Afrezza
Drug - Afrezza® (insulin,human) [Sanofi-Aventis U.S. LLC]
January 2018
Therapeutic area - Insulins
Approval criteria - Type 1 diabetes mellitus
The patient or prescribing physician must meet all of the following criteria:
- Patient has a diagnosis of type 1 diabetes mellitus
- Patient must be 18 years of age or older
- Treatment with a prandial insulin has been initiated for at least 90 days or a documented intolerance or contraindication exists to prandial insulin (documentation showing the intolerance or contraindication must be submitted with prior authorization request)
- Prescribing physician must make a statement of anticipated benefit and defines when efficacy will be re-evaluated
- Afrezza must be used concurrently with a basal insulin
- Prescriber attests that the patient is a non-smoker or has stopped smoking for at least six months prior to request for Afrezza
- Patient has a compelling medical reason that prohibits him or her from self-injecting. Dislike of injections is not sufficient
- Patient must not have a history of underlying lung disease (asthma, COPD, lung cancer)
Approval criteria – Type 2 diabetes mellitus
Patient or prescribing physician must meet all of the following criteria:
- Patient has a diagnosis of type 2 diabetes mellitus
- Patient must be 18 years of age or older
- Patient must be on two or more oral hypoglycemic agents concurrently
- Treatment with a prandial insulin has been initiated for at least 90 days or a documented intolerance or contraindication exists to prandial insulin (clinical notes documenting the intolerance or contraindication must be submitted with prior authorization request)
- Prescribing physician must make a statement of anticipated benefit and defines when efficacy will be re-evaluated
- Prescriber attests that the patient is a non-smoker or has stopped smoking for at least six months prior to request for Afrezza
- Patient has a compelling medical reason that prohibits him or her from self-injecting. Dislike of injections is not sufficient
Quantity limit
- 4 units = 270 cartridges per 34 days
- 8 units = 270 cartridges per 34 days
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411