ModifiedHealth NetPolicy CP PHAR.357

Copanlisib (Aliqopa) Coverage Criteria

Defines medical necessity, prior authorization, and continuation criteria for copanlisib (Aliqopa) for members of Health Net/Centene lines of business, including commercial, HIM, and Medicaid.

Policy Summary

PayerHealth Net

PolicyCopanlisib (Aliqopa) Coverage Criteria

Policy CodePolicy CP PHAR.357

Change TypeRemoved initial approvaladded market withdrawal details

Effective DateDec 1, 2017

Next Review Date

Key ActionPrior authorization required; current users may be eligible for continuation if documentation shows current use with ≥30 days of therapy and continuation criteria are met.

SourceLink

POLICY UPDATE CHANGES

Initial approval criteria were removed due to manufacturer withdrawal.

Appendix D: details on Bayer's voluntary withdrawal of Aliqopa and withdrawal effective date.

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

J9057HCPCS code

60 mgPer-dose amount

6 monthsCommercial approval duration

Approval withdrawnRegulatory status

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Coverage Criteria

Initial Approval

Initial therapy is not permitted.

Initial Approval: Authorization is not permitted — member may not initiate therapy with Aliqopa following manufacturer withdrawalN/A

If member is currently using Aliqopa see continuation criteria (section II). See Appendix D for withdrawal details.

Non-FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the request is supported by the Health Plan's off-label use policy or other evidence of coverage documentation. Providers should refer to the applicable off-label use policies (e.g., CP CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, CP.PMN.53 for Medicaid) and submit sufficient clinical documentation demonstrating efficacy and safety for the requested off-label use.

Per the manufacturer, new patients should not be prescribed Aliqopa. Bayer announced voluntary withdrawal of its new drug application and stated that no new patients should be started on Aliqopa; the manufacturer's press release and subsequent actions resulted in approval withdrawal effective 2024-03-18.

Initial approval criteria for Aliqopa were removed from this policy due to the manufacturer's market withdrawal. The 4Q 2024 annual review documents removal of initial approval criteria and addition of market withdrawal details to Appendix D; see Appendix D for the manufacturer's withdrawal notice and supporting context.

Initiation of Aliqopa (copanlisib) for new patients is not authorized and is considered not medically necessary following the manufacturer's withdrawal and subsequent loss of approval. If a member is currently receiving Aliqopa, refer to the continuation criteria; new starts will be denied.

Initial Therapy

Initial therapy prohibited due to manufacturer withdrawal.

Manufacturer withdrawal: Bayer voluntarily withdrew the new drug application for Aliqopa; approval was withdrawn as of 2024-03-18 — new patients should not be prescribed AliqopaN/A

See Appendix D for details; Bayer noted it was exploring access options for current patients.

Policy action: Requests for initiation of Aliqopa will not be authorized following the market withdrawalN/A

Initial approval criteria removed during 4Q 2024 annual review.

Continuation Therapy

Continued Therapy

Covered for continuation when ALL of the following are met:

Current use: Member is currently receiving medication via Centene benefit; or documentation supports that member is currently receiving Aliqopa for a covered indication>=30 days

Member must have received this medication for at least 30 days. See Appendix D for withdrawal context.

Clinical response: Member is responding positively to therapyN/A

Clinical documentation (office notes, labs, imaging) must support response.

Dose limits: New dose does not exceed 60 mg (1 vial) per week for 3 out of 4 weeks

Coding

HCPCS CodesHCPCS

J9057

Injection, copanlisib;_ mg

HCPCS CodesHCPCS

J9057

Injection, copanlisib; ___ mg

Maximum per-dose amount

Maximum per-dose amount60 mg per dose (single‑dose vial) — standard dosing for follicular lymphoma: 60 mg IV on Days 1, 8, and 15 of a 28‑day cycle (intermittent schedule)

Weekly dose threshold for continuationNo more than 60 mg per week for 3 of 4 weeks

Dose formSingle‑dose vial: 60 mg

Aliqopa (copanlisib) — key dosing

Product and active ingredientAliqopa (copanlisib)

Standard per‑dose strength60 mg per single‑dose vial

Provider Actions and Administrative Requirements

Prior Authorization

Prior authorization required / Initiation prohibited

Prior authorization is required. Authorization for initiating Aliqopa is not permitted — no new patients should be started on Aliqopa following the manufacturer's voluntary withdrawal. Members currently receiving Aliqopa may be eligible for continuation of therapy if documentation supports current use and treating physician endorsement. Requests that do not meet continuation criteria should be denied.

