Viokace — Blue Cross Blue Shield of Montana

Preferred products

• Creon
• Zenpep

Initial criteria

• Requested agent is eligible for continuation of therapy AND patient has been treated with the requested agent (not including samples) within the past 90 days AND is at risk if therapy is changed OR ALL of the following:
• Patient has an FDA labeled indication or compendia supported indication for the requested agent
• If requested agent is Pancreaze, Pertzye, or Viokace, then ONE of the following:
• - Patient is currently being treated with and stable on requested agent [chart notes required] OR
• - Patient has tried and had inadequate response to BOTH Creon and Zenpep [chart notes required] OR
• - BOTH Creon and Zenpep discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
• - Patient has intolerance or hypersensitivity to BOTH Creon and Zenpep not expected to occur with requested agent [chart notes required] OR
• - Patient has FDA labeled contraindication to BOTH Creon and Zenpep not expected to occur with requested agent [chart notes required] OR
• - BOTH Creon and Zenpep expected to be ineffective or cause significant barrier, worsen comorbidity, or cause harm [chart notes required] OR
• - BOTH Creon and Zenpep are not in best interest of patient based on medical necessity [chart notes required] OR
• - Patient has tried another drug in same class as BOTH Creon and Zenpep and discontinued due to lack of efficacy or adverse event [chart notes required]
• If patient has an FDA labeled indication, then:
• - Patient’s age is within FDA labeling for requested indication OR
• - Supporting information for using requested agent for patient’s age and indication
• If request is for Viokace, patient will take with a proton pump inhibitor (PPI)
• Prescriber is a specialist in or has consulted specialist in disease area (e.g., cystic fibrosis, gastroenterology)
• Patient does not have any FDA labeled contraindications to requested agent
• Requested quantity (dose) ≤ 10,000 units/kg/day OR supporting information provided for higher dose
• Alternate approval path: Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND patient has no FDA contraindications AND ONE of the following:
• - Another FDA labeled indication OR
• - Another compendia supported indication OR
• - Prescriber submitted TWO peer-reviewed journal articles supporting use

Reauthorization criteria

• Patient previously approved for requested agent through plan’s PA process
• Patient has had clinical benefit with requested agent
• Prescriber is (or has consulted) a specialist in area of diagnosis (e.g., cystic fibrosis, gastroenterologist)
• Patient does not have any FDA labeled contraindications to requested agent
• Requested quantity (dose) ≤ 10,000 units/kg/day OR supporting information provided for higher dose

Approval duration

12 months