BlueCross BlueShield of Tennessee Medical Policy Manual

Radioimmunoscintigraphy Imaging (Monoclonal Antibody Imaging) with Indium-111 Capromab Pendetide for Prostate Cancer

DESCRIPTION

Radioimmunoscintigraphy (RIS) is an imaging modality that uses radiolabeled monoclonal antibodies to target specific tissue types. Monoclonal antibodies that react with specific cellular antigens are conjugated with a radiolabeled isotope. The labeled antibody-isotope conjugate is then injected into the individual and allowed to localize to the target over a 2 to 7 day period. The individual then undergoes imaging with a nuclear medicine gamma camera, and radioisotope counts are analyzed. Imaging can be performed with planar techniques or by using a single-photon emission computed tomography (SPECT). One example of a monoclonal antibody directed at extracellular prostate-specific membrane antigen is indium 111 capromab pendetide (ProstaScint®).

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

Current medical literature is insufficient to support conclusions concerning efficacy, optimal use and impact on the diagnosis, treatment or clinical management of prostate cancer using radioimmunoscintigraphy imaging with Indium-111 capromab pendetide.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2017). Radioimmunoscintigraphy (monoclonal antibody imaging) with indium 111 capromab pendetide for prostate cancer (6.01.37). Retrieved August 30, 2018 from BlueWeb. (29 articles and/or guidelines reviewed)

Ellis, R. J., Kaminsky, D. A., Zhou, E. H., Fu, P., Chen, W. D., Brelin, A., et al. (2011). Ten-year outcomes: the clinical utility of single photon emission computed tomography/computed tomography capromab pendetide (ProstaScint®) in a cohort diagnosed with localized prostate cancer. International Journal of Radiation Oncology, Biology, Physics, 81 (1), 29-34. (Level 3 evidence)

National Comprehensive Cancer Network. (2018). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Prostate cancer (v4.2018). Retrieved August 30, 2018 from the National Comprehensive Cancer Network.

Schuster, D., Nieh, P., Jani, A., Amzat, R., Bowman, F., Halkar, R., Master, V., et al. (2014). Anti-3-[18F]FACBC positron emission tomography-computerized tomography and 111 In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: results of a prospective clinical trial. Journal of Urology, 191 (5), 1446–1453. (Level 4 evidence)

U. S. Food and Drug Administration. (1997, July). Center for Drug Evaluation and Research. SBA for ProstaScint Kit (Capromab Pendetide). Retrieved June 26, 2009 from http://www.fda.gov.

U. S. Food and Drug Administration. (2011, December). Office of Prescription Drug Promotion . Letter of licensing action for ProstaScint® kit (Capromab Pendetide). Retrieved March 21, 2014 from http://www.fda.gov

Wong, W., Schild, S., Vora, S., Ezzell, G., Nguyen, B., Ram, P., et al. (2011). Image-guided radiotherapy for prostate cancer: a prospective trial of concomitant boost using indium-111-capromab pendetide (ProstaScint) imaging. International Journal of Radiation Oncology, Biology & Physics, 81(4), 423-429. Abstract retrieved September 15, 2017 from PubMed database.

ORIGINAL EFFECTIVE DATE:  11/10/2007

MOST RECENT REVIEW DATE:  10/11/2018

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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