CurrentmhnPolicy CP.PHAR.638

Nalmefene (Opvee, Zurnai) coverage

Defines medical necessity and authorization requirements for nalmefene products Opvee and Zurnai for emergency treatment of opioid overdose for applicable lines of business.

Policy Summary

Payermhn

PolicyNalmefene (Opvee, Zurnai) coverage

Policy CodePolicy CP.PHAR.638

Change TypeAdded product, coding, and step therapy updates

Effective DateSep 1, 2023

Next Review Date

Key ActionPrior authorization requires documentation that approval criteria are met for opioid overdose use, including age ≥ 12 and clinical justification for inability to use generic naloxone when applicable.

SourceLink

POLICY UPDATE CHANGES

Added newly approved Zurnai to the policy.

HCPCS code G0532 was added to the coding implications.

Added disclaimer restricting certain medical management techniques in Nevada.

Added step therapy bypass for Illinois HIM per IL HB 5395.

Age ≥ 12minimum age for coverage

2 boxesmax per Rx (Opvee)

4 autoinjectorsmax per Rx (Zurnai)

G0532billing code

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Coverage Criteria

inv-02: Continuation Therapy - Opioid Overdose

Covered when ALL of the following are met

Opioid Overdose continuation criteria: 1) Member meets one of the following: a) currently receiving medication via the Centene benefit or previously met initial approval criteria; or b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2) If request is for a dose increase, the requested quantity does not exceed product-specific limits (a. Opvee: two boxes/4 nasal spray devices per prescription; b. Zurnai: 4 autoinjectors per prescription).

For members in Nevada, medical management techniques beyond step therapy are not allowed.

inv-03: Other Diagnoses/Indications

Requests for other diagnoses/indications

Other uses: 1) If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, follow the appropriate formulary/no-coverage or non-formulary policy for the relevant line of business (see policy references); OR 2) If the requested use is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

See CP.CPA.190, HIM.PA.33, CP.PMN.255 for no coverage; HIM.PA.103, CP.PMN.16 for non-formulary; CP.CPA.09/HIM.PA.154/CP.PMN.53 for off-label guidance.

Non‑FDA approved indications for nalmefene are not authorized for coverage by this policy unless the request includes sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies or the member’s evidence of coverage. See the off‑label use policies referenced for each line of business for required supporting information.

Requests for nalmefene for uses that are not FDA‑approved and that do not include the documentation required by the applicable off‑label use policy are considered not authorized and will be denied. Providers should follow CP.CPA.09 (Commercial), HIM.PA.154 (HIM), or CP.PMN.53 (Medicaid) as applicable when submitting evidence to support off‑label requests.

Initial Therapy

inv-14: Initial Therapy

Initial coverage for opioid overdose

Initial nalmefene therapy: Age ≥ 12; member may have access to opioids; medical justification for inability to use generic naloxone when required; product-specific quantity limits (Opvee: two boxes/4 nasal sprays per prescription; Zurnai: 4 autoinjectors per prescription).

Not a substitute for emergency medical care. For Illinois HIM requests, step therapy requirements do not apply to formulary agents as of 1/1/2026 per IL HB 5395.

Continuation Therapy

inv-15: Continuation Therapy

Continuation criteria for ongoing nalmefene therapy

Continuation: Member is currently receiving medication via Centene benefit or previously met initial approval criteria, or is receiving medication and is enrolled in a state/product with continuity of care regulations; quantity limits apply for dose increases (Opvee: two boxes/4 nasal sprays per prescription; Zurnai: 4 autoinjectors per prescription).

For members in Nevada, medical management techniques beyond step therapy are not allowed.

Step Therapy Requirements

Step	Requirement	Notes
1	Document that member is unable to use generic naloxone nasal spray or naloxone solution for injection due to medical justification (e.g., contraindication, clinically adverse effects, or member is prescribed a long-acting opioid)	For Illinois HIM requests, step therapy requirements do not apply to formulary agents as of 1/1/2026 per IL HB 5395
2	Provider submits supporting documentation (e.g., office chart notes, lab results, clinical records) demonstrating inability to use naloxone or other specified justification	Prior authorization required; quantity limits apply per product (Opvee: 2 boxes/4 nasal sprays; Zurnai: 4 autoinjectors)
3	If documentation meets requirement, coverage for Opvee or Zurnai may be approved	Policy notes and coding implications reference HCPCS G0532 for take-home nasal nalmefene supply

Coding

Maximum per prescription

Opvee (nasal spray)Maximum per prescription: 2 boxes (4 nasal spray devices)

Zurnai (autoinjector)Maximum per prescription: 4 autoinjectors

Reference contextLimits apply to initial and continued therapy per product-specific quantity limits

Quantity Limits

Opvee (nasal spray) — quantity and dosing

ProductOpvee (nasal spray)

Limit2 boxes (4 nasal spray devices) per prescription

Dosing noteRecommended initial dose: one intranasal spray (2.7 mg); repeat every 2–5 minutes using a new device if needed

Zurnai (autoinjector) — quantity and dosing

ProductZurnai (autoinjector)

Limit4 autoinjectors per prescription

Dosing noteRecommended initial dose: 1.5 mg IM or SC into the thigh; repeat every 2–5 minutes with a new autoinjector if needed

Provider Actions & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Opvee and Zurnai for opioid overdose use; approval is contingent on documentation that all criteria are met (including age and clinical justification). Providers must submit clinical records demonstrating the member meets the policy criteria.

Prior authorization required for Opvee and Zurnai for opioid overdose indication
Approval requires documentation that member meets ALL criteria below (see policy)

Documentation Required

Required Documentation and Denial Risk

Providers must submit documentation (e.g., office chart notes, lab results, other clinical information) supporting that the member has met all applicable approval criteria. Lack of sufficient documentation that the member meets the criteria (for example: age ≥ 12, access to opioids, or inability to use generic naloxone formulations) may result in denial.

Definitions

Nalmefene (Opvee, Zurnai) — definition

Drug classOpioid antagonist

AgentsNalmefene (Opvee, Zurnai)

IndicationEmergency treatment of known or suspected opioid overdose in patients aged 12 years and older

Background

Nalmefene (Opvee, Zurnai) is indicated as an opioid antagonist for the emergency treatment of known or suspected opioid overdose in patients aged 12 years and older. It is intended for immediate administration in settings where opioids may be present and is not a substitute for emergency medical care.

Site of Care

Note

Intended for emergency home use; intranasal or autoinjector administration

Nalmefene products are intended for immediate administration as emergency therapy in settings where opioids may be present; Opvee is administered intranasally and Zurnai via autoinjector (IM/SC to the thigh) for take‑home or home use.

Opvee: intranasal spray (2.7 mg per 0.1 mL); repeat doses every 2–5 minutes as needed using a new device.
Zurnai: 1.5 mg IM/SC auto‑injector to the anterolateral thigh; repeat every 2–5 minutes as needed using a new auto‑injector.