CurrentCentenePolicy CP.PHAR.316

Cabazitaxel (Jevtana)

Defines medical necessity criteria, authorization requirements, dosing, and coverage boundaries for cabazitaxel (Jevtana) for treatment of metastatic castration-resistant prostate cancer and related indications for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyCabazitaxel (Jevtana)

Policy CodePolicy CP.PHAR.316

Change TypeNo material change

Effective Date03.01.17

Next Review Date

Key ActionPrior authorization required with documentation supporting that the member meets all approval criteria; approvals are issued for specified durations (typically 6 months initial).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9043, J9064HCPCS codes referenced

6 monthsinitial approval duration

25 mg/m2max dose frequency

20 mg/m2listed dosing regimen

Commercial addedcoverage population change

inv-01: Initial Approval — Prostate Cancer

Jevtana is medically necessary when ALL of the following are met:

Operational note: Prescribed regimen must be FDA-approved or recommended by NCCN.

inv-02: Continuation/Renewal — Prostate Cancer

For ongoing therapy, ALL of the following must be met:

Continuation Criteria

Member is currently receiving Jevtana via the Centene benefit or documentation supports the member has received Jevtana for a covered indication for at least 30 days.
Member is responding positively to therapy (clinical benefit).
Jevtana is prescribed concurrently with a corticosteroid.
Member continues to use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy.
ALL of the following
- Dose increase A: New dose does not exceed 25 mg/m2 once every 3 weeks.
- Dose increase B: New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Operational note: Prescribed regimen must be FDA-approved or recommended by NCCN.

inv-03: Coverage criteria referenced in policy history

Policy history notes and alignment with NCCN inform criteria (details in other sections):

Bypass prior docetaxel: Bypass of the prior docetaxel requirement is allowed if the member is not a candidate for or is intolerant of docetaxel per NCCN; an additional bypass was added for members with small cell/neuroendocrine prostate cancer per the NCCN Compendium.

Documented in policy history updates.

Androgen deprivation requirement: Member will use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy.

Added per NCCN alignment and policy updates.

Non–FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (see CP.CPA.09 for Commercial, CP.PMN.53 for Medicaid, and HIM.PA.154 for Health Insurance Marketplace) or other applicable evidence of coverage documents.

The policy was updated to reflect that pregnancy was removed from the contraindications per the cabazitaxel prescribing information; this prior explicit exclusion is no longer listed as a contraindication in the policy.

Uses of cabazitaxel for non‑FDA approved indications that lack sufficient supporting documentation (per the off‑label use policies referenced above) are considered not authorized and are not covered under this policy.

Any lists of procedure or billing codes in this clinical policy are provided for informational purposes only. Inclusion or exclusion of codes does not guarantee coverage; claims must be coded in a manner consistent with this policy and current professional coding guidance and may be denied if inconsistent.

Provider Requirements, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Providers must submit documentation (office chart notes, laboratory results, or other clinical information) supporting that the member meets all approval criteria. Requests may be denied if documentation is not provided to demonstrate the member meets policy requirements.

Prior authorization approvals are typically issued for specified durations (see Approval duration: HIM/Medicaid 6 months; Commercial 6 months or to the member's renewal date, whichever is longer).
Providers should include evidence of prior therapies, treatment intent, dosing, and any supporting literature for off‑label dosing.
Inadequate or missing documentation is a common denial trigger.

Documentation Required

Documentation and Coverage Governance

Providers must follow applicable Health Plan coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract), state and federal requirements, and Health Plan-level administrative policies and procedures when submitting requests. Inclusion or exclusion of codes in this policy does not guarantee coverage; providers should reference current coding guidance prior to claim submission.

Submit clinical notes demonstrating metastatic CRPC and prior therapies (or documentation supporting a bypass — see step therapy bypass below).
Attach relevant lab results (e.g., ANC, liver function tests) to show contraindications are absent.
When requesting off-label dosing, prescribers must submit supporting practice guidelines or peer‑reviewed literature.

Step Therapy

Preferred Alternatives / Step Therapy

Step-therapy preference: docetaxel-containing regimens are listed as preferred alternatives and are required prior to approval of cabazitaxel except when bypass conditions apply. Refer to Appendix B for therapeutic alternatives and dosing regimens.

Preferred alternative: docetaxel 75 mg/m2 for up to 6 cycles (per Appendix B).
Prior authorization may be required for the preferred alternative agents depending on line of business.

Step Therapy

Bypass of Prior Docetaxel in Specific Situations

The policy allows bypassing the prior docetaxel requirement in specified circumstances. Providers must document the rationale for bypass in the medical record.

Bypass is permitted when the member is not a candidate for or is intolerant of docetaxel — clinical justification and supporting documentation required.
Bypass is permitted for members with small cell/neuroendocrine prostate cancer (off‑label) — prescriber must document diagnosis and reference supporting NCCN Compendium guidance.
When bypassing prior docetaxel, include documentation of attempted therapies, adverse reactions, or clinical reasons why docetaxel is contraindicated or not feasible.

Definitions and Clinical Terms

inv-22: Castration-resistant prostate cancer (CRPC)

Definition of CRPCProstate cancer that progresses clinically, radiographically, or biochemically despite castrate levels of serum testosterone (evidenced by disease progression despite bilateral orchiectomy or other androgen deprivation therapy)

Androgen deprivation should continueAndrogen deprivation therapy should be continued in the setting of CRPC while additional therapies are applied (examples in Appendix D)

FDA indication contextJevtana is indicated in combination with prednisone for treatment of metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen

inv-23: Concurrent use of a GnRH analog or prior bilateral orchiectomy

Ongoing androgen suppression requirementMember will use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy

Examples of androgen deprivationExamples include bilateral orchiectomy; LHRH agonists (goserelin, leuprolide, triptorelin); LHRH antagonists (degarelix, relugolix); and anti-androgens (bicalutamide, flutamide, nilutamide, enzalutamide, apalutamide, darolutamide)

Policy history noteRequirement for concurrent GnRH analog or prior bilateral orchiectomy was added per NCCN alignment in 2Q 2022 policy update

OpenPayer

Cabazitaxel (Jevtana)

Coverage Criteria for Cabazitaxel (Jevtana)

Coding and Dosing Limits

Provider Requirements, Authorization, and Documentation

Background on Cabazitaxel (Jevtana)

Definitions and Clinical Terms