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    v1.0.28
    OpenPayerPolicy UpdatesGastroenterologyDelaware First Health Pancrelipase Coverage Update…
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    ModifiedDelaware First HealthPolicy CP.PMN.226

    Pancrelipase (Creon, Pancreaze, Pertzye, Viokace, Zenpep) — Coverage Criteria

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    Defines medical necessity, initial and continued authorization criteria, dosing limits, and product availability for pancrelipase products for members under the Medicaid line of business.

    Policy Summary
    PayerDelaware First Health
    PolicyPancrelipase (Creon, Pancreaze, Pertzye, Viokace, Zenpep) — Coverage Criteria
    Policy CodePolicy CP.PMN.226
    Change TypeDosing limits revisednew product strength addedindication language clarified
    Effective DateJan 1, 2020
    Next Review DateFeb 1, 2024
    Key ActionSubmit prior authorization with documentation showing member meets approval criteria and that dosing does not exceed revised limits (10,000 lipase units/kg/day).
    SourceLink
    POLICY UPDATE CHANGES

    Revised maximum dose criterion to include 10,000 lipase units/kg per day per product labeling.

    Added a new 60,000 USP unit strength for Zenpep.

    Updated FDA Approved Indication(s) language to generalize the approved indication for Creon, Pancreaze, Pertzye, and Zenpep, and specified Viokace requires concurrent PPI and adult age.

    Updated FDA-approved indication language was generalized for Creon, Pancreaze, Pertzye, and Zenpep and maximum dose criteria were revised to include 10,000 lipase units/kg per day per PI.

    For Pancreaze requests require redirection to Creon.

    Continuation of therapy positive response examples were added (e.g., reduction in steatorrhea, weight/muscle gain, improved fat-soluble vitamin levels) per AGA 2023 expert review.

    12 months

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    Approval duration
    2,500 U/kgMax per meal
    10,000 U/kgMax per day
    60,000 USPNew Zenpep strength
    MedicaidLine of business

    Coverage Criteria for Pancrelipase

    inv-01: Initial Therapy

    Covered when ALL of the following are met:

    Initial Approval - Pancreatic Insufficiency: 1. Diagnosis of exocrine pancreatic insufficiency (e.g., due to cystic fibrosis, chronic pancreatitis, pancreatectomy); 2. If request is for Pancreaze, Pertzye, Viokace or Zenpep: Failure of Creon, unless contraindicated or clinically significant adverse effects are experienced; 3. If request is for Viokace, both of the following (a and b): (a) Age ≥ 18 years; (b) Viokace is prescribed concurrently with a proton pump inhibitor; 4. Dose does not exceed one of the following (a, b, or c): (a) 2,500 lipase units/kg per meal; (b) 10,000 lipase units/kg per day; (c) 4,000 lipase units/g of fat ingested per day.

    inv-02: Continuation Therapy

    Covered for continuation when ALL of the following are met:

    Continued Therapy - Pancreatic Insufficiency: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or has previously met initial approval criteria; OR (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy (examples may 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); 3. If request is for a dose increase, new dose does not exceed one of the following: (a) 2,500 lipase units/kg per meal; (b) 10,000 lipase units/kg per day; (c) 4,000 lipase units/g of fat ingested per day.

    inv-03: Other Indications

    Other uses (not primary pancreatic insufficiency):

    Other Diagnoses/Indications: 1. If the drug has had a label change within the last 6 months not yet reflected in this policy, refer to either: (a) no coverage criteria policy CP.PMN.255 for Medicaid (formulary/PDL) or (b) non-formulary policy CP.PMN.16 for Medicaid; OR 2. If the requested use (diagnosis, age, dosing) is not listed under Section III and criterion 1 does not apply, refer to the off-label use policy CP.PMN.53 for Medicaid.

    inv-04: Continuation Therapy (updated)

    Continuation of therapy is supported when there is documented positive response and dosing is within revised PI limits.

