mp-249 - mp-249 - Medical Policies
Radioimmunoscintigraphy (Monoclonal Antibody Imaging) with Indium-111 Capromab Pendetide for Prostate Cancer
Policy Number: MP-249
Policy Grade: B
Effective for dates of service on or after May 31, 2011:
Radioimmunoscintigraphy using indium-111 capromab pendetide (ProstaScint®) is considered not medically necessary and investigational.
Radioimmunoscintigraphy (RIS) involves the administration of radiolabeled monoclonal antibodies, which are directed against specific molecular targets, followed by imaging with an external gamma camera. Indium-111 capromab pendetide (ProstaScint®) is a monoclonal antibody directed against a binding site on prostate-specific membrane antigen (PSA).
Radioimmunoscintigraphy 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 patient and allowed to localize to the target over a 2 to 7 day period. The patient then undergoes imaging with a nuclear medicine gamma camera, and radioisotope counts are analyzed. Imaging can be performed with planar techniques or by using single-photon emission computed tomography (SPECT).
The most recent literature review was updated through July 8, 2019.
Summary of Evidence
For individuals who have prostate cancer and are undergoing staging before curative treatment who receive RIS with indium 111 capromab pendetide, the evidence includes diagnostic accuracy studies and a systematic review (TEC Assessment). Relevant outcomes are overall survival, disease-specific survival, test accuracy, and test validity. For pretreatment staging before curative treatment, a TEC Assessment found that RIS has a modest sensitivity, estimated at 50% to 75%, and a moderate to high specificity, estimated at 72% to 93%. No studies have demonstrated that the use of RIS for pretreatment staging changes patient management or improves health outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have prostate cancer and have biochemical failure after curative treatment who receive RIS with indium 111 capromab pendetide, the evidence includes case series. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and test validity. The available case series were generally retrospective, descriptive, and did not provide consistent verification of disease status. Thus, the studies do not permit accurate estimation of the rate of false-positive and false-negative RIS. There is a lack of published evidence demonstrating an association between RIS findings and change in patient management or health outcomes in this population of patients. The evidence is insufficient to determine the effects of the technology on health outcomes.
Practice Guidelines and Position Statements
National Comprehensive Cancer Network
The National Comprehensive Cancer Network guidelines for prostate cancer (v.2.2019) do not mention ProstaScint or radioimmunoscintigraphy.
American College of Radiology
The American College of Radiology‘s 2017 Appropriateness Criteria rated the appropriateness of various imaging tests in men with rising prostate-specific antigen levels after prostatectomy or radiotherapy. Indium 111 capromab pendetide (ProstaScint) scans were found to be “not routinely used in the evaluation of prostate cancer recurrence” and studies “have demonstrated no benefit with use of capromab pendetide in selection of patients for local salvage therapy.” It was also noted that for salvage therapy with a rising prostate-specific antigen, use of “ProstaScint provided no incremental value in appropriately selected patients compared to basic clinicopathologic factors alone.”
U.S. Preventive Services Task Force Recommendations
Capromab Pendetide, Indium-111, ProstaScint®, Radioimmunoscintigraphy
APPROVED BY GOVERNING BODIES
In 1996, Indium 111 capromab pendetide (ProstaScint®) (also referred to as CYT-356) which targets an intracellular binding site on prostate-specific membrane antigen. It was approved by the U.S. Food and Drug Administration through the biologics license application process for use as a “diagnosing imaging agent in newly diagnosed patients with biopsy-proven prostate cancer, thought to be clinically localized after standard diagnostic evaluation, who are at high risk for pelvic lymph node metastases..[It] is also indicated in postprostatectomy patients with a rising prostate specific-antigen (PSA) and a negative or equivocal standard metastatic evaluation in whom there is a high clinical suspicion of occult metastatic disease.” Other monoclonal antibodies, directed at extracellular prostate-specific membrane antigen binding sites, are also under development.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply.
FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
|78800||Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); planar, single area, single day imaging|
|78801||Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); planar, 2 or more areas, 1 or more days imaging or single area imaging over 2 or more days|
|78802||Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); planar,whole body, single day imaging|
|78803||Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); single area, single day imaging, tomographic (SPECT)|
|78804||Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); planar, whole body, requiring 2 or more days imaging|
|A9507||Indium In-111 capromab pendetide, diagnostic, per study dose, up to 10 millicuries|
- American College of Radiology. ACR Appropriateness Criteria: Post-Treatment Followup of Prostate Cancer. 2017; www.guidelinecentral.com/summaries/acr-appropriateness-criteria-post-treatment-follow-up-of-prostate-cancer/#section-society.
