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

Preferred products

• Cystagon (immediate release cysteamine)

Initial criteria

• ONE of the following: (A) patient has a diagnosis of nephropathic cystinosis OR (B) patient has another FDA labeled indication for the requested agent and route of administration OR (C) patient has an indication supported in compendia for the requested agent and route of administration
• AND if the patient has an FDA labeled indication, ONE of the following: (A) 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
• AND ONE of the following: (A) patient is currently treated and stable on the requested agent [chart notes required] OR (B) patient has tried and had inadequate response to Cystagon (immediate release cysteamine) [chart notes required] OR (C) Cystagon was discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR (D) patient has intolerance or hypersensitivity to Cystagon not expected with requested agent [chart notes required] OR (E) patient has FDA labeled contraindication to Cystagon not expected with requested agent [chart notes required] OR (F) Cystagon is expected to be ineffective, hinder adherence, worsen comorbid condition, decrease functional ability, or cause adverse reaction or harm [chart notes required] OR (G) Cystagon is not in best interest of patient based on medical necessity [chart notes required] OR (H) patient has tried another prescription drug in same pharmacologic class as Cystagon and discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required]
• AND prescriber is a specialist in the area of diagnosis (e.g., nephrologist) or has consulted with such a specialist
• AND patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months