Currentmoda_health_plan_incPolicy N/A

Cabazitaxel (Jevtana®) intravenous therapy - Coverage Criteria

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Coverage and medical necessity criteria for intravenous cabazitaxel (Jevtana® and other cabazitaxel products) for use primarily in metastatic castration‑resistant prostate cancer and related indications; applies to Moda Health Plan Inc provider authorization and pharmacy/infusion billing. Affects providers requesting authorization for cabazitaxel.

Policy Summary

Payermoda_health_plan_inc

PolicyCabazitaxel (Jevtana®) intravenous therapy - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 24, 2025

Last ReviewJun 24, 2025

Next Review DateJun 1, 2025

Key ActionObtain prior authorization; initial approvals provided for 6 months and may be renewed when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum patient age for coverage

6 moinitial authorization length

60 unitsJevtana max

50 mgCabazitaxel max

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Currentmoda_health_plan_incPolicy N/A

Cabazitaxel (Jevtana®) intravenous therapy - Coverage Criteria

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Policy Summary

Payermoda_health_plan_inc

PolicyCabazitaxel (Jevtana®) intravenous therapy - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 24, 2025

Last ReviewJun 24, 2025

Next Review DateJun 1, 2025

Key ActionObtain prior authorization; initial approvals provided for 6 months and may be renewed when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum patient age for coverage

6 moinitial authorization length

60 unitsJevtana max

50 mgCabazitaxel max

4 codescovered ICD-10 codes

Coverage and Medical Necessity Criteria

Initial Approval Criteria

Covered when ALL of the following are met

Age: Patient is at least 18 years of age

Concomitant steroid: 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)total bilirubin <= 3x ULN

Prostate cancer specific

Single-agent use after docetaxel: Used as a single agent AND patient must have been previously treated with docetaxel unless not a candidate for or intolerant to docetaxel
Combination with carboplatin for aggressive variant: Used in combination with carboplatin for fit patients with aggressive variant disease or unfavorable genomics
Examples: visceral metastases, low PSA with bulky disease, high LDH, high CEA, lytic bone metastases, neuroendocrine prostate cancer histology, or defects in >=2 of PTEN, TP53, RB1
Sequencing with novel hormone therapy: Coverage allowed if disease progressed on prior docetaxel and patient has not received prior novel hormone therapy OR disease progressed on prior novel hormone therapy and patient has not received prior docetaxel OR disease progressed on prior docetaxel and prior novel hormone therapy

Renewal Criteria

Renewal criteria — coverage can be renewed when ALL are met

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

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

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

Applicability of CMS determinations

Medicare and non‑Medicare coverage interplay

Medicare compliance: For Medicare Part B beneficiaries, applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) govern coverage decisions and must be followed where applicable; use the CMS coverage database to search for NCD/LCD/LCA documents

Refer to the CMS coverage database link in the policy (https://www.cms.gov/medicare-coveragedatabase/search.aspx).

Uses not listed in the covered conditions have inadequate data to support efficacy and are therefore excluded from coverage. The policy lists alternative options that may be appropriate for patients when cabazitaxel is not covered, including radiation therapy, surgery, traditional chemotherapy (for example, platinum or taxane agents), compassionate use/expanded access programs, clinical trials, supportive care, and integrative or complementary therapies.

This policy applies to non‑Medicare coverage determinations. For Medicare Part B beneficiaries, applicable Medicare rules govern coverage: refer to the Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, §50 Drugs and Biologicals, and any relevant National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs). Compliance with those CMS determinations is required where applicable, and those Medicare determinations may supersede this policy. Use the CMS coverage database (https://www.cms.gov/medicare-coveragedatabase/search.aspx) to identify current NCD/LCD/LCA guidance.

