ModifiedCentenePolicy N/A

Duvelisib (Copiktra) — Coverage Criteria and Prior Authorization

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Defines medical necessity criteria, dosing limits, and prior authorization requirements for duvelisib (Copiktra) for CLL/SLL and certain T-cell lymphomas for Centene lines of business.

Policy Summary

PayerCentene

PolicyDuvelisib (Copiktra) — Coverage Criteria and Prior Authorization

Policy CodePolicy N/A

Change TypeMaterial revisions to prior therapy and dosingoff-label indications updated

Effective DateOct 16, 2018

Next Review DateNov 24, 2024

Key ActionObtain prior authorization and submit documentation showing prior BTK inhibitor and venetoclax-based therapy for CLL/SLL requests.

SourceLink

POLICY UPDATE CHANGES

For CLL/SLL, prior therapy requirement revised from at least one therapy to prior therapy with a BTK inhibitor and venetoclax-based regimens per NCCN and PI.

Dosing requirements updated to reflect modified dosing recommendations for co-administration with a moderate CYP3A4 inducer.

Off-label indications for follicular lymphoma (FL) and marginal zone lymphoma (MZL) were removed because they are no longer supported by NCCN.

Off-label criteria for T-cell lymphomas supported by NCCN were added, including requirement for use as a single agent.

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ModifiedCentenePolicy N/A

Duvelisib (Copiktra) — Coverage Criteria and Prior Authorization

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Know when Centene releases new policies or updates existing guidance.

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Defines medical necessity criteria, dosing limits, and prior authorization requirements for duvelisib (Copiktra) for CLL/SLL and certain T-cell lymphomas for Centene lines of business.

Policy Summary

PayerCentene

PolicyDuvelisib (Copiktra) — Coverage Criteria and Prior Authorization

Policy CodePolicy N/A

Change TypeMaterial revisions to prior therapy and dosingoff-label indications updated

Effective DateOct 16, 2018

Next Review DateNov 24, 2024

Key ActionObtain prior authorization and submit documentation showing prior BTK inhibitor and venetoclax-based therapy for CLL/SLL requests.

SourceLink

POLICY UPDATE CHANGES

For CLL/SLL, prior therapy requirement revised from at least one therapy to prior therapy with a BTK inhibitor and venetoclax-based regimens per NCCN and PI.

Dosing requirements updated to reflect modified dosing recommendations for co-administration with a moderate CYP3A4 inducer.

Off-label indications for follicular lymphoma (FL) and marginal zone lymphoma (MZL) were removed because they are no longer supported by NCCN.

Off-label criteria for T-cell lymphomas supported by NCCN were added, including requirement for use as a single agent.

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Approval - CLL/SLL: 1) Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL); 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Patient is ≥ 18 years of age; 4) Disease is relapsed or refractory after prior therapy that includes both a BTK inhibitor and a venetoclax-based regimen (see Appendix B for examples); 5) Prescribed as a single agent; 6) Dose does not exceed both: 50 mg per day (2 capsules per day) and 80 mg per day if co‑administered with a moderate CYP3A4 inducer; 7) For brand Copiktra requests, member must use generic duvelisib if available unless contraindicated or clinically significant adverse effects are experienced; 8) Prescribed regimen must be FDA‑approved or recommended by NCCN or supported by practice guidelines/peer‑reviewed literature for relevant off‑label use (prescriber must submit supporting evidence).dose limits 50 mg/day; 80 mg/day with moderate CYP3A4 inducer

See Appendix B for examples of prior therapies and Appendix D for CYP3A4 inducers.

Initial Therapy - T‑cell lymphomas (off‑label)

Covered when ALL of the following are met for specified T‑cell lymphoma subtypes:

Initial Approval - T‑cell lymphomas: 1) Diagnosis of one of: a) hepatosplenic T‑cell lymphoma (HSTCL) after two first‑line therapy regimens; b) breast implant‑associated anaplastic large cell lymphoma (ALCL) after at least one prior therapy; or c) peripheral T‑cell lymphoma (PTCL) after at least one prior therapy; 2) Patient is > 18 years of age; 3) Prescribed by or in consultation with an oncologist or hematologist; 4) Disease is relapsed or refractory; 5) Prescribed as a single agent; 6) Dose limits as per CLL/SLL: 50 mg/day (2 capsules) or up to 80 mg/day if co‑administered with a moderate CYP3A4 inducer; 7) For brand Copiktra requests, member must use generic duvelisib if available unless contraindicated or clinically significant adverse effects are experienced; 8) Dose/regimen is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence) and/or recommended by NCCN.dose limits 50 mg/day; 80 mg/day with moderate CYP3A4 inducer

Off‑label coverage pathway requiring supporting evidence; NCCN‑supported indications only.

Continuation Therapy

Continued coverage when ALL of the following are met:

Continued Therapy: 1) Member is currently receiving Copiktra via the Centene benefit or documentation shows member has received Copiktra for at least 30 days for a covered indication; 2) Member is responding positively to therapy; 3) If the request is for a dose increase, the new dose must not exceed dose limits (50 mg/day; 80 mg/day if co‑administered with a moderate CYP3A4 inducer) and any increase must be supported by FDA/NCCN guidance or practice guidelines/peer‑reviewed literature; 4) For brand Copiktra requests, member must use generic duvelisib if available unless contraindicated or clinically significant adverse effects are experienced.dose limits 50 mg/day; 80 mg/day with moderate CYP3A4 inducer

Approval durations differ by line of business.

