CurrentmhnPolicy CP.PCH.44

Clinical Policy: Pancrelipase (Creon, Pancreaze, Pertzye, Viokace, Zenpep)

Clinical policy defining medical necessity criteria, dosing limits, product-specific requirements, prior authorization expectations, and approval durations for pancrelipase products (Creon, Pancreaze, Pertzye, Viokace, Zenpep) for Commercial and Health Insurance Marketplace (HIM) lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Pancrelipase (Creon, Pancreaze, Pertzye, Viokace, Zenpep)

Policy CodePolicy CP.PCH.44

Change TypeDosing, step therapy, indication clarification

Effective DateMar 1, 2022

Next Review Date

Key ActionProvider must submit documentation (e.g., office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

POLICY UPDATE CHANGES

Revised maximum dose criterion to include 10,000 lipase units/kg per day and updated maximum dosing in Section V per revised FDA labels for all products.

Clarified step therapy/redirection: applies to HIM and California Exchange Plans; added for Commercial Plans if request is for Pertzye or Viokace: failure of Pancreaze, Creon, and Zenpep.

For Viokace, added requirement: age ≥18 and concomitant proton pump inhibitor.

Continuation therapy positive response examples added (reduction in steatorrhea, weight/muscle gain, improved fat-soluble vitamin levels).

5Products covered (brand names listed)

3Primary dose limit criteria (meal/day/g fat)

Coverage Summary

Coverage stance: covered with criteria for pancrelipase products (Creon, Pancreaze, Pertzye, Viokace, Zenpep) when policy approval criteria are met. The policy defines product-specific prior authorization expectations and dosing thresholds that must be satisfied for approval.

Scope summary: Clinical policy defining medical necessity criteria, dosing limits, product-specific requirements (including step therapy/redirection and Viokace adult/PPI requirements), prior authorization documentation expectations, and approval durations for the listed pancrelipase products for Commercial and Health Insurance Marketplace (HIM) lines of business.

Covered products: Creon, Pancreaze, Pertzye, Viokace, Zenpep.

Approval duration by line of business: HIM approvals are for 12 months; Commercial approvals are for 12 months or the duration of the request, whichever is less.

Initial Therapy Criteria — Pancreatic Insufficiency

I. Initial Approval Criteria - Pancreatic Insufficiency

Must meet ALL of the following:

ALL of the following

Diagnosis of exocrine pancreatic insufficiency (e.g., due to cystic fibrosis, chronic pancreatitis, pancreatectomy)
One of the following (a or b)
- For HIM and California Exchange Plans: If request is for Pancreaze, Pertzye, or Viokace: Failure of Creon and Zenpep
- For Commercial Plans: If request is for Pertzye or Viokace: Failure of Pancreaze, Creon, and Zenpep
If request is for Viokace (both required)
- Age ≥ 18 years
- Viokace is prescribed concurrently with a proton pump inhibitor
Dose does not exceed one of the following (a, b, or c)
- 2,500 lipase units/kg per meal<= 2,500 lipase units/kg/meal
- 10,000 lipase units/kg per day<= 10,000 lipase units/kg/day
- 4,000 lipase units/g of fat ingested per day<= 4,000 lipase units/g fat/day

Initial Therapy Criteria — Other Indications

I. Initial Approval Criteria - Other diagnoses/indications

Must meet ONE of the following:

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow no coverage criteria or non-formulary policy for relevant line of business (CP.CPA.190 for commercial; HIM.PA.33 for health insurance marketplace; HIM.PA.103 for non-formulary HIM).
If requested use is NOT listed under section III and criterion 1 does not apply, refer to the off-label use policy for relevant line of business (CP.CPA.09 for commercial; HIM.PA.154 for health insurance marketplace).

Continuation Therapy Criteria — Pancreatic Insufficiency

II. Continued Therapy - Pancreatic Insufficiency

Must meet ALL of the following:

ALL of the following

Member status
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy (examples include but are not limited to reduction in steatorrhea and associated gastrointestinal symptoms; gain of weight, muscle mass, and muscle function; improvement in fat-soluble vitamin levels)
If request is for a dose increase, new dose does not exceed one of the following (a, b, or c)

Continuation Therapy — Other Indications

II. Continued Therapy - Other diagnoses/indications

Must meet ONE of the following:

ANY of the following

If label change within last 6 months not reflected in policy, follow no coverage or non-formulary policy for line of business (CP.CPA.190 or HIM.PA.33/HIM.PA.103).
If requested use not listed under section III and above does not apply, refer to off-label use policy (CP.CPA.09 or HIM.PA.154).

Diagnoses / Indications Not Authorized

III. Diagnoses/Indications Not Authorized

Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09 for commercial; HIM.PA.154 for HIM) or evidence of coverage documents

Provider Actions & Prior Authorization Requirements

Step Therapy

Step therapy requirements / product redirection

Step therapy / product redirection requirements vary by line of business. For HIM and California Exchange Plans, requests for Pancreaze, Pertzye, or Viokace require prior failure of Creon and Zenpep (note: Illinois HIM requests are exempt from these step therapy requirements per IL HB 5395). For Commercial Plans, if the request is for Pertzye or Viokace, the member must have failed Pancreaze, Creon, and Zenpep.

Documentation Required

Supportive documentation required

Providers must submit supporting documentation that demonstrates the member meets all approval criteria. Acceptable supportive documentation includes office chart notes, laboratory results, and other clinical information that show the diagnosis, prior therapies (when applicable), dosing, and clinical response.

Office chart notes
Laboratory results

Applicable Codes

No specific billing codes listed in policymixed

No codes listed

Clinical Evidence & Sources

Evidence / references: Prescribing information for Creon, Pancreaze, Pertzye, Viokace, and Zenpep; American Gastroenterological Association (AGA) 2023 expert review; Cystic Fibrosis Foundation pancreatic enzyme clinical care guidelines.

Notes: Per the brief and policy revision history, AGA 2023 expert review examples were added to continuation (continued therapy) criteria and influenced wording in the policy; step therapy examples/changes were updated in subsequent revisions.

Background

Background: Pancrelipase products are porcine-derived combinations of lipases, proteases, and amylases indicated for treatment of exocrine pancreatic insufficiency.

Products have varying strengths and formulations and are not interchangeable with one another.

Policy alignment and product-specific requirements: The policy aligns coverage with FDA-labeled indications. Viokace is limited to adults and must be prescribed with a proton pump inhibitor per the FDA label. The policy includes product-specific step therapy/redirection requirements (see prior authorization criteria).

Definitions: Exocrine pancreatic insufficiency — a condition with insufficient pancreatic enzyme activity leading to malabsorption (examples include cystic fibrosis, chronic pancreatitis, pancreatectomy).

Revision History

revised_dosing

Revised maximum dose criterion to include 10,000 lipase units/kg per day and updated maximum dosing in Section V per revised FDA labels for Pancreaze, Pertzye, and Zenpep.

10.23.25step_therapy_bypass_addedLatest

Added step therapy bypass for Illinois HIM per IL HB 5395; clarified redirection/step therapy applies to HIM and California Exchange Plans and added for Commercial Plans if request is for Pertzye or Viokace: failure of Pancreaze, Creon, and Zenpep.

viokace_adult_ppi_requirement