CurrentMass General Brigham Health PlanPolicy N/A

Ohtuvayre (ensifentrine) prior authorization for COPD

Defines prior authorization requirements for the pharmacy benefit coverage of Ohtuvayre (ensifentrine) for adult patients with chronic obstructive pulmonary disease (COPD) under Mass General Brigham Health Plan Commercial/Exchange.

Policy Summary

PayerMass General Brigham Health Plan

PolicyOhtuvayre (ensifentrine) prior authorization for COPD

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2025

Next Review Date

Key ActionObtain prior authorization for Ohtuvayre under the pharmacy benefit; approvals (initial and reauthorization) are for up to 12 months with a 2 ampules per day quantity limit.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Commercial/ExchangePlan applicability

12 monthsApproval duration

2/dayQty limit

90 daysNew-to-plan grace period

Coverage Criteria for Ohtuvayre (ensifentrine)

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Initial Authorization Criteria

Covered when ONE of the following is met

Continuation for current stable therapy: Member new to the plan within the last 90 days who is currently receiving the requested medication and is stable (excluding when product was obtained as samples or via manufacturer's patient assistance programs)new-to-plan within 90 days and currently receiving therapy

See documentation for verification of current therapy and stability

Initial authorization based on prior regimen failure: Member has a diagnosis of chronic obstructive pulmonary disease (COPD) AND has had an inadequate response or adverse reaction to one of the following maintenance regimens: (a) LABA/LAMA OR (b) LABA/LAMA/ICSdocumented inadequate response or adverse reaction to specified regimens

Both elements (diagnosis + prior regimen failure) are required for this pathway

For the new-to-plan, currently receiving pathway, product that was obtained only as samples or through a manufacturer's patient assistance program is excluded and therefore does not qualify as evidence that the member is actively receiving therapy. Members who report therapy obtained solely by these means are not eligible for the 90‑day new‑to‑plan allowance and must meet the standard initial authorization criteria instead.

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ohtuvayre (ensifentrine) under the pharmacy benefit. Initial and reauthorization approvals are for up to 12 months.

Pharmacy benefit: Ohtuvayre (ensifentrine)
Initial and reauthorization: up to 12 months

Step Therapy

Required Prior Regimen Trial

Authorization requires prior inadequate response or adverse reaction to specified maintenance regimens before starting Ohtuvayre.

Required prior trial: inadequate response or adverse reaction to LABA/LAMA or LABA/LAMA/ICS

Documentation Required

Required Clinical Documentation

Documentation must include a diagnosis of COPD and prior medication history demonstrating inadequate response or adverse reaction to LABA/LAMA or LABA/LAMA/ICS. For reauthorization, documentation of positive clinical response is required.

Diagnosis: chronic obstructive pulmonary disease (COPD)
Prior medication history showing inadequate response or adverse reaction to LABA/LAMA or LABA/LAMA/ICS
Reauthorization: evidence of positive clinical response

Denial Risk

Denial Risk for Unmet Clinical Criteria

Requests that do not meet the diagnostic criteria or lack the required prior trial or documentation are at risk of denial.

Denial risk if diagnostic criteria not met
Denial risk if no documentation of prior trial (LABA/LAMA or LABA/LAMA/ICS)

Denial Risk

Denial Risk for Unverified Current Therapy

New-to-plan members who have not been receiving the medication (or who obtained product only as samples or through manufacturer patient assistance) may be denied. Authorization may be granted for new members within 90 days who are currently stable on the requested medication.

New-to-plan members: current, stable treatment required (within last 90 days)
Samples or manufacturer patient assistance alone do not establish current therapy

Key Definitions

Ohtuvayre (ensifentrine)

Drug classInhaled dual phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) inhibitor

IndicationMaintenance treatment of chronic obstructive pulmonary disease (COPD) in adults

FormulationDistributed as Ohtuvayre (ensifentrine) ampules

LABA/LAMA

DefinitionCombination of long-acting beta-agonist (LABA) and long-acting muscarinic antagonist (LAMA)

PurposeMaintenance bronchodilator therapy for COPD when used as a combined regimen

Role in policyRequired prior regimen trial option before Ohtuvayre authorization (inadequate response or adverse reaction)

LABA/LAMA/ICS

DefinitionCombination of long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA), and inhaled corticosteroid (ICS)

PurposeTriple maintenance therapy for COPD addressing bronchodilation and inflammation

Role in policyRequired prior regimen trial option before Ohtuvayre authorization (inadequate response or adverse reaction)

Background

Ensifentrine (Ohtuvayre) is addressed in this policy as a maintenance inhaled therapy for COPD. Authorization may be granted for members who are new to the plan within the last 90 days if they are currently receiving the requested medication and are clinically stable; however, this allowance specifically excludes situations where the product was received only as samples or via a manufacturer's patient assistance program. Standard prior authorization requirements and documentation apply for other members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyOhtuvayre (ensifentrine) prior authorization for COPD

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2025

Next Review Date

Key ActionObtain prior authorization for Ohtuvayre under the pharmacy benefit; approvals (initial and reauthorization) are for up to 12 months with a 2 ampules per day quantity limit.

SourceLink

On This Page

OpenPayer

Ohtuvayre (ensifentrine) prior authorization for COPD

Coverage Criteria for Ohtuvayre (ensifentrine)

Pharmacy Coding and Quantity Limits

Provider Requirements and Authorization Process

Key Definitions

Background