Pertzye — Blue Cross Blue Shield of New Mexico

Preferred products

• Creon
• Zenpep

Initial criteria

• The patient has an FDA labeled indication or an indication supported in compendia for the requested agent AND
• If the requested agent is Pancreaze, Pertzye, or Viokace, then ONE of the following:
• 1. The patient is currently being treated with the requested agent and the patient is currently stable on the requested agent [chart notes required] OR
• 2. The patient has tried and had an inadequate response to BOTH Creon and Zenpep [chart notes required] OR
• 3. BOTH Creon and Zenpep were discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event [chart notes required] OR
• 4. The patient has an intolerance or hypersensitivity to BOTH Creon and Zenpep that is not expected to occur with the requested agent [chart notes required] OR
• 5. The patient has an FDA labeled contraindication to BOTH Creon and Zenpep that is not expected to occur with the requested agent [chart notes required] OR
• 6. BOTH Creon and Zenpep are expected to be ineffective based on known clinical characteristics, cause barrier to adherence, worsen comorbid condition, decrease ability to perform daily activities, or cause adverse reaction or harm [chart notes required] OR
• 7. BOTH Creon and Zenpep are not in the best interest of the patient based on medical necessity [chart notes required] OR
• 8. The patient has tried another prescription drug in the same pharmacologic class or mechanism as BOTH Creon and Zenpep and that drug was discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event [chart notes required] AND
• If the patient has an FDA labeled indication, then ONE of: the patient’s age is within FDA labeling for the indication for the requested agent OR information supports use in that age group AND
• If request is for Viokace, the patient will take with a proton pump inhibitor (PPI) AND
• The prescriber is a specialist in or has consulted with a specialist in the area of the patient’s diagnosis (e.g., cystic fibrosis, gastroenterologist) AND
• The patient does not have any FDA labeled contraindications to the requested agent AND
• ONE of the following dose conditions: (1) requested dose does NOT exceed 10,000 units/kg/day OR (2) requested dose exceeds 10,000 units/kg/day AND support provided for higher dose

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
• The patient has had clinical benefit with the requested agent AND
• The prescriber is a specialist in or has consulted with a specialist in the area of the patient’s diagnosis AND
• The patient does NOT have any FDA labeled contraindications to the requested agent AND
• ONE of the following dose conditions: (1) requested dose does NOT exceed 10,000 units/kg/day OR (2) requested dose exceeds 10,000 units/kg/day AND support provided for higher dose

Approval duration

12 months