CurrentEmblemHealthPolicy N/A

Aliqopa (copanlisib) — Drug Policy (coverage criteria)

Defines coverage and authorization criteria for Aliqopa (copanlisib) for treatment of cancer (including FDA-approved and supported off-label uses) for members whose medication requests are processed by Evolent/EmblemHealth.

Policy Summary

PayerEmblemHealth

PolicyAliqopa (copanlisib) — Drug Policy (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApril 26, 2024

Next Review DateApril 10, 2024

Key ActionSubmit prior authorization; continuation requests are exempt if medication was used within the last year, there is no disease progression or intolerance, and no additional medications are being added.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

60Single dose max (mg)

≥2Prior systemic therapies

1 yrContinuation lookback

Apr 26, 2024Effective

Coverage Criteria for Aliqopa (copanlisib)

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Indications and continuation criteria

Covered when ALL of the following are met for continuation and for follicular lymphoma indication

Continuation request exemption: Continuation requests are exempt from the Evolent prior authorization policy provided: (1) the requested medication was used within the last year; AND (2) the member has not experienced disease progression or intolerance to the requested medication; AND (3) additional medication(s) are not being added to the continuation request.

derived from INDICATIONS FOR USE/INCLUSION CRITERIA

Follicular lymphoma indication: Member has relapsed/refractory indolent Follicular B‑cell Lymphoma grades 1–3a AND Aliqopa (copanlisib) is being used following disease progression on or after 2 or more systemic therapies, including an anti‑CD20–based regimen (e.g., rituximab +/- CHOP, bendamustine, or CVP).

from Follicular Lymphoma criteria

Requests for Aliqopa (copanlisib) will be excluded when any of the following apply: disease progression occurred while the member was taking copanlisib or another PI3K inhibitor (for example, idelalisib or duvelisib); concurrent use with other anticancer therapies; or the prescribed dosing exceeds the single-dose limit of 60 mg. These exclusions reflect situations where continued benefit is unlikely, where safety risks from combination therapy may exist, or where dosing surpasses the established quantity limit for a single administration.

Off-label use of Aliqopa (copanlisib) is considered investigational and will be denied when the evidence is insufficient or not generally accepted by the medical community. Documentation must show that published evidence adequately represents the patient and cancer characteristics, that the specific regimen is represented in the evidence, and that reported outcomes are clinically meaningful (generally benefits in overall survival or progression-free survival of at least 3 months). The policy also requires appropriate study design or, when randomization is not feasible, sufficiently powered non-randomized trials; case reports and meeting abstracts without full peer-reviewed publication are not adequate to support coverage.

Coding and Dose Limits

inv-04: Single dose limit for Aliqopa (copanlisib)

Single-dose maximum60 mg per single dose

Exclusion if exceededRequests will be excluded if dosing exceeds the single-dose limit of 60 mg

Related exclusion listPart of exclusion criteria that also excludes progression on another PI3K inhibitor and concurrent anticancer therapy

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Aliqopa (copanlisib). Requests for continuation therapy may be exempt when the drug was used within the last year, there is no disease progression or intolerance to the medication, and no additional agents are being added to the continuation request. All requests must include documentation demonstrating these conditions as applicable.

Continuation exemption lookback: medication used within the last 12 months
Continuation exemption clinical requirement: no disease progression and no intolerance
Continuation exemption scope: no additional medications added to the continuation request

Documentation Required

Evidence Required to Support Use

Use of Aliqopa (copanlisib) must be supported by one of the following evidence sources: FDA-approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN) guidelines, American Society of Clinical Oncology (ASCO) clinical guidelines, or peer-reviewed literature that meets the CMS Medicare Benefit Policy Manual Chapter 15 standards.

Prior Authorization

For Follicular Lymphoma — Prior Systemic Therapies Required

For follicular lymphoma (relapsed/refractory indolent Follicular B‑cell Lymphoma grades 1–3a), Aliqopa (copanlisib) is authorized only after disease progression on or after two or more systemic therapies, and the prior regimens must include an anti‑CD20–based regimen (for example, rituximab with or without CHOP, bendamustine, or CVP). Documentation of prior systemic therapies and progression is required.

Requirement: ≥ 2 prior systemic therapies including an anti‑CD20–based regimen (e.g., rituximab ± CHOP, bendamustine, CVP)
Must document disease progression on/after those therapies

Denial Risk

Exclusion Conditions and Denial Risks

Aliqopa (copanlisib) is excluded when there is documented disease progression while on copanlisib or another PI3K inhibitor, when dosing would exceed the single‑dose limit of 60 mg, when used concurrently with other anticancer therapies in a manner not supported by evidence, or when used investigationally for indications lacking sufficient evidence (as defined by absence from CMS compendia or acceptable peer‑reviewed literature).

Progression while receiving a PI3K inhibitor (e.g., idelalisib, duvelisib) — not eligible
Single dose limit: dosing that would exceed 60 mg per single dose — not eligible
Concurrent use with other anticancer therapies not supported by evidence — not eligible
Investigational/off‑label uses lacking sufficient evidence or CMS compendia support — not eligible

Background

Copanlisib (Aliqopa) is a phosphatidylinositol 3-kinase (PI3K) inhibitor indicated for treatment of relapsed or refractory indolent follicular B‑cell lymphoma. Its mechanism targets PI3K signaling pathways involved in B‑cell malignancies, and coverage is defined around its approved use and accepted evidence bases; the policy references FDA labeling and peer-reviewed literature or compendia to determine accepted uses and off-label support.

Definitions

inv-10: Definition of relapsed/refractory follicular lymphoma (grades 1–3a) for policy purposes

DefinitionRelapsed/refractory indolent follicular B‑cell lymphoma grades 1–3a: disease that has returned or not responded after prior systemic therapies

Required prior therapiesUse is for patients following disease progression on or after ≥2 systemic therapies, including an anti‑CD20–based regimen (e.g., rituximab ± CHOP, bendamustine, CVP)

Grades includedGrade 1 through 3a follicular lymphoma

Indication scopePolicy applies to relapsed or refractory indolent follicular B‑cell lymphoma for coverage decisions

Initial Therapy — Follicular Lymphoma

Initial therapy — follicular lymphoma

Disease-specific initial therapy coverage

Follicular lymphoma initial use: Use of Aliqopa (copanlisib) for relapsed/refractory indolent Follicular B‑cell Lymphoma grades 1–3a after disease progression on or after 2 or more systemic therapies, including an anti‑CD20–based regimen (for example, rituximab +/- CHOP, bendamustine, or CVP).

Initial therapy criteria extracted from policy

Continuation Requests

Continuation requests

Continuation requests handling

Continuation exemption: Continuation requests are exempt when ALL of the following are met: the medication was used within the last year; the member has not experienced disease progression or intolerance to the requested medication; AND no additional medication(s) are being added to the continuation request.

Continuation exemption criteria

Step Therapy Requirements

Step	Requirement
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Quantity Limits

inv-14: Aliqopa (copanlisib) quantity limit — single-dose / policy numeric limit

Quantity limit (single dose)60 mg per single dose

Quantity limit sourceListed under drug-specific quantity limits for Aliqopa (copanlisib)

EnforcementRequests exceeding this single-dose limit will be excluded per the exclusion criteria