Autologous Cellular Immunotherapy for Prostate Cancer

Policy ID: I-26-014

Section: Injections

Effective Date: June 01, 2019

Revised Date: July 17, 2023

Revision Effective Date: October 01, 2023

Last Reviewed: July 26, 2023

Applies To: Commercial and Medicaid Expansion

Description

Sipuleucel-T (Provenge®) is an autologous cellular immunotherapy that includes antigen presenting cells that have been activated by a recombinant human protein consisting of prostatic acid phosphatase (PAP), which is expressed in prostate cancer tissue, linked with granulocyte-macrophage colony stimulating factor (GM-CSF). Cells are obtained from the individual via leukapheresis, and during ex vivo culture the PAP-GM-CSF binds to the antigen presenting cells, which induces an immune response against PAP.

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.

Sipuleucel-T (Provenge) may be considered medically necessary for the treatment of adults with metastatic castrate-resistant prostate cancer (mCRPC) when ALL of the following criteria are met:

Individual is asymptomatic or minimally symptomatic; and
A serum testosterone level of less than 50 ng/dl; and
Serum prostate specific antigen (PSA) greater than or equal to 5 ng/mL; and
Have an Eastern Cooperative Oncology Group (ECOG) performance status of zero (0) or one (1); and
Have no visceral (liver, lung or brain) metastases; and
Have a life expectancy of greater than six (6) months; or

Compendia Sources

Sipuleucel-T (Provenge) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

mCRPC is resistant/refractory to standard hormone treatment, and is further defined as follows:

Disease progression evidenced by a progressively rising PSA, defined as a PSA rise by 2 ng/ml or more above the nadir PSA, or an increase in tumor mass despite a castrate level of testosterone less than 50 ng/dl.

The use of sipuleucel-T (Provenge) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

Q2043

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.

Diagnostic Code

C61

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-19-2020

Removed table attachment and criteria 'No use of narcotics for cancer related pain'

Internal Medical Policy Committee 5-20-2021 Annual review, no clinical content change

Internal Medical Policy Committee 11-23-2021 No clinical content change

Internal Medical Policy Committee 11-26-2023 Annual review - no changes in criteria

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

Changed to precertification
Added Compendia sources statement 'Drug may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'
Removed diagnosis code Z85.46
Updated experimental/investigational statement

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.

Policy ID: I-26-012

Section: Injections

Effective Date: June 01, 2019

Revised Date: May 05, 2021

Revision Effective Date: July 01, 2021

Last Reviewed: January 26, 2023

Archived Date: September 30, 2023

Applies To: Commercial and Medicaid Expansion

Description

Criteria

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

Sipuleucel-T (Provenge) may be considered medically necessary for the treatment of adults with metastatic castrate-resistant prostate cancer (mCRPC) when ALL of the following criteria are met:

Individual is asymptomatic or minimally symptomatic; and
A serum testosterone level of less than 50 ng/dl; and
Serum prostate specific antigen (PSA) greater than or equal to 5.0 ng/mL; and
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; and
Have no visceral (liver, lung or brain) metastases; and
Have a life expectancy of greater than 6 months.

mCRPC is resistant/refractory to standard hormone treatment, and is further defined as follows:

The use of sipuleucel-T (Provenge) for any other indication not listed on this policy is considered experimental/investigational and, therefore, non-covered. Scientific evidence does not support its use for any other indications.

Procedure Codes

Q2043

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

Diagnostic Codes

C61

Z85.46