rituximab Products
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This policy governs coverage and prior authorization rules for rituximab (Rituxan) and its biosimilars (Riabni, Truxima, Ruxience) for members of Blue Cross Blue Shield - Louisiana Medicare Advantage products.
No material clinical or coverage changes in this revision.
Coverage Criteria for Rituximab and Biosimilars
Coverage criteria
Coverage for rituximab and specific biosimilars is allowed when benefit and medical necessity criteria are met; preferred and non-preferred distinctions apply.
This is a required prior trial before coverage of Truxima or Ruxience unless contraindicated.
Use of rituximab-abbs (Truxima) or rituximab-pvvr (Ruxience) is considered not medically necessary when the patient selection criterion is not met. Specifically, these non-preferred biosimilars require prior trial and failure of the preferred rituximab products before they will be considered for coverage.
The Health Plan considers use of rituximab-abbs (Truxima) or rituximab-pvvr (Ruxience) not medically necessary when the documented patient selection requirement — trial and failure of both Rituxan and Riabni — has not been satisfied.
Initial Therapy Requirements
Initial therapy requirements for Truxima and Ruxience
Patient selection for non-preferred biosimilars
This functions as a step requirement prior to coverage of Truxima or Ruxience.
Step Therapy / Required Trials
| Step | Requirement | Duration/Threshold | Coverage status |
|---|---|---|---|
| 1 | Patient must trial and fail BOTH rituximab (Rituxan) and rituximab-arrx (Riabni) | At least TWO months on each product unless clinical evidence or patient history indicates likely ineffectiveness or adverse reaction | Coverage of rituximab-abbs (Truxima) or rituximab-pvvr (Ruxience) |
HCPCS, CPT, and Diagnosis Codes
Prior Authorization and Provider Requirements
Prior authorization required for all listed codes
All codes listed on this Medical Policy require prior authorization to ensure appropriate utilization and alignment with current clinical guidelines.
Require trials of Rituxan and Riabni before non‑preferred biosimilars
Coverage for rituximab-abbs (Truxima) and rituximab-pvvr (Ruxience) will be considered only after the patient has tried and failed BOTH rituximab (Rituxan) AND rituximab-arrx (Riabni) for at least two months each, unless clinical evidence or patient history indicates likely ineffectiveness or adverse reaction.
- Failure may include intolerance or inadequate response.
- Each preferred product must be used for at least two months prior to considering the biosimilar.
Provide prior‑plan authorization documentation for 90‑day transitions
When honoring a prior authorization from a previous health plan during a 90-day transition, documentation of the previous plan’s authorization for the ongoing course of treatment must be provided by the member or their provider.
- Services must otherwise be covered under the Blue Advantage health plan for the transition to apply.
- This applies to ongoing courses of treatment and is limited to a 90-day transition period.
Risk of denial if prior trials of preferred products are not documented
Use of rituximab-abbs (Truxima) or rituximab-pvvr (Ruxience) is considered not medically necessary when the required patient selection criterion (failure of both Rituxan and Riabni) is not met; requests lacking documented trials and failures of the preferred products risk denial.
- Denial risk applies if intolerance/inadequate response to both preferred products is not documented.
- Ensure chart documentation shows at least two months of therapy and evidence of failure for each preferred product when requesting coverage for Truxima or Ruxience.
Biosimilar Coverage Notes
Non-preferred biosimilars require prior failure of Rituxan and Riabni
Coverage for non-preferred biosimilars (Truxima, Ruxience) is allowed only after documented failure of both Rituxan and Riabni for at least two months each, unless there is clinical evidence or patient history indicating ineffectiveness or adverse reaction.
- Required trial duration: ≥ two months on each preferred product
- Failure criteria: intolerance or inadequate response
Document prior trials of Rituxan and Riabni before coverage
Requests for Truxima or Ruxience must document prior trials showing failure of both Rituxan and Riabni for at least two months each, unless contraindicated by clinical evidence or patient history.
- Document duration and reason for discontinuation (intolerance or inadequate response) for each prior product
Riabni eligible for coverage alongside Rituxan
Riabni (rituximab-arrx) is considered an eligible product for coverage alongside Rituxan as a preferred/covered option.
- Riabni is recognized as a biosimilar to Rituxan with no clinically meaningful differences
Infusion and Site-of-Care Considerations
Provide rituximab infusions in an infusion center
Infusion services for rituximab products are expected to be provided in an infusion center setting as indicated by the policy coding and site-of-care guidance.
- Site of care listed: infusion center
Definitions
Background
Rituximab is an anti-CD20 monoclonal antibody that targets CD20+ B-cells to reduce B-cell numbers in lymphomas and autoimmune diseases thought to be B-cell mediated. Biosimilars such as Riabni, Truxima, and Ruxience are biological products highly similar to the FDA-approved reference product (Rituxan) and are considered to have no clinically meaningful differences for labeled indications.
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