CurrentCignaPolicy N/A

Oncology - Copiktra Prior Authorization Policy

Defines Cigna prior authorization requirements and medical necessity criteria for coverage of Copiktra (duvelisib capsules) for adults with specific hematologic malignancies.

Policy Summary

PayerCigna

PolicyOncology - Copiktra Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCriteria revised

Effective DateN/A

Next Review DateJun 4, 2025

Key ActionObtain prior authorization and document that the adult patient has tried at least one Bruton tyrosine kinase inhibitor and at least one B-cell lymphoma 2 inhibitor before approval for CLL/SLL.

SourceLink

POLICY UPDATE CHANGES

Chronic lymphocytic leukemia and small lymphocytic lymphoma criteria changed to require the patient has tried at least one Bruton tyrosine kinase inhibitor and at least one B-cell lymphoma 2 inhibitor.

T-cell lymphoma requirement for relapsed or refractory disease narrowed to apply only to breast implant-associated anaplastic large cell lymphoma or hepatosplenic T-cell lymphoma.

3covered indications listed

1 yearauthorization duration

≥18minimum age

BTK + BCL2prior therapy req

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage and Medical Necessity Criteria

FDA-Approved Indications - Small Lymphocytic Lymphoma (SLL)

Approve for 1 year if ALL of the following are met:

ALL of the following

Patient is ≥ 18 years of age.
Patient has tried at least one Bruton tyrosine kinase inhibitor. Note: Examples include Imbruvica (ibrutinib capsules, tablets, and oral solution), Brukinsa (zanubrutinib capsules), Calquence (acalabrutinib tablets), or Jaypirca (pirtobrutinib tablets).
Patient has tried at least one B-cell lymphoma 2 inhibitor. Note: Example includes Venclexta (venetoclax tablets).

Other Uses with Supportive Evidence - T-Cell Lymphoma

Approve for 1 year if BOTH of the following are met:

ALL of the following

Patient is ≥ 18 years of age.
ONE of the following
- i
  - Patient has relapsed or refractory disease.
  - Patient has breast implant-associated anaplastic large cell lymphoma or hepatosplenic T-cell lymphoma.
- Patient has peripheral T-cell lymphoma.

Copiktra® (duvelisib capsules) is not medically necessary for uses not listed in the Recommended Authorization Criteria. Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria; criteria will be updated as newly published data are available.

Limitations of Use: Copiktra is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second-line treatment due to an increased risk of treatment-related mortality. Clinicians should follow available guideline recommendations and consider risks when using Copiktra outside of the approved relapsed/refractory setting.

Supported Regimens and Guideline Context

Regimen	Indication / Required criteria	Authorization duration	Coverage
Copiktra (duvelisib) monotherapy	Chronic lymphocytic leukemia (CLL): Patient is ≥ 18 years of age; patient has tried at least one Bruton tyrosine kinase (BTK) inhibitor; AND patient has tried at least one B-cell lymphoma 2 (BCL2) inhibitor.	1 year	Covered with criteria
Copiktra (duvelisib) monotherapy	Small lymphocytic lymphoma (SLL): Patient is ≥ 18 years of age; patient has tried at least one Bruton tyrosine kinase (BTK) inhibitor; AND patient has tried at least one B-cell lymphoma 2 (BCL2) inhibitor.	1 year	Covered with criteria
Copiktra (duvelisib) monotherapy	T‑cell lymphoma: Patient is ≥ 18 years of age AND one of the following: i) relapsed or refractory disease AND diagnosis of breast implant‑associated anaplastic large cell lymphoma or hepatosplenic T‑cell lymphoma; OR ii) peripheral T‑cell lymphoma (per NCCN guideline–supported indications).	1 year	Covered with criteria (NCCN-supported uses)

Line of Therapy Definitions and Requirements

Coding Guidance

Coding guidancemixed

NDC and HCPCS not specified

Document does not list specific billing codes; providers must use most appropriate codes as of submission date.

Provider Actions, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior Authorization Recommended — Prior authorization is recommended for Copiktra (duvelisib). Approvals are provided for 1 year when criteria are met.

Prior authorization recommended for prescription benefit coverage of Copiktra.
Approvals granted for 1 year when member meets the required criteria.

Step Therapy

PROVIDER ACTIONS — Prior Therapies Required for CLL/SLL

For Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL), the patient must have tried at least one Bruton tyrosine kinase (BTK) inhibitor and at least one B-cell lymphoma 2 (BCL2) inhibitor prior to approval. Examples of BTK inhibitors: Imbruvica (ibrutinib), Brukinsa (zanubrutinib), Calquence (acalabrutinib), Jaypirca (pirtobrutinib). Example of a BCL2 inhibitor: Venclexta (venetoclax).

Definitions and Drug Information

Copiktra — Duvelisib: definition and indication summary

Generic nameDuvelisib (Copiktra)

Mechanism / drug classPhosphatidylinositol 3‑kinase (PI3K) inhibitor

FDA‑approved indication summaryIndicated for treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in adults after at least two prior lines of systemic therapy; not indicated or recommended as initial or second‑line treatment for CLL/SLL due to increased risk of treatment‑related mortality.

Age requirementAdults (≥ 18 years)

Authorization duration per policyApprovals provided for 1 year when criteria are met

Policy prior‑therapy expectation for CLL/SLLPolicy requires prior Bruton tyrosine kinase (BTK) and B‑cell lymphoma 2 (BCL2) inhibitor therapy for CLL/SLL (per updated criteria)

Background and Rationale

Copiktra (duvelisib) is a phosphatidylinositol 3-kinase (PI3K) inhibitor indicated for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in adults. Per the prescribing information and policy, coverage is limited to specified relapsed/refractory situations and aligns with guideline-supported uses in certain T‑cell lymphomas. Prior authorization is required and approvals are granted for 1 year when the patient meets the applicable criteria.

Policy Change Highlights

Note

Material change — CLL/SLL prior therapy requirement revised

Material change: CLL/SLL prior therapy requirement was updated to require the patient has tried at least one Bruton tyrosine kinase inhibitor and at least one B-cell lymphoma 2 inhibitor, replacing the prior language referencing Venclexta-based or two systemic regimens.

Note

Material change — T‑cell lymphoma relapsed/refractory limitation narrowed

Material change: the relapsed/refractory limitation for T-cell lymphoma was edited to apply only to breast implant-associated anaplastic large cell lymphoma and hepatosplenic T-cell lymphoma.