CurrentCentenePolicy CP.PHAR.597

Leniolisib (Joenja)

Defines medical necessity criteria, prior authorization and reauthorization requirements, dosing limits, and coverage stance for leniolisib (Joenja) for members aged ≥12 years with APDS across Centene lines of business.

Policy Summary

PayerCentene

PolicyLeniolisib (Joenja)

Policy CodePolicy CP.PHAR.597

Change TypeMaterial clinical clarifications and approval duration updates

Effective Date03.24.23

Next Review Date

Key ActionSubmit prior authorization with documentation of APDS diagnosis, PI3Kδ genetic confirmation, age/weight, measurable nodal lesion on CT/MRI, and evidence of clinical response.

SourceLink

POLICY UPDATE CHANGES

Added minimum body weight dosing requirement (weight ≥ 45 kg) per FDA labeling.

Extended initial approval duration from 3 months to 6 months and continued therapy approval from 6 months to 12 months.

Updated criteria to require documented PI3Kδ genetic mutation (PIK3CD or PIK3R1) and at least one measurable nodal lesion on CT or MRI.

12minimum eligible patient age

≥45 kgminimum body weight requirement

140 mg/daymaximum daily dose

70 mgproduct strength available

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6 moinitial approval duration

12 mocontinued therapy approval duration

Coverage Criteria for Leniolisib (Joenja)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Therapy - APDS: 1) Diagnosis of APDS; 2) Prescribed by or in consultation with an immunologist; 3) Age ≥ 12 years; 4) Weight ≥ 45 kg; 5) Confirmed PI3Kδ genetic mutation of either the PIK3CD (APDS1) or PIK3R1 (APDS2) gene; 6) Documentation of at least one measurable nodal lesion on a computed tomography (CT) or magnetic resonance imaging (MRI) scan; 7) Evidence of clinical findings and manifestations compatible with APDS/PASLI (e.g., history of repeated oto-sino-pulmonary infections and/or organ dysfunctions); 8) Dose does not exceed both of the following: (a) 140 mg per day; and (b) 2 tablets per day.

Approval duration: 6 months

Continuation Therapy — Covered for continued therapy when ALL of the following are met

Covered for continued therapy when ALL of the following are met

Continuation Therapy - APDS: 1) Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2) Weight ≥ 45 kg; 3) Member is responding positively to therapy as evidenced by reduction in size of nodal lesions from baseline prior to initiating leniolisib; 4) If request is for a dose increase, the new dose does not exceed both of the following: (a) 140 mg per day; and (b) 2 tablets per day.

Approval duration: 12 months

Non-FDA approved indications that are not specifically addressed by this policy are not authorized for coverage unless the request includes sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or the member’s evidence of coverage documents.

Requests for leniolisib for diagnoses or indications that are not FDA‑approved and not addressed by this policy will be considered not authorized unless the provider supplies sufficient off‑label evidence per the referenced off‑label policies or evidence of coverage. Absent that documentation, the request may be denied.

Dosing and Coding Limits

inv-05: Minimum body weight

Minimum body weight>= 45 kg

Applies to initial and continued therapyWeight ≥ 45 kg required for both initial approval and continuation

Source criteria locationPolicy criteria A.4 and continuation criteria A.2 specify weight threshold

inv-06: Maximum daily dose

Maximum daily dose<= 140 mg/day (2 tablets/day)

Per-dose regimenTypical dosing: 70 mg orally twice daily (70 mg PO BID) — do not exceed 2 tablets/day

Applies to dose increases

Prior Authorization, Documentation, and Routing

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria for the requested indication (e.g., diagnosis of APDS, genetic confirmation, age/weight criteria, and radiographic evidence of nodal lesion). Approval durations differ by intent: initial approval for Activated Phosphoinositide 3-Kinase Delta Syndrome is 6 months; continuation approvals (meeting response criteria) are 12 months.

Approval duration: Initial therapy — 6 months (see A. Activated Phosphoinositide 3‑Kinase Delta Syndrome criteria).
Continuation therapy: 12 months when continuation criteria are met (documented response such as reduction in nodal lesion size).
Required documentation: office chart notes, lab results, CT/MRI reports showing measurable nodal lesion, genetic testing confirming PIK3CD or PIK3R1 mutation, and evidence of clinical manifestations compatible with APDS.

Denial Risk

Definitions and Abbreviations

inv-12: APDS / PASLI

APDS (activated PI3Kδ syndrome)Activated phosphoinositide 3-kinase delta syndrome (APDS) — immunodeficiency caused by PI3Kδ pathway dysfunction; abbreviation defined in Appendix A

PASLIPASLI: p110δ-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency (term listed in Appendix A)

Related genesAPDS may be caused by gain-of-function mutations in PIK3CD (APDS1) or PIK3R1 (APDS2) as referenced in approval criteria

Background

Activated PI3Kδ syndrome (APDS) is an immunodeficiency caused by gain‑of‑function mutations in the PI3Kδ pathway (classically PIK3CD for APDS1 and PIK3R1 for APDS2) and presents with recurrent sino‑pulmonary infections, lymphoproliferation (including measurable nodal lesions on CT or MRI), increased risk of viral viremia, and autoimmune manifestations. Leniolisib is a selective PI3Kδ inhibitor approved to treat APDS in patients aged ≥ 12 years and dosing is constrained by a maximum of 140 mg per day (2 tablets/day); clinical documentation of genetic confirmation and compatible clinical findings is required for coverage consideration.

Policy Summary

PayerCentene

PolicyLeniolisib (Joenja)

Policy CodePolicy CP.PHAR.597

Change TypeMaterial clinical clarifications and approval duration updates

Effective Date03.24.23

Next Review Date

Key ActionSubmit prior authorization with documentation of APDS diagnosis, PI3Kδ genetic confirmation, age/weight, measurable nodal lesion on CT/MRI, and evidence of clinical response.

SourceLink

On This Page

Any request for dose increase must still not exceed 140 mg/day and 2 tablets/day

Documentation Insufficiency or Non‑Covered Indication

Requests lacking sufficient documentation to confirm the requested indication or that the member meets all approval criteria may be denied or routed per applicable policy. Examples of insufficiency include absence of confirmed PI3Kδ genetic mutation, missing CT/MRI evidence of a measurable nodal lesion, failure to document age/weight eligibility, or lack of clinical history consistent with APDS. If a request is denied for insufficient documentation, providers may submit additional records for reconsideration.

Denial risk if genetic confirmation (PIK3CD or PIK3R1) is not provided.
Denial risk if no CT/MRI report documenting measurable nodal lesion is included.
If the requested use is a non‑FDA indication not addressed in this policy, route per off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or formulary/non‑coverage policies referenced in this policy.

Step Therapy

Step Therapy / Alternative Routing

No formal step therapy is specified in this policy. If the drug’s labeling or formulary status has recently changed (within the last 6 months) or the requested use is not included in the policy, route requests according to the referenced formulary/non‑coverage or off‑label policies for the member's line of business.

If recently changed label or new indication not reflected here: follow formulary/no‑coverage policies — CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP.PMN.255 (Medicaid) for formulary items; CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP.PMN.16 (Medicaid) for non‑formulary items.
If requested use is not listed and criterion 1 in section B does not apply: follow off‑label use policies — CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid).