Major US insurer to cover use of HIFU for treatment of radiorecurrent prostate cancer


According to a media release issued on March 18 by EDAP TMS, the US healthcare insurance firm CIGNA has agreed to cover the use of high-intensity focal ultrasound (HIFU) as a second-line, salvage therapy for men with radiorecurrent prostate cancer.

Specifically, to quote the media release from EDAP TMS:

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 10 ng/mL
    • Absence of distant metastases

The full text of this media release can be accessed on the EDAP TMS corporate web site.

The “New” Prostate Cancer InfoLink notes that this is an approval of coverage for the use of HIFU outside of the approved labeling issued by the US Food and Drug Administration (FDA) for the treatment of HIFU. The approved indication of HIFU as issued by the FDA was simply for “ablation of prostate tissue”. The ablation of cancerous prostate tissue is not explicitly mentioned in the FDA labeling.

Readers should also be aware that,

  • As far as The “New” Prostate Cancer InfoLink is aware, HIFU has not been approved for the treatment of radiorecurrent prostate cancer by any other insurer at this time (Medicare included).
  • The US FDA had previously refused to approve any form of HIFU for the treatment of radiorecurrent prostate cancer because the agency did not believe that the benefits of such treatment outweighed the risks (as reported in clinical trials).

For those men who wish to consider having HIFU as a second-line treatment for radiorecurrent, localized prostate cancer, and who have insurance through CIGNA, this coverage decision by CIGNA is obviously highly beneficial. On the other hand, we would note that the evidence is limited as to the benefits of this form of treatment for recurrent disease, and the potential risks are not insignificant.

EDAP TMS is the developer of one of three differing forms of HIFU that are currently being used in North America for the ablation of prostate tissue. The precise circumstances under which CIGNA will cover the use of these three differing but similar technologies is addressed in the policy decision above-mentioned.

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