CurrentAvMedPolicy N/A

Prior authorization criteria for Joenja (leniolisib)

This document is a pharmacy prior authorization/step-edit form governing clinical authorization for Joenja (leniolisib) for AvMed members; it describes required documentation and clinical criteria for initial and reauthorization decisions and applies to prescribers and pharmacies handling this specialty drug.

Policy Summary

PayerAvMed

PolicyPrior authorization criteria for Joenja (leniolisib)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a signed prior authorization form with required documentation (labs, imaging, progress notes) and fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial authorization duration

12 moReauthorization duration

≥12Minimum age

2/dayQuantity limit

Coverage Criteria for Joenja (leniolisib)

inv-01: Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial Authorization Criteria: Member is ≥ 12 years of age; Member is ≥ 45 kg; Provider is an immunologist, has been in consultation with one, or is a specialist in treating patients with activated phosphoinositide 3-kinase (PI3K) delta syndrome (APDS); Member has a diagnosis of APDS confirmed by submission of laboratory results confirming the presence of an APDS-associated PI3Kδ mutation with a documented variant in either PIK3CD or PIK3R1; Provider has submitted documentation of the member's medical history (may note recurrent sinopulmonary infections, sinusitis, pneumonia, bronchitis, chronic EBV/CMV viremia, autoimmune cytopenia, and/or lymphadenopathy/hepatomegaly); For members with splenomegaly, provider submitted measured spleen volume by CT or MRI; For members with evidence of nodal lesions, provider submitted CT/MRI results; Member is NOT on concurrent immunosuppressive therapy (examples: mTOR inhibitors, B-cell depleters, glucocorticoids >25 mg/day prednisone equivalent, cyclophosphamide, mycophenolate); Provider submitted baseline objective laboratory documentation within the past 30 days including a complete blood count with differential to include T and B cell screening and measurement of serum immunoglobulin M (IgM) level.all listed

Initial authorization duration: 6 months

inv-02: Continuation/Reauthorization

Policy Summary

PayerAvMed

PolicyPrior authorization criteria for Joenja (leniolisib)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a signed prior authorization form with required documentation (labs, imaging, progress notes) and fax to 1-305-671-0200.

SourceLink

On This Page

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Reauthorization Criteria: Member is NOT on concurrent immunosuppressive therapy (examples: mTOR inhibitors, B-cell depleters, glucocorticoids >25 mg/day prednisone equivalent, cyclophosphamide, mycophenolate); Member has been observed to have a positive clinical response since the beginning of therapy evidenced by disease stability or mild progression as shown by any of the following (submitted documentation/chart notes): reduction in lymph node lesions on CT/MRI if present at baseline; follow-up CBC observing normalization in T and B cells; reduction in spleen size on CT/MRI if applicable; follow-up serum immunoglobulin screening observing normalization in IgM levels; submission of progress notes documenting frequency or severity of infections; Member has experienced an absence of unacceptable toxicity from the drug (examples: severe neutropenia ANC <500 cells/μL, skin rash).all listed

Reauthorization duration: 12 months

Approval is contingent on the member NOT being on concurrent immunosuppressive therapy. Examples of excluded concomitant agents include mTOR inhibitors, B-cell depleters, glucocorticoids at doses >25 mg/day prednisone equivalent, cyclophosphamide, and mycophenolate. Documentation must explicitly confirm the absence of these therapies at the time of request; presence of such agents is an exclusionary condition for initial approval and reauthorization.

For members with splenomegaly or nodal lesions, imaging must be submitted (measured spleen volume by CT or MRI for splenomegaly; CT or MRI results for nodal lesions). Baseline laboratory documentation obtained within the past 30 days is required prior to initiating treatment and must include a complete blood count with differential including T and B cell screening and a measurement of serum IgM.

Initial Therapy — Detailed Requirements

inv-13: Initial Therapy — Joenja

Initial authorization criteria for Joenja

Initial: Meets genetic confirmation of APDS with a documented PI3Kδ mutation in PIK3CD or PIK3R1; Age ≥ 12 years; Weight ≥ 45 kg; Provider is an immunologist, has consulted with one, or is a specialist in treating APDS; Baseline labs obtained within 30 days prior to initiation including CBC with differential with T and B cell screening and serum IgM level; Imaging (CT/MRI) submitted if splenomegaly or nodal lesions are present; Not on concurrent immunosuppressive therapy (examples: mTOR inhibitors, B-cell depleters, glucocorticoids >25 mg/day prednisone equivalent, cyclophosphamide, mycophenolate).all listed

