Subject: Pancrelipase PA Policy 3134-A UDR 10-2023

Drug

PANCREATIC ENZYMES

CREON  (pancrelipase)

PANCREAZE  (pancrelipase)

PERTZYE  (pancrelipase)

VIOKACE  (pancrelipase)

ZENPEP  (pancrelipase)

Note: *Drugs that are listed in the target drug box include both brand and generic and all dosage forms and strengths unless otherwise stated. OTC products are not included unless otherwise stated.

Policy:

FDA-APPROVED INDICATIONS
Creon
Creon (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions.

Pancreaze, Pertzye, Zenpep
Pancreaze, Pertzye, and Zenpep (pancrelipase) are indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Viokace
Viokace (pancrelipase) tablets, in combination with a proton pump inhibitor, is indicated in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.


COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
     •   The requested drug is being prescribed for the treatment of
          exocrine pancreatic insufficiency due to cystic fibrosis, chronic
          pancreatitis, pancreatectomy, or other conditions
     AND
     •   If the request is for Viokace, the patient will take Viokace in
          combination with a proton pump inhibitor (PPI)

Duration of Approval (DOA):
     •   3134-A: DOA: 12 months


RATIONALE
The intent of the criteria is to provide coverage consistent with product labeling, FDA guidance, standards of medical practice, evidence-based drug information, and/or published guidelines. Creon (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions.¹ Pancreaze, Pertzye, and Zenpep (pancrelipase) are indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.^2,3,5 Viokace (pancrelipase) tablets, in combination with a proton pump inhibitor, is indicated in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.⁴ Pancrelipase is not effective in the treatment of functional digestive disorders unrelated to pancreatic insufficiency.⁶

 

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Creon [package insert]. North Chicago, IL: AbbVie Inc.; June 2022.
2. Pancreaze [package insert]. Campbell, CA: Vivus LLC.; January 2022.
3. Pertzye [package insert]. Bethlehem, PA: Digestive Care, Inc.; September 2022.
4. Viokace [package insert]. Bridgewater, NJ: Nestlé HealthCare Nutrition, Inc.; March 2020.
5. Zenpep [package insert]. Bridgewater, NJ: Nestlé HealthCare Nutrition, Inc.; March 2020.
6. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2023. https://online.lexi.com. Accessed August 31, 2023.
7. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 08/31/2023).

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

February 11, 2024