AFREZZA (insulin human, inhalation powder)

AFREZZA (insulin human, inhalation powder)

Self-Administration – oral inhalation

Diagnosis considered for coverage:

• Diabetes Mellitus: Indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use: Afrezza is not a substitute for long-acting insulin. Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus. Afrezza is not recommended for the treatment of diabetic ketoacidosis. The safety and efficacy of Afrezza in patients who smoke has not been established. The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking.

Coverage Criteria:

For diagnosis of diabetes mellitus:

• One of the following: 
  • Both of the following: 
    • Diagnosis of type 1 diabetes mellitus, and
    • Used in combination with a long-acting insulin (e.g., Lantus, Levemir) 
  • Diagnosis of type 2 diabetes mellitus; AND
• Prescribed by or in consultation with an endocrinologist; AND
• Unable to self-inject short-acting insulin multiple times daily due to one of the following: 
  • Physical impairment 
  • Visual impairment 
  • Lipohypertrophy; AND
• Documented FEV1 within the last 60 days greater than or equal to 70% of expected normal as determined by the physician; AND
• Afrezza will NOT be approved in patients: 
  • Who smoke cigarettes 
  • Who recently quit smoking (within the past 6 months) 
  • With chronic lung disease (e.g., asthma, chronic obstructive pulmonary disease [COPD]) 

Reauthorization Criteria:

For diagnosis of diabetes mellitus:

• Repeat pulmonary function test confirms that the patient has NOT experienced a decline of 20% or more in FEV1 from baseline; AND
• Documentation of positive clinical response to therapy; AND
• Both of the following: 
  • Patient does NOT have chronic lung disease (e.g., asthma, chronic obstructive pulmonary disease [COPD]) 
  • Patient does not smoke cigarettes 

Coverage Duration: 

• Initial: 6 months
• Reauthorization: 1 year

Dosing:

• For insulin naïve patients, start on 4 units of AFREZZA at the beginning of each meal.
• For patients using subcutaneous, mealtime (prandial) insulin:
  • Determine the appropriate AFREZZA dose for each meal by converting from the injected insulin dose using Table 1.
  • When switching from another insulin to AFREZZA, a different insulin dose may be needed requiring increased frequency of blood glucose monitoring.
• For patients using subcutaneous, pre-mixed insulin:
  • Estimate the mealtime injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day. When switching from another insulin to AFREZZA, a different insulin dose may be needed. When switching a patient’s insulin regimen, increase the frequency of blood glucose monitoring.
  • Convert each estimated injected mealtime dose to an appropriate AFREZZA dose using Table 1.
  • Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose
• For AFREZZA doses exceeding the contents of a single cartridge at mealtime, inhalations from more than one cartridge are necessary. To achieve the required total mealtime dose, use a combination of 4 unit, 8 unit, and 12 unit cartridges. 

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• The inclusion criteria for the phase III trial includes the following parameters: Forced expiratory volume in 1 second (FEV1) = 70% of predicted values. 
• The exclusion criteria for the phase III trial excludes current smokers or smoking history within the past 6 months. 
• Afrezza (insulin human) is contraindicated in patients with chronic lung disease, such as asthma or chronic obstructive pulmonary disease (COPD), because of the risk of acute bronchospasm.

Policy Updates:

• 03/01/2024 –New policy for Afrezza approved by WHA P&T Committee. (P&T, 02/20/2024)

References:

1. Afrezza Prescribing Information. MannKind Corporation. Danbury, CT. February 2020. 
2. Bode BW, McGill JB, Lorber DL, et al. Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial. Diabetes Care. 2015 Dec;38(12):2266-73. 
3. Rosenstock J, Franco D, Korpachev V, et al. Inhaled Technosphere Insulin Versus Inhaled Technosphere Placebo in Insulin-Naïve Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Agents. Diabetes Care. 2015 Dec;38(12):2274-81. 
4. Per clinical consult with endocrinologist, August 6, 2014.