Subject:
Cabazitaxel (Jevtana)
Description:
_______________________________________________________________________________________
IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
__________________________________________________________________________________________________________________________
Prostate cancer is an adenocarcinoma that occurs in the prostate, a gland in the male reproductive system that produces the seminal fluid that nourishes and transports sperm. Prostate cancer is one of the most common cancers in the world. In the United States, 11% of men will develop prostate cancer at some point; the incidence of prostate cancer increases with age. In 2019, an estimated 174,650 men will be diagnosed with prostate cancer in the US, accounting for nearly 20% of new cancer diagnoses among US men. Moreover, approximately 31,620 men are expected to die from this cancer in 2019. The median age of diagnosis is 67 years of age. Prostate cancer usually grows slowly, initially localized to the gland itself. While early disease stages may remain largely asymptomatic, with disease progression patients may experience trouble urinating, decreased force in urination stream, blood in urine or semen, discomfort in the pelvic region, and possibly systemic bone pain.
Screening for and diagnosis of the disease may include digital rectal exam and measuring of Prostate-Specific Antigen (PSA). Prognosis is dependent on patient age, disease stage, and comorbid conditions. If diagnosed when involvement is limited to the gland itself, disease may be curable and median survival is in excess of 5 years. Metastatic advanced disease is usually not curable, however, survival can be as long as 5 years. Overall median survival is 1 to 3 years with advanced disease. Treatment is dependent on disease stage. Non-metastatic disease is often treated by watchful waiting, followed by escalation to radiotherapy with or without hormonal therapy (LHRH, orchiectomy, anti-androgens, or biologics) or radical prostatectomy with or without hormonal therapy. Advanced disease may be treated with hormonal therapy or chemotherapy.
Jevtana® (cabazitaxel) is a microtubule inhibitor approved by the FDA in combination with prednisone for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. Cabazitaxel binds to tubulin to promote the assembly of microtubules while simultaneously inhibiting disassembly leading to the stabilization of microtubules and the inhibition of mitotic and interphase cellular activities. The drug is administered as a one hour intravenous infusion every three weeks in combination with oral prednisone 10 mg daily throughout treatment cycle. Dosing is based on body surface area (BSA) at 25 mg/m2. Treatment cycles should be delayed and the dose decreased to 20 mg/m2 if patients experience grade 3 or greater neutropenia for one week or longer despite G-CSF therapy, febrile neutropenia, or grade 3 or greater diarrhea. The therapy should be discontinued if experience grade ≥3 peripheral neuropathy or continue to experience above symptoms even at the dose of 20mg/m2. It is also required that patients receive premedication with a H2 antagonist, an antihistamine, and a corticosteroid at least 30 minutes prior to each therapy.
The efficacy and safety of Jevtana® (cabazitaxel) in combination with prednisone were evaluated in a randomized, open-label, international, multi-center study in patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. Seven hundred fifty-five patients aged 18 years or older were randomized to either cabazitaxel 25 mg/m2 IV every three weeks for up to 10 cycles with prednisone 10 mg orally daily or to mitoxantrone 12 mg/m2 IV every three weeks for up to 10 cycles with prednisone 10 mg orally daily. Median survival (months) in the cabazitaxel arm was 15.1 (95% CI 14.1-16.3) vs 12.7 (11.6-13.7) in the mitoxantrone arm (p<0.0001). Deaths due to causes other than disease progression were reported in 18 (5%) cabazitaxel patients; four of these deaths were infection-related, with other fatal adverse reactions such as ventricular fibrillation, cerebral hemorrhage, and dyspnea occurring. The most common (>10%) grade 1-4 adverse reactions were anemia, leukopenia, neutropenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysguesia, cough, arthralgia, and alopecia.
[INFORMATIONAL NOTE: Jevtana (cabazitaxel) packaging includes the following BOXED WARNINGS:
Neutropenic deaths have been reported. In order to monitor the occurrence of neutropenia, frequent blood cell counts should be performed on all patients receiving Jevtana (cabazitaxel). Jevtana (cabazitaxel) should not be given to patients with neutrophil counts of <1,500 cells/mm3. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.
Severe hypersensitivity can occur and may include generalized rash/erythema, hypotension and bronchospasm. Discontinue Jevtana (cabazitaxel) immediately if severe reactions occur and administer appropriate therapy. Contraindicated if history of severe hypersensitivity reactions to Jevtana (cabazitaxel) or to drugs formulated with polysorbate 80.]
Policy:
(Note: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
The requirements of the Horizon BCBSNJ Cabazitaxel (Jevtana) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).
1. The prescriber is a specialist in the area of the patient’s diagnosis (e.g. oncologist) or has consulted with a specialist in the area of the patient’s diagnosis
2. Jevtana (cabazitaxel) is medically necessary for adult members with hormone-refractory metastatic prostate cancer if the following are met:
- The member failed a prior docetaxel-containing regimen; and
- Jevtana (cabazitaxel) is prescribed concomitantly with daily prednisone or dexamethasone on the day of chemotherapy and
- Member has an ECOG performance score of 0-2 and
- Jevtana (cabazitaxel) is not being used with other chemotherapy agents (including but no limited to Zytiga, Xtandi, etc.)
