CurrentCentenePolicy CP.PCH.44

Pancrelipase (Creon, Pancreaze, Pertzye, Viokace, Zenpep)

Policy governs medical necessity criteria, prior authorization requirements, dosing limits, continuation criteria, and coverage/denial rules for pancrelipase products (Creon, Pancreaze, Pertzye, Viokace, Zenpep) for Commercial and HIM lines of business.

Policy Summary

PayerCentene

PolicyPancrelipase (Creon, Pancreaze, Pertzye, Viokace, Zenpep)

Policy CodePolicy CP.PCH.44

Change TypeRevised, Clarified, Added

Effective DateMar 1, 2022

Next Review Date

Key ActionProvider must submit office chart notes, lab results or other clinical information supporting that member meets all approval criteria.

POLICY UPDATE CHANGES

Updated FDA Approved Indications language for Creon, Pancreaze, Pertzye, and Zenpep and revised maximum dose criterion to include 10,000 lipase units/kg per day per PI.

Added Pancreaze as a required step-through drug for Pertzye and Viokace requests in addition to Creon and Zenpep (later revised/removed per SDC).

Clarified dosing by separating various dosing options and updated Pancreaze as delayed-release capsules per updated prescribing information.

Added new Zenpep 60,000 USP unit strength to product availability.

5Products covered

3Covered indications examples

3Approval duration (months)

Coverage stance: covered_with_criteria. Subject: Pancrelipase (Creon, Pancreaze, Pertzye, Viokace, Zenpep). Scope: Policy governs medical necessity criteria, prior authorization requirements, dosing limits, continuation criteria, and coverage/denial rules for pancrelipase products for Commercial and HIM lines of business. Drug products governed by this policy (Pancrelipase brands): Creon, Pancreaze, Pertzye, Viokace, Zenpep. Effective date: 03.01.22. Last review date: 12.24. Policy number: CP.PCH.44.

Initial Therapy Criteria

Initial Approval Criteria

Pancrelipase (Pertzye, Viokace, Zenpep) is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of exocrine pancreatic insufficiency (e.g., due to fibrosis, chronic pancreatitis, pancreatectomy, cystic fibrosis)
Pancreatic insufficiency (must meet all internal requirements)
- Step therapy/brand-specific failures: If request is for Pancreaze, Pertzye, or Viokace: failure of Creon and Zenpep, unless clinically significant adverse effects are experienced or both are contraindicated
- Viokace requirement: If request is for Viokace, Viokace is prescribed concurrently with a proton pump inhibitor
- Age criterion: Age > 18 years
  Policy text includes age >18 as a criterion in one location; pediatric dosing is addressed separately
- Dose limits: Dose request meets dosing thresholds and does not exceed maximum dose limits (see Dosage limits node)

Dosage limits

Dosage limits (applies to initial and continuation requests)

Dose must meet per-meal and per-day maximum thresholds:

Per-meal limit: Per meal: 2,500 lipase units/kg per meal<= 2,500 lipase units/kg per meal
Per-day limit: Per day: does not exceed 10,000 lipase units/kg per day<= 10,000 lipase units/kg per day
Per-fat threshold: Alternative per-fat threshold: does not exceed 4,000 lipase units per gram of fat ingested per day<= 4,000 lipase units per gram of fat ingested per day
Allowance for exceedance: Higher dosages may be administered if documented effective by fecal fat measures or improvement of malabsorption
Operational allowance for doses exceeding maxima with objective documentation

Continuation (Renewal) Criteria

Continued therapy is approved when ALL of the following are met:

ALL of the following

Member status: Member is currently receiving medication via Centene benefit or member previously met initial approval criteria
Member is responding positively to therapy
- Examples of positive response (one or more): Reduction in steatorrhea and associated gastrointestinal symptoms; Gain of weight; Improvement in muscle mass and muscle function; Improvement in fat-soluble vitamin levels
  Examples of positive response (one or more)
Dose increase check: If request is for a dose increase, new dose does not exceed dosing maxima (2,500 lipase units/kg per meal; 10,000 lipase units/kg per day; 4,000 lipase units/g fat ingested per day)

Unproven / Not Authorized Uses

Diagnoses/Indications Not Authorized

Coverage is not authorized for:

Diagnoses/Indications Not Authorized: Non‑FDA approved indications not addressed in this policy unless sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents

Provider Actions

Step Therapy

Step therapy requirements for certain brands

If request is for Pancreaze, Pertzye, or Viokace: failure of Creon and Zenpep is required unless clinically significant adverse effects are experienced or both are contraindicated. If request is for Viokace, Viokace must be prescribed concurrently with a proton pump inhibitor.

Viokace must be co‑prescribed with a proton pump inhibitor.
For Pancreaze, Pertzye, or Viokace requests: prior failure of Creon and Zenpep is required unless both are contraindicated or cause clinically significant adverse effects.

Documentation Required

Submit supporting documentation

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

Office chart notes
Laboratory results
Other clinical information supporting criteria

Documentation Required

Dose exceedance documentation

Higher than maximum dosages may be approved only if documented effective by fecal fat measures or improvement of malabsorption.

Objective fecal fat measures demonstrating effectiveness
Clinical documentation of improvement in malabsorption (e.g., reduction in steatorrhea, weight gain, improved vitamin levels)

Billing Rule

Approval duration

Approval duration differs by line of business: HIM — 12 months; Commercial — 12 months or duration of request, whichever is less. (Note: some sections list 6 months, but the policy specifies the durations above.)

HIM: 12 months
Commercial: 12 months or duration of request, whichever is less
Some sections of the policy list 6 months, but the final stated durations are as above

Clinical Evidence & References

References reviewed/updated include Prescribing Information for Creon, Pancreaze, Pertzye, Viokace, and Zenpep (February 2024) and guideline/review sources including the Cystic Fibrosis Foundation pancreatic enzymes clinical care guidelines and the American Gastroenterological Association expert review (2023). Dosing and labeling changes from revised FDA prescribing information were incorporated into the policy (see changes noting Section V dosing updates and revised maximum dose criterion to include 10,000 lipase units/kg per day).

Background

Background: Pancrelipase products are porcine-derived pancreatic enzyme combinations containing lipase, protease, and amylase used to treat exocrine pancreatic insufficiency (EPI) in adult and pediatric patients. Creon, Pancreaze, Pertzye, and Zenpep are indicated for EPI in adults and pediatric patients; Viokace is indicated for adult EPI due to chronic pancreatitis or pancreatectomy only when coadministered with a proton pump inhibitor. Definitions: EPI = Exocrine pancreatic insufficiency. Dosing metric definition: lipase units/kg is the dosing metric used for pancreatic enzyme replacement therapy.

Revision History

03.06.24revisedLatest

Section V dosing updated per revised FDA labels; references updated. Updated FDA Approved Indications language for Creon, Pancreaze, Pertzye, and Zenpep and revised maximum dose criterion to include 10,000 lipase units/kg per day per PI.

11.18.22revised

Policy history shows step therapy redirections modified: for Pertzye and Viokace requests added Pancreaze as a required step-through drug in addition to Creon and Zenpep (later revised/removed per SDC).

12.05.23added

RTA: Zenpep new 60,000 USP unit strength added to product availability.

07.11.22clarified

Template and dosing clarifications applied; references reviewed and updated; clarified dosing by separating various dosing options and modified Pancreaze as delayed-release capsules per updated prescribing information.