Latest Review Date: October 2024

Category: Radiology

POLICY:

Radioimmunoscintigraphy using indium-111 capromab pendetide (ProstaScint®) is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

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).

KEY POINTS:

The most recent update with literature review covers the period through October 3, 2024.

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.4.2024) do not mention ProstaScint or radioimmunoscintigraphy.

American College of Radiology

In 2018, the American College of Radiology's 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

Not applicable.

KEY WORDS:

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 post-prostatectomy 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.

As of April 2018, Aytu BioScience voluntarily discontinued the manufacture and distribution of Prostascint® in the United States.

BENEFIT APPLICATION

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.  

CURRENT CODING

CPT Codes:    

HCPCS:

REFERENCES:

1. American College of Radiology. ACR Appropriateness Criteria: Post-Treatment Followup of Prostate Cancer. 2022; www.guidelinecentral.com/summaries/acr-appropriateness-criteria-post-treatment-follow-up-of-prostate-cancer/#section-society.
2. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
3. Manafi-Farid R, Ranjbar S, Jamshidi Araghi Z, et al. Molecular Imaging in Primary Staging of Prostate Cancer Patients: Current Aspects and Future Trends. Cancers (Basel). 2021 Oct 26;13(21):5360.  
4. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 4.2024. ww.nccn.org/professionals/physician_gls/pdf/prostate.pdf.
5. Rieter WJ, Keane TE, Ahlman MA et al. Diagnostic performance of In-111 capromab pendetide SPECT/CT in localized and metastatic prostate cancer. Clin nucl med 2011 Oct; 36(10):872-8.
6. Rizvi T, Deng C, Rehm PK. Indium-111 Capromab Pendetide (ProstaScint(®)) Demonstrates Renal Cell Carcinoma and Aortocaval Nodal Metastases from Prostate Adenocarcinoma. World J Nucl Med. 2015 Sep-Dec;14(3):209-11.
7. Schuster DM, Nieh PT, Jani AB, et al. Anti-3-[18F]FACBC PET-CT and 111In-capromab-pendetide SPECT-CT for Recurrent Prostate Carcinoma: Results of a Prospective Clinical Trial. J Urol. 2014 May;191(5):1446-53.
8. Sengupta S, Asha Krishnan M, Chattopadhyay S, Chelvam V. Comparison of prostate-specific membrane antigen ligands in clinical translation research for diagnosis of prostate cancer. Cancer Rep (Hoboken). 2019 Aug;2(4):e1169.  
9. 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 Mar-Apr; 30(2):150-4.
10. 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 Nov 15; 81(4):e423-9.

POLICY HISTORY:

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. 

Medical Policy Panel, September 2020

Medical Policy Group, September 2020 (2): 2020 Updates to Key Points. No change to Policy Statement. 

Medical Policy Group, October 2020 (2): Effective 10/20/20, active policy but no longer scheduled for regular literature reviews and updates.

Medical Policy Group, October 2021 (2): Updates to Key Points, Approved by Governing Bodies, and References. Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Policy statement updated to remove “not medically necessary,” no change in intent.

Medical Policy Group, October 2022 (2): Updates to Key Points, and References. No change to Policy Statement. Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, November 2023 (2): Reviewed by consensus. Minor updates to Key Points and Benefit Application. No change to Policy Statement. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, October 2024 (11): Updates to Key Points, Benefit Application, and References. No change to Policy Statement. Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

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.