Procysbi (cysteamine bitartrate) — Blue Cross Blue Shield of New Mexico

Preferred products

• Cystagon (immediate release cysteamine)

Initial criteria

• 1. ONE of the following: A. The patient has a diagnosis of nephropathic cystinosis OR B. The patient has another FDA labeled indication for the requested agent and route of administration OR C. The patient has an indication that is supported in compendia for the requested agent and route of administration
• 2. If the patient has an FDA labeled indication, then ONE of the following: A. The patient’s age is within FDA labeling for the requested indication OR B. There is support for using the requested agent for the patient’s age for the requested indication
• 3. ONE of the following: A. The patient is currently being treated with the requested agent and is currently stable OR B. The patient has tried and had an inadequate response to Cystagon (immediate release cysteamine) OR C. Cystagon was discontinued due to lack of efficacy, diminished effect, or adverse event OR D. The patient has intolerance or hypersensitivity to Cystagon not expected with the requested agent OR E. The patient has an FDA labeled contraindication to Cystagon not expected with the requested agent OR F. Cystagon is expected to be ineffective or cause adherence issues, worsen comorbid condition, decrease functional ability, or cause adverse reaction OR G. Cystagon is not in the best interest of the patient based on medical necessity OR H. The patient has tried another prescription drug in the same pharmacologic class as Cystagon that was discontinued due to lack of efficacy or adverse event
• 4. The prescriber is a specialist in the area of the patient's diagnosis (e.g., nephrologist) or has consulted with one
• 5. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months