Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Cabazitaxel (Jevtana®)
Policy #:MA08.054b

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

MEDICALLY NECESSARY

A maximum of 10 doses of cabazitaxel (Jevtana®) in combination with prednisone is considered medically necessary and, therefore, covered in the treatment of individuals with progressive, metastatic, hormone-refractory prostate cancer (mHRPC) when all of the following criteria are met:
  • The individual has been previously treated with a docetaxel-containing treatment regimen unless documented failure, contraindication, or intolerence to docetaxel exists.
  • The individual has an Eastern Cooperative Oncology Group (ECOG) performance status of zero-to-two.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for cabazitaxel (Jevtana®) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, test reports, and performance status. The individual’s performance status must be zero to two; the medical record is to clearly support the performance status. The medical record for an individual with an ECOG performance status of zero-to-two must reflect the ability to either carry on all pre-disease performance without restriction or the individual is ambulatory and able to perform work of a light or sedentary nature (e.g., light house work, office work); or the individual is ambulatory and capable of all self care but unable to carry out any work activities (up and about more than 50 percent of waking hours).

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
Policy Guidelines

There is no Medicare determination for cabazitaxel (Jevtana®), therefore, the Company policy is applicable.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, cabazitaxel (Jevtana®) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when cabazitaxel (Jevtana®) is covered under a member's medical benefit (Part B benefit). It does not address instances when cabazitaxel (Jevtana®) is covered under a member’s pharmacy benefit (Part D benefit).

BLACK BOX WARNING

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

THE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS

The Eastern Cooperative Oncology Group (ECOG), established in 1955, was one of the first groups to coordinate multicenter cancer clinical trials. The National Cancer Institute (NCI) is the primary funding source, and ECOG has evolved from a small consortium of institutions in the eastern United States to one of the largest clinical cancer research organizations in the country. As part of their work in the treatment of cancer, ECOG has developed the ECOG Performance Status (EPS), originally published in 1982 in the American Journal of Clinical Oncology. The use of the scales and the criteria in the EPS allows clinicians and researchers to determine an individual’s disease progression in terms of how the activities of daily living (ADL) are affected.

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 self care but unable to carry out any work activities. Up and about more than 50 percent of waking hours
3
Capable of only limited self care, confined to bed or chair more than 50 percent of waking hours
4
Completely disabled. Cannot carry on any self care: Totally confined to bed or chair
5
Dead
Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol.1982;5(6):649-655.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Cabazitaxel (Jevtana®) injection was approved by the FDA on June 17, 2010 for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen.

Description

Prostate cancer is the second leading cause of cancer-related deaths among American men, with an estimated incidence of 233,000 cases and 29,480 deaths in 2014. The widespread use of the prostate-specific antigen (PSA) test for the screening and monitoring of individuals with prostate cancer has allowed for the majority of prostate cancer cases to be diagnosed at a localized stage. Despite early detection and appropriate treatment, some individuals progress to metastatic, hormone-refractory prostate cancer (mHRPC) after the failure of several lines of antihormonal therapies. For these individuals, no standard of care exists for treatment, leading to a poor prognosis for survival. To address this issue, pharmaceutical entities have pursued the development of drugs for use in men with mHRPC after they have received a docetaxel-containing regimen.

On June 17, 2010, the US Food and Drug Administration (FDA) approved the use of cabazitaxel (Jevtana®) injection, with prednisone, for the treatment of mHRPC that was previously treated with a docetaxel-containing treatment regimen. Cabazitaxel (Jevtana®) is an antineoplastic agent belonging to the taxane class. Cabazitaxel (Jevtana®) is a microtubule inhibitor that binds to tubulin to promote its assembly into microtubules, while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules and the hindering of microtubule depolymerization and cell division. The result is an interruption of mitotic and interphase cellular functions, cell arrest, and limited tumor cell proliferation. Cabazitaxel (Jevtana®) has demonstrated antitumor activity in docetaxel-sensitive tumors. Additionally, it has demonstrated antitumor activity in tumor models that are insensitive to chemotherapy that contained docetaxel.

