CurrentCignaPolicy IP0557

Nembutal (pentobarbital) injection outpatient use

Defines Cigna's coverage position for pentobarbital (Nembutal) injection when used in an outpatient setting; does not address inpatient/hospitalized use.

Policy Summary

PayerCigna

PolicyNembutal (pentobarbital) injection outpatient use

Policy CodePolicy IP0557

Change TypeNo material change

Effective DateMay 1, 2023

Next Review DateMay 1, 2024

Key ActionClaims for Nembutal (pentobarbital) injection administered in an outpatient setting will be considered not medically necessary and are therefore not covered.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes.

0Outpatient indications covered

1FDA-approved indications (not covered outpatient)

Coverage Summary

Outpatient Use Coverage Determination

Not Medically Necessary — Outpatient Use Coverage Determination:

ALL of the following

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Scope Exclusions

Scope Exclusions:

ALL of the following

This policy addresses only outpatient use of Nembutal (pentobarbital) injection.
Inpatient or hospitalized use (including anesthetic-dose pentobarbital administered with continuous EEG monitoring for refractory status epilepticus) is outside the scope of this policy and is not addressed here.
Coverage determinations for inpatient settings should be made based on applicable benefit plan language, inpatient clinical guidelines, and any relevant utilization review processes.

Clinical Evidence & Guidance

FDA prescribing information: Nembutal (pentobarbital) [prescribing information], Akorn Inc; February 2020.

AASM guideline: 2017 AASM clinical practice guideline for pharmacologic treatment of chronic insomnia in adults (Sateia et al., J Clin Sleep Med. 2017).

AES guideline: 2016 American Epilepsy Society Evidence-Based Guideline: Treatment of Convulsive Status Epilepticus in Children and Adults (Glauser et al., Epilepsy Currents. 2016).

Background

Nembutal (pentobarbital) injection is FDA approved as a sedative/hypnotic for the short-term treatment of insomnia and as a preanesthetic (FDA prescribing information).

Current clinical practice guidelines do not support outpatient use for insomnia; the AASM guideline states barbiturates such as pentobarbital are no longer recommended for the treatment of insomnia (no support for outpatient insomnia use in guidelines).

The AES guideline lists pentobarbital at anesthetic doses among agents considered for the third therapy phase of status epilepticus treatment in inpatient settings with continuous EEG monitoring, and notes there is no clear evidence to guide therapy in this phase (level 'U'); the guideline does not provide support for outpatient injection use.

This policy addresses outpatient use of Nembutal (pentobarbital) injection and considers any outpatient use not medically necessary; it does not address inpatient or hospitalized use.

Policy metadata

Policy NumberIP0557

Effective Date2023-05-01

Next Review Date2024-05-01

Scope SummaryDefines Cigna's coverage position for pentobarbital (Nembutal) injection when used in an outpatient setting; does not address inpatient/hospitalized use.

StatusCURRENT

Revision History

2023-05-01Policy effective dateLatest

Policy effective date: 2023-05-01. Coverage Policy: The use of Nembutal (pentobarbital) injection in an outpatient setting for any use is considered not medically necessary (Coverage Policy Number IP0557).

2024-05-01Next review scheduled

Next review scheduled: 2024-05-01.