CurrentUnitedHealthcarePolicy N/A

Prior authorization and notification criteria for Copiktra (duvelisib)

Prior authorization and notification criteria for coverage of Copiktra (duvelisib) for UnitedHealthcare members, including age-based rules and indications (CLL/SLL and selected T‑cell lymphomas). Applies to pharmacy benefit management for affected members.

Policy Summary

PayerUnitedHealthcare

PolicyCopiktra (duvelisib) prior authorization and notification criteria

Policy CodePolicy N/A

Change TypeRevised (clinical and operational updates)

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis and prior-therapy history (>=2 prior regimens for CLL/SLL) when requesting coverage for Copiktra.

SourceLink

POLICY UPDATE CHANGES

Updated criteria for peripheral T-cell lymphoma based on NCCN guidance.

Updated background and references to July 2024 package insert and NCCN Compendium accessed March 31, 2025.

Added state mandate language affecting off-label coverage and compendium usage.

12 monthsstandard authorization duration

>=2prior therapies required for CLL/SLL

age <19automatic processing without coverage review

NCCN 1/2A/2B

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Coverage / Medical Necessity Criteria

Initial Authorization — Patients less than 19 years

Covered when ALL of the following are met

Pediatric automatic approval: Member is less than 19 years of age

Authorization will be issued for 12 months

Initial Authorization — CLL/SLL

Covered when ALL of the following are met

CLL/SLL initial: (1) Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL); (2) Disease is relapsed or refractory; (3) History of failure, contraindication, or intolerance to at least two prior therapies for CLL/SLL (examples provided, e.g., chlorambucil, obinutuzumab, ofatumumab, bendamustine, ibrutinib, acalabrutinib, venetoclax)at least two prior therapies

Authorization will be issued for 12 months

Initial Authorization — T‑cell lymphoma indications

Covered when ONE of the following sets of criteria is met

Hepatosplenic T-cell lymphoma: (a) Diagnosis of hepatosplenic T-cell lymphoma AND (b) Disease is relapsed or refractory AND (c) History of failure, contraindication, or intolerance to at least two prior systemic therapiesat least two prior systemic therapies

Authorization will be issued for 12 months

Breast implant-associated ALCL: (a) Diagnosis of breast implant-associated anaplastic large cell lymphoma AND (b) Disease is relapsed or refractory

Authorization will be issued for 12 months

Peripheral T-cell lymphoma: (a) Diagnosis of peripheral T-cell lymphoma AND (b) One of the following: used as initial palliative intent therapy OR used as second-line and subsequent therapy

Authorization will be issued for 12 months

Initial therapy

Initial authorization criteria per indication

CLL/SLL initial therapy: Diagnosis of CLL/SLL; relapsed/refractory disease; history of failure, contraindication, or intolerance to >=2 prior therapies>=2 prior therapies

Authorization for 12 months

T‑cell lymphoma initial therapy: See hepatosplenic T-cell lymphoma, breast implant-associated ALCL, and peripheral T-cell lymphoma pathways (see criteria sets)

Authorization for 12 months

Reauthorization

Covered when the following is met

Reauthorization: Patient does not show evidence of progressive disease while on Copiktra therapy

Authorization will be issued for 12 months

Reauthorization / Continuation

Reauthorization rules

Continuation if no progression: Patient does not show evidence of progressive disease while on Copiktra therapy

Authorization will be issued for 12 months

Some states have laws that require coverage of off‑label medication uses or mandate reliance on alternative compendia. Where a state mandate applies, the state requirement supersedes this policy and will govern coverage and compendium selection for the affected members.

UnitedHealthcare may use automated approval or reauthorization processes that rely solely on prior claim or medication history, diagnosis codes, and claim logic. These automated pathways may be applied variably by program or therapeutic class; when used, they can approve initial or continuing therapy without separate coverage review.

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization — CLL/SLL

Prior authorization required. Copiktra requests for CLL/SLL must include documentation that the disease is relapsed or refractory and that the member has failed, has a contraindication to, or is intolerant of at least two prior therapies.

Authorization duration: 12 months
Provide medication names and treatment dates to support prior therapy history
If member has contraindication or intolerance, include clinical rationale and supporting documentation

Step Therapy

Step Requirement — CLL/SLL (≥2 prior therapies)

Step requirement — CLL/SLL. Approval requires documented failure, contraindication, or intolerance to at least two prior therapies for CLL/SLL before initiating Copiktra.

Document each prior systemic therapy (drug name, start/stop dates, and reason for discontinuation)

Step Therapy Requirements

Requirement	Details
Step requirement
Patient has history of failure, contraindication, or intolerance to at least two prior therapies for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Examples include, but are not limited to, chlorambucil, obinutuzumab, ofatumumab, bendamustine, ibrutinib, acalabrutinib, venetoclax, etc. Authorization will be issued for 12 months.

Quantity Limits and Coding Notes

Copiktra (duvelisib) — quantity / supply limits

Quantity limit noteSupply limits may be in place for Copiktra (duvelisib)

Unit periodPer month (as specified in policy quantity limits)

Approval processesUnitedHealthcare may use automated approval or re-approval processes based on claims/medication history which can interact with supply limits

Site-of-Care Requirements

Note

No site‑of‑care requirements specified

No site‑of‑care restrictions are specified for Copiktra; therapy may be administered in the home setting when clinically appropriate.

Background and Indication Summary

Copiktra (duvelisib) is a dual inhibitor of phosphoinositide 3‑kinases PI3Kδ and PI3Kγ. It is indicated for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. The policy also recognizes Copiktra for certain T‑cell lymphoma indications per NCCN‑aligned pathways (including hepatosplenic T‑cell lymphoma after two prior regimens, breast implant–associated anaplastic large cell lymphoma, and select peripheral T‑cell lymphoma uses). Additional clinical rules note that UnitedHealthcare may apply automated approval based on previous claim/medication history and that supply limits may be in place.

Definitions

Relapsed or refractory — definition and application

DefinitionRelapsed or refractory: disease status described in the criteria as needing treatment after prior therapy failure or lack of response.

Usage in CLL/SLL criteriaRequired descriptor for initial authorization: diagnosis of CLL or SLL with disease that is relapsed or refractory (and history of failure, contraindication, or intolerance to ≥2 prior therapies).

Usage in T‑cell lymphoma criteriaApplied to hepatosplenic T‑cell lymphoma and breast implant–associated ALCL pathways where criteria specify disease is relapsed or refractory; may inform requirement for prior regimen failures.