- Bander NH. Technology insight: monoclonal antibody imaging of prostate cancer. Nat Clin Pract Urol. 2006; 3(4):216-25.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Radioimmunoscintigraphy for Prostate Cancer – Update. TEC Assessments 1998; Volume 13, Tab 21.
- DeWyngaert JK, Noz ME, Ellerin B et al. Procedure for unmasking localization information from ProstaScint scans for prostate radiation therapy treatment planning. Int J Radiat Oncol Biol Phys 2004; 60(2):654-62.
- Elgamal AA, Troychak MJ, Murphy GP. ProstaScint® scan may enhance identification of prostate cancer recurrences after prostatectomy, radiation, or hormone therapy: analysis of 136 scans of 100 patients. Prostate 1998; 37(4):261-9.
- Kahn D, Williams RD, Haseman MK et al. Radioimmunoscintigraphy with In-111-labeled capromab pendetide predicts prostate cancer response to salvage radiotherapy after failed radical prostatectomy. J Clin Oncol 1998; 16(1):284-9.
- Khan A, Caride VJ. Indium-111 capromab pendetide (ProstaScint) uptake in neurofibromatosis. Urology 2000; 56(1):154.
- Lange PH. ProstaScint scan for staging prostate cancer. Urology 2001; 57(3):402-6.
- Lau HY, Kindrachuk G, Carter M et al. Surgical confirmation of ProstaScint® abnormalities in two patients with high-risk prostate cancer. Can J Urol 2001; 8(1):1199-1202.
- Liauw SL, Weichselbaum RR, Zagaja GP et al. Salvage radiotherapy after postprostatectomy biochemical failure: does pretreatment radioimmunoscintigraphy help select patients with locally confined disease? Int J Radiat Oncol Biol Phys 2008; 71(5):316-21.
- Manyak MJ, Hinkle GH, Olsen JO et al. Immunoscintigraphy with indium-111-capromab pendetide: evaluation before definitive therapy in patients with prostate cancer. Urology 1999; 54(6):1058-63.
- Michaels EK, Blend M, Quintana JC. 111 Indium-capromab pendetide unexpectedly localizes to renal cell carcinoma. J Urol 1999; 161(2):597-8.
- Middleton ML, Shell EG. Nuclear medicine applications in the clinical setting. Imaging studies aid disease staging and management. Postgrad Med 2002; 111(5):89-96.
- Moul JW, Kane CJ, Malkowicz SB. The role of imaging studies and molecular markers for selecting candidates for radical prostatectomy. Urol Clin North Am 2001; 28(3):459-72.
- Mouraviev V, Madden JF, Broadwater G et al. Use of 111in-capromab pendetide immunoscintigraphy to image localized prostate cancer foci within the prostate gland. The Journal of urology 2009; 182(3):938-47.
- Murphy GP, Elgamal AA, Troychak MJ et al. Follow-up ProstaScint® scans verify detection of occult soft-tissue recurrence after failure of primary prostate cancer therapy. Prostate 2000; 42(4):315-7.
- Murphy GP, Snow PB, Brandt J et al. Evaluation of prostate cancer patients receiving multiple staging tests, including ProstaScint® scintiscans. Prostate 2000; 42(2):145-9.
- Nagda SN, Mohideen N, Lo SS et al. Long-term follow-up of 111In-capromab pendetide (ProstaScint) scan as pretreatment assessment in patients who undergo salvage radiotherapy for rising prostate-specific antigen after radical prostatectomy for prostate cancer. Int J Radiat Oncol Biol Phys 2007; 67(3):834-40.
- National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 3.2018. ww.nccn.org/professionals/physician_gls/pdf/prostate.pdf.
- Petronis JD, Regan F, Lin K. Indium-111 capromab pendetide (ProstaScint) imaging to detect recurrent and metastatic prostate cancer. Clin Nucl Med 1998; 23(10):672-7.
- Polascik TJ, Manyak MJ, Haseman MK et al. Comparison of clinical staging algorithms and 111-indium-capromab pendetide immunoscintigraphy in the prediction of lymph node involvement in high risk prostate carcinoma patients. Cancer 1999; 85(7):1586-92.
- Proano JM, Sodee DB, Resnick MI et al. The impact of a negative (111) indium-capromab pendetide scan before salvage radiotherapy. J Urol 2006; 175(5):1668-72.
- Quintana JC, Blend J. The dual-isotope ProstaScint imaging procedure–clinical experience and staging results in 145 patients. Clin Nucl Med 2000; 25(1):33-40.
- Radioimmunoscintigraphy for Prostate Cancer – Update. Technology Evaluation Center Assessment Program 1998; 13(Tab 21).
- Raj GV, Partin AW, Polascik TJ. Clinical utility of indium 111-capromab pendetide immunoscintigraphy in the detection of early, recurrent prostate carcinoma after radical prostatectomy. Cancer 2002; 94(4):987-96.
