Sipuleucel-T (Provenge®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indication
Provenge (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
B. Compendial Use
Biochemical relapse of nonmetastatic androgen-dependent (castration-naïve) prostate cancer
II. CRITERIA FOR INITIAL APPROVAL
Prostate cancer
Authorization of 6 months may be granted when the requested medication is prescribed for a maximum of 3 doses for either of the following indications:
A. Asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer
B. Biochemical relapse of nonmetastatic androgen-dependent (castration-naïve) prostate cancer
III. CONTINUATION OF THERAPY
All members (including new members) requesting authorization for continuation of therapy must be currently receiving therapy with the requested agent.
The requested medication is administered every 2 weeks for a total of 3 doses. Authorization for 3 months to complete the 3-dose treatment may be granted when all of the following criteria are met:
A. The member is currently receiving treatment with the requested medication
B. The requested medication is being used to treat an indication enumerated in Section II
C. The member has not yet completed treatment with all 3 doses
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Provenge [package insert]. Seal Beach, CA: Dendreon Pharmaceuticals LLC; July 2017.
2. The NCCN Drugs & Biologics Compendium ®© 2022 National Comprehensive Cancer Network. Available at: http://www.nccn.org. Accessed August 7, 2023.
3. Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Updated periodically. www.micromedexsolutions.com [available with subscription]. Accessed August 7, 2023.
ORIGINAL EFFECTIVE DATE: 10/9/2010
MOST RECENT REVIEW DATE: 5/14/2024
ID_CHS
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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