Afrezza (insulin regular human) — Blue Cross Blue Shield of Montana

Preferred products

• Fiasp (insulin aspart)
• Humalog (insulin lispro)
• Humalog U200 (insulin lispro)
• Lyumjev (insulin lispro-aabc)
• NovoLog (insulin aspart)

Initial criteria

• 1. ONE of the following: A. The patient has a diagnosis of diabetes mellitus type 1 AND the patient is currently on long acting insulin therapy OR B. The patient has a diagnosis of diabetes mellitus type 2
• 2. The patient has received ALL of the following to identify any potential lung disease: A. Detailed medical history review AND B. Physical examination AND C. Spirometry with Forced Expiratory Volume in 1 second (FEV1)
• 3. The patient has not smoked in the past 6 months
• 4. If the patient has an FDA labeled indication, then ONE of the following: A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR B. There is support for using the requested agent for the patient’s age for the requested indication
• 5. ONE of the following: A. The request is for a BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR B. The prescriber states the patient is currently being treated with a requested agent AND the patient is currently stable on the requested agent OR C. The patient has tried and had an inadequate response to ONE preferred agent OR D. ONE preferred agent was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event OR E. The patient has an intolerance or hypersensitivity to ONE preferred agent that is not expected to occur with the requested agent OR F. The patient has an FDA labeled contraindication to ALL preferred agents, that is not expected to occur with the requested agent OR G. ONE preferred agent is expected to be ineffective based on the known clinical characteristics of the patient and known characteristics of the drug; OR cause a significant barrier to adherence; OR worsen a comorbid condition; OR decrease the patient’s ability to achieve daily functioning; OR cause adverse reaction or harm OR H. ONE preferred agent is not in the best interest of the patient based on medical necessity OR I. The patient has tried another prescription drug in the same class or with the same mechanism of action as ONE preferred agent and that drug was discontinued due to lack of efficacy, diminished effect, or adverse event OR J. The requested agent is medically necessary and appropriate for the patient OR K. There is support that the patient has a physical or a mental disability that would prevent them from using a preferred rapid acting insulin agent OR L. The patient has a documented needle phobia
• 6. The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND 2. The patient has had clinical benefit with the requested agent AND 3. The patient has received ALL of the following to identify any potential lung disease: A. Detailed medical history review AND B. Physical examination AND C. Spirometry with Forced Expiratory Volume in 1 second (FEV1) AND 4. The patient has not smoked in the past 6 months AND 5. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months