CurrentUnitedHealthcarePolicy N/A

Zydelig (idelalisib) prior authorization

Prior authorization and coverage criteria for Zydelig (idelalisib) for UnitedHealthcare members, including indications, initial and reauthorization criteria, and pediatric automatic approvals; applies to pharmacy benefit management programs.

Policy Summary

PayerUnitedHealthcare

PolicyZydelig (idelalisib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2025

Next Review DateMay 25, 2025

Key ActionSubmit prior authorization for members with relapsed or refractory CLL/SLL; prescriptions for patients under 19 auto-process without coverage review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

08/01/2025policy effective date

<19 auto-approvepediatric processing

12 monthsauthorization period

05/2025latest P&T approval

Coverage Criteria

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Initial Therapy

Initial therapy coverage rules

Initial therapy: Diagnosis of CLL/SLL and disease is relapsed or refractory; use in combination with rituximab when rituximab alone would be considered appropriate due to comorbidities (per labeling) or as single-agent or with rituximab per NCCN for certain mutations

Provider Actions & Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required for Zydelig (idelalisib) for members aged 19 and older. Initial authorization is granted when the member has a diagnosis of CLL/SLL and disease is relapsed or refractory. Reauthorization is granted when the member does not show evidence of progressive disease while on therapy. For members under 19 years of age, prescriptions will automatically process without a coverage review and will be authorized for 12 months.

Initial authorization: Diagnosis of CLL/SLL AND disease relapsed or refractory
Reauthorization: No evidence of progressive disease while on Zydelig
Members <19 years: automatic processing; authorization issued for 12 months

Note

Clinical placement / Combination with Rituximab

Zydelig may be used as a single agent or in combination with rituximab per NCCN placement. Indication includes relapsed CLL in combination with rituximab for patients where rituximab alone would be appropriate due to co-morbidities; NCCN also supports second-line and subsequent therapy including for del(17p)/TP53-mutated disease.

Combination therapy: Zydelig + rituximab when rituximab alone would be appropriate
NCCN placement: second-line and subsequent therapy, single agent or with rituximab, including del(17p)/TP53 mutation

Billing Rule

Automated Approval & Supply Limits

UnitedHealthcare may use automated approval and re-approval processes based on prior claim/medication history, diagnosis codes (ICD-10), and claim logic. Where automated approval applies, supply limits may be enforced. For pediatric members (<19 years) prescriptions auto-process without coverage review.

Automated approval may rely on previous claim/medication history and diagnosis codes (ICD-10)
Supply limits may be in place — adherence to quantity/supply limits will be enforced
Members <19 years: automatic processing without coverage review

Denial Risk

Denial Triggers & State Mandates

Denial may occur if the member does not meet the clinical criteria (e.g., lacks qualifying diagnosis, not relapsed/refractory for initial approval, or shows disease progression at time of reauthorization). State mandates for off‑label coverage or compendium use may supersede these criteria; check state requirements where applicable.

Possible denial triggers: missing qualifying CLL/SLL diagnosis, initial therapy without relapsed/refractory disease, evidence of progressive disease at reauthorization
State- level mandates for off-label coverage or compendium references may supersede policy and affect coverage determinations

Definitions

CLL / SLL definition — chronic lymphocytic leukemia / small lymphocytic lymphoma

TermChronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL)

DescriptionA B‑cell lymphoproliferative disorder; Zydelig (idelalisib) is indicated for relapsed CLL in combination with rituximab and is recommended by NCCN as second‑line or subsequent therapy for CLL/SLL in appropriate settings.

Clinical contextMay be treated with idelalisib plus rituximab when rituximab alone would be appropriate due to comorbidities; NCCN supports single‑agent or combination use in later lines of therapy.

del(17p)/TP53 mutation — genomic alteration and relevance

AlterationDeletion of chromosome 17p [del(17p)] and/or TP53 mutation

RelevanceThese genomic alterations in CLL/SLL are associated with adverse prognosis and are specifically noted by NCCN as an indication for second‑line or subsequent use of idelalisib (single agent or with rituximab) in patients who require treatment.

Implication for therapyPresence of del(17p)/TP53 mutation may influence selection of idelalisib as later‑line therapy per NCCN recommendations.

Background

Idelalisib (Zydelig) is a phosphoinositide 3‑kinase (PI3K) inhibitor indicated for patients with relapsed chronic lymphocytic leukemia (CLL/SLL). The agent is used in combination with rituximab for relapsed CLL when appropriate and is recommended by NCCN as a second‑line or subsequent option — either as a single agent or in combination with rituximab — for CLL/SLL patients with genomic alterations such as del(17p)/TP53 mutation. This policy references manufacturer labeling and NCCN guidance for regimen placement and clinical use.

Step Therapy / Placement

Clinical placement	NCCN placement / guidance	Combination guidance
Zydelig (idelalisib) as therapy for CLL/SLL	Recommended by NCCN as second-line and subsequent therapy	Used in combination with rituximab when rituximab alone would be appropriate due to comorbidities; may be used as single agent or with rituximab for del(17p)/TP53-mutated disease