CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Drug Policy: Jevtana (cabazitaxel) — coverage criteria

Defines accepted indications, authorization criteria, exclusions, and review requirements for Jevtana (cabazitaxel) for members of Neighborhood Health Plan of Rhode Island processed via New Century Health (NCH). Applies to providers requesting coverage for cabazitaxel.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Jevtana (cabazitaxel) — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 27, 2023

Next Review DateN/A

Key ActionSubmit prior authorization requests through New Century Health and include supporting documentation per FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

11committee review dates listed

20 mg/m2single-dose maximum cited

FDA/CMS/NCCNsupporting sources required

M1 CRPCcovered indication

Coverage Criteria for Jevtana (cabazitaxel)

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Prostate cancer indication: Member has a diagnosis of castration‑resistant distant metastatic (M1) prostate cancer and has experienced disease progression on docetaxel therapy.

Concomitant ADT: Jevtana (cabazitaxel) will be administered in combination with a steroid plus LHRH analog or in a patient with prior orchiectomy (androgen deprivation therapy).

Supporting evidence: Use is supported by FDA product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature per CMS requirements.

The policy excludes coverage when any of the following apply: disease progression while on Jevtana (cabazitaxel); dosing that exceeds the single-dose limit of 20 mg/m2; or use that is investigational or an off-label indication without sufficient supporting evidence as defined by CMS-recognized compendia or acceptable peer-reviewed literature.

Off-label indications will be considered not supported — and therefore not covered — when the available evidence fails to meet the policy’s sufficiency criteria. Specific shortcomings include inadequate representation of the patient or cancer characteristics in published evidence; the regimen administered in practice not being adequately represented by the studied therapy; reported outcomes that are not clinically meaningful (for example, lack of a hazard ratio <0.80 or survival benefit of at least 3 months as recommended by ASCO); inappropriate experimental design for the question; reliance solely on uncontrolled case reports; or use of meeting abstracts without a full peer-reviewed article.

Provider Actions, Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization and Continuation Rules

Prior authorization required. New Century Health (NCH) processes all medication requests from network ordering providers; medications not authorized by NCH may be deemed not approvable and not reimbursable. Continuation requests for a medication that would otherwise be not approvable are exempt from this NCH policy if ALL of the following are met: the requested medication was used within the last year; the member has not experienced disease progression and/or no intolerance to the requested medication; and no additional medication(s) are being added to the continuation request.

All requests must be submitted to New Century Health for review.
Continuation exemption requires use within last 12 months, no disease progression or intolerance, and no addition of other medications.

Prior Authorization

Prostate Cancer — Prerequisite Therapy

For prostate cancer, coverage requires that the member has castration‑resistant, distant metastatic (M1) disease and has experienced disease progression on prior docetaxel therapy. Jevtana (cabazitaxel) must be administered in combination with a steroid and with androgen deprivation therapy (either an LHRH analog or orchiectomy) to maintain castrate levels of testosterone.

Indication restricted to castration‑resistant metastatic (M1) prostate cancer with progression on docetaxel.
Must be given with a steroid and concurrent ADT (LHRH analog or orchiectomy).

Documentation Required

Supporting Documentation Requirements

Use of Jevtana (cabazitaxel) must be supported by one of the following: FDA‑approved product labeling; CMS‑recognized compendia; National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines; or peer‑reviewed literature that meets CMS criteria. Documentation submitted with requests should reference the supporting source(s).

Acceptable supporting sources: FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.
Clinical rationale and citations should be included with the prior authorization request.

Denial Risk

Denial Triggers and Exclusion Criteria

Denial considerations include: evidence of disease progression while on cabazitaxel; dosing that exceeds the single‑dose limit of 20 mg/m2; investigational use or off‑label indications lacking sufficient supporting evidence (not supported by CMS compendia or acceptable peer‑reviewed literature). Insufficient evidence may include lack of appropriate patient population representation, regimen mismatch, absence of clinically meaningful outcomes, reliance on uncontrolled case reports or meeting abstracts without full peer‑reviewed publication, or other methodological limitations.

Do not exceed a single dose of 20 mg/m2.
Requests for investigational or unsupported off‑label uses may be denied if evidence does not meet CMS/peer‑review thresholds.

Background

Cabazitaxel (Jevtana) is an antineoplastic taxane agent used in prostate cancer management. In this policy the drug is addressed primarily for treatment of castration-resistant metastatic (M1) prostate cancer after progression on docetaxel. Clinical and authorization guidance in the policy references trial and post-marketing data to define dosing, benefit considerations, and required combination with androgen-deprivation therapy.

Definitions

Castration-resistant metastatic (M1) disease — definition

DefinitionProstate cancer that progresses despite androgen deprivation therapy and has distant metastatic spread (castration-resistant metastatic, M1)

Coverage contextMember must have castration-resistant distant metastatic (M1) disease and have experienced disease progression on docetaxel therapy

ADT requirementJevtana must be used in combination with a steroid plus LHRH analog or in patients with prior orchiectomy (as ADT)

Initial Therapy Authorization Criteria

Initial therapy — structured initial authorization criteria for Jevtana

Initial authorization criteria

Diagnosis and prior therapy: Member has castration‑resistant distant metastatic (M1) prostate cancer and has experienced disease progression on docetaxel therapy.

Combination therapy requirement: Cabazitaxel will be administered with a steroid and LHRH analog or in a patient with prior orchiectomy (ADT).

Documentation requirement: Request is supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature as required by the CMS Medicare Benefit Policy Manual Chapter 15.

Provide citations or compendia/guideline references with the request.

Continuation Therapy Criteria

Continuation therapy exemption — criteria and conditions for ongoing authorization

Continuation requests

Continuation criteria: The requested medication was used within the last year AND the member has not experienced disease progression or intolerance AND no additional medications are being added to the continuation request.

Continuation requests meeting these conditions may be exempt from additional NCH prior authorization requirements.

Step Therapy Requirements

Step	Requirement	Failure criteria / notes
1
Prior docetaxel therapy required: Member must have castration-resistant distant metastatic (M1) prostate cancer and have experienced disease progression on prior docetaxel therapy.
Failure criteria: Progression on prior docetaxel (i.e., therapy requirement met by documented progression despite prior docetaxel). Cabazitaxel must be given with a steroid plus LHRH analog or in patients with prior orchiectomy (ADT).