Billing and Code References

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)

NDCsNDC

00024-5824-xx	Jevtana 60 mg/1.5mL solution for injection kit in a single-dose vial
00781-3186-xx	Cabazitaxel (Sandoz) 45 mg/4.5 mL solution for injection in a multiple-dose vial
00781-3193-xx	Cabazitaxel (Sandoz) 60 mg/6 mL solution for injection in a multiple-dose vial

Covered ICD-10 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

inv-09: Jevtana (J9043) billing — 60 billable units per 21 days

J9043 billing limit60 billable units per 21 days

Unit definitionHCPCS J9043: 1 billable unit = 1 mg (Jevtana only)

Measurement periodLimit applies per 21-day dosing cycle (q3w)

inv-10: Cabazitaxel (J9064) limit — 50 mg per 21 days

J9064 per-cycle limit50 mg per 21 days

Applies toCabazitaxel HCPCS J9064 (Sandoz/generic)

Provider Responsibilities and Authorization

Prior Authorization

Prior authorization required; 6‑month initial approval

Prior authorization is required for cabazitaxel (HCPCS J9043, J9064, and other applicable product codes). Initial approvals are issued for 6 months and may be renewed when renewal criteria are met.

Applicable codes: J9043, J9064, J9999

Prior Authorization

Follow Medicare NCD/LCD/LCA for Part B members

This policy governs non‑Medicare coverage determinations. For Medicare Part B beneficiaries, providers must follow applicable Medicare Benefit Policy Manual guidance and any relevant NCDs, LCDs, or LCAs when making coverage or billing decisions.

Refer to CMS coverage database for applicable NCD/LCD/LCA: https://www.cms.gov/medicare-coveragedatabase/search.aspx

Clinical Background

Cabazitaxel is an intravenous cytotoxic taxane chemotherapy used primarily to treat metastatic castration‑resistant prostate cancer (mCRPC), often after progression on docetaxel. It is administered intravenously every three weeks in the oncology infusion setting and is given in combination with an oral corticosteroid (for example, prednisone or dexamethasone). Dosing and regimen selection consider prior therapies, performance status, and organ function, particularly hepatic function.

Key Definitions and Universal Criteria

inv-20: Universal Criteria — Baseline requirements applicable across indications

Minimum agePatient is at least 18 years of age

Concomitant steroidMust be used in combination with an oral corticosteroid (eg, prednisone or dexamethasone)

Hepatic functionNo severe hepatic impairment (eg, total bilirubin ≤ 3× ULN)

Administration settingAdministered intravenously every 3 weeks (typical oncology infusion setting)

inv-21: C61 — Malignant neoplasm of prostate

ICD-10 codeC61

Description

Initial Dosing and Use Criteria

Continuation and Renewal Criteria

Prior Treatment and Sequencing

Step	Requirement / Rule	Notes
1
Prior treatment with docetaxel is required unless the patient is not a candidate or is intolerant to docetaxel.
Alternative sequencing relative to novel hormone therapies is allowed per the policy (coverage permitted whether disease progressed on prior docetaxel and not received novel hormone therapy, progressed on prior novel hormone therapy and not received docetaxel, or progressed on both).

Step	Requirement / Rule	Notes / Evidence
1
No explicit additional step therapy sequencing rules are mandated in the policy text beyond the docetaxel prerequisite; the document cites clinical trials and literature to support therapeutic positioning.
References cited include randomized and phase trials (eg, de Wit et al. NEJM 2019; Corn et al. Lancet Oncol. 2019) and other literature supporting use and sequencing decisions.

Quantity and Billing Limits

inv-29: Jevtana (J9043) — 60

Jevtana (J9043) max units60 billable units per 21 days

Typical dose guidanceJevtana dosing: 20–25 mg/m² IV every 3 weeks with an oral corticosteroid

Billing implicationLimit corresponds to HCPCS billing (1 unit = 1 mg) for the 21-day treatment cycle

inv-30: Cabazitaxel (J9064) — 50 mg

Cabazitaxel (J9064) max per cycle50 mg per 21 days

Typical dose guidanceGeneric cabazitaxel dosing option: 20 mg/m² IV every 3 weeks with an oral corticosteroid

Billing implication

Administration Setting

Note

IV administration q3w with concomitant oral corticosteroid

Cabazitaxel is administered intravenously every 3 weeks in combination with an oral corticosteroid; administration is performed in an outpatient oncology infusion setting and should follow standard infusion billing and clinical protocols.

Typical dosing schedule: IV every 3 weeks with concomitant oral corticosteroid (eg, prednisone or dexamethasone).

