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

nephropathic cystinosis

Preferred products

  • Cystagon (immediate release cysteamine)

Initial criteria

  • 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
  • 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
  • ONE of the following: A. The patient is currently being treated with the requested agent and the patient is currently stable on the requested agent [chart notes required] OR B. The patient has tried and had an inadequate response to Cystagon (immediate release cysteamine) [chart notes required] OR C. Cystagon was discontinued due to lack of efficacy/effectiveness, diminished effect, or an adverse event [chart notes required] OR D. The patient has an intolerance or hypersensitivity to Cystagon that is not expected to occur with the requested agent [chart notes required] OR E. The patient has an FDA labeled contraindication to Cystagon that is not expected to occur with the requested agent [chart notes required] OR F. Cystagon is expected to be ineffective based on known clinical characteristics of the patient and drug; OR cause a significant barrier to adherence; OR worsen a comorbid condition; OR decrease ability to perform daily activities; OR cause adverse reaction or harm [chart notes required] OR G. Cystagon is not in the best interest of the patient based on medical necessity [chart notes required] OR H. The patient has tried another prescription drug in the same pharmacologic class or mechanism as Cystagon that was discontinued due to lack of efficacy/effectiveness or adverse event [chart notes required]
  • The prescriber is a specialist in the area of the patient's diagnosis (e.g., nephrologist) OR has consulted with such a specialist
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months