Augmenix wins Japanese reimbursement for SpaceOar hydrogel

Augmenix said yesterday that its SpaceOar hydrogel won national reimbursement in Japan from the Ministry of Health, Labour & Welfare.

The Belford, Mass.-based company’s SpaceOar hydrogel is designed to separate the prostate from the rectal wall during radiation treatment for prostate cancer.

The product is delivered through a small needle as a liquid, which then solidifies into a soft gel that expands the space between the prostate and rectum during radiotherapy. The substance then liquefies and is absorbed and cleared from the body in the patient’s urine, Augmenix said.

“We are delighted that SpaceOar hydrogel is now available through the MHLW national reimbursement programme for all men undergoing prostate cancer radiotherapy treatment throughout Japan. We believe the commitment of the Japanese MHLW to reimburse SpaceOar is a significant leap forward to improving radiotherapy outcomes and reducing the associated risks. It is our goal to be able to provide global access to SpaceOar hydrogel, a minimally invasive intervention, that significantly benefits patients by reducing the side effects of radiation exposure. The opening of our new Augmenix K.K. headquarters and successful reimbursement are positive steps in that direction,” Augmenix international GM Stephen McGill said in a press release.

Augmenix said that SpaceOar became available in Japan beginning June 25.

“SpaceOar hydrogel is a proven solution that can make a life-changing difference to men receiving prostate cancer radiotherapy. We hope that by working closely with the many Japanese clinicians that have already expressed an interest in this product, we can help enable the advancement of radiotherapy and make prostate-rectum spacing the standard of care for all patients,” Augmenix Japan GM Yoshi Kuratani said in a prepared statement.

Last November, Augmenix said that the American Medical Association established a Current Procedural Terminology code for its SpaceOar hydrogel and similar devices, with the Centers for Medicare and Medicaid Services setting a payment rate for procedures with the injectable.

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Augmenix touts AMA code, CMS reimbursement for SpaceOar

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Augmenix

Augmenix said today that the American Medical Association established a Current Procedural Terminology code for its SpaceOar hydrogel and similar devices, with the Centers for Medicare and Medicaid Services setting a payment rate for procedures with the injectable.

The Bedford, Mass.-based company said that the AMA established CPT code 55874 for the periprostatic implantation of biodegradable materials, which SpaceOar will be billed under. The code is set to go into effect January 1, 2018.

Augmenix also noted that CMS promulgated their 2018 Medicare Hospital Outpatient Prospective Payment System rule to provide an average reimbursement of $3,706 for outpatient departments and an average of $1,757 for ambulatory service centers that use the AMA code for procedures with the SpaceOar. The rules will also provide an average of $3,797 when the procedure is performed in a physician’s office.

The SpaceOar is designed to separate the prostate from the rectal wall during radiation treatment for prostate cancer, the Belford, Mass.-based company said.

The device is delivered through a small needle as a liquid, which then solidifies into a soft gel that expands the space between the prostate and rectum during radiotherapy. The substance then liquefies and is absorbed and cleared from the body in the patient’s urine, Augmenix said.

“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. 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,” prez & CEO John Pedersen said in a press release.

In May, Augmenix said it won Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its SpaceOAR system.