CurrentCareSourcePolicy N/A

Oncology (Injectable) Aliqopa Utilization Management Medical Policy

Defines prior authorization and medical necessity criteria for Aliqopa (copanlisib) intravenous infusion for relapsed follicular lymphoma and certain marginal zone lymphomas; affects providers seeking medical benefit coverage from CareSource.

Policy Summary

PayerCareSource

PolicyOncology (Injectable) Aliqopa Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeClarifiedRevisedRemoved

Effective DateN/A

Next Review DateSep 4, 2024

Key ActionSubmit prior authorization with documentation that the patient is ≥18, is currently receiving Aliqopa, has the required prior systemic therapies, and the drug is prescribed by or in consultation with an oncologist.

SourceLink

POLICY UPDATE CHANGES

Added requirement that the patient is currently receiving Aliqopa for follicular lymphoma and marginal zone lymphoma approvals.

NCCN no longer recommends Aliqopa for relapsed/refractory follicular lymphoma and multiple marginal zone lymphoma subtypes.

New drug application for Aliqopa withdrawn by the FDA; manufacturer voluntarily withdrew product from U.S. market.

1 yeartypical authorization duration

60 mg IV x3/28dapproved dosing

Current userequires current use

Withdrawn

Policy Summary

PayerCareSource

PolicyOncology (Injectable) Aliqopa Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeClarifiedRevisedRemoved

Effective DateN/A

Next Review DateSep 4, 2024

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage and Medical Necessity Criteria

FDA-Approved Indication — Follicular Lymphoma

Covered when ALL of the following are met for FDA-approved indication (Follicular Lymphoma):

Follicular Lymphoma approval: A) Patient is ≥ 18 years of age; AND B) Patient is currently receiving Aliqopa; AND C) Patient has received > 2 prior systemic therapies (examples: bendamustine, cyclophosphamide, doxorubicin, vincristine, rituximab products, obinutuzumab); AND D) Aliqopa is prescribed by or in consultation with an oncologist.

Approve for 1 year; dosing: up to 60 mg IV administered up to three times per 28-day cycle.

Other Uses with Supportive Evidence — Marginal Zone Lymphoma

Covered when ALL of the following are met for Other Uses with Supportive Evidence (Marginal Zone Lymphoma):

Marginal Zone Lymphoma approval: A) Patient is > 18 years of age; AND B) Patient is currently receiving Aliqopa; AND C) Patient has received ≥ 2 prior systemic therapies (examples: bendamustine, cyclophosphamide, doxorubicin, vincristine, rituximab products, obinutuzumab); AND D) Aliqopa is prescribed by or in consultation with an oncologist.

Includes extranodal (gastric and nongastric), nodal, and splenic marginal zone lymphoma; Approve for 1 year; dosing: up to 60 mg IV administered up to three times per 28-day cycle.

Coverage is limited to the situations explicitly described in the Recommended Authorization Criteria. Requests that do not meet those criteria are not recommended for coverage. The criteria will be reviewed and updated as new published evidence becomes available; the policy’s review cadence is documented in the policy metadata and the clinical team will incorporate substantive practice-changing data when identified.

Following the manufacturer’s voluntary market withdrawal and the FDA’s withdrawal of the New Drug Application, initiation of Aliqopa in new patients is discouraged. Operationally, the policy focuses approvals on patients who are already receiving Aliqopa and who meet the documented eligibility and dosing criteria; clinicians should avoid starting new patients on Aliqopa pending further regulatory or clinical guidance.

Dosing and Authorized Regimens

Regimen	Indication	Dosing	Coverage
Copanlisib (Aliqopa) 60 mg IV	Continuation therapy for patients currently receiving Aliqopa for: • Relapsed follicular lymphoma (grade 1–2) when patient is ≥18 years and has received >2 prior systemic therapies; • Marginal zone lymphoma (extranodal, nodal, splenic) when patient is ≥18 years and has received ≥2 prior systemic therapies	Up to 60 mg administered intravenously up to three times in each 28‑day cycle	Covered (approve for 1 year) when all policy criteria are met, including current use, required number of prior systemic therapies, and prescription by or in consultation with an oncologist

Drug and Billing Codes

Referenced drug identifierNDC

NDC	Aliqopa (copanlisib) injection (policy references 60 mg per vial)

Prior systemic therapies — required prior lines

Follicular lymphoma> 2 prior systemic therapies required (patient must have received > 2 prior systemic therapies).

Marginal zone lymphoma≥ 2 prior systemic therapies required (patient must have received ≥ 2 prior systemic therapies).

Examples of systemic therapiesExamples include bendamustine, cyclophosphamide, doxorubicin, vincristine, rituximab (Rituxan and biosimilars), obinutuzumab (Gazyva).

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior Authorization is required for medical benefit coverage of Aliqopa. Approvals will be granted only for members who meet the criteria and dosing specified for the listed indications. Approvals are provided for the duration noted in the criteria and may be extended if the patient continues to meet those criteria. Requests for doses outside the established dosing in this policy will be reviewed on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist). Aliqopa must be prescribed by or in consultation with an oncologist due to the specialized evaluation and monitoring required.

Automation: None.

Step Therapy

Prior Therapies Requirement

For approval, documentation must show the patient meets the prior therapies requirement for the requested indication. For follicular lymphoma, the patient must have received > 2 prior systemic therapies. For marginal zone lymphoma (including extranodal gastric, extranodal nongastric, nodal, and splenic marginal zone lymphoma), the patient must have received ≥ 2 prior systemic therapies. Examples of systemic therapies include bendamustine, cyclophosphamide, doxorubicin, vincristine, rituximab (Rituxan and biosimilars), and obinutuzumab (Gazyva) intravenous infusion. Approvals are for 1 year when criteria are met.

Line of Therapy Requirements

second-line_or_later

Line of therapy: Patient must have received >2 prior systemic therapies for follicular lymphoma; marginal zone lymphoma requires ≥2 prior systemic therapies.

Examples of systemic therapies include bendamustine, cyclophosphamide, doxorubicin, vincristine, rituximab products, and obinutuzumab.

Definitions and Drug Identifier

Aliqopa (copanlisib) — product definition and status

ProductAliqopa (copanlisib), an intravenous kinase inhibitor formerly indicated for relapsed follicular lymphoma in adults.

Regulatory/market statusManufacturer voluntarily withdrew Aliqopa from the U.S. market (Bayer announcement Nov 13, 2023); FDA withdrew the New Drug Application on March 18, 2024.

Guideline contextNCCN no longer recommends Aliqopa for relapsed/refractory follicular lymphoma and multiple marginal zone lymphoma subtypes.

Operational impactManufacturer recommended that no new patients be started; approvals focused on patients currently receiving Aliqopa and meeting policy criteria.

Background and Clinical Context

Aliqopa (copanlisib) is an intravenous kinase inhibitor that was indicated for adults with relapsed follicular lymphoma after prior systemic therapies. Bayer announced a voluntary withdrawal of the product from the U.S. market after trials failed to confirm clinical benefit and the FDA subsequently withdrew the NDA. In addition, the National Comprehensive Cancer Network no longer recommends Aliqopa for relapsed/refractory follicular lymphoma or for several marginal zone lymphoma subtypes. The policy therefore limits routine initiation and centers authorization on patients currently receiving the drug who meet the policy’s prior-therapy and prescriber requirements.