Initiation prohibited — no new starts per manufacturer withdrawal (see Appendix D).
Continuation may be considered only for members currently receiving Aliqopa with supporting clinical documentation.
Requests not meeting continuation criteria should be denied.

Prior Authorization

Prior authorization duration and recent change

Approval duration for commercial line of business was revised: authorizations should be granted for up to 6 months or the duration of the request, whichever is less. Initial approval criteria were removed due to manufacturer withdrawal; therefore only continuation requests meeting the policy criteria should be considered.

Background

Copanlisib is a phosphatidylinositol-3-kinase (PI3K) inhibitor that received accelerated FDA approval for adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. Continued approval was contingent on confirmatory trials; following results from CHRONOS-4 and the manufacturer's voluntary withdrawal of the application, regulatory status changed and formal approval was withdrawn effective 2024-03-18. The NCCN subsequently removed Aliqopa as a B‑cell lymphoma treatment option. See Appendix D for full withdrawal details and the regulatory history.

Definitions

Definition: FL

TermFollicular lymphoma (FL)

Abbreviation definedFL stands for follicular lymphoma

ContextListed in Appendix A: abbreviation/acronym key

Definition: NCCN

OrganizationNational Comprehensive Cancer Network (NCCN)

Abbreviation definedNCCN stands for National Comprehensive Cancer Network

ContextListed in Appendix A: abbreviation/acronym key

Policy Summary

PayerHealth Net

PolicyCopanlisib (Aliqopa) Coverage Criteria

Policy CodePolicy CP PHAR.357

Change TypeRemoved initial approvaladded market withdrawal details

Effective DateDec 1, 2017

Next Review Date

Key ActionPrior authorization required; current users may be eligible for continuation if documentation shows current use with ≥30 days of therapy and continuation criteria are met.

SourceLink

On This Page

<=60 mg/week for 3/4 weeks

If request is for a dose increase, the new dose must be supported by practice guidelines or peer-reviewed literature; prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval duration per line of businessN/A

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

Continuation Therapy

Continuation allowed for current users under specific criteria despite market withdrawal.

Current receipt and duration: Member currently receiving Aliqopa via benefit or documentation supports current receipt for a covered indication with at least 30 days of therapy>=30 days

Manufacturer noted exploring access options for current patients; see Appendix D.

Ongoing response and dosing: Member is responding positively to therapy AND dose does not exceed 60 mg per week for 3 of 4 weeks; dose increases require guideline or literature support<=60 mg/week for 3/4 weeks

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.

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

Commercial authorization duration: 6 months or duration of request, whichever is less.
Initial approval criteria removed — do not approve new starts.

Documentation Required

Required documentation and administrative requirements

Providers must submit documentation (office chart notes, lab results, or other clinical information) demonstrating that the member meets all applicable criteria for continuation therapy. Follow Health Plan administrative policies and any applicable legal/regulatory requirements when submitting requests.

Required documentation: office chart notes, labs, and other clinical records supporting current use and clinical benefit.
Ensure documentation includes treating physician support for continued use when applicable.
Follow Health Plan administrative submission requirements and applicable legal/regulatory notifications.

Note

Formulary / off-label referrals

For requests for diagnoses or uses not covered here, refer to the applicable formulary/non-coverage or off-label policies for the member's line of business before making an authorization decision.

Commercial formulary/no-coverage: CP.CPA.190; Off-label commercial: CP.CPA.09.
Marketplace formulary/no-coverage: HIM.PA.33; Off-label marketplace: HIM.PA.154.
Medicaid PDL/no-coverage: CP.PMN.255 (or CP.PMN.16 for non-formulary); Off-label Medicaid: CP.PMN.53.