Copiktra (duvelisib) prior authorization
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Prior authorization and coverage criteria for Copiktra (duvelisib) for treatment of relapsed/refractory CLL/SLL and certain T-cell lymphomas; applies to UnitedHealthcare pharmacy benefit members and prescribers requesting coverage.
No material clinical or coverage changes in this revision.
Coverage Criteria for Copiktra (duvelisib)
inv-01: Patients less than 19 years of age
Covered when ALL of the following are met
Authorization will be issued for 12 months.
inv-02: Initial Authorization — CLL/SLL
Covered when ALL of the following are met
Authorization will be issued for 12 months.
inv-04: Initial Authorization — T-cell Lymphomas
Covered when ONE of the following criteria sets is met
(listed in background as NCCN recommended use)
inv-05: NCCN Recommended Regimens
Covered when the regimen is recognized by NCCN
Authorization will be issued for 12 months.
Copiktra (duvelisib) is not indicated or recommended for use as initial or second-line treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) because clinical data have shown an increased risk of treatment-related mortality when used in those settings. When considering Copiktra for CLL/SLL, prior therapies must have failed or been contraindicated/intolerable and the agent is reserved for relapsed or refractory disease after at least two prior therapies per the coverage criteria.
Initial Therapy Authorization Criteria
inv-13: Initial therapy — Initial authorization criteria by indication
Initial authorization criteria by indication
Authorization will be issued for 12 months.
Authorization will be issued for 12 months.
| Indication | Prior therapy requirement |
|---|---|
| {"text":"Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)","status":""}|{"text":"History of failure, contraindication, or intolerance to at least two prior therapies (examples: chlorambucil, obinutuzumab, ofatumumab, bendamustine, ibrutinib, acalabrutinib, venetoclax)","status":""} | |
| {"text":"Hepatosplenic T-cell lymphoma","status":""}|{"text":"History of failure, contraindication, or intolerance to at least two prior systemic therapies; OR disease is relapsed/refractory and used as second-line or subsequent therapy","status":""} | |
| {"text":"Peripheral T-cell lymphoma","status":""}|{"text":"Used as initial palliative-intent therapy OR used as second-line and subsequent therapy (prior systemic therapy requirement varies by pathway)","status":""} | |
| {"text":"Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)","status":""}|{"text":"Disease is relapsed or refractory (NCCN‑recommended use); prior therapy requirement per NCCN-recognized regimen","status":""} |
Reauthorization / Continuation Criteria
inv-03: Reauthorization — Covered when ALL of the following are met
Covered when ALL of the following are met
Authorization will be issued for 12 months.
inv-14: Reauthorization/Continuation — Reauthorization requirements
Reauthorization requirements
Authorization renewed for 12 months if met.
Provider Actions and Prior Authorization Requirements
Prior authorization required; 12-month initial approval
Prior authorization is required for Copiktra (duvelisib). When the specified coverage criteria are met, initial authorizations are issued for 12 months.
Document prior therapies — failures/contraindications/intolerances required
Coverage requires a documented history of failure, contraindication, or intolerance to prior systemic therapies as specified by indication; for CLL/SLL and hepatosplenic T‑cell lymphoma this typically means at least two prior therapies must have failed or been contraindicated/intolerable.
- CLL/SLL: history of failure, contraindication, or intolerance to at least two prior therapies (examples listed in policy).
- Hepatosplenic T‑cell lymphoma: history of failure, contraindication, or intolerance to at least two prior systemic therapies (or used as second‑line+ per criteria).
Consider state mandates and member benefit limitations
Coverage decisions may be affected by state mandates and the member’s specific benefit plan; some states mandate coverage for off‑label uses or other compendia which supersede this policy. Lack of required prior therapies or evidence of progressive disease does not meet coverage criteria and may result in denial.
- State mandates and compendium requirements can supersede the policy.
- Members under age 19 auto‑process without coverage review (see policy).
- Absence of required prior therapies or progressive disease on therapy are grounds for noncoverage.
Administrative approval may use prior claims, ICD‑10, or claim logic
UnitedHealthcare may approve initial or re‑authorization requests based solely on prior claim or medication history, diagnosis codes (ICD‑10), and/or claim logic; automated approval and re‑approval processes vary by program. Providers should ensure claims and medication histories accurately reflect required diagnoses and prior therapies.
- Approvals may be granted based on previous claim/medication history, ICD‑10 codes, and/or claim logic.
- Supply limits may apply and could affect approval/dispensing.
Background
Copiktra (duvelisib) is a 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 National Comprehensive Cancer Network (NCCN) also recognizes Copiktra for certain T‑cell lymphomas, including hepatosplenic T‑cell lymphoma (after two first‑line regimens or as second‑line and subsequent therapy), breast implant‑associated anaplastic large cell lymphoma (for relapsed/refractory disease), and select peripheral T‑cell lymphomas as initial palliative intent therapy or for second‑line and subsequent therapy.
Definitions
Quantity Limits and Supply
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