CurrentCignaPolicy N/A

Oncology - Copiktra Prior Authorization Policy

Cigna's prior authorization requirements for coverage of Copiktra (duvelisib capsules) for adults with specified hematologic malignancies, including CLL/SLL and certain T‑cell lymphomas; applies to health benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyOncology - Copiktra Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial revisions to indication and prior-therapy requirements

Effective DateJun 4, 2025

Next Review DateJun 4, 2025

Key ActionObtain prior authorization and submit documentation showing age, diagnosis, and required prior targeted therapies (BTK inhibitor and BCL2 inhibitor) for CLL/SLL.

SourceLink

POLICY UPDATE CHANGES

Chronic lymphocytic leukemia and small lymphocytic lymphoma criteria changed from requiring two prior systemic regimens to requiring one prior systemic regimen (and later refined to require specific prior therapies).

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

3indications with explicit authorization criteria

1 yeartypical approval duration

≥18 yearsminimum age for all approved indications

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Recommended Authorization Criteria

FDA-Approved Indications — Chronic Lymphocytic Leukemia (CLL)

Approve for 1 year if the patient meets ALL of the following (A, B and C):

CLL approval criteria: A) Patient is ≥ 18 years of age; AND B) Patient has tried at least one Bruton tyrosine kinase inhibitor; AND C) Patient has tried at least one B-cell lymphoma 2 inhibitor.

Examples of BTK inhibitors include ibrutinib, zanubrutinib, acalabrutinib, or pirtobrutinib; example of BCL2 inhibitor: venetoclax.

FDA-Approved Indications — Small Lymphocytic Lymphoma (SLL)

Approve for 1 year if the patient meets ALL of the following (A, B and C):

SLL approval criteria: A) Patient is ≥ 18 years of age; AND B) Patient has tried at least one Bruton tyrosine kinase inhibitor; AND C) Patient has tried at least one B-cell lymphoma 2 inhibitor.

Examples of BTK inhibitors include ibrutinib, zanubrutinib, acalabrutinib, or pirtobrutinib; example of BCL2 inhibitor: venetoclax.

Other Uses with Supportive Evidence — T‑Cell Lymphoma

Approve for 1 year if the patient meets BOTH of the following (A and B):

T-cell lymphoma approval

T-cell subcriteria: i. Patient meets BOTH of the following: a) relapsed or refractory disease; AND b) breast implant-associated anaplastic large cell lymphoma or hepatosplenic T-cell lymphoma; OR ii. Patient has peripheral T-cell lymphoma.

Copiktra (duvelisib capsules) is considered not medically necessary for any uses not explicitly listed in the Recommended Authorization Criteria.

Coverage is not recommended for requests that fall outside the indications and criteria specified in the Recommended Authorization Criteria; such requests may be denied and the criteria set will be updated as new evidence becomes available.

Approved Regimens and Indications

Regimen	Indication	Coverage
Copiktra (duvelisib) — oral capsules, single‑agent	Chronic lymphocytic leukemia (CLL) — relapsed or refractory after specified prior targeted therapies	Approve for 1 year when criteria met: patient ≥ 18 years AND has tried at least one Bruton tyrosine kinase (BTK) inhibitor AND has tried at least one B‑cell lymphoma 2 (BCL2) inhibitor.
Copiktra (duvelisib) — oral capsules, single‑agent	Small lymphocytic lymphoma (SLL) — relapsed or refractory after specified prior targeted therapies	Approve for 1 year when criteria met: patient ≥ 18 years AND has tried at least one Bruton tyrosine kinase (BTK) inhibitor AND has tried at least one B‑cell lymphoma 2 (BCL2) inhibitor.

