Subject: Pancrelipase PA 3134-A P10-2024_R

Drug

Pancreatic Enzymes

CREON  (pancrelipase)

PANCREAZE  (pancrelipase)

PERTZYE  (pancrelipase)

VIOKACE  (pancrelipase)

ZENPEP  (pancrelipase)

Policy:

Indications

FDA-approved Indications

Creon, Pancreaze, Pertzye, Zenpep

These products are indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.

Viokace

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

Coverage Criteria

Exocrine Pancreatic Insufficiency

Authorization may be granted when the requested drug is being prescribed for the treatment of exocrine pancreatic insufficiency when the following criteria is met:

• 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

Place of Service:

Outpatient

The above policy is based on the following references:

1. Creon [package insert]. North Chicago, IL: AbbVie Inc.; February 2024.
2. Pancreaze [package insert]. Campbell, CA: Vivus LLC; February 2024.
3. Pertzye [package insert]. Bethlehem, PA: Digestive Care, Inc.; February 2024.
4. Viokace [package insert]. Bridgewater, NJ: Aimmune Therapeutics, Inc.; February 2024.
5. Zenpep [package insert]. Bridgewater, NJ: Aimmune Therapeutics, Inc.; February 2024.
6. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com.https://online.lexi.com. Accessed September 3, 2024.
7. Lexicomp Online, Lexi-Drugs Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed September 3, 2024.
8. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 09/03/2024).

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 16, 2025