Palonosetron: Aloxi®; Posfrea™ (Intravenous) — Coverage Criteria
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Defines prior authorization, dosing limits, and medical necessity criteria for intravenous palonosetron products (Aloxi and Posfrea) for prevention of chemotherapy-induced nausea and vomiting (CINV) and post-operative nausea and vomiting (PONV). Applies to eocco payer benefit administration.
No material clinical or coverage changes in this revision.
Coverage Criteria — Indications and Limits
inv-01: CINV (Adults) — Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Adults; covered when ALL criteria are met
Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Adults — Covered when ALL of the following are met
Failure defined in policy
inv-02: CINV (Pediatrics) — Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Pediatric Members; covered when ALL criteria are met
Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Pediatric Members — Covered when ALL of the following are met
inv-03: PONV (Adults) — Prevention of Post-Operative Nausea and Vomiting (PONV) in Adults; covered when ALL criteria are met
Prevention of Post-Operative Nausea and Vomiting (PONV) in Adults — Covered when ALL of the following are met
Refer to dosage/administration for timing and dose
Palonosetron is NOT covered for breakthrough emesis when used for prevention of chemotherapy‑induced nausea and vomiting (CINV) in adults and pediatric members. This exclusion applies to both the adult CINV criteria and the pediatric CINV criteria described in the policy and means palonosetron will not be authorized for treatment of breakthrough emesis in these settings.
Initial Therapy Prerequisites
inv-23: Initial therapy prerequisites — Initial approval conditions for Posfrea
Initial approval conditions for Posfrea
Failure for step requirement defined as two or more documented episodes of vomiting attributed to the current chemotherapy regimen
Renewal / Continuation Criteria
inv-24: Renewal Criteria — Renewal requirements for continued coverage
Renewal requirements
Refer to Section I for duration limits
Coding: HCPCS, NDCs, ICD-10, and Billing Limits
| 69639-103-xx | Aloxi 0.25 mg/5 mL solution for injection in a single-dose vial: 69639-103-xx |
| 83831-0105-xx | Posfrea 0.25 mg/5 mL solution for injection in a single-dose vial: 83831-0105-xx |
| 83831-0104-xx | Posfrea 0.075 mg/1.5 mL solution for injection in a single-dose vial: 83831-0104-xx |
| R11.0 | Nausea |
| R11.10 | Vomiting, unspecified |
| R11.11 | Vomiting without nausea |
| R11.12 | Projectile vomiting |
| R11.2 | Nausea with vomiting, unspecified |
| T41.0X5A | Adverse effect of inhaled anesthetics, initial encounter |
| T41.1X5A | Adverse effect of intravenous anesthetics, initial encounter |
| T41.205A | Adverse effect of unspecified general anesthetics, initial encounter |
| T41.295A | Adverse effect of other general anesthetics, initial encounter |
| T41.45XA | Adverse effect of unspecified anesthetic, initial encounter |
| T45.1X5A | Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter |
| T45.1X5D | Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter |
| T45.1X5S | Adverse effect of antineoplastic and immunosuppressive drugs, sequela |
| T45.95XA | Adverse effect of unspecified primarily systemic and hematological agent , initial encounter |
| T45.95XD | Adverse effect of unspecified primarily systemic and hematological agent, subsequent encounter |
| T45.95XS | Adverse effect of unspecified primarily systemic and hematological agent, sequela |
| T50.905A | Adverse effect of unspecified drugs, medicaments and biological substances, initial encounter |
| T50.905D | Adverse effect of unspecified drugs, medicaments and biological substances, subsequent encounter |
| T50.905S | Adverse effect of unspecified drugs, medicaments and biological substances, sequela |
Prior Authorization, Documentation, and Step Therapy
Prior authorization required for Posfrea (J2468)
Prior authorization is required for Posfrea (HCPCS J2468). Initial prior authorization is generally granted for 6 months (180 days); for PONV the PA is valid for a single dose and is not renewable. Aloxi (generic J2469) does not require prior authorization and is managed via pre-payment claims edits for diagnosis and maximum units.
- Initial PA validity: 6 months (180 days)
- PONV: PA provided for 1 dose and may NOT be renewed
- Aloxi (J2469) is exempt from PA; reviewed via pre-payment claims edits
PA may be applied based on NQTL findings
The policy's NQTL checklist documents that the drug indication and the cost of the drug were considered when designing and applying prior authorization and utilization management for this product.
