Pharmacy Prior Authorization Criteria

Joenja (leniolisib)

Indications for Prior Authorization

Joenja (leniolisib)

• For diagnosis of Activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome
  Indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.

Criteria

Joenja

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s) [A]

• Diagnosis of activated phosphoinositide 3-kinase delta syndrome (APDS)
AND
• Molecular genetic testing confirms mutations in the PIK3CD or PIK3R1 gene
AND
• Patient is 12 years of age or older
AND
• Patient weighs greater than or equal to 45kg
AND
• Both of the following:
• Presence of nodal and/or extranodal proliferation (e.g., lymphadenopathy, splenomegaly, hepatomegaly)
• Presence of other clinical findings and manifestations consistent with APDS (e.g., recurrent sino-pulmonary infections, bronchiectasis, enteropathy)
AND
• Trial and failure, contraindication, or intolerance to at least one standard of care treatment for APDS (e.g., Immunoglobulin replacement therapy, antimicrobial prophylaxis [e.g., azithromycin, bactrim], rituximab, tacrolimus, etc.) [3]
AND
• Prescribed by or in consultation with one of the following:
• Hematologist
• Immunologist
• Geneticist

Joenja

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., reduced lymph node size, increased naïve B-cell percentage, decreased severity or frequency of infections/hospitalizations)

P & T Revisions

2024-05-01, 2023-11-02, 2023-05-26

References

1. Joenja Prescribing Information. Pharming Technologies, Inc. Foster City, CA. March 2023.
2. Per clinical consultation with allergist/immunologist specialist, May 10, 2023.
3. Rao VK, Webster S, Šedivá A, et al. Randomized, Placebo-Controlled, Phase 3 Trial of PI3Kδ Inhibitor Leniolisib for Activated PI3Kδ Syndrome. Blood. Published online November 18, 2022.

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End Notes

1. Per consult with specialist, extending initial authorization to 6 months will give providers more time to assess efficacy and see those surrogate outcomes such as reduced lymph node size. [2]

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Revision History

• 2024-05-01: 2024 Annual Review - Update to add geneticist as an additional specialist option
• 2023-11-02: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-05-26: New Program

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