mhn Jevtana (cabazitaxel) Coverage Update

Coverage and Medical Necessity Criteria

Initial Therapy (Prostate Cancer)

Covered when ALL of the following are met (Initial Approval for Prostate Cancer):

Initial Approval - Prostate Cancer: 1) Diagnosis of metastatic castration‑resistant prostate cancer (CRPC) with disease progression despite bilateral orchiectomy or other androgen‑deprivation therapy; 2) Prescribed by or in consultation with an oncologist or urologist; 3) Age ≥ 18 years; 4) Previously treated with a docetaxel‑containing regimen unless member is not a candidate for or is intolerant of docetaxel, or has small cell/neuroendocrine prostate cancer (off‑label); 5) At time of request, member has no contraindications: a) absolute neutrophil count > 1,500/mm3, b) no severe hepatic impairment (total bilirubin ≤ 3 × ULN), and no history of severe hypersensitivity to cabazitaxel/polysorbate 80; 6) Jevtana is prescribed concurrently with a corticosteroid; 7) Member will use a gonadotropin‑releasing hormone (GnRH) analog concurrently or has had bilateral orchiectomy; 8) Requested dose does not exceed 25 mg/m2 every 3 weeks OR the dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Continuation Therapy (Prostate Cancer)

Continuation/Renewal Criteria (Prostate Cancer) - Covered when ALL of the following are met:

Continuation Therapy - Prostate Cancer: 1) Member is currently receiving Jevtana via the Centene benefit or documentation shows member has received Jevtana for at least 30 days for a covered indication; 2) Member is responding positively to therapy; 3) Jevtana is prescribed concurrently with a corticosteroid; 4) Member continues use of a GnRH analog concurrently or has had a bilateral orchiectomy; 5) If a dose increase is requested, the new dose does not exceed 25 mg/m2 every 3 weeks OR is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

Authorization Criteria Updates

Policy coverage includes NCCN‑aligned bypasses and concurrent therapy requirements.

Prostate cancer-specific requirement: Member will use a gonadotropin‑releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy.

Added per NCCN alignment and 2Q 2022 update.

Non–FDA approved uses of cabazitaxel described in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), CP.PMN.53 (Medicaid), or HIM.PA.154 (Marketplace), or unless coverage is otherwise defined in the member’s evidence of coverage. Requests for off‑label indications must include the clinical evidence and rationale referenced by those policies to be considered.

Coverage under this clinical policy is governed by the terms and conditions of the member’s benefit documents and by applicable state and federal law. This policy is a guide to medical necessity and does not constitute a contract or guarantee of payment. Final coverage decisions and benefit administration remain subject to the member’s evidence of coverage, certificate of coverage, policy or contract, and any Health Plan administrative rules.

When cabazitaxel is requested for indications not approved by the FDA and not specifically addressed by this policy, the request will only be considered with adequate supporting documentation per the payer’s off‑label use policies. Providers must submit relevant clinical evidence, peer‑reviewed literature, or guideline support as required by CP.CPA.09, CP.PMN.53, or HIM.PA.154 to demonstrate the agent’s safety and effectiveness for the requested off‑label use.

The lists of procedure and billing codes included in this policy are provided for informational purposes only. Inclusion or exclusion of any code does not guarantee coverage or reimbursement. Providers should consult current professional coding guidance and the member’s benefit rules when submitting claims; claim adjudication may deny payment if the service does not meet applicable medical‑necessity or coding requirements.

Billing and Code References

HCPCS CodesHCPCS

J9043	Injection, cabazitaxel, 1 mg
J9064	Injection, cabazitaxel (sandoz), not therapeutically equivalent to J9043, 1 mg

Covered HCPCS CodesHCPCSCovered

J9043

Injection, cabazitaxel, 1 mg

Covered HCPCS Codes (added)HCPCSCovered

J9064

Injection, cabazitaxel (sandoz), not therapeutically equivalent to J9043, 1 mg

Absolute neutrophil count (ANC) contraindication

ANC thresholdAbsolute neutrophil count (ANC) ≤ 1,500/mm3 is a contraindication to cabazitaxel at time of request.

Related contraindicationsSevere hepatic impairment (total bilirubin > 3× ULN) is also listed as a contraindication.

Clinical implicationVerify recent neutrophil count prior to approving therapy; requests may be denied if ANC ≤ 1,500/mm3.

Product strengths availability and changes

Current available strengths (examples)Product listings have included 60 mg/1.5 mL, 60 mg/6 mL, and 45 mg/4.5 mL concentrations at various reviews.

Prior Authorization, Documentation, and Denial Risk

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all applicable approval criteria, including diagnosis of metastatic castration‑resistant prostate cancer (CRPC) and progression despite androgen deprivation therapy when applicable. Requests should document prior treatment with a docetaxel‑containing regimen prior to cabazitaxel (Jevtana) unless an allowed bypass applies.

Prior authorization required — provider must document metastatic CRPC and progression on ADT when applicable.
Required documentation includes office chart notes, lab results, and other clinical information supporting all approval criteria.

