CurrentColorado Rocky Mountain Health PlansPolicy N/A

Afrezza (inhaled insulin) prior authorization

Defines prior authorization and medical necessity criteria for coverage of Afrezza (inhaled insulin) for adult patients with diabetes who cannot self-inject short-acting insulin. Applies to UnitedHealthcare Pharmacy clinical pharmacy programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAfrezza (inhaled insulin) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2025

Next Review DateApr 1, 2025

Key ActionObtain prior authorization and document diagnosis, inability to self-inject, and FEV1 ≥ 70% within 60 days.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7/1/2025effective date

≥70%FEV1 initial

20%FEV1 decline

12 moreauthorization

Adultspopulation

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Initial Therapy — Afrezza

Afrezza will be approved when ALL of the following are met:

Initial Authorization

Diagnosis: (1) Type 1 diabetes mellitus with basal insulin or continuous insulin pump OR (2) Type 2 diabetes mellitus.
See physician documentation

Inability to self-inject: Patient is unable to self-inject short-acting injectable insulin due to one of: physical impairment; visual impairment; lipohypertrophy; or documented needle‑phobia to the degree that the patient has previously refused injectable therapy or a medical procedure (refer to DSM‑5 for specific phobia criteria).

Must document one reason

Pulmonary function: FEV1 measured within the last 60 days is greater than or equal to 70% of expected normal as determined by the physician.>= 70%

Required baseline pulmonary function

Contraindications: Patient must NOT be a current cigarette smoker, must NOT have quit smoking within the past 6 months, and must NOT have chronic lung disease (e.g., asthma, COPD).

These conditions disallow approval

Continuation Therapy / Reauthorization

Reauthorization will be approved when ALL of the following are met:

Pulmonary stability: Repeat pulmonary function test confirms the patient has NOT experienced a decline of 20% or more in FEV1.<20% decline

Required for reauthorization

Continued inability to self-inject: Patient continues to be unable to self-inject short‑acting insulin due to one of: physical impairment; visual impairment; lipohypertrophy; or documented needle‑phobia (previous refusal of injectable therapy/procedure).

Must persist

Smoking status: Patient continues to not smoke cigarettes (no current smoking).

Required

Afrezza will NOT be approved for patients who: (1) currently smoke cigarettes, (2) recently quit smoking within the past 6 months, or (3) have chronic lung disease (for example, asthma or chronic obstructive pulmonary disease).

These exclusions reflect pulmonary safety concerns related to the inhalation route of administration and are absolute criteria for denial of coverage.

Initial Authorization Requirements

Initial Authorization — Afrezza

Diagnosis: Document one of the following diagnoses: (1) Type 1 diabetes mellitus with use of Afrezza in combination with a basal insulin or continuous insulin pump; OR (2) Type 2 diabetes mellitus.

Diagnosis must be documented in the medical record

Inability to self-inject: Document reason patient cannot self-administer short-acting injectable insulin: physical impairment; visual impairment; lipohypertrophy; or documented needle‑phobia (patient previously refused injectable therapy or procedure).

Provide supporting clinical documentation

Baseline pulmonary function: Provide FEV1 measured within the prior 60 days that is >= 70% of expected normal as determined by the physician.>= 70%

Attach PFT report within 60 days

Exclusions/Contraindications: Confirm patient is not a current cigarette smoker, has not quit smoking within the past 6 months, and does not have chronic lung disease (e.g., asthma, COPD).

If any of these are present, Afrezza will NOT be approved

Reauthorization / Continuation Rules

Reauthorization — Afrezza

Pulmonary function monitoring: Repeat pulmonary function testing must demonstrate the patient has NOT experienced a decline of 20% or more in FEV1 compared with baseline.<20% decline

If decline >=20%, reauthorization is denied

Ongoing inability to self-inject: Document that the patient continues to be unable to self-inject short‑acting insulin for one of the same reasons required at initiation: physical impairment; visual impairment; lipohypertrophy; or documented needle‑phobia.

Must be documented in the medical record

Smoking status: Document that the patient remains a non‑smoker (no cigarette smoking).

Required

Authorization duration: When reauthorized, coverage will be issued for 12 months.12 months

State mandates (FL, ME, TN) may modify documentation requirements or allow approval by provider attestation when applicable

Provider Actions, Documentation, and Denial Conditions

Prior Authorization

Prior Authorization Required

Prior authorization required; approve only when all specified clinical criteria are met.

