CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Idelalisib (Zydelig) — Coverage Criteria for Relapsed/Refractory CLL/SLL

Defines coverage criteria for idelalisib (Zydelig) for relapsed/refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), including FDA-approved and compendial uses and limitations. Applies to members of the payer population when approval criteria are met and no exclusions to therapy exist.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIdelalisib (Zydelig) — Coverage Criteria for Relapsed/Refractory CLL/SLL

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, prior therapy history, and intended regimen (single agent or with rituximab) to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

Relapsed CLL + rituximabFDA-approved use

Relapsed/refractory CLL/SLLcompendial use

With bendamustine + rituximabnot recommended

Coverage Criteria for idelalisib (Zydelig)

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inv-01: Covered indications

Covered when ALL of the following are met

FDA-approved relapsed CLL + rituximab: Patient has relapsed chronic lymphocytic leukemia (CLL) and idelalisib will be used in combination with rituximab for patients for whom rituximab alone would be appropriate therapy due to comorbidities.

based on FDA-approved indication

Compendial relapsed/refractory CLL/SLL: Patient has relapsed or refractory CLL or small lymphocytic lymphoma (SLL) and idelalisib will be used as a single agent or in combination with rituximab; authorization may be granted for 12 months when used for relapsed or refractory CLL/SLL.

compendial use considered covered; 12-month authorization possible

inv-02: Limitations of use

Not covered / not recommended uses

Excluded combinations and settings: Idelalisib in combination with bendamustine and rituximab; idelalisib in combination with rituximab for treatment of follicular lymphoma (FL), small lymphocytic lymphoma (SLL), and other indolent non‑Hodgkin lymphomas; any first‑line treatment use for CLL, SLL, FL, or other indolent non‑Hodgkin lymphomas.

explicit limitations of use

Zydelig (idelalisib) is not indicated and is not recommended for use in combination with bendamustine plus rituximab. It is also not indicated for use in combination with rituximab for the treatment of patients with follicular lymphoma (FL), small lymphocytic lymphoma (SLL), or other indolent non‑Hodgkin lymphomas. Additionally, Zydelig is not indicated for first‑line treatment of any patient, including those with CLL, SLL, FL, or other indolent non‑Hodgkin lymphomas.

All indications for Zydelig beyond the FDA‑approved relapsed chronic lymphocytic leukemia (CLL) indication and compendial relapsed/refractory CLL/SLL uses are considered experimental/investigational and not medically necessary when used for other conditions or settings not supported by FDA approval or recognized compendia.

Regimens and Regimen-Specific Coverage

Regimen	Indication / Notes	Coverage status
idelalisib (Zydelig) ± rituximab
Relapsed chronic lymphocytic leukemia (CLL) — idelalisib used in combination with rituximab for patients for whom rituximab alone would be appropriate therapy due to comorbidities; compendial relapsed/refractory CLL/SLL use (single agent or with rituximab).
Covered

Regimen	Indication / Notes	Coverage status
idelalisib + bendamustine + rituximab
Use in combination with bendamustine and rituximab — not indicated or recommended; basis for denial.
Not covered

Line of Therapy

inv-12: second-line

Line of therapy: Not for first‑line therapy; indicated for relapsed or refractory disease. Authorization of up to 12 months may be granted for treatment of relapsed or refractory CLL/SLL when idelalisib is used as a single agent or in combination with rituximab.

explicitly not recommended as first‑line; 12‑month authorization for relapsed/refractory settings

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization and authorization period

Prior authorization required. Authorization may be granted for up to 12 months for initial treatment of relapsed or refractory CLL/SLL or for continuation when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Authorization period: up to 12 months

Note

Placement relative to rituximab

Intended for patients with relapsed CLL in combination with rituximab — specifically for patients for whom rituximab alone would be appropriate therapy due to comorbidities, or for relapsed disease where rituximab-containing regimens are appropriate.

Documentation Required

Required clinical documentation

Provider must document the diagnosis of relapsed or relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), the planned regimen (single-agent or combination with rituximab), and that use aligns with an FDA-approved indication or accepted compendial use.

Document diagnosis (relapsed CLL or relapsed/refractory CLL/SLL)
Document planned regimen: single-agent or in combination with rituximab
Document prior treatment history and rationale for therapy

Denial Risk

Excluded combinations and indications

The drug is not indicated and is not recommended in combination with bendamustine and rituximab, nor in combination with rituximab for treatment of follicular lymphoma (FL), SLL, and other indolent non-Hodgkin lymphomas. It is also not indicated or recommended for first-line treatment of any patient with CLL, SLL, FL, or other indolent non-Hodgkin lymphomas. All other uses are considered experimental/investigational and not medically necessary.

Excluded combination: bendamustine + rituximab + this agent
Excluded indication: combination with rituximab for FL, SLL, and other indolent non-Hodgkin lymphomas
Not indicated for first-line treatment of CLL, SLL, FL, or other indolent non-Hodgkin lymphomas
All other indications not listed are experimental/investigational and not medically necessary

Definitions and Compendial Use

Compendial use (definition and scope)

DefinitionUses supported by cancer compendia such as NCCN; in this policy compendial use includes relapsed or refractory CLL/SLL.

Covered compendial scenarioRelapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) when supported by compendia.

Relation to FDA indicationCompendial use is distinct from the FDA‑approved indication (idelalisib + rituximab for relapsed CLL in patients for whom rituximab alone would be appropriate due to comorbidities).

Coverage implicationCompendial relapsed/refractory CLL/SLL uses are considered covered when all policy criteria are met.

Excluded beyond compendiaAll other indications not supported by compendia are considered experimental/investigational and not medically necessary.

Background

Idelalisib (Zydelig) is addressed in this policy primarily for relapsed chronic lymphocytic leukemia (CLL) and for relapsed or refractory CLL/small lymphocytic lymphoma (SLL) when supported by compendia. The agent is approved in combination with rituximab for relapsed CLL in patients for whom rituximab alone would be appropriate due to comorbidities. It is not recommended in combination with bendamustine plus rituximab, is not indicated for treatment of follicular lymphoma or other indolent non‑Hodgkin lymphomas with rituximab, and is not indicated as first‑line therapy for CLL, SLL, FL, or other indolent non‑Hodgkin lymphomas.