Appeal type: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the positron emission tomography (PET) scan with computed tomography (CT) for attenuation provided for evaluation of the enrollees prostate cancer. Findings:  2/3 of the physician reviewers found that the U.S. Food and Drug Administration (FDA) approved a new radiopharmaceutical used for PET scanning of the prostate. This agent, fluciclovine (Axumin), offers two distinct advantages. Axumin can detect recurrent disease at PSA levels far less than can be detected by more conventional imaging techniques. Also, since Axumin accumulates in non-bony metastases as well as in bone, it offers the advantage of potentially localizing tumor in the prostate bed or in lymph nodes that might not be noted on cross-sectional studies. At this time, Axumin is only approved for cases that are post therapy, and it is not approved as an initial screening or staging device. Fluciclovine is currently FDA approved for the localization of recurrent prostate cancer in a patient with elevated PSA. Based on comprehensive clinical data, fluciclovine is beneficial in the identification of disease even when other conventional imaging is negative. Moreover, CT scans and magnetic resonance imaging (MRI) are dependent on the site scanned, and will only pick up gross anatomic distortions or disease.  Microscopic or small lesions will be very difficult to detect. And to effectively cover the areas detectable by PET scanning, one would have to perform CT or MRI scans of the head, neck, chest, abdomen, and pelvis. The value of PET scanning, especially when combined with CT scans is that these modalities depend on metabolic changes to detect abnormalities. In conclusion, Axumin PET/CT are more likely to detect metastases not appreciable by other modalities. As such, the PET scan with CT for attenuation provided was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Final Result: 2/3 of the reviewers determined that the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewer number one is board certified in diagnostic radiology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number two is board certified in diagnostic radiology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number three is board certified in diagnostic radiology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.