Pancreatic Enzymes – Net Results Formulary

Restricted Product(s)

• Pancreaze® (pancrelipase) 
• Pertzye® (pancrelipase) 
• Viokace® (pancrelipase)

FDA Approved Use

• Treatment of exocrine pancreatic insufficiency caused by cystic fibrosis or other conditions.

Criteria for Approval of Restricted Product(s)

1. The patient is stable on the requested medication (either Pancreaze, Pertzye, or Viokace) and unable to convert to either Creon or Zenpep; OR 
2. The patient has had a trial and failure of the following alternatives Creon and Zenpep; OR 
3. The patient has a clinical contraindication or intolerance to all of the unrestricted alternatives; AND 
4. The requested quantity (dose) does NOT exceed 10,000 lipase units/kg/day; OR 
   1. The patient is < 4 years of age and requires ≥ 6 meals/snacks/feedings per day; OR 
   2. The provider has submitted a written clinical rationale in support of therapy with a higher quantity (dose) for the requested indication (if criteria point is not met, 30 day authorization provided); AND 
5. For products that require Value PA, refer to the Value PA UM Criteria. 

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Borowitz DS, Grant RJ Durie PR, the Consensus Committee. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. J Pediatr. 1995; 127:681-84.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

November 2023: Updated terminology from Medical Necessity PA to Value PA.
September 2023: Criteria change: Addition of criteria regarding patients < 4 years of age who require 6 or more meals/snacks per day. 30 day authorization provided if 10,000 units/kg/day criteria point not met
July 2023: Criteria change: Added requirement that dosing does not exceed 10,000 units/kg/day unless supported by clinical documentation
October 2021: Criteria update: Annual criteria review. Created Net Results only policy. Changed duration of approval to 365 days.
July 2019: Original utilization management criteria issued.