CurrentBlue Cross Blue Shield - IowaPolicy 05.01.83

Afrezza (inhaled insulin) prior authorization and medical necessity

Defines medical necessity, prior authorization criteria, quantity limits, and billing guidance for Afrezza (inhaled rapid-acting insulin) for adult patients with type 1 or type 2 diabetes mellitus for Wellmark Blue Cross and Blue Shield (Iowa).

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyAfrezza (inhaled insulin) prior authorization and medical necessity

Policy CodePolicy 05.01.83

Change TypeNo material changes

Effective DateMar 14, 2025

Next Review Date

Key ActionObtain prior authorization and submit required documentation including pulmonary function test results and evidence of HbA1c reduction and a stable maintenance dose for continuation approvals.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12Approval duration when criteria met

3Required stable maintenance prior to renewal (months)

6Recent smoking excluded window (months)

2–6Typical quantity limit range per 30 days (boxes)

Medical Necessity Criteria for Afrezza

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Medically necessary — General conditions

Afrezza may be considered medically necessary when ALL of the following are met:

ALL of the following

Exclusion for chronic lung disease or smoking
- Patient has been evaluated with pulmonary function tests to rule out bronchospasm or chronic lung disease prior to initial approval and repeated with each renewal
- Patient does NOT have chronic lung disease such as asthma or chronic obstructive pulmonary disease (COPD)
- Patient does NOT smoke and has not recently stopped smoking within the past 6 months
Patient has been receiving a stable maintenance dose of Afrezza for at least 3 months>= 3 months
Patient has demonstrated a reduction in hemoglobin A1c (HbA1c) since starting Afrezza

Medically necessary — Alternate pathway: Type 1 diabetes

Afrezza may be considered medically necessary for an adult with type 1 diabetes when ALL of the following are met:

ALL of the following

Requested drug is being prescribed for an adult with type 1 diabetes mellitus
Patient has experienced an intolerance or has a contraindication to the preferred injectable rapid-acting insulins
Requested drug will be used in combination with long-acting insulin

Medically necessary — Alternate pathway: Type 2 diabetes

Afrezza may be considered medically necessary for an adult with type 2 diabetes when ALL of the following are met:

ALL of the following

Requested drug is being prescribed for an adult with type 2 diabetes mellitus
Patient has experienced an intolerance or has a contraindication to the preferred injectable rapid-acting insulins
Additional requirement for type 2 pathway
- Patient has experienced an inadequate treatment response to metformin AND another non-insulin antidiabetic agent
- Patient has intolerance to metformin AND another non-insulin antidiabetic agent

Not medically necessary

Afrezza is considered not medically necessary when the above criteria are not met.

ANY of the following

Patient has chronic lung disease (e.g., asthma, COPD), smokes, or stopped smoking within the past 6 months
Required pulmonary function testing not performed prior to initiation or not repeated at renewal
No demonstrated HbA1c reduction since starting Afrezza (for continuation pathway)

Product Packaging, NDCs, and Quantity Limits

NDC / Product packaging (quantity limits)NDC/mfgCovered

Afrezza - 4/8 unit combo (90x4 & 90x8)	Total units/box = 1080 units; Quantity limit per 30 days = 3 boxes (3240 units)/30 days
Afrezza - 8/12 unit combo (90x8 & 90x12)	Total units/box = 1800 units; Quantity limit per 30 days = 2 boxes (3600 units)/30 days
Afrezza - 90 cartridges (4 unit)	Total units/box = 360 units; Quantity limit per 30 days = 6 boxes (2160 units)/30 days
Afrezza - 90 cartridges (8 unit)	Total units/box = 720 units; Quantity limit per 30 days = 5 boxes (3600 units)/30 days
Afrezza - 90 cartridges (12 unit)	Total units/box = 1080 units; Quantity limit per 30 days = 3 boxes (3240 units)/30 days

Procedures and billing codes (document instructs to use appropriate codes)mixed

Document refers providers to report appropriate CPT, HCPCS, Revenue, and ICD diagnostic codes; no specific codes listed

Policy identifiermixed

05.01.83

Wellmark policy number

Billing Rule

Adhere to quantity limits

Prescriptions for Afrezza must conform to the specified product/package quantity limits per 30 days; requests that exceed the listed limits may be denied or require justification during adjudication.

Quantity limits vary by package (examples: 4/8 unit combo = 3 boxes/30 days; 90×4 cartridges = 6 boxes/30 days; 90×8 cartridges = 5 boxes/30 days).
Billing or pharmacy requests above these limits may be subject to claim denial or require additional documentation to justify the quantity.

Prior Authorization and Documentation Requirements

Prior Authorization

Prior authorization required

Afrezza is subject to prior authorization and will be approved only when the documented medical necessity criteria are met; approvals are issued for 12 months.

Approval duration when criteria met: 12 months.

Documentation Required

Pulmonary function testing required

Obtain pulmonary function tests to rule out bronchospasm or chronic lung disease prior to initial approval and repeat testing with each renewal; document the results in the patient chart and include them with the prior authorization submission.

PFTs are required to evaluate for chronic lung disease (e.g., asthma, COPD) before initiating Afrezza and must be repeated at each renewal.

Documentation Required

Demonstrate treatment response

For continuation approvals, document a reduction in hemoglobin A1c since initiating Afrezza and provide evidence that the patient has been on a stable maintenance dose for at least 3 months.

Stable maintenance dose requirement: patient has been receiving a consistent dosing regimen for >= 3 months prior to renewal.
Include HbA1c change from baseline in the chart and prior authorization renewal.

Denial Risk

Contraindication / exclusion risks

Requests will be denied if the patient has chronic lung disease, currently smokes, has stopped smoking within the past 6 months, or if required pulmonary function testing was not performed.

Chronic lung disease examples: asthma, chronic obstructive pulmonary disease (COPD).
Recent smoking exclusion window: stopped smoking within the past 6 months is an exclusion.

Billing Rule

Adhere to quantity limits

Prescriptions must conform to the specified product/package quantity limits per 30 days; claims exceeding these limits may be denied or require justification — billing teams should apply the listed quantity limits for each package when processing.

Apply the published quantity limits by package when adjudicating pharmacy claims (examples provided in policy quantity limits section).
If submitted quantities exceed policy limits, request supporting clinical justification or deny per policy.

Clinical and Safety Context

Afrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. It is not a substitute for long-acting insulin and, for patients with type 1 diabetes, must be used in combination with long-acting insulin. Afrezza is not recommended for treatment of diabetic ketoacidosis.

Afrezza is contraindicated in patients with chronic lung disease such as asthma or chronic obstructive pulmonary disease (COPD). The safety and efficacy of Afrezza in patients who smoke has not been established; therefore Afrezza is not recommended for patients who currently smoke or who have stopped smoking within the past 6 months.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyAfrezza (inhaled insulin) prior authorization and medical necessity

Policy CodePolicy 05.01.83

Change TypeNo material changes

Effective DateMar 14, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Afrezza (inhaled insulin) prior authorization and medical necessity

Medical Necessity Criteria for Afrezza

Product Packaging, NDCs, and Quantity Limits

Prior Authorization and Documentation Requirements

Clinical and Safety Context

Defined Terms

Document Details & Review Dates