BlueCross BlueShield of Tennessee Medical Policy Manual

Sipuleucel-T

NDC CODE(S)

30237-8900-XX – Provenge suspension for injection (Dendreon)

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Prostate Cancer

1 pre-made bag (containing at least 50 million autologous CD54+ cells activated with PAPGM-CSF) every 2 weeks for 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.

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 

ECOG PERFORMANCE STATUS

Grade

ECOG

0

Fully active, able to carry on all pre-disease performance without restriction

1

Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work

2

Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours

3

Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours

4

Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair

5

Dead

 

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).

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

BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2015). Cellular immunotherapy for prostate cancer (8.01.53). Retrieved November 28, 2016 from BlueWeb.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, November). Sipuleucel-T. Retrieved November 28, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium™. Sipuleucel-T. Retrieved November 28, 2016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2010, April). Center for Biologics  Evaluation and Research. Provenge® (sipuleucel-T) suspension for intravenous infusion. Retrieved November 28, 2016 from http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM210031.pdf.

ORIGINAL EFFECTIVE DATE:  10/9/2010

MOST RECENT REVIEW DATE:  12/1/2016

ID_MRx

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®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the diagnosis metastatic prostate cancer with the absence of hepatic metastases and testosterone levels <50 ng/dl and the disease castrate resistant (i.e., hormone refractory)?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the individual ALL of the following?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the documentation show that sipuleucel-T will NOT be used in combination with chemotherapy?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 1 billable unit every 14 days for three doses only as administered in 1 pre-made bag every 2 weeks for three doses for a single, non-renewable authorization?

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.