Emflaza — Blue Cross Blue Shield of Montana

Preferred products

• prednisone
• prednisolone
• deflazacort (generic Emflaza)

Initial criteria

• Diagnosis of Duchenne Muscular Dystrophy confirmed by genetic analysis (dystrophin deletion or duplication mutation) [genetic test required] OR another FDA labeled indication for the requested agent and route of administration
• If the patient has an FDA labeled indication, then ONE of: patient's age is within FDA labeling for the requested indication and agent OR there is support for use in patient’s age for the requested indication
• ONE of: request is for BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR patient is currently treated and stable on requested agent [chart notes required] OR patient has tried and had inadequate response after 6 months therapy with generic prednisone or prednisolone [chart notes required] OR prednisone/prednisolone discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event [chart notes required] OR intolerance or hypersensitivity to prednisone/prednisolone [chart notes required] OR labeled contraindication to prednisone/prednisolone [chart notes required] OR prednisone/prednisolone expected to be ineffective based on patient characteristics or causes adherence barrier/comorbid worsening/functional decline/adverse reaction [chart notes required] OR prednisone/prednisolone not in best interest of patient [chart notes required] OR patient tried another drug in same pharmacologic class and discontinued due to inefficacy/adverse event [chart notes required]
• If brand Emflaza requested and generic deflazacort available, ONE of: request is for BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR patient is currently treated and stable on requested agent [chart notes required] OR tried and had inadequate response to generic equivalent [chart notes required] OR generic equivalent discontinued for inefficacy/adverse event [chart notes required] OR intolerance/hypersensitivity to generic that is not expected with brand [chart notes required] OR labeled contraindication to generic not expected with brand [chart notes required] OR generic expected to be ineffective or causes adherence barrier/adverse reaction [chart notes required] OR generic not in best interest of patient [chart notes required] OR tried another agent in class with failure OR support for brand over generic
• Prescriber is a specialist in area of diagnosis (e.g., pediatric neurologist) or has consulted with such specialist
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Requested dose does NOT exceed max FDA labeled dose based on weight

Reauthorization criteria

• Patient previously approved for requested agent through plan’s Prior Authorization process
• Patient has had improvements or stabilization with requested agent (e.g., improved strength, timed motor function, pulmonary function; reduced need for scoliosis surgery)
• If brand Emflaza requested and generic deflazacort available, ONE of: request is for BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR patient is currently treated and stable on requested agent [chart notes required] OR tried and had inadequate response to generic equivalent [chart notes required] OR generic equivalent discontinued for inefficacy/adverse event [chart notes required] OR intolerance/hypersensitivity to generic that is not expected with brand [chart notes required]

Approval duration

12 months (36 months for BCBSOK; 6 months for Agamree in other plans)