BlueCross BlueShield of Tennessee Medical Policy Manual

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

DESCRIPTION

Radioimmunoscintigraphy (RIS) involves the administration of radio-labeled monoclonal antibodies (MAbs), which are directed against specific molecular targets, followed by imaging with an external gamma camera. Given by intravenous injection, they circulate throughout the body and attach to prostate cancer cells. They are allowed to localize to the target over a 2- to 7-day period. A scan intended to detect if prostate cancer has spread to the lymph nodes, adjacent tissue or bone is done. Imaging can be performed with planar techniques or by using 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. Therefore, this technology remains investigational.

SOURCES

American College of Radiology, (2016) ACR Appropriateness Criteria® prostate cancer—pretreatment detection, staging and surveillance. Retrieved September 15, 2017 from: http://www.guideline.gov.(NCG:011153).

American College of Radiology. (2010). ACR_SPR practice guideline for the performance of tumor scintigraphy (with gamma cameras). Retrieved March 21, 2014 from: http://www.acr.org.

BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2016). Radioimmunoscintigraphy imaging (monoclonal antibody imaging) with indium-111 capromab pendetide (ProstaScint®) for prostate cancer (6.01.37). Retrieved September 15, 2017 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, September). 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. (2017, February) Clinical Practice Guidelines in Oncology (NCCN®) Prostate cancer (v2.2017). Retrieved September 15, 2017 from www.nccn.org.

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 111In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: results of a prospective clinical trial. Journal of Urology. 2014 May; 191(5): 1446-1453. (Level 4 evidence)

Schuster, D., Savir-Baruch, B., Nieh, P., Master, V., Halkar, R., Rossi, P., et. al. (2011) Detection of recurrent prostate carcinoma with anti-1-Amino-3-18ffluorocyclobutane-1-carboxylic acid PET/CT and 111In–capromab pendetide SPECT/CT. Radiology. Vol. 259, Issue 3. (Level 3 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, November) 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), 423-29. Abstract retrieved September 15, 2017 from PubMed database.

ORIGINAL EFFECTIVE DATE:  11/10/2007

MOST RECENT REVIEW DATE:  10/26/2017

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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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