This FDA approval was based primarily on the results of a single, randomized, open-label, international trial of 755 patients with mHRPC previously treated with docetaxel-containing regimens. Individuals were treated with cabazitaxel (Jevtana®) in combination with prednisone until disease progression, death, unacceptable toxicity, or completion of 10 cycles of therapy. The results showed that treatment with cabazitaxel (Jevtana®) in combination with prednisone for hormone-refractory metastatic prostate cancer resulted in a statistically significant reduction in the risk of death by 30 percent (p<0.0001). A median overall survival improvement of 15.1 months was observed in the cabazitaxel (Jevtana®) combination group compared to 12.7 months in the control combination treatment. Individuals treated with the cabazitaxel (Jevtana®) combination also experienced a significant improvement in median progression-free survival of 2.8 months compared to 1.4 months in the control arm (p<0.0001). However, this superior efficacy came at the cost of relatively high toxicity, with the cabazitaxel (Jevtana®) combination causing a considerable decrease in white blood cell count, resulting in 82 percent of patients having grade 3/4 neutropenia.

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
References

American Hospital Formulary Service – Drug Information (AHFS-DI). [AHFS Website]. March 8, 2017. Available at:http://online.lexi.com/lco/action/doc/retrieve/docid/complete_ashp/3543686 [via subscription only]. Accessed May 24, 2017.

Cabazitaxel (Jevtana®). Sanofi-Aventis US LLC, Bridgewater, NJ. 09/2016. Available at: http://products.sanofi.us/jevtana/jevtana.html . Accessed May 22, 2017.

de Bono JS, Oudad M, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resisitant prostate cancer progressing after docetaxel treatment: a randomised open-label. Lancet. 2010; 376:1147-1154.

Lexi-Drugs Compendium. Cabazitaxel. [Lexicomp Online Web site]. 05/03/2017. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed May 24, 2017.

Micromedex® Healthcare Series. [Internet database]. Jevtana® (Cabazitaxel). May 3, 2017. Available at: http://www.thomsonhc.com [via subscription only]. Accessed May 24, 2017.

National Cancer Institute (NCI). Prostate Cancer Treatment.[NCS Web site]. March 31, 2017. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/prostate/HealthProfessional. Accessed May 22, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Drugs and Biologics Compendium. Cabazitaxel (Jevtana®). [NCCN Web site, subscription required.] 05/22/2017. Available at: http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=360 Accessed May 22, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Guidelines Clinical Practice Guidelines in Oncology: Prostate Cancer. V2.2017. [NCCN Web site, login required]. 02/21/17. Available at: http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf
Accessed May 22, 2017.

US Food and Drug Administration (FDA), Center for Drug Evaluation and Research. Clinical review #201023, Amy McKee, M.D. (Efficacy) and Ian Waxman, M.D. (Safety), March 2010. [FDA web site]. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201023s000MedR.pdf.
Accessed May 22, 2017.

US Food and Drug Administration (FDA). Drug Approval package. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201023s020lbl.pdf. Accessed May 22, 2017.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

C61 Malignant neoplasm of prostate


HCPCS Level II Code Number(s)

J9043 Injection, Cabazitaxel, 1 mg


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References




Policy History

MA08.054b:
09/25/2019This policy has been reissued in accordance with the Company's annual review process.
12/19/2018This policy has been reissued in accordance with the Company's annual review process.
07/12/2017This version of the policy will become effective 07/12/2017.

This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling and NCCN compendia.

Policy criteria was updated to allow use of cabazitaxel in individuals with a contraindication to or intolerant of docetaxel.

MA08.054a
05/11/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Cabazitaxel (Jevtana®). The references were updated accordingly.
01/28/2015This policy was updated to be consistent with US Food and Drug Administration (FDA) Labeling and Drug Compendia.

MA08.054
01/01/2015This is a new policy.






Version Effective Date: 07/12/2017
Version Issued Date: 07/12/2017
Version Reissued Date: 09/25/2019