Initial authorization: 6 months

Continuation / Reauthorization Requirements

inv-14: Reauthorization

Reauthorization requirements for continued coverage

Reauthorization: Continued coverage requires: evidence of positive clinical response since therapy initiation demonstrated by disease stability or mild progression as evidenced by one or more of: reduction in lymph node lesions on CT/MRI if present at baseline; normalization in T and B cell counts on follow-up CBC; reduction in spleen size on CT/MRI if applicable; normalization in IgM levels on follow-up serum testing; submission of progress notes documenting infection frequency or severity; Absence of unacceptable toxicity from the drug (e.g., severe neutropenia ANC <500 cells/μL, severe skin rash); Member remains NOT on concurrent immunosuppressive therapy (examples: mTOR inhibitors, B-cell depleters, glucocorticoids >25 mg/day prednisone equivalent, cyclophosphamide, mycophenolate).all listed

12-month reauthorization

Provider Actions and Submission Requirements

Prior Authorization

Prior Authorization Form and Submission

Prior Authorization Required: Prescribing physician must sign and clearly print name on the prior authorization (PA) request form (preprinted stamps are not valid). Office staff may complete other fields. Fax the completed form to 1-305-671-0200. Ensure phone and fax numbers on the form are correct — incomplete, incorrect, or illegible information can delay or result in denial of the authorization.

Fax: 1-305-671-0200
Provider signature and printed name required (no preprinted stamps)
Ensure phone and fax numbers are current and legible

Documentation Required

Required Supporting Documentation

Required supporting documentation must be submitted with the PA request. To support each criterion checked on the form, provide relevant labs, diagnostic reports, and chart notes. Missing documentation may result in delay or denial.

Baseline labs obtained within past 30 days: complete blood count with differential including T and B cell screening; serum IgM level
Genetic testing results confirming PI3Kδ mutation in PIK3CD or PIK3R1 for APDS diagnosis
Imaging reports (CT or MRI) for spleen volume or nodal lesions when applicable
Progress notes documenting medical history (recurrent infections, EBV/CMV viremia, autoimmune cytopenia, lymphadenopathy/hepatomegaly)
Documentation of member weight and date when applicable

Step Therapy

Step-Edit / Samples and Verification of Previous Therapies

Step-edit and sample policy: initiation with drug samples does not satisfy step-edit or preauthorization requirements. Prior therapies will be verified via pharmacy paid claims or submitted chart notes. Incomplete or illegible requests (including missing signature or supporting documentation) risk delay or denial.

Samples do NOT meet step-edit/preauthorization criteria
Previous therapies will be checked via pharmacy claims or chart notes
Non‑formulary medications require medical necessity documentation

Denial Risk

Risk of Delay or Denial for Incomplete/Illegible Requests

Incomplete or illegible requests — including missing provider signature, missing or outdated contact information, or absent required labs/diagnostics — can cause delays or denial of the PA. Provide complete, legible submissions and all requested supporting documentation to avoid processing delays.

Missing provider signature or illegible form elements may delay processing
Omit relying on samples as documentation of prior therapy
Ensure all checked clinical criteria have corresponding documentation attached

Step	Rule	Verification
1	Use of samples to initiate therapy does not meet step edit/preauthorization criteria.	Previous therapies will be verified through pharmacy paid claims or submitted chart notes.

Background and Clinical Context

Activated phosphoinositide 3-kinase (PI3K) delta syndrome (APDS) is a genetic immunodeficiency characterized by recurrent sinopulmonary infections, chronic viral viremia (eg, EBV, CMV), autoimmune cytopenias, and lymphadenopathy or hepatomegaly/splenomegaly. Leniolisib (Joenja) is indicated for APDS when genetic testing confirms a PI3Kδ mutation with a documented variant in either PIK3CD or PIK3R1 and clinical criteria are met.

Prior to initiating therapy, providers must document characteristic clinical manifestations (for example recurrent sinusitis, pneumonia, bronchitis, chronic EBV/CMV viremia, autoimmune cytopenia, and/or lymphadenopathy/hepatomegaly) and submit the supporting labs and imaging described above; initial approvals are issued for 6 months when all criteria are satisfied.

OpenPayer

Prior authorization criteria for Joenja (leniolisib)

Coverage Criteria for Joenja (leniolisib)

Initial Therapy — Detailed Requirements

Continuation / Reauthorization Requirements

Coding and Clinical Limits

Quantity and Dispensing Limits

Provider Actions and Submission Requirements

Site of Care and Specialty Pharmacy

Step Therapy and Sample Use

Background and Clinical Context

Definitions