Afrezza initial authorization: must meet ALL criteria under Initial Authorization (diagnosis, inability to self-inject, FEV1 ≥ 70%, and not having contraindicated characteristics).
Reauthorization: approved only when repeat PFT shows < 20% decline in FEV1; reauthorization granted for 12 months.

Note

State Mandate Exceptions

State-specific mandates may allow approval based on provider attestation in certain states; apply member benefit and federal requirements as applicable.

In Florida, Maine, and Tennessee only: medication prescribed for diabetes may be approved when the provider attests the product is medically necessary and, if applicable, documents that covered preferred alternatives are precluded or would worsen the patient's condition.
Apply any federal regulatory requirements and the member-specific benefit plan coverage; other policies/utilization management programs may also apply.

Documentation Required

Initial Authorization Documentation

Documentation must support the diagnosis, inability to self-inject, recent pulmonary function, and any other required evidence for initial or continued approval.

Initial authorization: documentation of diagnosis (e.g., type 1 diabetes mellitus) and evidence patient is unable to self-inject due to physical impairment, visual impairment, lipohypertrophy, or documented needle phobia (per DSM-5 criteria).
Initial authorization: FEV1 measurement within the last 60 days ≥ 70% of expected normal as determined by the physician.
If applicable, document prior use and inadequacy or contraindication of covered preferred alternatives (especially when relying on state attestation allowances).

Denial Risk

Contraindicated Patient Characteristics

Patients with specific pulmonary or smoking-related characteristics are contraindicated and will not be approved.

Do NOT approve Afrezza for patients who currently smoke cigarettes.
Do NOT approve for patients who recently quit smoking within the past 6 months.
Do NOT approve for patients with chronic lung disease (e.g., asthma, COPD).

Denial Risk

Pulmonary Function Decline

Reauthorization will be denied if pulmonary function declines substantially.

Denial for reauthorization if repeat pulmonary function test shows a decline of 20% or more in FEV1.
Reauthorization when criteria met is issued for 12 months.

Key Definitions

Unable to self-inject (definition)

DefinitionUnable to self-inject: patient cannot self-administer injectable short‑acting insulin due to physical impairment, visual impairment, lipohypertrophy, or documented needle‑phobia (per DSM‑5 criteria)

Physical impairment examplesAny physical limitation that prevents manipulation or administration of injectable insulin (refer to provider documentation)

Visual impairmentVisual deficits that preclude safe self‑administration of injections, as documented by provider

Needle‑phobiaDocumented needle‑phobia to the degree the patient has previously refused injectable therapy or medical procedures (see DSM‑5 for specific phobia criteria)

LipohypertrophyPresence of lipohypertrophy at injection sites that prevents reliable subcutaneous administration, documented by provider

Pulmonary function requirement

Initial requirementFEV1 measured within the last 60 days must be ≥ 70% of expected normal for initial approval

Reauthorization requirementReauthorization requires a repeat pulmonary function test showing the patient has NOT experienced a ≥20% decline in FEV1

Measurement windowBaseline FEV1 must be performed within 60 days prior to initial authorization

DocumentationProvider must document FEV1 results in the medical record to support initial authorization and reauthorization evaluations

Background

Afrezza is a rapid-acting inhaled insulin intended to improve glycemic control in adults with diabetes who are unable to self-administer short-acting injectable insulin. Because it is inhaled, baseline pulmonary function testing is required prior to initiation.

For initial use the policy requires documentation that the patient is unable to self-inject short-acting insulin due to one of: physical impairment, visual impairment, lipohypertrophy, or documented needle-phobia (per DSM-5 criteria). Additionally, a baseline FEV1 measured within the last 60 days must be ≥ 70% of predicted before Afrezza will be approved.

Step Therapy and State-specific Exceptions

State	Exception detail
Florida (FL)	In Florida only, approval may be granted when the provider attests that use of this product is medically necessary for the treatment of diabetes, and when applicable, documents that clinical characteristics preclude use of covered preferred alternatives or that use of preferred alternatives could worsen the patient’s condition or provide inadequate treatment.
Maine (ME)	In Maine only, approval may be granted when the provider attests that use of this product is medically necessary for the treatment of diabetes, and when applicable, documents that clinical characteristics preclude use of covered preferred alternatives or that use of preferred alternatives could worsen the patient’s condition or provide inadequate treatment.
Tennessee (TN)	In Tennessee only, approval may be granted when the provider attests that use of this product is medically necessary for the treatment of diabetes, and when applicable, documents that clinical characteristics preclude use of covered preferred alternatives or that use of preferred alternatives could worsen the patient’s condition or provide inadequate treatment.