Pharmacy Prior Authorization Criteria

Epinephrine Injection Products

Indications for Prior Authorization

EpiPen (epinephrine injection), EpiPen Jr. (epinephrine injection), epinephrine injection

• For diagnosis of Allergic reactions
  Indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

Criteria

Brand EpiPen, Brand EpiPen Jr.

For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed.

Step Therapy

Length of Approval: 6 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (within the past 180 days) or intolerance to generic epinephrine

P & T Revisions

1970-01-01, 2025-12-18, 2024-04-15, 2023-10-02, 2023-04-11, 2022-06-21, 2022-05-28, 2021-06-02, 2020-05-25

References

1. EpiPen prescribing information. Mylan Specialty L.P. Morgantown, WV. February 2023.
2. EpiPen Jr prescribing information. Mylan Specialty L.P. Morgantown, WV. February 2023.

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Revision History

• 2025-12-18: no criteria changes, added IL statute operational note
• 2024-04-15: 2024 Annual Review
• 2023-10-02: update guideline
• 2023-04-11: 2023 Annual Review.
• 2022-06-21: Updated criteria.
• 2022-05-28: Annual Review - No changes.
• 2021-06-02: Updated references.
• 2020-05-25: Updated references section.

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