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Mar 21, 2018
EDAP Announces CIGNA as First Major U.S. Private Health Insurer to Cover HIFU for Prostate Procedure


EDAP Announces CIGNA as First Major U.S. Private Health Insurer to Cover HIFU for Prostate Procedure

Insurer Takes its Cue from Updated NCCN Guidelines,
Which Recognizes HIFU as Salvage Treatment for Prostate Cancer

Lyon, France, Austin, TX -- March 21, 2018 - EDAP TMS SA (Nasdaq: EDAP) today announced that CIGNA became the first major U.S. private health insurance company to reimburse prostate cancer patients who failed radiation and are eligible for High-Intensity Focused Ultrasound (HIFU) as a salvage therapy. EDAP TMS manufactures the Ablatherm® Robotic High Intensity Focused Ultrasound (HIFU) device, used by urologists in the U.S. for prostate tissue ablation.

The CIGNA move signals a shift in the private health insurance market regarding HIFU procedures.  CIGNA is one of the five largest payors in the U.S., covering 15.9 million lives. HIFU as a salvage therapy is already reimbursed by a number of regional payors, including Asuris Northwest Health in Washington State and Priority Health in Michigan.

The CIGNA policy aligns with National Comprehensive Cancer Network (NCCN) guidelines recognizing that some men with localized prostate cancer may benefit from salvage HIFU.
The policy acknowledges HIFU as "medically necessary as a local treatment for recurrent prostate cancer following radiation therapy" for patients meeting specific medical criteria.

HIFU works by directing high-frequency sound waves that heat up and burn off the targeted area of the prostate.  In 2015, the FDA cleared HIFU for prostate tissue ablation. Because no radiation is involved HIFU is considered a "repeatable technology," which means that unlike conventional radiotherapy or surgical treatments patients can repeat the HIFU procedure if necessary.

Typically performed in an outpatient setting, HIFU therapy is non-invasive, and according to the CIGNA policy it "remains unique compared with other modalities for localized prostate cancer in that it has been proposed to result in much less adjacent tissue damage."

The CIGNA policy covers HIFU as a salvage therapy for patients whose early stage prostate cancer has not metastasized and who meet both of these criteria:

positive, recent (i.e., repeat) transrectal ultrasound guided (TRUS) biopsy completed due to suspicion of local recurrence of prostate cancer
candidate for local therapy alone as evidenced by ALL of the following:original clinical stage T1-T2, NX or N0
recent PSA (Prostate Specific Antigen) of less than 10ng/mL
absence of distant metastases
Often, patients experiencing a recurrence of prostate cancer who are no longer candidates for radiation therapy, are limited to active surveillance, or "watchful waiting," to assess progress of the disease. HIFU offers a medical alternative to this approach for some of these patients.

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