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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-J1000-77

Original Effective Date: 12/15/12

Reviewed: 03/12/14

Revised: 04/15/14

Subject: Cabazitaxel (Jevtana®) Injection

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.

Dosage/ Administration

Position Statement

Billing/Coding

Reimbursement

Program Exceptions

Definitions

Related Guidelines

Other

References

Updates

Decision Tree

Previous Information

DESCRIPTION:

Cabazitaxel (Jevtana®) is a novel semi-synthetic taxane demonstrating in vitro activity in docetaxel-sensitive and docetaxel-resistant cell lines and tumor models. Similar to other taxanes (e.g., paclitaxel [Taxol®], docetaxel [(Taxotere®]), cabazitaxel impairs microtubule assembly ultimately resulting in mitotic arrest and apoptosis. Although cabazitaxel is mechanistically similar to paclitaxel and docetaxel, it has poor affinity for P-glycoprotein (P-gp); consequently, cabazitaxel’s penetration of the blood-brain barrier is superior to that of paclitaxel and docetaxel.

Cabazitaxel was approved by the Food and Drug Administration (FDA) on June 17, 2010, for the treatment of individuals with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. For most men with metastatic prostate cancer, androgen-deprivation therapy, usually with a luteinizing hormone-releasing hormone (LHRH) agonist, improves symptoms, but tumors invariably become castration resistant and progressive disease ensues. National Comprehensive Cancer Network (NCCN) Guidelines (Version 1.2014) for prostate cancer designate docetaxel and prednisone as preferred first-line chemotherapy treatment in individuals with symptomatic metastatic castration-resistant prostate cancer (CRPC). No consensus exists for the best additional therapy following docetaxel therapy in metastatic CRPC individuals. Options include abiraterone acetate (Zytiga®) (category 1), cabazitaxel (category 1), salvage chemotherapy, docetaxel re-challenge, mitoxantrone (Novantrone), secondary androgen deprivation therapy (ADT), sipuleucel-T (Provenge®), and participation in clinical trials.

Although NCCNs inclusion of cabazitaxel as an option for second-line therapy is a category 1 recommendation based on randomized phase III study data, the extension of survival is relatively short and the side effects are relatively high. Careful monitoring (e.g., neutrophil counts), prophylactic granulocyte colony-stimulating factor (G-CSF), and supportive care (e.g., pre-medication with antihistamines, corticosteroids, histamine-2 receptor antagonists, anti-emetics, and anti-diarrheals) are important components of cabazitaxel administration.

POSITION STATEMENT:

I. Initiation of cabazitaxel (Jevtana®) meets the definition of medical necessity when ALL of the following criteria are met:

1. Member is 18 years of age or older

2. Member is diagnosed with hormone-refractory metastatic prostate cancer

3. Member has previously received a docetaxel-containing regimen

4. Member has tried and failed, or has a contraindication to abiraterone (Zytiga)

5. Cabazitaxel is used in combination with prednisone

6. Dose does not exceed 25 mg/m2

7. Cabazitaxel is not used concomitantly with ANY of the following:

a. Abiraterone (Zytiga™)

b. Docetaxel (Taxotere®)

c. Enzalutamide (Xtandi®)

d. Mitoxantrone (Novantrone®)

e. Sipuleucel-T (Provenge®)

II. Continuation of cabazitaxel meets the definition of medical necessity when ALL of the following criteria are met:

1. Member has demonstrated a beneficial clinical response to therapy

2. Member has been approved by another healthplan or met Florida Blue’s initial criteria for coverage

3. Cabazitaxel will be used in combination with prednisone

4. Cabazitaxel is not used concomitantly with ANY of the following:

a. Abiraterone (Zytiga™)

b. Docetaxel (Taxotere®)

c. Enzalutamide (Xtandi®)

d. Mitoxantrone (Novantrone®)

e. Sipuleucel-T (Provenge®)

5. The dose does not exceed 25 mg/m2

Approval duration: 1 year

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: Cabazitaxel is approved for the treatment of members with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen. It should be used in combination with prednisone. The recommended dosage is based on calculation of Body Surface Area (BSA) and is 25 mg/m2 every three weeks with oral prednisone 10 mg daily throughout treatment. Cabazitaxel is administered as an intravenous (IV) infusion over one hour.

Pre-medication, consisting of an antihistamine (e.g., diphenhydramine 25 mg), corticosteroid (e.g., dexamethasone 8 mg), and a histamine-2 receptor antagonist (e.g., ranitidine 50 mg) should be administered 30 minutes prior to each cabazitaxel dose. Antiemetic prophylaxis, either oral or intravenous, is also recommended as needed.

Dosage Adjustments

Renal Impairment: Dosage adjustments are not required in members with a creatinine clearance (CrCl) greater than 30 ml/min. Cabazitaxel was not studied in individuals with severe renal impairment (CrCl less than 30 ml/min); as such, it should be used with caution in members with severe renal impairment or end-stage renal disease.

Hepatic Impairment: Although dedicated hepatic impairment studies have not been conducted, cabazitaxel is extensively metabolized in the liver. Consequently, hepatic impairment is likely to increase cabazitaxel concentrations. Individuals with hepatic impairment were excluded from clinical trials.

Adverse reactions: the dose of cabazitaxel should be reduced to 20 mg/m2 if members experience the adverse reactions described in Table 1. If the member continues to experience any of these reactions, cabazitaxel should be discontinued.