Billing Rule

Medicare Part B outpatient coverage and billing guidance

For Medicare Part B outpatient infusions, follow Medicare Benefit Policy Manual Chapter 15 §50 and any applicable NCD/LCD/LCA guidance for coverage and claims payment; non‑Medicare site‑of‑care and billing is governed by this policy.

Medicare coverage search: https://www.cms.gov/medicare-coveragedatabase/search.aspx

Policy Summary

Payermoda_health_plan_inc

PolicyCabazitaxel (Jevtana®) intravenous therapy - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 24, 2025

Last ReviewJun 24, 2025

Next Review DateJun 1, 2025

Key ActionObtain prior authorization; initial approvals provided for 6 months and may be renewed when criteria are met.

SourceLink

On This Page

Limit applies per 21-day dosing cycle (q3w)

Step Therapy

Require prior docetaxel unless not candidate/intolerant

For metastatic castration‑resistant prostate cancer used as a single agent, the patient must have been previously treated with docetaxel unless the patient is not a candidate for or is intolerant to docetaxel. Sequencing rules relative to novel hormone therapies are described in the prostate cancer criteria.

Allowed sequencing: progressed on docetaxel and no prior novel hormone therapy; OR progressed on novel hormone therapy and no prior docetaxel; OR progressed on both prior docetaxel and prior novel hormone therapy.

Note

References cited — no additional step therapy rules

The policy cites clinical trials and literature to support therapeutic positioning for cabazitaxel (see references), but the document does not impose additional explicit step therapy sequencing beyond the prostate cancer prerequisite described elsewhere.

References include randomized trials and phase 1–2 studies (e.g., de Wit et al., Corn et al.).

Documentation Required

Renewal requires evidence of continued benefit and tolerability

For renewal requests, submit documentation demonstrating the patient continues to meet universal and indication‑specific criteria, shows evidence of treatment benefit (no disease progression, tumor size improvement, and/or symptom improvement), and is tolerating therapy without unacceptable toxicity.

Unacceptable toxicity examples: severe bone marrow suppression, severe hypersensitivity, severe GI adverse reactions, renal failure, hepatic impairment, respiratory disorders.

Documentation Required

Submit one of the Appendix 1 ICD‑10 diagnosis codes

Provide a diagnosis that corresponds to one of the covered ICD‑10 codes listed in Appendix 1 (for example: C61, C7A.1, C7A.8, or Z85.46) when submitting authorization and claims.

Appendix 1 covered codes: C61; C7A.1; C7A.8; Z85.46.

Denial Risk

Uses not listed are excluded and may be denied

Any use of cabazitaxel that is not listed in the policy’s coverage section is considered excluded from coverage and may be denied; alternative treatment options or clinical trial participation may be appropriate.

Excluded uses have inadequate data to support efficacy per the policy.

Denial Risk

Noncompliance with applicable Medicare determinations may affect coverage

For Medicare members, failure to follow applicable CMS determinations (NCDs/LCDs/LCAs and Medicare Benefit Policy Manual guidance) may lead to modified coverage or denial; always verify applicable Medicare coverage documents for outpatient Part B drugs.

Medicare Part B coverage is governed by CMS manuals and any applicable NCD/LCD/LCA; check CMS coverage database prior to authorization/billing.

Malignant neoplasm of prostate

Use noteListed as a covered diagnosis in Appendix 1

inv-22: C7A.1 — Malignant poorly differentiated neuroendocrine tumors

ICD-10 codeC7A.1

DescriptionMalignant poorly differentiated neuroendocrine tumors

Use noteIncluded among covered diagnoses in Appendix 1

inv-23: C7A.8 — Other malignant neuroendocrine tumors

ICD-10 codeC7A.8

DescriptionOther malignant neuroendocrine tumors

Use noteIncluded among covered diagnoses in Appendix 1

inv-24: Z85.46 — Personal history of malignant neoplasm of prostate

ICD-10 codeZ85.46

DescriptionPersonal history of malignant neoplasm of prostate

Use noteListed in Appendix 1 (may be used for relevant history coding)

Limit applies to HCPCS J9064 billing over the 21-day (q3w) cycle