Pharmacy Prior Authorization Criteria

Vijoice (alpelisib) - PA, NF

Indications for Prior Authorization

Vijoice (alpelisib)

• For diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS)
  Indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

  This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Criteria

Vijoice

Prior Authorization (Initial Authorization)

Length of Approval: 6 months [A]

• Diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS)
AND
• Disease is confirmed by the presence of mutation in the PIK3CA gene as detected by an FDA-approved test or test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Patient is 2 years of age or older
AND
• Documentation of severe clinical manifestations (e.g., Congenital Lipomatous Overgrowth, Vascular malformations, Epidermal nevi, Scoliosis/skeletal and spinal [CLOVES], Facial Infiltrating Lipomatosis [FIL], Klippel-Trenaunay Syndrome [KTS], Megalencephaly-Capillary Malformation Polymicrogyria [MCAP])
AND
• Prescribed by or in consultation with one of the following:
• Geneticist
• Physician who specializes in the treatment of PROS

Vijoice

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., radiological response defined as a ≥ 20% reduction from baseline in the sum of target lesion volume)
AND
• Prescribed by or in consultation with one of the following:
• Geneticist
• Physician who specializes in the treatment of PROS

Vijoice

Non Formulary (Initial Authorization)

Length of Approval: 6 months [A]

• Diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS)
AND
• Submission of medical records (e.g., chart notes) confirming disease has the presence of mutation in the PIK3CA gene as detected by an FDA-approved test or test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Patient is 2 years of age or older
AND
• Submission of medical records (e.g., chart notes) confirming documentation of severe clinical manifestations (e.g., Congenital Lipomatous Overgrowth, Vascular malformations, Epidermal nevi, Scoliosis/skeletal and spinal [CLOVES], Facial Infiltrating Lipomatosis [FIL], Klippel-Trenaunay Syndrome [KTS], Megalencephaly-Capillary Malformation Polymicrogyria [MCAP])
AND
• Prescribed by or in consultation with one of the following:
• Geneticist
• Physician who specializes in the treatment of PROS

Vijoice

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., radiological response defined as a ≥ 20% reduction from baseline in the sum of target lesion volume)
AND
• Prescribed by or in consultation with one of the following:
• Geneticist
• Physician who specializes in the treatment of PROS

P & T Revisions

2025-06-04, 2024-07-02, 2024-05-17, 2023-07-05, 2023-06-12, 2022-09-06, 2022-06-01

References

1. Vijoice Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, New Jersey. April 2024.

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End Notes

1. Patients without any response assessment at Week 24 were considered non-responders. [1]

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Revision History

• 2025-06-04: 2025 Annual Review - Updated mutation criteria to align with standard verbiage and added prescriber requirement
• 2024-07-02: Addition of new 50mg oral granule formulation to guideline.
• 2024-05-17: 2024 annual review. Background changes.
• 2023-07-05: update guideline
• 2023-06-12: Annual review - updated references.
• 2022-09-06: Add NF criteria for Vijoice. Updated guideline name.
• 2022-06-01: New program for Vijoice.

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