Procysbi (cysteamine bitartrate) — Blue Cross Blue Shield of Texas

Preferred products

• Cystagon (immediate release cysteamine)

Initial criteria

• ONE of the following: (A) Diagnosis of nephropathic cystinosis OR (B) Another FDA labeled indication for the requested agent and route of administration OR (C) Indication supported in compendia for the requested agent and route of administration
• AND if the patient has an FDA labeled indication, then ONE of the following: (A) Patient age is within FDA labeling for the indication OR (B) There is support for use at the patient’s age for the requested indication
• AND ONE of the following: (A) Patient is currently being treated with and stable on the requested agent [chart notes required] OR (B) Tried and had inadequate response to Cystagon (immediate release cysteamine) [chart notes required] OR (C) Cystagon was discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event [chart notes required] OR (D) Intolerance or hypersensitivity to Cystagon not expected to occur with requested agent [chart notes required] OR (E) FDA labeled contraindication to Cystagon not expected to occur with requested agent [chart notes required] OR (F) Cystagon expected to be ineffective or cause significant barrier to adherence, worsen comorbid condition, decrease functional ability, or cause harm [chart notes required] OR (G) Cystagon not in the best interest of patient based on medical necessity [chart notes required] OR (H) Tried another drug in same pharmacologic class as Cystagon that was discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event [chart notes required]
• AND prescriber is a specialist in patient’s diagnosis (e.g., nephrologist) or has consulted with one
• AND patient has no FDA labeled contraindications to the requested agent

Approval duration

12 months