=0.01). A significant finding in terms of sexual quality of life was also reported, with SpaceOAR hydrogel treated patients having an 8 times greater likelihood of having erections sufficient for intercourse at 5-years post-treatment (24 percent vs. 3 percent, p<0.01).5
ABOUT SPACEOAR HYDROGEL
Radiation therapy in the treatment of prostate cancer can cause unintended radiation injury to adjacent healthy tissue (organs at risk). This injury can lead to a range of bowel, urinary and sexual symptoms that can negatively affect patient health and quality of life during radiotherapy, and for years afterward. In recent years, radiation oncologists have considered use of “spacing” techniques to reduce the risk of radiation injury to surrounding tissue during radiotherapy. SpaceOAR hydrogel is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer. By creating this space, SpaceOAR hydrogel reduces the radiation dose delivered to the anterior rectum and other surrounding tissues.4 Injected as a liquid into the space between the prostate and rectum, SpaceOAR hydrogel pushes the structures apart and then solidifies into a soft hydrogel, which remains stable for three months during radiation therapy then liquefies and is completely absorbed by the body. See the Instructions for Use for complete information on potential risks, warnings and precautions.
The SpaceOAR System, is cleared by the U.S. Food and Drug Administration (FDA) and is currently being used in many leading cancer centers throughout the United States. It has also received CE Mark approval in Europe, is approved in Australia and Japan, and is licensed in Canada. To date, over 17,000 patients worldwide have benefitted from the SpaceOAR hydrogel procedure.
ABOUT AUGMENIX, INC.
Augmenix, Inc. is a privately held company based in the Boston area and focused on the development and commercialization of radiation oncology products using its proprietary hydrogel technology. Focusing initially on protection during prostate radiation therapy, Augmenix next-generation products will address spacing and marking applications throughout the body to improve radiotherapy and interventional oncology procedure outcomes. SpaceOAR, the company’s lead product, is a registered trademark of Augmenix, Inc. More information about Augmenix and the SpaceOAR hydrogel can be found at http://www.Augmenix.com.
- American Medical Association, Current Procedural Terminology, CPT®, Professional Edition, 2018.
- Hamstra D, et al. Continued Benefit to Rectal Separation for Prostate RT: Final Results of a Phase III Trial. Int J Radiat Oncol Biol Phys; 2017 Volume 97, Issue 5, Pages 976–985.
- Pinkawa, M, et al. Quality of Life After Radiation Therapy for Prostate Cancer With a Hydrogel Spacer: 5-Year Results. Int J Radiat Oncol Biol Phys; 2017 Oct 1;99(2):374-377. Epub 2017, May 31.
CPT is a registered trademark of the American Medical Association.