CurrentNeighborhood Health Plan of Rhode IslandPolicy 3134-A

Pancrelipase (pancreatic enzyme) prior authorization

Defines prior authorization requirements for pancreatic enzyme products (pancrelipase brands) for treatment of exocrine pancreatic insufficiency; applies to Neighborhood Health Plan of Rhode Island members subject to CVS/Caremark PA process.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPancrelipase (pancreatic enzyme) prior authorization

Policy CodePolicy 3134-A

Change TypeNo material change

Effective DateOct 1, 2023

Next Review Date

Key ActionObtain prior authorization and document diagnosis of exocrine pancreatic insufficiency; for Viokace, confirm concomitant use of a proton pump inhibitor.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsDuration of approval

6Products listed

PA requiredType

Coverage Criteria for Pancrelipase

Authorization Criteria

Covered when ALL of the following are met

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Indication: The requested drug is prescribed for treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions.

Supported by product labeling and policy intent.

Viokace specific: If the request is for Viokace, the patient will take Viokace in combination with a proton pump inhibitor (PPI).

Applies to Viokace in adults per product labeling.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for pancrelipase products; the drug will be covered when prescribed for exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions. The authorization is valid for 12 months.

Affected drugs: Creon, Pancreaze, Pertzye, Viokace, Zenpep (all pancrelipase products)
Duration of approval: 12 months (Policy 3134-A)

Note

Viokace PPI Requirement

If the request is for Viokace, the patient must be taking Viokace in combination with a proton pump inhibitor (PPI) as a condition of coverage.

Viokace must be used concomitantly with a PPI

Documentation Required

Required Documentation

Documentation must support the diagnosis of exocrine pancreatic insufficiency (e.g., due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other documented conditions). Include relevant clinical notes, diagnostic test results, surgical history, and prior treatment information as applicable to substantiate medical necessity.

Documented diagnosis of exocrine pancreatic insufficiency and underlying cause
Relevant diagnostic tests or assessments (e.g., fecal elastase, clinical evaluation)
Medication history and prior therapies
Surgical history if pancreatectomy is the reason

Denial Risk

Non‑Indicated Use

Requests for pancrelipase to treat functional digestive disorders that are unrelated to exocrine pancreatic insufficiency are not appropriate and will be denied.

Non-indicated use: functional digestive disorders unrelated to pancreatic insufficiency — denial risk

Key Definitions

Exocrine pancreatic insufficiency — definition and common causes

DefinitionA disorder in which the pancreas does not produce sufficient digestive (exocrine) enzymes, requiring pancreatic enzyme replacement therapy (pancrelipase).

Common causesCystic fibrosis; chronic pancreatitis; pancreatectomy (surgical removal of all or part of the pancreas).

Other causesOther conditions leading to loss of exocrine pancreatic function (per product labeling).

Treatment relevancePancrelipase products are indicated to replace pancreatic enzymes for exocrine pancreatic insufficiency — effectiveness is specific to this condition and not for functional digestive disorders unrelated to pancreatic insufficiency.

Viokace-specific noteViokace tablets are indicated in adults for exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy and must be used with a proton pump inhibitor (PPI).

Background

Pancrelipase products are indicated as pancreatic enzyme replacement therapy for patients with exocrine pancreatic insufficiency due to causes such as cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions. Viokace (pancrelipase) tablets require coadministration with a proton pump inhibitor in adults. The policy aligns coverage with these labeled indications and does not support use outside of pancreatic insufficiency.