ModifiedCentenePolicy CP PHAR.357

Copanlisib (Aliqopa)

Coverage and medical necessity criteria for copanlisib (Aliqopa) for treatment of relapsed follicular lymphoma and other B-cell lymphomas for Centene lines of business.

Policy Summary

PayerCentene

PolicyCopanlisib (Aliqopa)

Policy CodePolicy CP PHAR.357

Change TypeManufacturer withdrawalinitial criteria removed

Effective DateDec 1, 2017

Next Review Date

Key ActionPrior authorization required; initial authorization for new starts is not permitted — requests for continued therapy must show member is currently receiving Aliqopa and has received it for at least 30 days.

SourceLink

POLICY UPDATE CHANGES

Initial approval criteria were removed due to manufacturer withdrawal.

Appendix D describing Bayer's voluntary withdrawal of the Aliqopa application and withdrawal of approval as of March 18, 2024.

Commercial line of business approval duration revised to '6 months or duration of request, whichever is less.'

60 mgsingle-dose vial / per-dose maximum

2024-03-18approval withdrawn

J9057HCPCS

6 monthscommercial approval duration

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Coverage Criteria

Initial Approval Criteria

Initial Approval — Initial therapy is not authorized.

Authorization is not permitted. Member may not initiate therapy with Aliqopa. If member is currently using Aliqopa proceed to Continued Therapy criteria (see Appendix D).
Reference: Manufacturer voluntary withdrawal (see Appendix D) — no new patients should be prescribed Aliqopa; approval withdrawn as of March 18, 2024.

Continued Therapy

Continued Therapy — Covered for continuation only when ALL of the following are met:

Follicular and Other B-Cell Lymphomas

Member is currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Aliqopa for a covered indication and has received this medication for at least 30 days.
Indication: Follicular and Other B-Cell Lymphomas (member must meet all subcriteria).
ALL of the following
- Member is responding positively to therapy.
- New dose does not exceed 60 mg (1 vial) per week for 3 out of 4 weeks.
ANY of the following
- If request is for a dose increase, the new dose is supported by practice guidelines or peer-reviewed literature for the indication.
- Prescribed regimen must be FDA‑approved or recommended by NCCN.
Approval duration: Medicaid/HIM — 12 months; Commercial — 6 months or duration of request, whichever is less.

Initial/Continuation Criteria (removed)

Initial/Continuation Criteria (removed) — No active clinical criteria in this excerpt.

Initial approval criteria were removed after manufacturer withdrawal of the new drug application; see Appendix D for market withdrawal details and guidance for patients currently receiving therapy.

Non‑FDA approved indications, which are not addressed in this policy, require sufficient documentation of efficacy and safety according to the off‑label use policy CP CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or other evidence of coverage documents.

Bayer announced voluntary withdrawal of its new drug application for Aliqopa (November 13, 2023) and stated no new patients should be prescribed Aliqopa. Bayer is exploring access options for patients currently receiving Aliqopa with a favorable response whose treating physician supports continued treatment and for whom no suitable alternative exists. See Appendix D for full details.

For Medicaid members, when state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence. Refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.

Initial Therapy Criteria

Initial Therapy Prohibition

Initial use restriction

Initial use prohibition: Authorization for initiation of Aliqopa is not permitted. No new patients should be prescribed Aliqopa following Bayer's announcement; see Appendix D for details on market withdrawal and access options for current patients.

If member is currently receiving Aliqopa, consider continuation criteria.

Continuation Therapy Criteria

Continuation Therapy

Criteria to continue Aliqopa for current users

Continuation: 1. Member is currently receiving Aliqopa with at least 30 days of therapy; 2. Member is responding to therapy; 3. Dose does not exceed 60 mg per week for 3 of 4 weeks; 4. Any dose increase must be supported by practice guidelines or peer-reviewed literature and the prescribed regimen must be FDA-approved or NCCN-recommended.

Approval durations: Medicaid/HIM 12 months; Commercial 6 months or duration of request, whichever is less.

