DESCRIPTION
Sipuleucel-T is the first autologous cellular immunotherapy approved for use in the United States. It is designed to induce an immune response targeted against the protein prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers. Sipuleucel-T is administered by infusion, generally in three doses.
Approximately three days prior to each infusion, the individual undergoes a standard leukapheresis procedure in which peripheral blood mononuclear cells, including antigen presenting cells (APCs) are harvested. During a defined culture period, the APCs are activated with recombinant human protein PAP linked with granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune cell activator. During culture, the recombinant PAP and GM-CSF can bind to and be processed by APCs into smaller protein fragments which are then infused into the individual along with other cells retrieved by the leukapheresis, including T cells, B cells, natural killer (NK) cells and other cells suspended in 250 mL of Lactated Ringer’s Injection, USP.
An example of a preparation of sipuleucel-T is Provenge®.
REFER TO DECISION SUPPORT TREE
POLICY
Sipuleucel-T for the treatment of prostate cancer is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Sipuleucel-T for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Sipuleucel-T for the treatment of prostate cancer is considered medically appropriate if ALL of the following criteria are met:
Disease is metastatic
Disease is ANY ONE of the following:
Asymptomatic
Minimally symptomatic
Disease is castrate resistant (i.e., hormone refractory)
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies withTennessee 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.
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, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
No controlled studies were found in the published literature that validate the use of Sipuleucel-T in the treatment/prevention of any other conditions/diseases.
SOURCES
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2011, October). Sipuleucel-T. Retrieved November 22, 2011 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2011). NCCN Drugs & Biologics Compendium™. Sipuleucel-T. Retrieved November 22, 2011 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2010, May). Center for Biologics Evaluation and Research. Provenge® (sipuleucel-T) suspension for intravenous infusion. Retrieved April 30, 2010 from http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM210031.pdf.
ORIGINAL EFFECTIVE DATE: 10/9/2010
MOST RECENT REVIEW DATE: 5/4/2012
ID_BT
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.
Pharmaceutical Decision Support Tree
Sipuleucel-T (Provenge®)
Does the individual have a diagnosis of prostate cancer that is ALL of the following?
Asymptomatic or minimally symptomatic
Metastatic
Hormone refractory (castrate resistant)
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.