- Rieter WJ, Keane TE, Ahlman MA et al. Diagnostic performance of In-111 capromab pendetide SPECT/CT in localized and metastatic prostate cancer. Clinical nuclear medicine 2011; 36(10):872-8.
- Rosenthal SA, Haseman MK, Polascik TJ. Utility of capromab pendetide (ProstaScint®) imaging in the management of prostate cancer. Tech Urol 2001; 7(1):27-37.
- Sartor O, McLeod D. Indium-111-capromab pendetide scans: an important test relevant to clinical decision making. Urology 2001; 57(3):399-401.
- Schuster DM, Nieh PT, Jani AB et al. Anti-3-[18F]FACBC PET-CT and 111In-capromab-pendetide SPECT-CT in Recurrent Prostate Carcinoma: Results of a Prospective Clinical Trial. J Urol 2013.
- Schuster DM, Nieh PT, Jani AB, et al. Anti-3-[18F]FACBC PET-CT and 111In-capromab-pendetide SPECT-CT in Recurrent Prostate Carcinoma: Results of a Prospective Clinical Trial. J Urol. Oct 18 2013.
- Scott DL, Halkar RK, Fischer A et al. False-positive 111 indium capromab pendetide scan due to benign myelolipoma. J Urol 2001; 165(3):910-1.
- Seltzer MA, Barbaric Z, Belldegrun A et al. Comparison of helical computerized tomography, positron emission tomography and monoclonal antibody scans for evaluation of lymph node metastases in patients with prostate specific antigen relapse after treatment for localized prostate cancer. J Urol 1999; 162(4):1322-8.
- Seo Y, Franc BL, Hawkins RA et al. Progress in SPECT/CT imaging of prostate cancer. Technol Cancer Res Treat 2006; 5(4):329-36.
- Sodee DB, Malguria N, Faulhaber P et al. Multicenter ProstaScint imaging findings in 2154 patients with prostate cancer. Urology 2000; 56(6):988-93.
- Sodee DB, Nelson AD, Faulhaber PF et al. Update on fused capromab pendetide imaging of prostate cancer. Clin Prostate Cancer 2005; 3(4):230-8.
- Thomas CT, Bradshaw PT, Pollock BH et al. Indium-11 capromab pendetide radioimmunoscintigraphy and prognosis for durable biochemical response to salvage radiation therapy in men after failed prostatectomy. J Clin Oncol 2003; 21(9):1715-21.
- Tsivian M, Wright T, Price M et al. 111-In-capromab pendetide imaging using hybrid-gamma camera-computer tomography technology is not reliable in detecting seminal vesicle invasion in patients with prostate cancer. Urol Oncol 2012; 30(2):150-4.
- Wong TZ, Turkington TG, Polascik TJ et al. ProstaScint (capromab pendetide) imaging using hybrid gamma camera-CT technology. AJR Am J Roentgenol 2005; 184(2):676-80.
- Wong WW, Schild SE, Vora SA et al. 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 2011; 81(4):e423-9.
- Yao D, Trabulsi EJ, Kostakoglu L et al. The utility of monoclonal antibodies in the imaging of prostate cancer. Semin Urol Oncol 2002; 20(3):211-8.
Medical Policy Group, April 2011 (1)
Medical Policy Administration Committee, April 2011
Available for comment April 13 – May 30, 2011
Medical Policy Group, February 2012 (1): 2012 Update to Key Points and References related to MPP update; no change in policy statement
Medical Policy Group, May 2013 (4): 2013 Update to Key Points.
Medical Policy Panel January 2014
Medical Policy Group January 2014 (4): 2014 Updated Key Points and References, There were no changes to the policy at this time.
Medical Policy Panel, January 2015
Medical Policy Group, January 2015 (3): 2015 Updates – Key Points and References; no change to policy statement
Medical Policy Panel, September 2016
Medical Policy Group, September 2016 (3): 2016 Updates to Title, Key Points & References; No change to policy statement
Medical Policy Panel, September 2017
Medical Policy Group, October 2017 (3): 2017 Updates to Description & Key Points; Updated NCCN reference, no new references added; no change to policy statement.
Medical Policy Panel, September 2018
Medical Policy Group, September 2018 (9): 2018 Updates to Description, Key Points & References. No change to policy statement.
Medical Policy Panel, September 2019
Medical Policy Group, October 2019 (2): 2019 Updates to Key Points and References. No change to Policy Statement.
Medical Policy Group, November 2019 (2): 2020 Annual Coding Update. Revised CPT codes 78800-78802 and 78804 to include planar. 78803 revised to include single area.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.