CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 2305-3

Joenja (leniolisib) prior authorization / medical necessity

Defines prior authorization and medical necessity criteria for Joenja (leniolisib) for treatment of activated PI3Kδ syndrome (APDS) in patients ≥12 years and ≥45 kg, including initial authorization, reauthorization, prescriber requirements, and authorization duration.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyJoenja (leniolisib) prior authorization / medical necessity

Policy CodePolicy 2025 P 2305-3

Change TypeAnnual review (no material change in 5/2025)

Effective DateAug 1, 2025

Next Review Date

Key ActionJoenja requires prior authorization and will be approved only when all initial or reauthorization criteria are met; initial and reauthorization approvals are issued for 12 months.

POLICY UPDATE CHANGES

Program created and Joenja (leniolisib) prior authorization/medical necessity program added.

Updated initial authorization duration to 12 months and updated references.

Annual review with no changes to coverage criteria; references updated.

1Covered Indication (APDS)

12 monthsAuthorization duration

>=12 yrs; >=45 kgAge/Weight eligibility

Coverage Summary

Joenja (leniolisib) is covered with criteria for treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in patients 12 years of age or older who weigh >= 45 kg. Coverage requires documented diagnosis of APDS confirmed by a pathogenic variant in PIK3CD or PIK3R1, clinical manifestations consistent with APDS, and history of trial and failure, intolerance, or contraindication to standard of care therapies. Initial authorizations are issued for 12 months. Policy number: 2025 P 2305-3; effective date: 8/1/2025.

Initial Therapy Criteria

Initial Authorization

Joenja will be approved based upon all of the following criteria:

ALL of the following

Diagnosis of activated phosphoinositide 3-kinase delta syndrome (APDS)
Genetic confirmation: Diagnosis has been confirmed by the presence of an APDS-associated genetic variant in either PIK3CD or PIK3R1
Providers must document presence of an APDS-associated genetic variant in PIK3CD or PIK3R1 to meet confirmation criterion.
Clinical findings: Documentation of other clinical findings and manifestations consistent with APDS (e.g., recurrent respiratory tract infections, recurrent herpesvirus infections, lymphadenopathy, hepatosplenomegaly, autoimmune cytopenias)
Standard of care trial: Patient has a history of trial and failure, intolerance or contraindication to current standard of care for APDS (e.g., antimicrobial prophylaxis, immunoglobulin replacement therapy, immunosuppressive therapy)
Prescriber specialty: Prescribed by one of the following: Hematologist OR Immunologist
Age and weight: Both: Patient is 12 years of age or older; Patient weighs greater than or equal to 45 kg
Authorization will be issued for 12 months.

Documentation Required

Clinical history required

For initial authorization, document clinical manifestations consistent with APDS and history of trial and failure, intolerance, or contraindication to standard of care.

Antimicrobial prophylaxis (e.g., trimethoprim/sulfamethoxazole, azithromycin)
Immunoglobulin replacement therapy
Immunosuppressive therapy (e.g., glucocorticoids, rituximab)

Continuation / Reauthorization Criteria

Reauthorization

Joenja will be approved based on all the following criterion:

ALL of the following

Clinical response: Documentation of positive clinical response to Joenja therapy (e.g., reduced lymph node size, increased naïve B-cell percentage, decreased frequency or severity of infections, decreased frequency of hospitalizations)
Providers must provide documentation of positive clinical response for reauthorization.
Prescriber specialty: Prescribed by one of the following: Hematologist OR Immunologist
Weight: Patient weighs greater than or equal to 45 kg>=45 kg
Authorization will be issued for 12 months.

Documentation Required

Clinical response documentation for reauthorization

For reauthorization, provide objective documentation of a positive clinical response to Joenja therapy.

Reduced lymph node size
Increased naïve B‑cell percentage
Decreased frequency or severity of infections
Decreased frequency of hospitalizations

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Joenja requires prior authorization. Approvals (initial and reauthorization) are issued for 12 months and are granted only when all initial or reauthorization criteria are met.

Billing Rule

Supply limits and automated approval

Supply limits may be applied. UnitedHealthcare may also approve initial and reauthorization requests based solely on prior claims/medication history, diagnosis codes, and/or claim logic via automated processes.

Supply limits may be in place
Automated approvals based on prior claim/medication history, diagnosis codes (ICD‑10), or claim logic

Joenja must be prescribed by a hematologist or an immunologist. Providers are expected to submit documentation of genetic confirmation and relevant clinical history or response as part of prior authorization; UnitedHealthcare may also use prior claims, diagnosis codes, or claim logic for automated approvals. Prior authorization requests should follow the payer’s standard submission processes as specified in the program header.

Background

APDS (activated phosphoinositide 3-kinase delta syndrome) is a rare primary immunodeficiency caused by variants in the genes encoding subunits of the PI3Kδ enzyme complex (notably PIK3CD or PIK3R1) leading to PI3Kδ hyperactivity, abnormal B- and T-cell development, lymphoproliferation, recurrent infections, autoimmune disorders, and risk of malignancy. Diagnosis is confirmed by genetic testing. Standard care options include antimicrobial prophylaxis, immunoglobulin replacement therapy (IRT), immunosuppressive therapy (e.g., glucocorticoids, rituximab), and hematopoietic stem cell transplant (HSCT).

Definition: Activated phosphoinositide 3-kinase delta syndrome, a primary immunodeficiency caused by variants in PIK3CD or PIK3R1.

Revision History

5/2023New program creation

Program created and Joenja (leniolisib) prior authorization/medical necessity program added. (P&T Approval Date 5/2023)

5/2024Annual review (material)

Annual review; updated initial authorization duration to 12 months and updated references.

5/2025Annual review (no changes)Latest