CurrentMass General Brigham Health PlanPolicy N/A

Nuedexta

Defines prior authorization and quantity limit requirements for Nuedexta under the Pharmacy Benefit for Commercial/Exchange members; covers authorization criteria, approvals duration, and quantity limits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyNuedexta

Policy CodePolicy N/A

Change TypeClarified (plan separation)

Effective DateJan 1, 2023

Next Review Date

Key ActionPrior authorization is required for Nuedexta under the Pharmacy Benefit for Commercial/Exchange members; authorization may be granted for members meeting the listed criteria.

SourceLink

POLICY UPDATE CHANGES

Separated Commercial/Exchange vs MassHealth policies; no clinical updates as of 09/21/2022, effective 01/01/2023.

12 monthsApproval Duration

60Quantity Limit (capsules per 30 days)

Commercial/ExchangePlan Applicability

Coverage Summary

Coverage stance: covered_with_criteria for Nuedexta (dextromethorphan hydrobromide/quinidine sulfate). This policy applies to Commercial/Exchange members under the Pharmacy Benefit and defines prior authorization and quantity limit requirements for Nuedexta.

Authorization Criteria

Authorization may be granted when ONE of the following is met:

ANY of the following

Member is new to the plan and currently receiving treatment with Nuedexta (excludes product obtained as samples or via manufacturer’s patient assistance programs)
Allows rollover/continuation for established therapy when member is new to plan
PBA indication
- Member has a diagnosis or indication for the treatment of Pseudobulbar Affect (PBA)
- PBA is due to a neurological condition (e.g., amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), stroke, traumatic brain injury, Alzheimer’s disease, Parkinson’s disease)

ref": "b1_0

title": "Authorization Criteria

Continuation / Renewal Criteria

Continuation/rollover: Authorization may be granted to members who are new to the plan and currently receiving treatment with Nuedexta (excludes product obtained as samples or via manufacturer's patient assistance programs). Approvals will be for 12 months.

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required for Nuedexta under the Pharmacy Benefit for Commercial/Exchange members; authorization may be granted for members meeting the criteria listed (new-to-plan continuation or PBA due to neurological condition).

Pharmacy Benefit — Commercial/Exchange members

Billing Rule

Approval duration

Approvals will be for 12 months.

Approval = 12 months

Billing Rule

Quantity limit

The following quantity limits apply: Nuedexta 20-10 mg — 60 capsules per 30 days.

Limit: Nuedexta 20-10 mg — 60 capsules per 30 days

Clinical Evidence

Background: Nuedexta is a combination of dextromethorphan (an uncompetitive NMDA receptor antagonist and sigma-1 agonist) and quinidine (a CYP2D6/CYP450 2D6 inhibitor) and is FDA-indicated for the treatment of pseudobulbar affect (PBA), which typically occurs in people with certain neurological conditions or injuries such as amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), stroke, traumatic brain injury, Alzheimer’s disease, and Parkinson’s disease.

Evidence: Prescribing information — Nuedexta (dextromethorphan/quinidine) prescribing information, Avanir Pharmaceuticals; January 2016.

Definitions: Pseudobulbar Affect (PBA) — Condition characterized by episodes of sudden uncontrollable and inappropriate laughing or crying, typically in people with certain neurological conditions or injuries.