Clinical UM Guideline

 

Subject: Cabazitaxel (Jevtana®)
Guideline #: CG-DRUG-80 Publish Date:    12/27/2017
Status: New Last Review Date:    11/02/2017

Description

 

This document addresses cabazitaxel (Jevtana). Cabazitaxel is a tubulin-binding taxane used in combination with prednisone for the treatment of hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen. It acts to inhibit cell division and growth of cancer and can promote cell death.

 

Clinical Indications

Medically Necessary:

Cabazitaxel is considered medically necessary for the treatment of hormone-refractory metastatic prostate cancer (also known as castrate-resistant prostate cancer) when all of the following criteria are met:

  1. Cabazitaxel is used in combination with prednisone; and
  2. Disease has progressed during or after treatment with a docetaxel-containing regimen; and
  3. Individual’s current Eastern Cooperative Oncology Group (ECOG) performance status is 0-2.

Not Medically Necessary:

Cabazitaxel is considered not medically necessary when the medically necessary criteria are not met and for the treatment of all other solid tumors and uses, including but not limited to: appendiceal cancer, bladder cancer, brain tumor, breast cancer, head and neck cancer, lung cancer, melanoma and pancreatic cancer.

Coding

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

 

 

J9043

Injection, cabazitaxel, 1 mg [Jevtana]

 

 

 

 

ICD-10 Diagnosis

 

C61

Malignant neoplasm of prostate

Z19.2

Hormone resistant malignancy status

Z85.46

Personal history of malignant neoplasm of prostate

Discussion/General Information

In 2017, the American Cancer Society estimates that there will be about 161,360 new cases of prostate cancer diagnosed in the United States and approximately 26,730 deaths from the disease. The majority (92%) of men with prostate cancer are diagnosed with localized disease for which treatment options are radiotherapy and surgery (Oudard, 2011).

In June 2010, the U.S. Food and Drug Administration (FDA) approved cabazitaxel (Jevtana) in combination with prednisone for the treatment of advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel. The FDA-approved agent cabazitaxel has demonstrated an improved rate of survival for men with metastatic castration resistant prostate cancer progressing during or after treatment with docetaxel.

The safety and efficacy of cabazitaxel plus prednisone for the treatment of prostate cancer was evaluated by de Bono and colleagues (2010) in an open-label randomized phase III trial of men with metastatic castration-resistant prostate cancer who had received previous hormone therapy, but whose disease had progressed during or after treatment with a docetaxel-containing regimen (TROPIC Trial, NCT00417079). The study was undertaken internationally in 26 countries at 146 centers. Inclusion criteria included an age of at least 18 years and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Additional inclusion criteria were previous and ongoing castration by orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonists, or both; antiandrogen withdrawal followed by progression had to have taken place at least 4 weeks (6 weeks for bicalutamide) prior to enrollment; adequate hematological, hepatic, renal, and cardiac function; and left-ventricular ejection fraction of greater than 50%. Between January 2007 and October 2008, a total of 755 men were treated with 10 mg oral prednisone daily, and randomized to receive either 12 mg/m2 mitoxantrone intravenously over 15-30 minutes (n=377) or 25 mg/m2 cabazitaxel intravenously over 1 hour every 3 weeks (n=378). The random allocation schedule was computer-generated and participants and treating physicians were not masked to treatment allocation; however, the study team was masked to data analysis. The primary endpoint was overall survival and secondary endpoints included progression-free survival and safety. Disease characteristics and demographics of the treatment groups were balanced at baseline. Treatment was continued for a maximum of 10 cycles. Median overall survival was 15.1 months (95% confidence interval [CI], 14.1-16.3) in the cabazitaxel group and 12.7 months (11.6-13.7) in the mitoxantrone group. Median progression-free survival was 2.8 months (95% CI, 2.4-3.0) in the cabazitaxel group and 1.4 months (1.4-1.7) in the mitoxantrone group. Those treated with cabazitaxel had significantly higher tumor and PSA responses than those treated with mitoxantrone. The most common clinically significant grade 3 or higher adverse events were neutropenia (cabazitaxel, 303 [82%] subjects vs mitoxantrone, 215 [58%]) and diarrhea (23 [6%] vs 1 [< 1%]). A total of 28 (8%) men in the cabazitaxel group and 5 (1%) in the mitoxantrone group had febrile neutropenia. The significant adverse event of neutropenia present in this study suggests that individuals treated with cabazitaxel require an adequate neutrophil count prior to the start of therapy.

In a 2013 update of the TROPIC Trial, Bahl and colleagues demonstrated a sustained survival benefit of cabazitaxel in a subset of individuals who survived 2 years or more with a median follow-up of 25.5 months. Individual characteristics were well balanced within and between those who survived ≥ 2 years and < 2 years. Sixty (15.9%) of 378 subjects in the cabazitaxel group and 31 (8.2%) of 377 subjects in the mitoxantrone group survived ≥ 2 years (odds ratio 2.11; 95% CI, 1.33-3.33). No statistically significant difference was noted between groups for time to pain progression or pain response.

The National Comprehensive Cancer Network (NCCN) Guidelines for Prostate Cancer (V2.2017) and the NCCN drug compendium currently assign a category 1 recommendation to cabazitaxel with prednisone for metastatic castration-recurrent prostate cancer after failure of docetaxel.

The American Urological Association (AUA) Clinical Practice Guideline for castration-resistant prostate cancer (2015) includes the following recommendation:

Clinicians should offer treatment with abiraterone + prednisone, cabazitaxel or enzalutamide to patients with mCRPC with good performance status who received prior docetaxel chemotherapy. If the patient received abiraterone + prednisone prior to docetaxel chemotherapy, they should be offered cabazitaxel or enzalutamide. [Standard; Evidence Level Grade A (abiraterone) / B (cabazitaxel)/ A (enzalutamide)].

