CurrentUnitedHealthcarePolicy N/A

Step therapy for pancreatic enzyme products (Pancreaze, Pertzye, Viokace)

Defines step therapy requirements for coverage of Pancreaze, Pertzye, and Viokace for members with exocrine pancreatic insufficiency; applies to UnitedHealthcare pharmacy benefit members subject to this program.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for pancreatic enzyme products (Pancreaze, Pertzye, Viokace)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization showing documented failure, contraindication, or intolerance to BOTH Creon and Zenpep before approving Pancreaze, Pertzye, or Viokace.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

Creon, Zenpeprequired step agents

10/1/2025effective

2014-2025P&T review years

Coverage Criteria

Initial Therapy

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for pancreatic enzyme products (Pancreaze, Pertzye, Viokace)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization showing documented failure, contraindication, or intolerance to BOTH Creon and Zenpep before approving Pancreaze, Pertzye, or Viokace.

SourceLink

On This Page

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No explicit exclusions are specified in this policy beyond the programmatic step-therapy requirements and product labeling. Coverage for Pancreaze, Pertzye, or Viokace is governed by the requirement that the member has a documented history of failure, contraindication, or intolerance to both Creon and Zenpep prior to approval; additional limitations and usage instructions in the manufacturers’ labeling (for example, Viokace’s required coadministration with a proton pump inhibitor for its labeled indications) also apply.

Provider Actions and Requirements

Prior Authorization

Prior authorization and approval period

Prior authorization is required. Approval will be issued for 12 months. State mandates, federal requirements, and the member's benefit plan may affect coverage and duration.

Approval period: 12 months
State and federal mandates and member-specific benefits may affect coverage

Step Therapy

Step therapy failure requirement

Member must have documented failure, intolerance, or contraindication to required step agents before Pancreaze, Pertzye, or Viokace will be covered.

Coverage denied unless there is documentation of failure, contraindication, or intolerance to step agents
UnitedHealthcare may use prior claims, diagnosis codes, and medication history to verify step therapy failure

Step Therapy

Required step agents

Required step agents: the member must try Creon and Zenpep prior to coverage of Pancreaze, Pertzye, or Viokace. Note: Viokace requires co-administration with a proton pump inhibitor for approved indication; ensure documentation reflects PPI use when applicable.

Required step agents: Creon and Zenpep
Step requirement applies before coverage of Pancreaze, Pertzye, or Viokace
Viokace: indicated for use in combination with a proton pump inhibitor in adults — document PPI co-administration when applicable

Documentation Required

Use of claim/diagnosis history for approvals

UnitedHealthcare may approve initial or reauthorization requests based solely on prior claim/medication history, diagnosis codes (ICD-10), and claim logic. Automated approval and re-approval processes may be used per program.

Approvals may be based on prior claims, ICD-10 diagnosis codes, and medication history
Automated approval/re-approval processes vary by program and therapeutic class

Definitions

Exocrine pancreatic insufficiency — key definitions

DefinitionExocrine pancreatic insufficiency — clinical condition treated with pancrelipase replacement therapy.

Primary agents usedPancrelipase products include Creon, Pancreaze, Pertzye, and Zenpep; Viokace is indicated with a proton pump inhibitor for certain adult indications.

Indications for ViokaceViokace indicated in combination with a proton pump inhibitor for exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in adults.

Program intentStep therapy is used to encourage the use of lower-cost alternatives within this therapeutic class.

Step requirement summaryMembers must try Creon and Zenpep prior to coverage of Pancreaze, Pertzye, or Viokace.

Background

Pancrelipase products — including Creon, Pancreaze, Pertzye, and Zenpep — are indicated for the treatment of exocrine pancreatic insufficiency. Viokace is indicated, in combination with a proton pump inhibitor, for exocrine pancreatic insufficiency due to chronic pancreatitis or following pancreatectomy in adults. This policy’s step-therapy program requires trial of Creon and Zenpep before coverage of Pancreaze, Pertzye, or Viokace will be authorized.

Initial Therapy Criteria

Initial coverage

Initial coverage requires step therapy failure

Step requirement: Documented history of failure, contraindication, or intolerance to BOTH Creon AND Zenpep is required prior to approval of Pancreaze, Pertzye, or Viokace.

This program requires trial of Creon and Zenpep before coverage for Pancreaze, Pertzye, or Viokace; Viokace is indicated with a proton pump inhibitor for certain diagnoses.

Step Therapy Requirements

Required prior agents	Agents requiring step-failure before approval	Notes / special requirements
{"text":"Creon","status":""}\|{"text":"Pancreaze","status":"covered"}\|{"text":"Member must have history of failure, contraindication, or intolerance to BOTH Creon and Zenpep prior to approval; prior authorization required. Approval issued for 12 months.","status":""}
{"text":"Zenpep","status":""}\|{"text":"Pertzye","status":"covered"}\|{"text":"Viokace requires co-administration with a proton pump inhibitor per product labeling when indicated (chronic pancreatitis or post‑pancreatectomy in adults).","status":""}
{"text":"","status":""}\|{"text":"Viokace","status":"covered"}\|{"text":"Step therapy program requires trial of Creon and Zenpep before coverage of Pancreaze, Pertzye, or Viokace; approvals contingent on documented failure, contraindication, or intolerance to both agents.","status":""}

OpenPayer