CurrentViva HealthPolicy IC-0074

Cabazitaxel (Jevtana) — Coverage Criteria

This policy governs coverage criteria, dosing, authorization length, and billing codes for cabazitaxel (Jevtana and specified alternatives) for Viva Health members, focused on metastatic castration-resistant prostate cancer and related neuroendocrine variants.

Policy Summary

PayerViva Health

PolicyCabazitaxel (Jevtana) — Coverage Criteria

Policy CodePolicy IC-0074

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization for cabazitaxel; initial approval is provided for 6 months when age, universal, and indication-specific criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsLength of initial authorization

J9043, J9064, J9999HCPCS codes listed

20-25 mg/m2Jevtana dosing

≥18Minimum patient age

Coverage Criteria

Initial Approval Criteria

Policy Summary

PayerViva Health

PolicyCabazitaxel (Jevtana) — Coverage Criteria

Policy CodePolicy IC-0074

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization for cabazitaxel; initial approval is provided for 6 months when age, universal, and indication-specific criteria are met.

SourceLink

On This Page

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Age: Patient is at least 18 years of age

Universal concomitant therapy: Must be used in combination with a steroid (e.g., prednisone or dexamethasone)

Hepatic function: Patient does not have severe hepatic impairment (e.g., total bilirubin > 3 times the upper limit of normal)

Indication - Prostate cancer (single agent or with carboplatin)

Single-agent use: Used as a single agent; patient must have been previously treated with docetaxel unless not a candidate for or intolerant to docetaxel
FDA approved indication
Combination with carboplatin: Used in combination with carboplatin for fit patients with aggressive variant disease or unfavorable genomics (defects in at least two of PTEN, TP53, RB1)
Compendia recommended indication

Prior therapy sequencing

Scenario 1: Disease has progressed on prior docetaxel and patient has not received prior novel hormone therapy
Scenario 2: Disease has progressed on prior novel hormone therapy and patient has not received prior docetaxel
Scenario 3: Disease has progressed on prior docetaxel and prior novel hormone therapy

Castration-resistant metastatic small cell/neuroendocrine disease: Patient has castration-resistant metastatic small cell/neuroendocrine prostate cancer and the drug is used in combination with carboplatin for fit patients with aggressive variant disease or unfavorable genomics (defects in at least two of PTEN, TP53, RB1)

Renewal Criteria

Renewal covered when ALL of the following are met

Continued eligibility: Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements and performance status (excluding prerequisite therapy)

Disease response defined by lack of disease progression, improvement in tumor size and/or improvement in patient symptoms

Toxicity: Absence of unacceptable toxicity from the drug (examples include bone marrow suppression, severe hypersensitivity, severe gastrointestinal adverse reactions, severe urinary disorders, renal failure, hepatic impairment, respiratory disorders, etc.)

During renewal evaluation, coverage may be denied if the patient no longer demonstrates clinical benefit or tolerability. Renewal is contingent on continued meeting of criteria and, if there is disease progression, unacceptable toxicity (for example severe bone marrow suppression, severe hypersensitivity, severe gastrointestinal events, renal or hepatic failure, or serious respiratory disorders), or failure to meet the policy’s specified renewal criteria, the use of cabazitaxel may be considered not medically necessary.

Regimen	Dose & Schedule	Administration Notes	Indication / Use
Jevtana (cabazitaxel)	20–25 mg/m² IV every 3 weeks	Give in combination with an oral corticosteroid (e.g., prednisone or dexamethasone)	Single‑agent use for metastatic castration‑resistant prostate cancer; follow prior‑therapy sequencing requirements (typically post‑docetaxel unless docetaxel‑ineligible)
Cabazitaxel (Sandoz)	20 mg/m² IV every 3 weeks	Give in combination with an oral corticosteroid (e.g., prednisone or dexamethasone)	Alternative cabazitaxel product; used as single agent for mCRPC or in combination with carboplatin for fit patients with aggressive variant disease or unfavorable genomics

Coding and Billing

HCPCS CodesHCPCS

J9043	Injection, cabazitaxel, 1 mg; 1 billable unit = 1 mg (Jevtana ONLY)
J9064	Injection, cabazitaxel (sandoz), not therapeutically equivalent to J9043, 1 mg; 1 billable unit = 1 mg
J9999	Not otherwise classified, antineoplastic drugs (Applicable to other unclassified 505(b)(2) NDA for cabazitaxel not otherwise listed)

Covered Diagnosis CodesICD-10Covered

C61	Malignant neoplasm of prostate
C7A.1	Malignant poorly differentiated neuroendocrine tumors
C7A.8	Other malignant neuroendocrine tumors
Z85.46	Personal history of malignant neoplasm of prostate

Max units per 21 days

J9043 (Jevtana)60 units (60 mg) per 21 days

J9064 (Cabazitaxel, Sandoz)50 units (50 mg) per 21 days

Provider Actions and Requirements

Prior Authorization

Prior authorization required; initial approval 6 months

Prior authorization is required for cabazitaxel. Initial approval will be provided for 6 months when the patient meets age, universal, and indication-specific criteria.

Initial authorization length: 6 months

Step Therapy

Prerequisite: prior docetaxel for single-agent use

For single-agent use, the patient must have been previously treated with docetaxel unless the patient is not a candidate for or is intolerant to docetaxel.

Documentation Required

Required documentation for authorization and renewal

Document the patient's age (≥18) and continued fulfillment of universal criteria (including concomitant steroid use and absence of severe hepatic impairment), indication-specific criteria, prior docetaxel status or reason for ineligibility, evidence of disease response, and absence of unacceptable toxicity for renewal.

Age ≥18 documented
Concomitant steroid use (e.g., prednisone or dexamethasone) documented
No severe hepatic impairment (e.g., total bilirubin ≤ 3x ULN) documented
Indication-specific criteria and prior docetaxel status or reason for ineligibility
Evidence of disease response and no unacceptable toxicity

Denial Risk

Renewal denial triggers: progression, toxicity, or failure to meet criteria

Renewal may be denied if the patient demonstrates disease progression, has unacceptable toxicity, or no longer meets universal and indication-specific criteria.

Examples of unacceptable toxicity include bone marrow suppression, severe hypersensitivity, severe GI adverse reactions, renal or hepatic failure, and severe respiratory disorders

Definitions

Aggressive variant disease — criteria summary

DefinitionAggressive variant prostate cancer includes visceral metastases, low PSA with bulky disease, high LDH, high CEA, lytic bone metastases, or neuroendocrine prostate cancer histology.

Genomic featuresMay be associated with unfavorable genomics (defects in at least two of PTEN, TP53, RB1).

Treatment implicationOften considered for combination therapy with carboplatin in fit patients.

Severe hepatic impairment — example

Example thresholdTotal bilirubin > 3 times the upper limit of normal (example of severe hepatic impairment)

Clinical implicationSevere hepatic impairment is an exclusion for use of cabazitaxel.

AssessmentEvaluate baseline hepatic function prior to initiation and on renewal as needed.

Background

Cabazitaxel (Jevtana) is an intravenous antineoplastic agent used for metastatic castration‑resistant prostate cancer, including neuroendocrine/small cell variants and aggressive variant disease. It is administered every 3 weeks in combination with an oral corticosteroid (for example prednisone or dexamethasone). Dosing, expected concomitant steroid use, and monitoring for hepatic function and treatment toxicity are specified in the policy, and renewal requires evidence of disease response and acceptable tolerability.

OpenPayer