- NQTL checklist: Indication considered for PA
- NQTL checklist: Cost of drug considered for PA
Prior trial with Aloxi required before Posfrea
Approval of Posfrea requires a prior trial and inadequate response, contraindication, or intolerance to Aloxi before Posfrea will be authorized.
- Patient must try Aloxi and have inadequate response, contraindication, or intolerance prior to Posfrea approval
No other explicit step therapy requirements specified
The document does not impose additional or separate step therapy requirements beyond the specified Aloxi prerequisite for Posfrea; no other explicit step therapy sequences are stated.
Renewal requires documentation of continued benefit and safety
Renewal (continued authorization) requires documentation that the member continues to meet the indication-specific criteria, that the duration of authorization has not been exceeded, that there is a documented beneficial response (reduction in nausea and/or vomiting), and that there is absence of unacceptable toxicity.
- Member continues to meet indication-specific criteria (including concomitant therapy requirements)
- Duration of authorization has not been exceeded (see Section I)
- Documented beneficial response (reduction in nausea/vomiting)
- No unacceptable toxicity (e.g., serotonin syndrome, severe hypersensitivity)
Document a covered Appendix 1 ICD-10 diagnosis
When requesting coverage, providers must document a covered diagnosis from Appendix 1; clinical documentation should support one of the ICD-10 codes listed (e.g., R11.0, R11.10, T41.x, T45.x, Z51.11, Z51.12).
- Submit documentation supporting one of the Appendix 1 ICD-10 codes
- Examples include R11.0 (Nausea), R11.10 (Vomiting, unspecified), T41.x and T45.x series, Z51.11/Z51.12
Prior trial requirement: Aloxi trial needed before Posfrea
Prior authorization for Posfrea is only granted after a prior trial with Aloxi demonstrating inadequate response, intolerance, or contraindication; Aloxi (J2469) itself does not require prior authorization and may be used as the prerequisite.
- Aloxi (J2469) may be used as the required prior agent and is exempt from PA
- Posfrea approval requires inadequate response, contraindication, or intolerance to Aloxi
PA consideration due to drug cost and NQTLs
The NQTL factor checklist indicates that prior authorization was considered because of the drug's cost and that utilization management NQTLs are applied comparably across benefits; providers should anticipate PA requirements consistent with those considerations.
- NQTL conclusion: Cost of drug = consider for PA
- Utilization management NQTLs applied comparably across MH/SUD and M/S benefits
Quantity Limits and Billing Units
Step Therapy Requirements
| Step | Requirement | Notes |
|---|---|---|
| 1 | Trial and inadequate response, contraindication, or intolerance to Aloxi (palonosetron, J2469) prior to approval of Posfrea (J2468) | Aloxi (generic J2469) does not require prior authorization and is reviewed via pre-payment claims edits for diagnosis and maximum units; failure is defined as two or more documented episodes of vomiting attributed to the current chemotherapy regimen |
Definitions and Product Designations
Site of Care and Medicare Part B Considerations
No site-of-care restriction for infusion center specified
This policy does not specify any site-of-care restriction for infusion center administration in the sections provided.
Medicare Part B outpatient coverage/NCD-LCD-LCA considerations — consult CMS guidance
For hospital outpatient claims and Medicare Part B, Medicare coverage rules and any applicable NCDs/LCDs/LCAs may apply; providers should consult CMS guidance when billing Medicare Part B outpatient drugs.
- Refer to Medicare Benefit Policy Manual and CMS coverage database for applicable NCD/LCD/LCA guidance.
Background and Clinical Context
Palonosetron is a 5‑HT3 receptor antagonist indicated for prevention of chemotherapy‑induced nausea and vomiting (CINV) and for prevention of post‑operative nausea and vomiting (PONV). The policy references palonosetron (Aloxi, Posfrea, and multi‑sourced generics) in the context of these antiemetic indications and aligns dosing and use with the labeled CINV and PONV guidance.
Product and Regulatory Notes
Aloxi (palonosetron): 505(b)(2) products not rated therapeutically equivalent
Aloxi (palonosetron) and designated 505(b)(2) products are available from multiple manufacturers but are not rated therapeutically equivalent in the FDA Orange Book; they are considered single-source products under the statutory definition.
- Designated 505(b)(2) NDA products may be listed separately and are not rated therapeutically equivalent to the reference product.
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