Prior Authorization

Prior Authorization Updates and NCCN Alignment

Prior authorization criteria have been updated to allow bypassing the prior‑docetaxel requirement when the member is not a candidate for or is intolerant of docetaxel per NCCN, and to allow bypass for members with small cell/neuroendocrine prostate cancer per NCCN Compendium. Policy also continues to require that cabazitaxel be prescribed with corticosteroid and that members use a GnRH analog concurrently or have had a bilateral orchiectomy per NCCN alignment.

Clinical Background

Cabazitaxel (Jevtana) is a microtubule inhibitor indicated, in combination with prednisone, for the treatment of patients with metastatic castration‑resistant prostate cancer (CRPC) previously treated with a docetaxel‑containing regimen. CRPC denotes prostate cancer that progresses clinically, radiographically, or biochemically despite castrate levels of serum testosterone; androgen‑deprivation therapy should generally be continued while applying additional therapies. Cabazitaxel is dosed and monitored per the policy dosing limits and contraindications, and clinicians should be familiar with its antineoplastic mechanism and the requirement to manage hematologic and hepatic risk factors before and during therapy.

Terms and Clinical Definitions

Castration-resistant prostate cancer (CRPC)

DefinitionCastration-resistant prostate cancer (CRPC): prostate cancer that progresses clinically, radiographically, or biochemically despite castrate levels of serum testosterone (<50 ng/dL).

Treatment contextAndrogen-deprivation therapy should be continued in the setting of CRPC while additional therapies are applied.

Indication noteCabazitaxel (Jevtana) is indicated in combination with prednisone for metastatic CRPC previously treated with a docetaxel-containing regimen.

Androgen deprivation therapy (examples and policy note)

Examples of ADT per NCCNBilateral orchiectomy (surgical castration) and LHRH approaches (agonists such as goserelin, leuprolide, triptorelin).

Additional ADT agents

Initial Therapy Requirements and Exceptions

Initial Therapy

Initial therapy criteria for castration‑resistant prostate cancer (CRPC):

Initial (CRPC): Refer to Initial Approval - Prostate Cancer: metastatic CRPC, prescribed by/with oncologist or urologist, age ≥18, prior docetaxel required unless not a candidate/intolerant or small cell/neuroendocrine exception, no contraindications as listed, Jevtana given with corticosteroid, concurrent GnRH or prior orchiectomy, dosing per policy (20 mg/m2 IV q3 weeks typical; maximum 25 mg/m2 q3 weeks unless guideline‑supported).

Initial Therapy Bypass Rules

Initial therapy requirements updated to allow specified bypasses in alignment with NCCN:

Docetaxel bypass: Member may bypass prior use of a docetaxel‑containing regimen if the member is not a candidate for or is intolerant of docetaxel per NCCN; an additional bypass is allowed for small cell/neuroendocrine prostate cancer (off‑label).

Added in 2Q 2021 and retained in subsequent updates.

Renewal and Ongoing Therapy Criteria

Continuation Therapy

Renewal/continuation requires evidence of benefit and continuation of required concurrent therapies:

Continuation: Member must be currently receiving Jevtana via the benefit or have received it for ≥30 days, demonstrate clinical benefit/response, continue corticosteroid therapy, continue GnRH analog or have had bilateral orchiectomy, and any requested dose increase must meet the policy maximum (≤25 mg/m2 q3 weeks) or be supported by guidelines/literature with prescriber evidence.

Continuation Therapy Notes

Continuation must remain consistent with NCCN guidance and prior authorization requirements.

Ongoing use and documentation: Continued therapy must align with NCCN recommendations (including concurrent steroid use and GnRH/orchiectomy requirements) and prior authorizations; providers must submit supporting documentation of continued benefit when requested.

Continuation nodes reference prior authorization and NCCN alignment from policy updates.

Step Therapy / Prior Treatment Requirements

Step	Requirement	Exceptions / Notes
1	Prior treatment with a docetaxel-containing regimen is required before Jevtana (cabazitaxel).	Exceptions allowed when member is not a candidate for or is intolerant of docetaxel, or for small cell/neuroendocrine prostate cancer (off‑label).

Coverage Label	Policy Position	Supporting Criteria
Prior docetaxel generally required	Prior use of a docetaxel-containing regimen is generally required before approving Jevtana unless bypass criteria are met.	Bypass permitted if member is not a candidate for or is intolerant of docetaxel per NCCN; additional bypass for small cell/neuroendocrine prostate cancer. Concurrent corticosteroid and GnRH/orchiectomy requirements remain applicable.

Dosing and Quantity Limits

Cabazitaxel dosing regimen and policy limits

Standard dosing (CRPC)20 mg/m2 IV every 3 weeks is the dosing regimen listed for CRPC (common approved starting dose).

Maximum per policyPolicy allows up to 25 mg/m2 IV every 3 weeks when criteria are met (dose must not exceed 25 mg/m2 or must be supported by guidelines/literature).

Approval conditionDose increases above 25 mg/m2 require supporting evidence from practice guidelines or peer-reviewed literature submitted by prescriber.

Site of Care and Infusion

Note

Site of care not specified in this policy section

Site of care is not specified in this portion of the policy; the policy does not define an infusion center requirement here.

OpenPayer

Clinical Policy: Cabazitaxel (Jevtana)