    Continuation of therapy: Member demonstrates positive clinical response AND prescribed dosing does not exceed 10,000 lipase units/kg per day per product PI10,000 lipase units/kg/day

    Positive response examples: reduction in steatorrhea and associated gastrointestinal symptoms; gain of weight, muscle mass, and muscle function; improvement in fat-soluble vitamin levels; policy examples of exocrine pancreatic insufficiency include cystic fibrosis, chronic pancreatitis, and pancreatectomy.

    Non-FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the request is supported by sufficient documentation of efficacy and safety in accordance with the off‑label use policy CP.PMN.53 or applicable evidence of coverage documents.

    Administrative updates to the policy include removal of the Commercial and CA Exchange lines of business per SDC direction. These are operational changes and do not alter clinical coverage criteria or medical necessity determinations.

    Use of pancrelipase products for non‑FDA approved indications without sufficient supporting clinical documentation is not authorized. Requests for off‑label uses must meet the documentation and evidence requirements outlined in off‑label use policy CP.PMN.53 to be considered.

    Annual reviews noted no significant changes to the policy’s not medically necessary conditions. The 4Q 2023 and 4Q 2024 reviews indicated references were reviewed and updated, and continuation criteria were clarified with examples per the AGA 2023 expert review, but no new explicit 'not medically necessary' conditions were added.

    Coding, Dosing Limits, and Product Strengths

    Coding Implicationsmixed
    No codes listed
    Product strengths / NDC-level noteNDC
    60,000 USPZenpep new strength added
    inv-11: Maximum lipase per meal — 2,500 lipase units/kg per meal.
    Maximum lipase per meal2,500 lipase units/kg per meal
    ContextListed as one of three dosing limits for initial and continued therapy (also appears in Section V Dosage and Administration).
    Use caseApplies to children >12 months, adults, and as a maximum for meal dosing per product guidance.
    inv-12: Maximum lipase per day — 10,000 lipase units/kg per day (revised per PI).
    Maximum lipase per day10,000 lipase units/kg per day
    Revision noteUpdated to include 10,000 lipase units/kg per day per product PI in recent policy revisions.

    Provider Actions, Prior Authorization, and Documentation

    Prior Authorization

    Prior authorization required for pancrelipase products

    Prior authorization is required. Creon, Pancreaze, Pertzye, Viokace, and Zenpep are medically necessary only when the policy's approval criteria are met.

    Prior Authorization

    Prior authorization — dosing and product updates

    Update prior authorization requests to reflect revised dosing limits and new product strength: maximum dosing criteria now include 10,000 lipase units/kg per day per product PI, and Zenpep 60,000 USP unit strength has been added.

    • Revised maximum dose criterion: 10,000 lipase units/kg per day per product PI
    • New Zenpep strength: 60,000 USP
    Step Therapy

    Background and Drug Description

    Pancrelipase products (porcine‑derived combinations of lipase, protease, and amylase) are enzyme replacement therapies used to treat exocrine pancreatic insufficiency resulting from conditions such as cystic fibrosis, chronic pancreatitis, or pancreatectomy. Clinical response is typically assessed by reduction in steatorrhea and gastrointestinal symptoms, weight gain or improved muscle mass/function, and improvement in fat‑soluble vitamin levels. Note that Viokace requires coadministration with a proton pump inhibitor in adults per product labeling.