3. Jevtana (cabazitaxel) is not considered medically necessary in patients with the following contraindications or warnings/precautions:
- Neutrophil count ≤ 1,500/mm3
- Severe hepatic impairment (Total Bilirubin >3 × ULN)
- Hypersensitivity to Jevtana (cabazitaxel) or polysorbate 80
- Pregnancy
4. When Jevanta (cabazitaxel) is considered medically necessary, initial therapy will be eligible at the following FDA approved doses for a period of 6 months:
- 20 mg/m2 IV infusion administered as a one-hour intravenous infusion every three weeks in combination with oral prednisone 10 mg administered daily throughout Jevtana (cabazitaxel) treatment OR
- 25 mg/m2 IV infusion every three weeks with oral prednisone 10 mg daily for entire treatment duration (can be used in select patients at the discretion of the treating healthcare provider)
- Patients at a 20 mg/m2 IV infusion dose who require dose reduction should decrease dosage to 15 mg/m2. Patients at a 25 mg/m2 IV infusion dose who require dose reduction should decrease dosage to 20 mg/m2, one additional dose reduction to 15 mg/m2 may be considered.
[INFORMATIONAL NOTE: Premedicate at least 30 minutes prior to each dose of Jevtana (cabazitaxel)with the following intravenous medications to reduce the risk and/or severity of hypersensitivity antihistamine (dexchlorpheniramine 5 mg, or diphenhydramine 25 mg or equivalent antihistamine),corticosteroid (dexamethasone 8 mg or equivalent steroid),H2 antagonist (ranitidine 50 mg or equivalent H2 antagonist).]
| Recommended Dose Modifications for Adverse Reactions in Patients Treated with Jevtana as per the FDA package insert. |
Toxicity | Dosage Modification |
| Prolonged grade ≥3 neutropenia (greater than 1 week) despite appropriate medication including granulocyte-colony stimulating factor (G-CSF) | Delay treatment until neutrophil count is >1,500 cells/mm3, then reduce dosage of Jevtana by one dose level. Use G-CSF for secondary prophylaxis. |
| Febrile neutropenia or neutropenic infection | Delay treatment until improvement or resolution, and until neutrophil count is >1,500 cells/mm3, then reduce dosage of Jevtana by one dose level. Use G-CSF for secondary prophylaxis. |
| Grade ≥3 diarrhea or persisting diarrhea despite appropriate medication, fluid and electrolytes replacement | Delay treatment until improvement or resolution, then reduce dosage of Jevtana by one dose level. |
| Grade 2 peripheral neuropathy | Delay treatment until improvement or resolution, then reduce dosage of Jevtana by one dose level. |
| Grade ≥3 peripheral neuropathy | Discontinue Jevtana |
5. Continued therapy will be considered annually if
- Member continues to meet initial review criteria; AND
- Disease response as defined by lack of disease progression, improvement in tumor size and/or improvement in patient symptoms; AND
- Absence of unacceptable toxicity from the drug (e.g.: Neutropenia, severe nausea/vomiting/diarrhea, renal impairment, hepatic impairment).
6. Jevanta (cabazitaxel) is considered medically necessary for off-label indications that have in effect a rating of 'Category 1' or 'Category 2A' in the current recommendations in the National Comprehensive Cancer Network (NCCN) compendium. Refer to National Comprehensive Cancer Network: Drugs and Biologics Compendium - cabazitaxel. Available at: [https://www.nccn.org/professionals/drug_compendium/content/]
7. Other uses of Jevtana (cabazitaxel) are considered investigational; including but not limited to:
- Non-Small Cell Lung Cancer
- Solid Tumor
- Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium
- Malignant Glioma
- HER2-Positive and Negative Metastatic Breast Cancer
- Advanced Solid Tumors
- Gastroesophogeal Adenocarcinoma
- Transitional Cell Carcinoma
- Advanced or Metastatic Gastric Cancer
- Refractory Ovarian Cancer
.
- Dedifferentiated Liposarcoma
- Testicular Cancer
- Colorectal Cancer
- Malignant Nervous System Neoplasm
- Advanced Adrenocortical Carcinoma
- Small Cell Lung Cancer
Medicare Coverage
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ medical policy.
Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
________________________________________________________________________________________
Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
___________________________________________________________________________________________________________________________
Index:
Cabazitaxel (Jevtana)
Jevtana (Cabazitaxel)
Prostate Cancer, Cabazitaxel (Jevtana) for
References:
1. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Prostate Cancer. Version. 4.2019. Accessed 17 December 2019.
2. National Cancer Institute: Prostate Cancer. [Available at http://www.cancer.gov/cancertopics/types/prostate (accessed on 12/5/2017).]
3. Jevtana (cabazitaxel) [Prescribing Information]Sanofi-aventis. Bridgewater, NJ. January 2018.
4. Altekruse SF, Kosary CL, Krapcho M, Neyman N, Aminou R, Waldron W, Ruhl J, Howlader N, Tatalovich Z, Cho H, Mariotto A, Eisner MP, Lewis DR, Cronin K, Chen HS, Feuer EJ, Stinchcomb DG, Edwards BK (eds). SEER Cancer Statistics Review, 1975-2007, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2007/, based on November 2009 SEER data submission, posted to the SEER web site, 2010.
5. National Institutes of Health. Clinical Trials Database. Available at Clinicaltrials.Gov, 2019, https://clinicaltrials.gov/ct2/results/details?term=jevtana Accessed 17 Dec 2019.
6. National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium. Jevtana. Accessed 7 January 2020.
7. Clinicaltrials.gov. XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer (TROPIC). NCT00417079. Available at: https://clinicaltrials.gov/ct2/show/NCT00417079
8. Clinicaltrials.gov. Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer (PROSELICA). NCT01308580. Available at: https://clinicaltrials.gov/ct2/show/NCT01308580
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
_________________________________________________________________________________________
Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
____________________________________________________________________________________________________________________________ |