Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the
www.fepblue.org
website.
Lumasiran (Oxlumo) may be considered medically necessary when the following are met:
-
The individual has a diagnosis of primary hyperoxaluria type 1 (PH1) confirmed by ONE of the following:
-
Genetic testing of the
AGXT
gene indicates a pathogenic mutation
OR
-
Liver biopsy demonstrates absent or significantly reduced alanine:glyoxylate aminotransferase (AGT) activity
AND
-
The requested agent will be used to lower urinary or plasma oxalate levels
AND
-
ONE of the following:
-
The individual has tried and had an inadequate response to pyridoxine (vitamin B6) for at least 3 months
ANDONE of the following:
-
The individual is unresponsive to pyridoxine (vitamin B6) (unresponsive defined as less than or equal to 30% decrease in urine oxalate after 3 months of treatment with maximally tolerated pyridoxine)
OR
-
The individual is responsive to pyridoxine (vitamin B6) (responsive defined as greater than 30% decrease in urine oxalate after 3 months of treatment with maximally tolerated pyridoxine)
ANDwill continue treatment with pyridoxine (vitamin B6) in combination with the requested agentOR
-
The individual has an intolerance or hypersensitivity to pyridoxine (vitamin B6) therapy
OR
-
The individual has an FDA labeled contraindication to pyridoxine (vitamin B6)
AND
-
The individual has NOT received a liver transplant
AND
-
The prescriber is a specialist in the area of the individual's diagnosis (e.g., gastroenterologist, nephrologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis
AND
-
The individual will NOT be using the requested agent in combination with Rivfloza (nedosiran)
AND
-
The individual does NOT have any FDA labeled contraindications to the requested agent
AND
- The requested quantity (dose) is within FDA labeled dosing for the requested indication.
Reauthorization Criteria
Reauthorization of lumasiran (Oxlumo) may be considered medically necessary when the following criteria are met:
-
The individual has been previously approved for the requested agent through Blue Cross Blue Shield of North Dakota's Medical Drug Review process [Note: individuals not previously approved for the requested agent will require initial evaluation review]
AND
-
The individual has had clinical benefit with the requested agent (e.g., decrease in urinary or plasma oxalate levels)
AND
-
ONE of the following:
-
ONE of the following:
-
The individual will continue treatment with pyridoxine (vitamin B6) in combination with the requested agent
OR
-
The individual was unresponsive to pyridoxine (vitamin B6) (unresponsive defined as less than or equal to 30% decrease in urine oxalate after 3 months of treatment with maximally tolerated pyridoxine)
OR
-
The individual has an intolerance or hypersensitivity to pyridoxine (vitamin B6) therapy
OR
-
The individual has an FDA labeled contraindication to pyridoxine (vitamin B6)
AND
-
The individual has NOT received a liver transplant
AND
-
The prescriber is a specialist in the area of the individual's diagnosis (e.g., gastroenterologist, nephrologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis
AND
-
The individual will NOT be using the requested agent in combination with Rivfloza (nedosiran)
AND
-
The individual does NOT have any FDA labeled contraindications to the requested agent
AND
- The requested quantity (dose) is within FDA labeled dosing for the requested indication.
The use of lumasiran (Oxlumo) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
