Therapeutic Radiopharmaceuticals for Prostate Cancer

Policy ID: I-5043-001

Section: Injections

Effective Date: August 01, 2023

Last Reviewed: July 26, 2023

Applies To: Commercial and Medicaid Expansion

Description

Radiopharmaceuticals are composed of a radioisotope (i.e., a radioactive particle) bond to an organic molecule and are used for diagnostic and therapeutic purposes. The organic molecule acts as a targeting compound (ligand) that conveys the radioisotope to specific organs, tissues, or cells. Lutetium Lu 177 vipivotide tetraxetan (Pluvicto ^TM ), commonly abbreviated as Lu-177-PSMA-617, is a radioligand therapy that targets prostate-specific membrane antigen (PSMA), which is highly expressed on prostate cancer cells. Lu-177-PSMA-617 is indicated for use in adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with other anticancer treatments, including androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. Gallium Ga 68 gozetotide (Locametz ^® ) is a corresponding radioactive diagnostic agent for positron emission tomography (PET) of PSMA-positive lesions, including for the selection of patients with mCRPC for whom Lu-177-PSMA-617 therapy is indicated.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Therapeutic Radiopharmaceuticals for Prostate Cancerusing Lu-177-PSMA-617, may be considered medically necessary for the treatment of adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) in individuals with greater than or equal to one (1) PSMA-positive lesion and/or metastatic disease that is predominately PSMA-positive and with no dominant PSMA-negative metastatic lesions, who have been treated previously with androgen receptor-directed therapy and a taxane-based chemotherapy.

Therapeutic Radiopharmaceuticals for Prostate Cancer using Lu-177-PSMA-617 is considered investigational for the treatment of prostate cancer when the above criteria are not met.

Procedure Codes

A9607

79101

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

C61

C79.82

D07.5

Professional Statements and Societal Positions Guidelines

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in 'Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

National Comprehensive Cancer Network

The National Comprehensive Cancer Network guideline for prostate cancer (v4.2022) provides the following relevant recommendations with regard to the use of lutetium Lu 177 vipivotide tetraxetan (Lu-177-PSMA-617):

'The NCCN Panel recommends Lu-177-PSMA-617 as a category 1, useful in certain circumstances treatment option for patients with 1 PSMA-positive lesion and/or metastatic disease that is predominately PSMA-positive and with no dominant PSMA-negative metastatic lesions who have been treated previously with androgen receptor-directed therapy and a taxane-based chemotherapy. PSMA-negative lesions are defined as metastatic disease that lacks PSMA uptake including bone with soft tissue components 1.0 cm, lymph nodes 2.5 cm in short axis, and solid organ metastases 1.0 cm in size. The NCCN Panel believes that both Ga-68 PSMA-11 or F-18 piflufolastat PSMA imaging can be used to determine eligibility.'

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 3.

Table 3. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT04720157 ^a

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination with SoC, Versus SoC Alone, in Adult Male Patients with mHSPC (PSMAddition)

1126

Feb 2026

NCT04689828 ^a

177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer (PSMAfore)

450

Oct 2023

NCT04663997

A Randomized Phase II Study of 177 LuPSMA-617 vs Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive Disease

200

Jul 2025

NCT05150236

Phase II Study of Radionuclide 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With MetastaticCastration Resistant Prostate Cancer (mCRPC)

110

Dec 2024

NCT: national clinical trial.
^a Denotes industry-sponsored or cosponsored trial.

ND Committee Review

Internal Medical Policy Committee 7-26-2023 - Effective August 01, 2023

Adopted new precertification policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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