Other Uses

Cabazitaxel has also been evaluated as a treatment for other indications, including advanced gastric cancer (Kang, 2015), brain tumors (Ghoochani, 2016; Girard, 2015), breast cancer (Villanueva, 2011), small cell lung cancer (Evans, 2015) and other solid malignancies (appendiceal, melanoma, lung, pancreas, bladder, and head and neck) (Rixe, 2015). However, the current published literature does not support that the use of cabazitaxel to treat these conditions provide additional benefit.

Contraindications and Warnings

The current prescribing information for cabazitaxel (Jevtana) includes the following contraindications and Black Box Warnings:

Contraindications:
Jevtana is contraindicated in individuals with:

Black Box Warnings:

Severe hypersensitivity: Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the Jevtana infusion and administration of appropriate therapy. Patients should receive premedication. Jevtana is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80.

Definitions

 

ECOG Performance Status: A scale used to determine the individual's level of functioning. This scale may also be referred to as the WHO (World Health Organization) or Zubrod score which is based on the following scale:

Metastatic: The spread of cancer from one part of the body to another. A metastatic tumor contains cells that are like those in the original (primary) tumor and have spread.

References

Peer Reviewed Publications:

  1. Bahl A, Oudard S, Tombal B, et al; TROPIC Investigators. Impact of cabazitaxel on 2-year survival and palliation of tumour-related pain in men with metastatic castration-resistant prostate cancer treated in the TROPIC trial. Ann Oncol. 2013; 24(9):2402-2408.
  2. de Bono JS, Oudard S, Ozguroglu M, et al.; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010; 376(9747):1147-1154.
  3. Evans TL, Cho BC, Udud K, et al. Cabazitaxel versus topotecan in patients with small-cell lung cancer with progressive disease during or after first-line platinum-based chemotherapy. J Thorac Oncol. 2015; 10(8):1221-1228.
  4. Ghoochani A, Hatipoglu Majernik G, et al. Cabazitaxel operates anti-metastatic and cytotoxic via apoptosis induction and stalls brain tumor angiogenesis. Oncotarget. 2016; 7(21):38306-38318.
  5. Girard E, Ditzler S, Lee D, et al. Efficacy of cabazitaxel in mouse models of pediatric brain tumors. Neuro Oncol. 2015; 17(1):107-115.
  6. Kang YK, Ryoo BY, Yoon S, et al. A Phase I study of cabazitaxel in patients with advanced gastric cancer who have failed prior chemotherapy (GASTANA). Cancer Chemother Pharmacol. 2015; 75(2):309-318.
  7. Oudard S. TROPIC: Phase III trial of cabazitaxel for the treatment of metastatic castration-resistant prostate cancer. Future Oncol. 2011; 7(4):497-506.
  8. Rixe O, Puzanov I, LoRusso PM, et al. Phase I dose-escalation study of cabazitaxel administered in combination with gemcitabine in patients with metastatic or unresectable advanced solid malignancies. Anticancer Drugs. 2015; 26(7):785-792.
  9. Villanueva C, Awada A, Campone M, et al. A multicentre dose-escalating study of cabazitaxel (XRP6258) in combination with capecitabine in patients with metastatic breast cancer progressing after anthracycline and taxane treatment: a phase I/II study. Eur J Cancer. 2011; 47(7):1037-1045.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Urological Association (AUA). Castration-Resistant Prostate Cancer. Amended 2015. Available at: http://www.auanet.org/guidelines/castration-resistant-prostate-cancer-(2013-amended-2015). Accessed on August 24, 2017.
  2. Basch E, Loblaw DA, Oliver TK, et al. Systemic therapy in men with metastatic castration-resistant prostate cancer: American Society of Clinical Oncology and Cancer Care Ontario clinical practice guideline. J Clin Oncol. 2014; 32(30):3436-3448.
  3. Cabazitaxel. In: DrugPoints® System (electronic version). Truven Health Analytics. Greenwood Village, CO. Updated August 11, 2017. Available at: http://www.micromedexsolutions.com. Accessed on August 25, 2017.
  4. Cabazitaxel Monograph. Lexicomp® Online, American Hospital Formulary Service® (AHFS®) Online, Hudson, Ohio, Lexi-Comp., Inc. Last revised March 8, 2017. Accessed on August 25, 2017.
  5. Jevtana® (cabazitaxel) [Product Information], Bridgewater, NJ. Sanofi-Aventis U.S. LLC. September 2016. Available at: http://products.sanofi.us/jevtana/jevtana.html. Accessed on August 25, 2017.
  6. National Comprehensive Cancer Network®. NCCN Drugs & Biologic Compendium (electronic version). For additional information visit the NCCN website: http://www.nccn.org. Accessed on August 25, 2017.
  7. NCCN Clinical Practice Guidelines in Oncology®. © 2017 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on August 25, 2017.
    • Prostate Cancer (V.2.2017). Revised February 21, 2017.
Websites for Additional Information
  1. American Cancer Society. Key statistics for prostate cancer. Revised January 5, 2017. Available at: http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-key-statistics. Accessed on August 25, 2017.
  2. National Cancer Institute. What you need to know about prostate cancer. Last updated June, 2012. Available at: http://www.cancer.gov/cancerinfo/wyntk/prostate. Accessed on October 5, 2017.
Index

Cabazitaxel
Jevtana

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.

History

Status

Date

Action

New

11/02/2017

Medical Policy & Technology Assessment Committee (MPTAC) review. Initial document development.

New

11/01/2017

Hematology/Oncology Subcommittee review. Initial document development. Moved content of DRUG.00102 Cabazitaxel (Jevtana®) to new clinical utilization management guideline document with the same title.