    Definitions and Clinical Examples

    inv-24: Exocrine pancreatic insufficiency — definition and examples (CF, chronic pancreatitis, surgical resection).
    DefinitionExocrine pancreatic insufficiency: a condition resulting in inadequate pancreatic enzyme secretion leading to malabsorption.
    Common examplesCystic fibrosis; chronic pancreatitis; pancreatectomy (surgical resection).
    Therapeutic implicationPancrelipase products are indicated for treatment of exocrine pancreatic insufficiency in adults and pediatric patients; Viokace requires a PPI in adults.
    inv-25: Positive response for continuation of therapy — Examples include reduction in steatorrhea, weight/muscle gain, improved labs.
    Positive response examplesReduction in steatorrhea and associated gastrointestinal symptoms; gain of weight, muscle mass, and muscle function; improvement in fat-soluble vitamin levels.
    Documentation use
    Policy Summary
    PayerDelaware First Health
    PolicyPancrelipase (Creon, Pancreaze, Pertzye, Viokace, Zenpep) — Coverage Criteria
    Policy CodePolicy CP.PMN.226
    Change TypeDosing limits revisednew product strength addedindication language clarified
    Effective DateJan 1, 2020
    Next Review DateFeb 1, 2024
    Key ActionSubmit prior authorization with documentation showing member meets approval criteria and that dosing does not exceed revised limits (10,000 lipase units/kg/day).
    SourceLink
    On This Page
    Coverage Criteria for PancrelipaseCoding, Dosing Limits, and Product StrengthsProvider Actions, Prior Authorization, and DocumentationBackground and Drug DescriptionDefinitions and Clinical Examples
    ApplicationLimits total daily dosing for initial approval and continuation; referenced in Section V dosing tables.
    inv-13: Maximum lipase per fat ingested — 4,000 lipase units/g fat/day.
    Maximum lipase per fat ingested4,000 lipase units/g of fat ingested per day
    RoleAlternative dosing limit based on dietary fat intake used to guide safe daily enzyme dosing.
    ReferenceIncluded among dosing limits for initial and continued therapy and in Section V dosing guidance.
    inv-14: Maximum lipase dose — 10,000 lipase units/kg per day (per product PI).
    Maximum lipase dose (policy/PI)10,000 lipase units/kg per day
    Policy changeRevised maximum dose criterion to include 10,000 lipase units/kg per day per product labeling as of policy updates.
    ImplementationContinuation of therapy requires dosing within this revised PI limit.

    Step requirement — trial of Creon required

    For requests for Pancreaze, Pertzye, Viokace, or Zenpep, prior authorization requires documentation of prior failure of Creon unless Creon is contraindicated or clinically significant adverse effects occurred.

    • Failure of Creon must be documented unless contraindication or significant adverse effects prevent its use
    Note

    Administrative: submit PA with current product/dosing information

    Provider should submit prior authorization through the plan's administrative process and ensure requests use current product strengths and dosing limits per the policy and updated FDA labeling.

    • Use updated dosing thresholds when calculating daily or per-meal doses
    • Include correct product strength (e.g., Zenpep 60,000 USP when applicable)
    Documentation Required

    Required documentation for initial PA

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

    • Office chart notes
    • Relevant laboratory results
    • Other clinical information demonstrating diagnosis and prior treatments
    Documentation Required

    Documentation required for continuation of therapy

    Continuation requests must be supported by documentation of a positive clinical response, with examples including reduction in steatorrhea, gain of weight or muscle mass/function, or improvement in fat‑soluble vitamin levels; dosing for continuation must remain within the revised PI limits (e.g., ≤10,000 lipase units/kg per day).

    • Examples of positive response: reduction in steatorrhea or GI symptoms; weight or muscle mass/function gain; improved fat‑soluble vitamin levels
    • If dose increase requested, new dose must not exceed 2,500 lipase U/kg/meal, 10,000 lipase U/kg/day, or 4,000 lipase U/g fat/day
    Denial Risk

    Non‑FDA indications may be denied without supporting evidence

    Requests for non‑FDA approved indications not addressed in this policy may be denied unless sufficient documentation supports efficacy and safety per the off‑label use policy (CP.PMN.53) or evidence of coverage documents.

    • Provide evidence of efficacy and safety consistent with CP.PMN.53 when requesting off‑label use
    Note

    Redirect Pancreaze requests to Creon

    Pancreaze requests must be redirected to Creon per policy editing; failure to redirect may result in administrative redirection or denial.

    • If submitting for Pancreaze, provide documentation or redirect request to Creon as required by the policy
    These examples support continuation of therapy per AGA 2023 expert review and are cited in the policy's continuation criteria.
    Outcome roleUsed to demonstrate clinical benefit when assessing renewal of pancrelipase therapy.