CurrentMass General Brigham Health PlanPolicy N/A

Valtoco (diazepam) nasal spray — coverage criteria

Defines prior authorization, coverage criteria, limits, and renewal requirements for Valtoco (diazepam) nasal spray for members of Mass General Brigham Health Plan under the pharmacy benefit.

Policy Summary

PayerMass General Brigham Health Plan

PolicyValtoco (diazepam) nasal spray — coverage criteria

Policy CodePolicy N/A

Change TypeRevised (age and new-member language)

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization under the pharmacy benefit and document neurologist involvement and age ≥2 years.

SourceLink

POLICY UPDATE CHANGES

Updated language for members who are new to the Plan and decreased minimum approvable age from 6 years to 2 years to align with FDA labeling.

2 yearsminimum approvable age for Valtoco

12 monthsinitial and reauthorization approval duration

5 boxesquantity limit per 30 days per strength

Commercial/Exchangeplan applicability checked

Coverage Criteria for Valtoco (diazepam) nasal spray

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Initial Therapy

Covered when ALL of the following are met

Initial Authorization Criteria: 1. Member is 2 years of age or older.age >= 2 years

Reflects FDA-approved age.

Indication: 2. Member is using the medication as an acute treatment for intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from the patient's usual seizure pattern.clinical diagnosis of seizure clusters

Indication must match prescribing information.

Provider Specialty: 3. Provider is a neurologist or provider is working in consultation with a neurologist.neurologist involvement

Specialist involvement required.

New-to-Plan Continuation

New-to-plan continuation: Authorization may be granted for members new to the plan within the past 90 days who are currently receiving treatment with the requested medication, excluding when the product is obtained as samples or via manufacturer's patient assistance program.member on therapy within 90 days

Allows continuation for recent transfers-in receiving therapy; excludes samples/assistance program supplies.

Continuation of Therapy / Reauthorization

Reauthorization will be approved when ALL of the following are met

Documentation of benefit: 1. Documentation of improvement of member's condition.evidence of improvement

Required for continued approval; initial and reauthorizations are granted for 12 months per policy limitations.

For members who are new to the Plan, continuation of therapy consideration excludes products that were obtained as samples or through a manufacturer's patient assistance program. In other words, when assessing whether a new-to-plan member is currently receiving Valtoco and qualifies for continuation, the Plan will not count supplies provided as samples or via the manufacturer's assistance program as evidence of active therapy.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required under the pharmacy benefit. May be granted for members new to the plan (within the past 90 days) who are currently receiving therapy with the requested medication. Note: prior authorization will not be supported if the member obtained the product only as samples or through a manufacturer's patient assistance program.

Benefit: Pharmacy Benefit
Plan: Commercial/Exchange
Program Type: Prior Authorization

Step Therapy

No step therapy requirement specified for this medication.

Documentation Required

Reauthorization Documentation

Reauthorization (continuation of therapy) requires documentation demonstrating improvement in the member's condition.

Continuation of Therapy: Documentation of improvement of member's condition required for reauthorization.

Denial Risk

Denial Triggers

Denial may be issued if the member is new to the plan and is not currently receiving the requested medication (this exclusion applies when the drug was only obtained as samples or via manufacturer's patient assistance programs).

Denial trigger: Member new to plan and not currently receiving medication (excludes samples/manufacturer assistance).
Eligibility window referenced: within the past 90 days for "new to plan" status.

Key Definitions

Seizure clusters / acute repetitive seizures — definition and descriptor

DefinitionIntermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures) that are distinct from the patient’s usual seizure pattern.

Clinical contextAcute events treated with Valtoco (diazepam) nasal spray as rescue therapy for patients with epilepsy.

Age thresholdOccurs in patients aged 2 years and older (per FDA indication).

SynonymsSeizure clusters; acute repetitive seizures.

Key distinguishing featureEpisodes are distinct from the patient’s usual seizure pattern (not routine seizures).

Background on Valtoco (diazepam) nasal spray

Valtoco (diazepam) nasal spray is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters or acute repetitive seizures) distinct from a patient's usual seizure pattern in patients aged 2 years and older. For prior authorization purposes, continuation may be granted for members who are new to the Plan within the past 90 days and who are currently receiving the requested medication, provided the product was not obtained as samples or via a manufacturer's patient assistance program.