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Date Printed: October 31, 2014: 10:53 PM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2014, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2014 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J1000-29

Original Effective Date: 08/01/10

Reviewed: 03/12/14

Revised: 04/15/14

Subject: Sipuleucel-T (Provenge®)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement

Dosage/ Administration

Billing/Coding

Reimbursement

Program Exceptions

Definitions

Related Guidelines

Other

References

Updates

Decision Tree

Previous Information

DESCRIPTION:

Prostate cancer remains the most common non-cutaneous malignancy among men worldwide. In the United States, 241,740 new diagnoses of prostate cancer and 28,170 prostate cancer deaths have been estimated for 2012, representing 28% of new cancer cases and 10% of male cancer deaths. Prostate cancer is a complex disease, with many controversial aspects of management and with a dearth of sound data to support treatment recommendations.

Sipuleucel-T (Provenge) was approved by the US Food and Drug Administration (FDA) in April 2010 and represents a novel class of cancer immunotherapeutic agents. Sipuleucel-T is an autologous cancer “vaccine” and involves collection of the white blood cell fraction containing antigen-presenting cells from each individual, exposure of the cells to the prostatic acid phosphatase-granulocyte macrophage colony-stimulating factor (PAP-GM-CSF recombinant fusion protein), and subsequent reinfusion of the cells into the member. Sipuleucel’s approval was based principally on a phase III, multi-center, randomized double-blind study of 512 subjects with asymptomatic or minimally symptomatic castration-resistant prostate cancer (CRPC). Subjects were randomized to receive either sipuleucel-T or placebo. Median survival in the vaccine arm was 25.8 months compared to 21.7 months in the control arm. Treatment with sipuleucel-T resulted in a 22% reduction in mortality risk (HR=0.78; 95% CI, 0.61-0.98, p=0.03).

National Comprehensive Cancer Network (NCCN) guidelines (version 1.2014) for the treatment of prostate cancer recommend sipuleucel-T for the treatment of metastatic CRPC (category 1) for individuals who are asymptomatic, have good performance level (ECOG 0-1) and have a life expectancy of at least 6 months. In addition, sipuleucel-T is an option after failure of or treatment with chemotherapy (category 2A). However, persons with rapidly progressing disease, liver metastasis, or a life expectancy of less than 6 months should not be considered for sipuleucel-T.

POSITION STATEMENT:

Sipuleucel-T (Provenge®) meets the definition of medical necessity when ALL of the following criteria are met:

1. Member is diagnosed with metastatic castrate resistant (hormone refractory) prostate cancer

2. Member is asymptomatic or minimally symptomatic

3. Member has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see TABLE 1)

4. Member has no liver metastases

5. Member has an expected survival of at least 6 months

6. Member is 18 years old or older

7. Member has not exceeded three (3) lifetime injections.

Sipuleucel-T therapy is considered experimental and investigational in all other situations, including but not limited to treatment of hormone-responsive prostate cancer, treatment of those with moderate to severe symptomatic metastatic prostate cancer, and those with visceral (liver, lung or brain) metastases.

NOTE: Immunization/vaccines are covered according to the member’s contract benefits.

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved: sipuleucel-T is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Sipuleucel should be administered as an intravenous (IV) infusion only over a period of 60 minutes. A Cell Filter should not be used. Sipuleucel is indicated for autologous use only; prior to infusion, confirm that the member’s identify matches the identifiers on the infusion bag. The recommended course of therapy is 3 doses at approximately 2 week intervals. Premedication with oral acetaminophen and an antihistamine (e.g., diphenhydramine) is recommended to minimize potential for acute infusion reactions.

Drug Availability: each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, suspended in 250 mL of Lactated Ringer’s Injection, USP in a sealed, member-specific infusion bag.

PRECAUTIONS:

Administration: Sipuleucel-T is intended solely for autologous use.

Acute infusion reactions: Acute infusion reactions (reported within 1 day of infusion) included, but were not limited to, fever, chills, respiratory reactions (dyspnea, hypoxia, and bronchospasm), nausea, vomiting, fatigue, hypertension, and tachycardia. In the event of an acute infusion reaction, the infusion rate may be decreased, or the infusion stopped, depending on the severity of the reaction. Appropriate therapy should be administered as needed. Closely monitor members with pulmonary or cardiac conditions.

Infectious diseases: Sipuleucel-T is not routinely tested for transmissible infectious diseases and may transmit disease to health care professionals handling the product. Universal precautions should be followed.

Concomitant chemotherapy: concomitant use of chemotherapy and immunosuppressive medications with sipuleucel-T has not been studied.

BILLING/CODING INFORMATION:

HCPCS Coding:

Q2043

Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with pap-gm-cst, including leukapheresis and all other preparatory procedures, per infusion

ICD-9 Diagnoses Codes That Support Medical Necessity:

185

Malignant neoplasm of prostate

V10.46

Personal history of malignant neoplasm of prostate

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

C61

Malignant neoplasm of prostate

Z85.46

Personal history of malignant neoplasm of prostate

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

Autologous: Derived from the same organism or from one of its parts.

Dendritic Cells: Dendritic cells in the periphery capture and process antigens, express lymphocyte co-stimulatory molecules, migrate to lymphoid organs and secrete cytokines to initiate immune responses.

Metastatic cancer: when cancer spreads from the primary site (place where it started) to other places in the body.

Castrate-resistant prostate cancer: occurs when a member’s cancer continues to progress (is refractory) despite medical (with drugs) or surgical (removal/destruction of testicles) intervention.

RELATED GUIDELINES:

Abiraterone acetate (Zytiga®) 09-J1000-36
Cabazitaxel (Jevtana®) 09-J1000-77

Docetaxel (Taxotere®) IV, 09-J0000-95

Enzalutamide (Xtandi®), 09-J1000-85

OTHER:

TABLE 1

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

* As published in Am. J. Clin. Oncol.:

Oken, M.M., Creech, R.H., Tormey, D.C., Horton, J., Davis, T.E., McFadden, E.T., Carbone, P.P.: Toxicity And Response Criteria Of The Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-655, 1982.

REFERENCES:

  1. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2014 [cited 2014 Jan 28]. Available from: http://www.clinicalpharmacology.com/.
  2. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2014 Jan 28]. Available from: http://clinicaltrials.gov/.
  3. Dendreon Corporation. Provenge (sipuelucel-t) injection, 2010 [cited 2014 Jan 28]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8309b497-5d4e-4408-ac0c-2452c11c8a35/.
  4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2014 Jan 28]. Available from: http://www.thomsonhc.com/.
  5. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Prostate Cancer, v. 1.2014 [cited 2014 Jan 28]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  6. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2014 [cited 2014 Jan 28]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  7. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2014 [cited 2014 Jan 28]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 03/12/14.

GUIDELINE UPDATE INFORMATION:

08/01/10

New Medical Coverage Guideline.

01/15/11

Revision to guideline; consisting of adding ICD-10 codes.

04/15/11

Review and revision to guideline; consisting of updating precautions, references and coding.

07/01/11

Revision to guideline; consisting of updating coding.

04/15/12

Review and revision to guideline; consisting of updating dosage and administration, precautions, and references.

04/15/13

Review and revision to guideline; consisting of revising position statement, description section, dosage/administration section, and precautions section; updating references; adding related guidelines and pertinent definitions.

04/15/14

Review and revision to guideline; consisting of description, position statement, program exceptions, decision tree, references

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is copyright 2013, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2013 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association.The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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Date Printed: October 31, 2014: 10:53 PM