pancrelipase (Pancreaze; Pertyze; Viokace)
Self Administration - Oral
Indications for Prior Authorization:
Pancreatic Insufficiency - indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
Coverage Criteria:
For diagnosis of pancreatic insufficiency and request for Pancreaze, Pertzye, or Viokace:
- Diagnosis is confirmed by medical record documentation; AND
- Dose of the requested drug does not exceed the maximum approved by the FDA based on the patient’s diagnosis, age, and weight; AND
- Patient has experienced an inadequate response, contraindication, or intolerable side effect to BOTH Creon and Zenpep; AND
- For Viokace only: patient is 18 years of age or older, and will use a proton pump inhibitor in combination with Viokace.
Reauthorization Criteria:
Request for continuation of treatment:
- Dose does not exceed FDA label maximum for an appropriate indication, AND
- Patient has experienced a positive clinical response to therapy.
Coverage Duration:
- Initial: 1 year
- Reauthorization: 1 year
Authorization is not covered for the following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
Additional Information:
- The preferred pancreatic enzymes are Creon and Zenpep.
- Examples of proton pump inhibitors (PPIs) include omeprazole (Prilosec), esomeprazole (Nexium), lansoprazole (Prevacid), rabeprazole (AcipHex), pantoprazole (Protonix), and dexlansoprazole (Dexilant).
Policy Updates:
- 08/17/2021 – New step therapy policy approved by P&T. Removed prior authorization for Creon. Added step therapy (ST) edit through Pancreaze, Pertzye, and Viokace through two preferred agents (Creon and Zenpep).
References:
- Pancreaze Prescribing Information. Janssen Pharmaceuticals, Inc.; Titusville, NJ. October 2018.
- Pertzye Prescribing Information. Digestive Care, Inc.; Bethlehem, PA. March 2020.
- Viokace Prescribing Information. Allergan USA, Inc.; Irvine, CA. March 2020.
- Creon Prescribing Information. AbbVie Inc.; North Chicago, IL. March 2020.
- Zenpep Prescribing Information. Allergan USA, Inc.; Irvine, CA. March 2020.