Coding

HCPCS CodesHCPCS

J9057

Injection, copanlisib; _ mg

HCPCS CodesHCPCS

J9057

Injection, copanlisib; _ mg

Maximum dose per week — inv-11: Maximum dose per week

Maximum dose per week60 mg (1 vial) per week for 3 out of 4 weeks (60 mg IV on Days 1, 8, and 15 of a 28-day cycle; 3 weeks on/1 week off)

Per-dose vial sizeSingle-dose vial: 60 mg

Dosing schedule referenceIntermittent schedule: Days 1, 8, and 15 of a 28-day treatment cycle

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorization for new starts is not permitted — members may not initiate therapy with Aliqopa/Copanlisib. Requests for continued therapy are considered only when documentation shows the member is currently receiving the medication through the Centene benefit or has received it for at least 30 days. Provider must submit supporting documentation (office chart notes, lab results, or other clinical information) demonstrating that the member meets all applicable approval criteria.

Initial authorization for new starts is not permitted; initial approvals removed following manufacturer withdrawal (see Appendix D).
Continued therapy requests require documentation that member is currently receiving the drug and has received it for ≥30 days.
Providers must submit office notes, lab results, or other clinical evidence to support that approval criteria are met.

Denial Risk

Coverage & Coding Limits / Triggers for Denial

Step Therapy / Therapeutic Alternatives

Therapeutic setting	Example first-line options	Example second-line / subsequent options	Notes / reference
Follicular lymphoma	Bendamustine + obinutuzumab (Gazyva) or rituximab; CHOP + obinutuzumab or rituximab; CVP + obinutuzumab or rituximab; single‑agent rituximab	Lenalidomide (Revlimid) + rituximab; single‑agent examples such as rituximab; other systemic regimens per treating clinician	Appendix B lists therapeutic alternatives and sequencing; examples drawn from follicular lymphoma section.
Marginal zone lymphoma	Bendamustine + rituximab; bendamustine + obinutuzumab; R‑CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone); R‑CVP	Single‑agent rituximab; chlorambucil (Leukeran) + rituximab; cyclophosphamide + rituximab; ibrutinib (Imbruvica); lenalidomide + rituximab	Appendix B provides disease‑specific examples of first‑line and subsequent therapies.

Step	Description	Status	Notes / rationale
1	Initial/step therapy and initial authorization criteria for Aliqopa (copanlisib) were removed following manufacturer withdrawal of the product application and withdrawal of approval.	Not Covered	4Q 2024 annual review: removed initial approval criteria due to manufacturer withdrawal; see Appendix D for market withdrawal information.

Quantity Limits

Aliqopa (copanlisib) — inv-29: 60 mg

Product and active ingredientAliqopa (copanlisib)

Per-dose strength60 mg per single-dose vial

Dosing regimen (FL)60 mg IV on Days 1, 8, and 15 of a 28‑day cycle (intermittent: 3 weeks on/1 week off)

Site of Care / Benefit Category

Billing Rule

Medical benefit coding — infusion center

Aliqopa (copanlisib) administered in an infusion setting is reported under the medical benefit using HCPCS code J9057.

Report administration under HCPCS J9057: 'Injection, copanlisib; _ mg.'

Background

Copanlisib (Aliqopa) is a phosphatidylinositol‑3‑kinase (PI3K) inhibitor that previously held FDA accelerated approval for adult patients with relapsed follicular lymphoma who had received at least two prior systemic therapies. The accelerated approval was granted based on overall response rate and required confirmatory trials; the manufacturer subsequently withdrew the application after confirmatory data failed to verify clinical benefit, and the approval was withdrawn in 2024.

Definitions

follicular lymphoma — inv-21: FL

TermFollicular lymphoma

AbbreviationFL

Appendix sourceListed in Appendix A: Abbreviation/Acronym Key

National Comprehensive Cancer Network — inv-22: NCCN

OrganizationNational Comprehensive Cancer Network

AbbreviationNCCN

Appendix sourceListed in Appendix A: Abbreviation/Acronym Key