Regimen	Indication / Subtypes	Coverage
Copiktra (duvelisib) — oral capsules, single‑agent	Peripheral T‑cell lymphoma (PTCL)	Approve for 1 year when patient is ≥ 18 years; policy aligns with NCCN recommending Copiktra as preferred initial palliative intent therapy or second‑line and subsequent therapy for peripheral T‑cell lymphoma.
Copiktra (duvelisib) — oral capsules, single‑agent	Breast implant‑associated anaplastic large cell lymphoma (BIA‑ALCL) — relapsed or refractory	Approve for 1 year when patient is ≥ 18 years and has relapsed or refractory disease; coverage consistent with supportive evidence for second‑line and subsequent therapy.
Copiktra (duvelisib) — oral capsules, single‑agent	Hepatosplenic T‑cell lymphoma — refractory disease after two first‑line regimens	Approve for 1 year when patient is ≥ 18 years and disease is refractory after prior regimens; coverage consistent with supportive evidence as a single agent in this setting.

Drug Codes, Age Limits, and Related Coding

Covered NDC / drug productNDCCovered

NDC	Copiktra (duvelisib capsules) NDC codes as applicable per dispensing

inv-07: Minimum age — ≥ 18 years.

Minimum age for all approved indications≥ 18 years

Applies to CLL/SLL and T‑cell lymphoma criteriaPolicy requires patients be adults (≥ 18 years) for FDA‑approved and supportive‑evidence indications

Source context — CLL/SLL criteriaCLL and SLL approval criteria explicitly state 'Patient is ≥ 18 years of age' as condition A

Source context — T‑cell lymphoma criteriaT‑cell lymphoma approval criteria list 'Patient is ≥ 18 years of age' as condition A

Prior Authorization, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for prescription benefit coverage of Copiktra; approvals are issued for 1 year when the specific indication criteria are met.

Step Therapy

Required Prior Targeted Therapies

For chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), patients must have tried at least one Bruton tyrosine kinase (BTK) inhibitor and at least one B‑cell lymphoma 2 (BCL‑2) inhibitor prior to approval. Examples of BTK inhibitors include Imbruvica (ibrutinib), Brukinsa (zanubrutinib), Calquence (acalabrutinib), and Jaypirca (pirtobrutinib). An example of a BCL‑2 inhibitor is Venclexta (venetoclax).

Documentation Required

Required Documentation and Billing

Operational Line-of-Therapy Rules

subsequent

Subsequent-line therapy: Relapsed or refractory disease after prior targeted therapies as specified (patient must have tried at least one Bruton tyrosine kinase inhibitor and at least one BCL2 inhibitor).

Policy aligns with FDA indication and NCCN guidance; Copiktra is not indicated for initial or second-line CLL/SLL due to increased treatment-related mortality risk.

first-line | second-line | salvage

First/second/salvage therapy use: NCCN recommends Copiktra as preferred initial palliative-intent therapy or as second-line and subsequent therapy for peripheral T-cell lymphoma; as second-line and subsequent therapy for relapsed/refractory breast implant-associated anaplastic large cell lymphoma; and as single-agent therapy for hepatosplenic T-cell lymphoma in refractory disease after prior regimens.

See NCCN T-Cell Lymphoma and CLL/SLL guideline references for details.

Drug Background and Context

Copiktra (duvelisib) is a phosphatidylinositol 3‑kinase (PI3K) inhibitor. Per the product overview and FDA‑approved indications, Copiktra is indicated for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in the context described in the approval language. The policy aligns with the FDA indication for relapsed or refractory CLL/SLL and with guideline and supportive evidence that support use in select T‑cell lymphomas.

Key Terms

inv-13: Copiktra — Duvelisib definition (PI3K inhibitor) and brief indication summary.

Generic name and classDuvelisib — a phosphatidylinositol 3‑kinase (PI3K) inhibitor

FDA‑approved indication (summary)Indicated for treatment of relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in adults after prior systemic therapy

Limitations of useNot indicated or recommended for initial or second‑line treatment of CLL/SLL due to increased risk of treatment‑related mortality

Role in T‑cell lymphomas (supportive evidence)Recognized for certain T‑cell lymphoma scenarios (policy allows use in peripheral T‑cell lymphoma and selected relapsed/refractory T‑cell histologies) per supportive evidence