Oncology (Injectable) - Aliqopa Utilization Management Medical Policy
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Defines prior authorization criteria, coverage conditions, dosing limits, and prescribing requirements for Aliqopa (copanlisib) for UCare plans, with specifics for follicular lymphoma and marginal zone lymphoma and guidance for patients currently receiving therapy.
Policy notes that Aliqopa was voluntarily withdrawn from the U.S. market and the NDA was withdrawn by the FDA.
Recommended Authorization Criteria
Initial Therapy - Follicular Lymphoma (FDA)
Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):
Dosing: Approve up to 60 mg administered intravenously up to three times in each 28-day cycle.
Other Uses with Supportive Evidence - Marginal Zone Lymphoma
Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):
Includes extranodal (gastric and nongastric), nodal, and splenic marginal zone lymphoma. Dosing: Approve up to 60 mg administered intravenously up to three times in each 28-day cycle.
Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Criteria will be updated as new published data become available.
The NCCN B‑Cell Lymphomas (v2.2025) guidance no longer recommends Aliqopa for relapsed/refractory follicular lymphoma (grade 1–2) and for multiple marginal zone lymphoma subtypes, including extranodal gastric, extranodal nongastric, splenic, and nodal marginal zone lymphoma.
Prescriber and Authorization Requirements
Prior Authorization Recommended
Prior Authorization is recommended for medical benefit coverage of Aliqopa. Approval is recommended for patients who meet the stated Criteria and Dosing for the listed indications. Because of the specialized skills required for evaluation and diagnosis of patients treated with Aliqopa, approval requires Aliqopa to be prescribed by or in consultation with a physician who specializes in the condition being treated. All approvals are provided for the duration noted in the policy; requests for doses outside the established dosing will be reviewed case-by-case by a clinician.
- Prior authorization recommended for medical benefit coverage
- Approval recommended for patients meeting Criteria and Dosing
- Prescriber requirement: must be prescribed by or in consultation with a specialist
Prior Therapy Requirement
Coverage requires that the patient has received more than two prior systemic therapies. Examples of systemic therapies include bendamustine, cyclophosphamide, doxorubicin, vincristine, rituximab products (e.g., Rituxan, biosimilars), and Gazyva (obinutuzumab IV). This prior therapy requirement applies to the approved indications (e.g., follicular lymphoma and marginal zone lymphoma) as specified in the policy.
- Requirement: > 2 prior systemic therapies
- Examples: bendamustine; cyclophosphamide; doxorubicin; vincristine; rituximab products (Rituxan, biosimilars); obinutuzumab (Gazyva)
Prescriber and Dosing Documentation
Approval requires documentation that Aliqopa is prescribed by or in consultation with a physician who specializes in the condition being treated (for example, an oncologist). Requests should include documentation of the prescriber, specialty or consultation note, and the planned dosing (e.g., up to 60 mg IV administered up to three times in each 28-day cycle where applicable).
- Document prescriber specialty or consultation (e.g., oncologist)
- Provide dosing documentation (e.g., up to 60 mg IV up to three times per 28-day cycle when applicable)
Denial Triggers
Requests that do not meet the Recommended Authorization Criteria (including age, current receipt of Aliqopa, prior therapy requirement, and prescriber/consultation requirement) are not recommended for coverage. Criteria will be updated as new published data are available.
- Denial trigger: does not meet all elements of the Recommended Authorization Criteria
- Criteria updates: may change with new published data
Dosing, Frequency, and Authorization Duration
| Regimen | Indication / Notes | Authorization Duration | Coverage Status |
|---|---|---|---|
| Copanlisib (Aliqopa) 60 mg IV | Continuing patients currently receiving Aliqopa who meet prior therapy and prescriber criteria (follicular lymphoma); dosing: up to three times per 28-day cycle | 1 year | Covered when criteria met |
| Copanlisib (Aliqopa) 60 mg IV | Continuing patients currently receiving Aliqopa who meet prior therapy and prescriber criteria (marginal zone lymphoma — includes extranodal gastric, extranodal nongastric, nodal, and splenic) | 1 year | Covered when criteria met |
Salvage / Prior Therapy Requirements
salvage
Examples of systemic therapies are provided in policy.
Terminology and Examples
Clinical and Regulatory Background
Copanlisib (Aliqopa) is a kinase inhibitor indicated for relapsed follicular lymphoma in adults who have received at least two prior systemic therapies. Bayer voluntarily withdrew Aliqopa from the U.S. market after failure to confirm clinical benefit in a confirmatory trial and the NDA was withdrawn by the FDA; professional guidelines no longer recommend Aliqopa for several indolent B‑cell lymphomas.
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