Pharmacy Prior Authorization Criteria

Procysbi (cysteamine bitartrate)

Indications for Prior Authorization

Procysbi (cysteamine bitartrate)

• For diagnosis of Nephropathic cystinosis
  Indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older.

Criteria

Procysbi Capsules, Procysbi Granules

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of nephropathic cystinosis
AND
• One of the following [A, 2, 3]:
• Diagnosis is confirmed by elevated leukocyte cystine levels (LCL)
OR
• Diagnosis is confirmed by genetic analysis of the CTNS gene
OR
• Diagnosis is confirmed by demonstration of cysteine corneal crystals by slit lamp examination
AND
• Trial and failure or intolerance to Cystagon (immediate-release cysteamine bitartrate)
AND
• Patient is 1 year of age or older

Procysbi Capsules, Procysbi Granules

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., decrease in cystine levels in white blood cells)

P & T Revisions

2024-06-05, 2023-10-12, 2023-06-06, 2022-06-02, 2021-06-02, 2020-05-05, 2020-03-24

References

1. Procysbi Prescribing Information. Horizon Pharma USA, Inc. Lake Forest, IL. February 2022.
2. Emma F, Nesterova G, Langman C, et al. Nephropathic cystinosis: an international consensus document. Nephrol Dial Transplant. 2014 Sep;29(Suppl 4): iv87–iv94.
3. Wilmer MJ, Schoeber JP, van den Heuvel LP, Levtchenko EN. Cystinosis: practical tools for diagnosis and treatment [educational review]. Pediatr Nephrol 2011 Feb; 26(2): 205-15.

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End Notes

1. A definitive diagnosis can be verified by measuring leukocyte cystine levels, genetic analysis of the CTNS gene or demonstration of corneal crystals by slit lamp examination. [2-3]

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Revision History

• 2024-06-05: Annual Review - No criteria changes
• 2023-10-12: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-06-06: Annual Review - no criteria changes
• 2022-06-02: Annual review - Addition of reauth criteria. Approval durations modified.
• 2021-06-02: 2021 Annual Review, no changes to criteria.
• 2020-05-05: Annual review, no changes to clinical criteria.
• 2020-03-24: Addition of granule products

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