Revised CLL/SLL coverage requirements

Noted coverage stance and specific clinical prerequisites per updated policy narrative

CLL/SLL coverage prerequisites: Coverage limited to patients whose prior therapy history includes treatment with a BTK inhibitor and a venetoclax‑based regimen, consistent with the prescribing information (PI) and NCCN guidance; boxed warning and limitation of use apply per PI; use should follow NCCN or other practice guidelines.

Prior therapy requirement revised from 'at least one therapy' to specific agents per NCCN and PI; see policy revision history for details.

Off-label T-cell lymphoma

Off‑label T‑cell lymphoma (NCCN‑supported)

T-cell lymphoma: Coverage allowed for T‑cell lymphoma indications supported by NCCN when duvelisib is used as a single agent per NCCN guidance; requests must be supported by guideline or peer‑reviewed literature evidence and meet the age, prescriber, and relapsed/refractory requirements specified in the off‑label criteria set.

Off‑label but NCCN‑supported; criterion for single‑agent use added in 4Q2023.

Requests for non‑FDA approved indications that are not specifically addressed by this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (for example, CP CPA.09 for commercial lines and HIM.PA.154 for health insurance marketplace).

Off‑label coverage criteria previously allowing use for follicular lymphoma (FL) and marginal zone lymphoma (MZL) have been removed because these indications are no longer supported by NCCN guidance; requests for FL or MZL therefore do not meet the off‑label coverage pathway under this policy.

Copiktra (duvelisib) is not indicated or recommended for initial or second‑line treatment of CLL/SLL because clinical data demonstrate an increased risk of treatment‑related mortality; coverage is limited to later‑line use per the FDA‑labeled limitation of use.

Use of duvelisib for follicular lymphoma (FL) and marginal zone lymphoma (MZL) is considered no longer supported by NCCN and therefore is not covered under the off‑label criteria in this policy.

Covered Regimens and Dosing

Regimen	Details	Coverage Status
Standard dosing
25 mg PO twice daily (may reduce to 15 mg PO twice daily for adverse reactions); treatment cycles per prescribing information.
Dose limits

Regimen	Requirements	Coverage Status
Duvelisib as single agent
Use as a single agent per NCCN guidance for supported T‑cell lymphoma subtypes; prescriber must submit supporting evidence per policy off‑label requirements.
Covered with criteria

Coding and Dose Limits

Maximum Dose — Dosing limits and adjustments

Maximum daily dose50 mg/day

Maximum daily dose when co‑administered with a moderate CYP3A4 inducer80 mg/day

Standard single‑agent dosing (CLL/SLL)25 mg PO BID (may reduce to 15 mg PO BID for adverse reactions)

Adjusted dosing example with moderate CYP3A4 inducerIf initial dose 25 mg PO BID → use 40 mg PO BID while co‑administered; if initial 15 mg PO BID → use 25 mg PO BID

Resume prior dose after inducer discontinuationResume prior Copiktra dose after the inducer has been discontinued for at least 14 days

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization and Required Criteria

Prior authorization is required. Provider must demonstrate that all medical necessity criteria are met for the requested use.

Prior authorization required for Copiktra (duvelisib) requests for CLL/SLL.
Prescribed by or in consultation with an oncologist or hematologist.

Prior Authorization

Prior Authorization Clinical Prerequisites

For CLL/SLL, prior therapy prerequisites must be documented. Coverage requires the disease to be relapsed or refractory after prior therapy with both a BTK inhibitor and a venetoclax-based regimen (see Appendix B for examples). Requests must show prior use of these specific therapies before approval.

Prior therapy must include a BTK inhibitor (e.g., acalabrutinib, ibrutinib, zanubrutinib, pirtobrutinib).
Prior therapy must include a venetoclax-based regimen (e.g., venetoclax ± anti-CD20 antibody such as obinutuzumab).

Line-of-Therapy Definitions

second-line_or_later

Second‑line or later - CLL/SLL: Relapsed or refractory disease after at least two prior therapies; Copiktra is not indicated or recommended for initial or second‑line treatment of CLL/SLL due to increased risk of treatment‑related mortality (limitation of use).

FDA indication requires prior ≥2 therapies; policy limits initial/second‑line use per PI.

salvage

Salvage - T‑cell lymphoma: HSTCL after two first‑line regimens; breast implant‑associated ALCL after at least one prior therapy; PTCL after at least one prior therapy (off‑label NCCN‑supported settings).

Defines allowable salvage settings for off‑label T‑cell lymphoma coverage.

second-line

Definitions and Safety

Boxed warnings / Serious toxicities

Boxed warning — treatment‑related mortalityTreatment‑related mortality and serious toxicities

Serious toxicities — infectionsInfections

Serious toxicities — gastrointestinalDiarrhea or colitis

Serious toxicities — dermatologicCutaneous reactions

Serious toxicities — pulmonaryPneumonitis

Examples of moderate CYP3A4 inducers

Examples of moderate CYP3A4 inducersBosentan; efavirenz; etravirine; phenobarbital; primidone

Background

Duvelisib (Copiktra) is an oral phosphoinositide 3‑kinase inhibitor indicated for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. The product carries boxed warnings for treatment‑related mortality and serious toxicities including infections, diarrhea/colitis, cutaneous reactions, and pneumonitis. Standard dosing for CLL/SLL is 25 mg PO twice daily (dose reductions to 15 mg PO twice daily may be used for adverse reactions); dose limits for this policy are 50 mg per day (or up to 80 mg per day when co‑administered with a moderate CYP3A4 inducer), and dosing adjustments and resumption instructions follow the prescribing information. Prior authorization is required and coverage is restricted to the labeled relapsed/refractory population and to off‑label T‑cell lymphoma indications only when supported by NCCN and used as a single agent per NCCN guidance.