CurrentCignaPolicy IP0385

Epinephrine Injection (Self-Administered)

Defines medical necessity criteria, reauthorization, and authorization duration for self-administered epinephrine products (Auvi-Q, Adrenaclick authorized generic, EpiPen/EpiPen Jr., Symjepi) for Cigna-administered plans; coverage may vary by specific customer benefit plan and preferred products apply.

Policy Summary

PayerCigna

PolicyEpinephrine Injection (Self-Administered)

Policy CodePolicy IP0385

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionProvider must document the individual's weight (16.5 to 33 lb / 7.5 to 15 kg) to support coverage of Auvi-Q 0.1 mg.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes.

5Listed Products (Auvi-Q, Adrenaclick generic, EpiPen/EpiPen Jr., Symjepi)

12 monthsApproval Duration (initial and reauthorization)

7.5–15 kgAuvi-Q 0.1 mg pediatric weight range

Coverage Summary

Defines medical necessity criteria, reauthorization, and authorization duration for self-administered epinephrine products (Auvi-Q, Adrenaclick authorized generic, EpiPen/EpiPen Jr., Symjepi) for Cigna-administered plans. Coverage may vary by specific customer benefit plan and requires the use of preferred products; providers must refer to the customer's benefit plan document for prior authorization and coverage details.

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Medical-Necessity Criteria

Medically Necessary Product-Specific Criteria

The listed products are considered medically necessary when the following product-specific criteria are met:

ALL of the following

Auvi-Q 0.1 mg
- There is documentation that the individual weighs 16.5 to 33 pounds (7.5 to 15 kg).
Auvi-Q 0.15 mg or 0.3 mg
- The individual has had an intolerance to epinephrine auto-injector (EpiPen/EpiPen Jr. generics).
- Documented inability to obtain epinephrine auto-injector (EpiPen/EpiPen Jr. generics).
- Individual or his/her caregiver is blind or significantly visually impaired.
Adrenaclick authorized generic (epinephrine 0.15 mg or 0.3 mg)
- The individual has had an intolerance to epinephrine auto-injector (EpiPen/EpiPen Jr. generics).
- Documented inability to obtain epinephrine auto-injector (EpiPen/EpiPen Jr. generics).
EpiPen or EpiPen Jr. (epinephrine 0.15 mg or 0.3 mg)
- The individual has had an intolerance to epinephrine auto-injector (EpiPen/EpiPen Jr. generics).
- Documented inability to obtain epinephrine auto-injector (EpiPen/EpiPen Jr. generics).
Symjepi (epinephrine 0.15 mg or 0.3 mg prefilled syringe)
- The individual has had an intolerance to epinephrine auto-injector (EpiPen/EpiPen Jr. generics).
- Documented inability to obtain epinephrine auto-injector (EpiPen/EpiPen Jr. generics).

Reauthorization Criteria

Continued use is medically necessary when:

ALL of the following

Initial criteria are met
There is documentation of beneficial response.

Medication Use Principles

Dosage, frequency, duration, and site of care should be reasonable, clinically appropriate, supported by evidence, and adjusted based on severity, alternatives, and prior response.

Provider Actions

Documentation Required

Document weight for Auvi-Q 0.1 mg

Provider must document the individual's weight to support coverage of Auvi-Q 0.1 mg. Weight threshold: 16.5 to 33 pounds (7.5 to 15 kg).

Documentation Required

Document intolerance or access issues for non-preferred products

Provider must document one of the following to justify use of the listed non-preferred products: intolerance to EpiPen/EpiPen Jr. generics; documented inability to obtain EpiPen/EpiPen Jr. generics; or that the individual or caregiver is blind or significantly visually impaired (the latter applies for Auvi-Q 0.15 mg or 0.3 mg).

Prior Authorization

Prior authorization may be required per plan

Coverage and requirements for prior authorization vary across plans and may require use of preferred products. Providers must refer to the customer's benefit plan document for prior authorization and coverage details.

Billing Rule

Authorization duration

Initial and reauthorization approvals are for up to 12 months.

Background & Evidence

Policy supports medical necessity review for self-administered epinephrine products used for the emergency treatment of severe allergic reactions including anaphylaxis; indicated products include Auvi-Q, EpiPen/EpiPen Jr., Adrenaclick authorized generic, and Symjepi.

Auvi-Q differs from other auto-injectors by providing audible (electronic voice instructions, beeps) and visual (LED light) cues to assist with use. Auvi-Q is also the only auto-injector available as a 0.1 mg strength indicated for patients weighing 7.5 kg to 15 kg (16.5 to 33 lb).

Bioavailability study: A single-blind, crossover study found that a single injection of 0.3 mg epinephrine from Auvi-Q and EpiPen resulted in similar peak and total epinephrine exposure in healthy adults.

Definitions

IntoleranceDocumented adverse reaction or inability to tolerate a specific epinephrine auto-injector product

Documented inability to obtainEvidence that the member cannot access a preferred epinephrine auto-injector (e.g., supply, distribution, or other access issues)

OpenPayer

Epinephrine Injection (Self-Administered)

Coverage Summary

Medical-Necessity Criteria

Provider Actions

Coding

Background & Evidence

Revision History