Table 1

Table 1: Recommended Dosage Adjustments for Adverse Reactions

Toxicity

Dosage Modification

Prolonged grade 3 or greater neutropenia (greater than 1 week) despite appropriate medication including G-CSF

Delay treatment until neutrophil count is greater than 1500 cells/mm3, then reduce dose to 20 mg/m2. Use G-CSF for secondary prophylaxis

Febrile neutropenia

Delay treatment until improvement or resolution, and until neutrophil count is greater than 1500 cells/mm3, then reduce dose to 20 mg/m2. Use G-CSF for secondary prophylaxis

Grade 3 or greater diarrhea or persisting diarrhea despite appropriate medication, fluid and electrolytes replacement.

Delay treatment until improvement or resolution, then reduce dose to 20 mg/m2.

G-CSF, Granulocyte Colony Stimulating Factor

Drug Availability

Cabazitaxel is available as a 60 mg/1.5 mL injection kit consisting of the following

• Cabazitaxel injection: 60 mg cabazitaxel in 1.5 mL polysorbate 80

• Diluent: 5.7 mL of 13% (w/w) ethanol in water for injection

CONTRAINDICATIONS

Boxed Warning

• Neutropenic deaths have been reported. Frequent blood counts should be obtained to monitor for neutropenia. Cabazitaxel is contraindicated in members with neutrophil counts less than or equal to 1500 cells/mm3. Primary prophylaxis with G-CSF should be considered in members with high-risk clinical features (e.g., age greater than 65, poor performance status, previous episodes of febrile neutropenia, other serious comorbidities, etc.)

• Severe hypersensitivity can occur and may include generalized rash/erythema, hypotension and bronchospasm. If severe reactions occur, discontinue cabazitaxel and administer appropriate therapy.

• Cabazitaxel is contraindicated in members with a history of severe hypersensitivity reactions to cabazitaxel or other drugs formulated with polysorbate 80.

PRECAUTIONS:

Neutropenia, febrile neutropenia: Monitor blood counts frequently to determine if initiation of G-CSF and/or dosage adjustment is needed. Primary prophylaxis with G-CSF should be considered in members with high-risk clinical features. See table 1 for dosage adjustment information.

Hypersensitivity: Pre-medicate members with antihistamines, corticosteroids, and histamine-2 receptor antagonists.

Gastrointestinal symptoms (nausea, vomiting, diarrhea): Mortality related to diarrhea has been reported. Members should be rehydrated and antiemetics and anti-diarrheals should be administered as needed. If member is experiencing grade ≥ 3 diarrhea, the dosage should be adjusted (refer to Table 1).

Renal failure: Renal failure, including cases with fatal outcomes, has been reported. The cause should be identified and managed aggressively.

Geriatric population: In clinical trials, individuals 65 years of age or older were more likely to experience fatal outcomes not related to disease progression and certain adverse reactions, including neutropenia and febrile neutropenia. Members 65 years of age and older should be monitored closely.

Hepatic Impairment: Cabazitaxel was not adequately evaluated in individuals with impaired hepatic function. Hepatic impairment is likely to increase cabazitaxel concentrations; as such cabazitaxel should not be administered to members with hepatic impairment.

Pregnancy/Lactation

• Cabazitaxel is classified as Pregnancy Category D. Although there are no adequate and well-controlled studies evaluating cabazitaxel in pregnant women, non-clinical studies in animals have shown that cabazitaxel is embryotoxic, fetotoxic, and abortifacient.

• Cabazitaxel or cabazitaxel metabolites are excreted in maternal milk of lactating rats. While it is not known whether cabazitaxel is excreted in human milk, it may be prudent to avoid use in nursing women.

BILLING/CODING INFORMATION:

HCPCS Coding:

J9043

Injection, cabazitaxel, 1 mg

ICD-9 Diagnoses Codes That Support Medical Necessity:

185

Malignant neoplasm of prostate

V10.46

History prostatic malignancy

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

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

DEFINITIONS:

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
Docetaxel (Taxotere®) IV 09-J0000-95

Enzalutamide (Xtandi®) Capsules 09-J1000-85

Gonadotropin Releasing Hormone Analogs and Antagonists 09-J0000-48

Granulocyte Colony Stimulating Factors 09-J0000-62

Paclitaxel and Nab-Paclitaxel IV 09-J1000-05

Sipuleucel-T (Provenge®) 09-J1000-29

OTHER:

None.

REFERENCES:

  1. Cabazitaxel. In McEvoy GK, editor. AHFS drug information 2013 [monograph on the internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2013 [cited 2014 Jan 17]. Available from http://online.statref.com Subscription required to review.
  2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2012. URL www.clinicalpharmacilogy-ip.com Accessed 1/17/2014.
  3. de Bono JS, Oudard S, Ozguroglu M, TROPIC Investigators, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomized open-label trial. Lancet. 2010;376(9747):1147-54.
  4. Jevtana (cabazitaxel) [package insert]. Sanofi-Aventis U.S. LLC. Bridgewater (NJ): May 2013.
  5. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 1/17/2014.
  6. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 1/17/2014.
  7. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2014. Prostate Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf Accessed 1/17/2014.
  8. Pal SK, Twardowski P, Sartor O. Critical appraisal of cabazitaxel in the management of advanced prostate cancer. Clin Interv Aging. 2010;5:395-402.
  9. Tannock IF, de Wit R, Berry WR, TAX 327 Investigators, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351(15):1502-15.

COMMITTEE APPROVAL:

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

GUIDELINE UPDATE INFORMATION:

12/15/12

New Medical Coverage Guideline.

04/01/13

Review and revision to guideline; consisting of revising position statement, updating references and adding related guidelines.

04/15/14

Review and revision to guideline; consisting of revising position statement, updating references and program exceptions.

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 23, 2014: 05:20 AM