CurrentCignaPolicy N/A

Idelalisib (Zydelig) — Coverage Criteria for CLL/SLL

Cigna prior authorization policy for coverage of Zydelig (idelalisib tablets) for specified hematologic malignancies (primarily relapsed chronic lymphocytic leukemia and small lymphocytic lymphoma) and who is eligible under these criteria.

Policy Summary

PayerCigna

PolicyIdelalisib (Zydelig) — Coverage Criteria for CLL/SLL

Policy CodePolicy N/A

Change TypeRevised prior-therapy requirements

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests and documentation; approvals are for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

The requirement that the patient has tried at least two systemic regimens was changed to one systemic regimen for CLL and SLL.

The criterion referencing a 'Venclexta-based regimen' was reworded to 'patient has tried at least one B-cell lymphoma 2 inhibitor' with an example added.

1 yearapproval duration for covered indications

>=18minimum patient age for approval

BTK inhibitorprior therapy requirement

BCL2 inhibitorprior therapy requirement

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Coverage Criteria for Idelalisib (Zydelig)

inv-01: FDA-Approved Indication - Chronic Lymphocytic Leukemia

Covered when ALL of the following are met for Chronic Lymphocytic Leukemia (approve for 1 year):

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: Imbruvica (ibrutinib), Brukinsa (zanubrutinib), Calquence (acalabrutinib), Jaypirca (pirtobrutinib). Example BCL2 inhibitor: Venclexta (venetoclax).

inv-02: Other Uses with Supportive Evidence - Small Lymphocytic Lymphoma

Covered when ALL of the following are met for Small Lymphocytic Lymphoma (approve for 1 year):

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: Imbruvica (ibrutinib), Brukinsa (zanubrutinib), Calquence (acalabrutinib), Jaypirca (pirtobrutinib). Example BCL2 inhibitor: Venclexta (venetoclax).

Zydelig (idelalisib) is not indicated and is not recommended for first-line treatment of any patient. This includes first-line use in CLL, SLL, follicular lymphoma (FL), and other indolent non-Hodgkin lymphomas. The agent is also not indicated and is not recommended in combination with bendamustine plus rituximab, nor in combination with rituximab for treatment of patients with FL, SLL, and other indolent non-Hodgkin lymphomas.

Any uses of Zydelig that are not explicitly listed as covered in this policy (including the FDA‑approved indication and other uses with supportive evidence described elsewhere in this document) are considered not medically necessary and will not be covered.

Regimens and Setting

Regimen	Indication	Coverage
Zydelig (idelalisib) used as first-line treatment
Zydelig in combination with bendamustine plus rituximab
Zydelig in combination with rituximab for follicular lymphoma (FL), small lymphocytic lymphoma (SLL), or other indolent non‑Hodgkin lymphomas

Regimen	Indication	Coverage
Zydelig (idelalisib) with rituximab
Zydelig (idelalisib) without rituximab

Line of Therapy Requirements

inv-13: second-line

line of therapy: Not indicated for first-line treatment; policy intended for relapsed/refractory settings after prior BTK and BCL2 inhibitor exposure per criteria.

NCCN lists Zydelig as 'other recommended regimen' for relapsed/refractory disease after prior BTK and BCL2 inhibitor-containing regimen.

Provider Actions, Authorization, and Denial Triggers

Prior Authorization

Prior authorization recommended; approvals for 1 year

Prior authorization is recommended for prescription benefit coverage of Zydelig; when the coverage criteria are met approvals are provided for 1 year.

Step Therapy

Required prior therapies: BTK and BCL2 inhibitors

Coverage requires prior exposure to at least one Bruton tyrosine kinase (BTK) inhibitor and at least one B-cell lymphoma 2 (BCL2) inhibitor before approval for the covered indications.

Examples of BTK inhibitors: Imbruvica (ibrutinib), Brukinsa (zanubrutinib), Calquence (acalabrutinib), Jaypirca (pirtobrutinib).
Example of a BCL2 inhibitor: Venclexta (venetoclax).

Coding and Billing

Covered CPT Codesmixed

No codes listed

Background

Idelalisib is a phosphatidylinositol 3‑kinase (PI3K) inhibitor. In approved use, Zydelig is indicated for relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab for patients in whom rituximab alone would be appropriate because of comorbidities. The policy reflects clinical guidance limiting use to relapsed/refractory settings and excluding routine first‑line therapy and the listed combination regimens noted above.

Definitions

Zydelig (idelalisib) — drug class

Drug classPhosphatidylinositol 3-kinase (PI3K) inhibitor

Generic nameidelalisib

Brand nameZydelig

Indication contextIndicated for relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab for select patients

CLL/SLL — relationship and treatment guidance

DefinitionChronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are different manifestations of the same condition and are treated similarly per NCCN guidance.

Guideline note