Pharmacy Prior Authorization Criteria

Afrezza (insulin human, inhalation powder) - PA, NF

Indications for Prior Authorization

Afrezza (insulin human, inhalation powder)

• For diagnosis of Diabetes Mellitus
  Indicated to improve glycemic control in adult patients with diabetes mellitus.

  Limitations of Use: 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.

Criteria

Afrezza

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• 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)
OR
• Diagnosis of type 2 diabetes mellitus
AND
• Unable to self-inject short-acting insulin multiple times daily due to one of the following: [4]
• 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 [A]
AND
• Prescribed by or in consultation with an endocrinologist
AND
• Afrezza will NOT be approved in patients:
• Who smoke cigarettes
• Who recently quit smoking (within the past 6 months) [B]
• With chronic lung disease (e.g., asthma, chronic obstructive pulmonary disease [COPD]) [C]

Afrezza

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Repeat pulmonary function test confirms that the patient has NOT experienced a decline of 20% or more in FEV1 from baseline [1]
AND
• Patient demonstrates positive clinical response to therapy
AND
• Both of the following: [1]
• Patient does NOT have chronic lung disease (e.g., asthma, chronic obstructive pulmonary disease [COPD])
• Patient does not smoke cigarettes

Afrezza

Non Formulary (Initial Authorization)

Length of Approval: 6 Month(s)

• 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)
OR
• Diagnosis of type 2 diabetes mellitus
AND
• Submission of medical records (e.g., chart notes) documenting that patient is unable to self-inject short-acting insulin multiple times daily due to one of the following: [4]
• Physical impairment
• Visual impairment
• Lipohypertrophy
AND
• Submission of medical records (e.g., chart notes) documenting FEV1 within the last 60 days greater than or equal to 70% of expected normal as determined by the physician [A]
AND
• Prescribed by or in consultation with an endocrinologist
AND
• Afrezza will NOT be approved in patients:
• Who smoke cigarettes
• Who recently quit smoking (within the past 6 months) [B]
• With chronic lung disease (e.g., asthma, chronic obstructive pulmonary disease [COPD]) [C]

Afrezza

Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) documenting repeat pulmonary function test confirms that the patient has NOT experienced a decline of 20% or more in FEV1 from baseline [1]
AND
• Patient demonstrates positive clinical response to therapy
AND
• Both of the following: [1]
• Patient does NOT have chronic lung disease (e.g., asthma, chronic obstructive pulmonary disease [COPD])
• Patient does not smoke cigarettes

P & T Revisions

2024-01-02, 2023-09-13, 2023-01-24, 2022-02-18, 2021-05-04, 2020-01-30

References

1. Afrezza Prescribing Information. MannKind Corporation. Danbury, CT. February 2023.
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.

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End Notes

1. The inclusion criteria for the phase III trial includes the following parameters: Forced expiratory volume in 1 second (FEV1) = 70% of predicted values. [2, 3]
2. The exclusion criteria for the phase III trial excludes current smokers or smoking history within the past 6 months. [2, 3]
3. Afrezza (insulin human) is contraindicated in patients with chronic lung disease such as asthma or chronic obstructive pulmonary disease (COPD).

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Revision History

• 2024-01-02: 2024 UM Annual Review. Added NF reauth criteria to mirror PA reauth criteria. Background updates
• 2023-09-13: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-01-24: 2023 UM Annual Review. Updated NF criteria to require submission of medical records to align with NF SOP.
• 2022-02-18: Annual review: no criteria changes.
• 2021-05-04: Updated guideline
• 2020-01-30: - no updates to clinical criteria - removed word "Afrezza from reauthorization criteria

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