CurrentNeighborhood Health Plan of Rhode IslandPolicy Pancrelipase PA Policy 3134-A 10-2022

Pancrelipase (pancreatic enzyme) prior authorization

Prior authorization criteria for pancreatic enzyme products (pancrelipase brands) for treatment of exocrine pancreatic insufficiency; applies to prescribers and prior authorization reviewers for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPancrelipase (pancreatic enzyme) prior authorization

Policy CodePolicy Pancrelipase PA Policy 3134-A 10-2022

Change TypeNo material changes

Effective DateOct 1, 2022

Next Review Date

Key ActionObtain prior authorization and document the clinical indication for exocrine pancreatic insufficiency; if Viokace is requested, document the patient will take it with a proton pump inhibitor (PPI).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5brand names listed

1primary coverage criterion

1Viokace PPI requirement

7references cited

Coverage Criteria

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Initial Prior Authorization

Covered when ALL of the following are met.

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

Supports Creon, Pancreaze, Pertzye, Viokace, Zenpep use

Viokace-specific: If the requested product is Viokace, the patient will take it with a proton pump inhibitor (PPI)

Viokace tablets require concomitant PPI per indication

Use of the requested drug for indications other than exocrine pancreatic insufficiency is not covered under this criteria.

Product Coding

Listed brand productsmixed

CREON	brand name — pancrelipase
PANCREAZE	brand name — pancrelipase
PERTZYE	brand name — pancrelipase
VIOKACE	brand name — pancrelipase
ZENPEP	brand name — pancrelipase

Additional coding key/value items

Coding inventoryListed brand pancrelipase products: Creon, Pancreaze, Pertzye, Viokace, Zenpep

Policy IDPancrelipase PA Policy 3134-A (effective 2022-10-01)

Coverage stanceCovered with prior authorization when prescribed for exocrine pancreatic insufficiency

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for listed pancrelipase products when prescribed for treatment of exocrine pancreatic insufficiency. This includes branded pancrelipase products such as CREON, PANCREAZE, PERTZYE, VIOKACE, and ZENPEP.

Applies to pancrelipase products for exocrine pancreatic insufficiency (cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions).
Viokace (pancrelipase) requires documentation that it will be taken concomitantly with a proton pump inhibitor (PPI).

Documentation Required

Required Clinical Documentation

Providers must submit clinical documentation supporting the diagnosis of exocrine pancreatic insufficiency when requesting pancrelipase therapy. If Viokace is requested, include documentation that the patient will use it in combination with a proton pump inhibitor (PPI).

Clinical indication supporting exocrine pancreatic insufficiency (for example: cystic fibrosis, chronic pancreatitis, pancreatectomy, or other supporting condition).
For Viokace requests: clear documentation that the patient will take Viokace concomitantly with a PPI.

Denial Risk

Indication Required

Requests for pancreatic enzyme therapy that are not prescribed for treatment of exocrine pancreatic insufficiency (for example, for indications not listed above) may be denied.

Ensure the prescription and submitted documentation indicate an approved indication: cystic fibrosis, chronic pancreatitis, pancreatectomy, or other recognized causes of exocrine pancreatic insufficiency.

Denial Risk

Viokace PPI Requirement

Requests for Viokace without documentation that the patient will take it concomitantly with a proton pump inhibitor (PPI) may be denied.

If prescribing Viokace, include the planned PPI regimen in the clinical documentation.

Definitions

Exocrine pancreatic insufficiency — definition and pancrelipase context

DefinitionExocrine pancreatic insufficiency: a condition in which the pancreas does not produce sufficient digestive enzymes; treated with pancreatic enzyme replacement therapy (pancrelipase).

Indications — CreonIndicated for exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions.

Indications — Pancreaze, Pertzye, ZenpepIndicated for exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

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

Context for usePancrelipase products are pancreatic enzyme replacements used to treat exocrine pancreatic insufficiency from causes such as cystic fibrosis, chronic pancreatitis, or pancreatectomy; prior authorization is required per policy when used for these indications.