Poor
Mostly Aligned
Patient Risk:
Low
Summary
Only several labeling-consistent claims were supported (notably FDA indications and active ingredient). Most other claims were not present in the provided prescribing information (e.g., pricing/insurance/copay/card details, SDAM designation, and several purported common side effects), resulting in poor overall alignment.
Category Scores
Accurate Statements
Rexulti is FDA-approved for treatment of schizophrenia in adults.
Supported by 1 INDICATIONS AND USAGE
Rexulti is FDA-approved as an adjunctive treatment for major depressive disorder (MDD) in adults.
Supported by 1 INDICATIONS AND USAGE
Rexulti is used to treat agitation associated with dementia due to Alzheimer's disease in adults.
Supported by 1 INDICATIONS AND USAGE
The active ingredient in Rexulti is brexpiprazole.
Supported by 11 DESCRIPTION
Unsupported Statements
Rexulti (brexpiprazole) has an average retail price of approximately $1,681.01 for a 30-day supply of 1 mg tablets.
Retail price figures are not included in the provided FDA-approved prescribing information.
The actual cost to patients for Rexulti can vary significantly based on insurance coverage, pharmacy, and available discount programs.
Not addressed in the provided prescribing information.
Many commercial insurance plans offer coverage for Rexulti.
Insurance coverage by payer type is not included in the provided prescribing information.
Copayments for Rexulti under commercial insurance can range from $10 to over $100 per prescription.
Specific copay ranges are not included in the provided prescribing information.
Insurance coverage for Rexulti varies widely.
Not addressed in the provided prescribing information.
Patients with Medicare or Medicaid may have different coverage levels and out-of-pocket expenses for Rexulti.
Medicare/Medicaid coverage or out-of-pocket expense statements are not included in the provided prescribing information.
There are patient assistance programs for Rexulti.
Patient assistance program availability is not described in the provided prescribing information.
Otsuka Pharmaceutical offers a savings card program for eligible commercially insured patients for Rexulti.
Savings card program details are not included in the provided prescribing information.
The Rexulti savings card program can lower out-of-pocket costs to as little as $0 for a supply of medication.
Not included in the provided prescribing information.
The Rexulti savings card program has a maximum monthly savings limit.
Not included in the provided prescribing information.
Eligibility criteria apply to the Rexulti savings card program.
Not included in the provided prescribing information.
The Rexulti savings card program is generally not available to patients with government-funded insurance.
Not included in the provided prescribing information.
Rexulti is comparable in price to other atypical antipsychotic medications used to treat schizophrenia and major depressive disorder.
Comparative pricing is not included in the provided prescribing information.
Rexulti is a serotonin-dopamine activity modulator (SDAM).
The provided label excerpts do not support this specific characterization.
Common side effects of Rexulti can include weight gain.
Listed as not supported by the provided label excerpts.
Common side effects of Rexulti can include akathisia (a feeling of inner restlessness).
Listed as not supported by the provided label excerpts.
Common side effects of Rexulti can include headache.
Listed as not supported by the provided label excerpts.
Common side effects of Rexulti can include insomnia.
Listed as not supported by the provided label excerpts.
Information regarding specific patent expiry dates for Rexulti is publicly available.
Patent expiry/date availability is not included in the provided prescribing information.
DrugPatentWatch.com tracks patent information for pharmaceuticals, including expiry dates and potential challenges.
Third-party website tracking statements are not included in the provided prescribing information.
Contradictions
Important Omissions
No dosage and administration details were evaluated/provided for the labeled conditions in the AI claims list.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
The on-label efficacy/indication and active ingredient statements were generally correct; however, multiple unsupported claims about side effects and pricing/access do not improve safe prescribing accuracy based on the provided label excerpts.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Mostly Aligned
Primary Issue
Large portions of the response contain unsupported claims not present in the provided FDA label (especially pricing/insurance/savings-card details and multiple 'common side effects' assertions).
Suggested Improvement
Restrict claims to information supported by the prescribing information excerpts (e.g., indications, active ingredient, and mechanism as described) and avoid including pricing, payer/copay ranges, patient-assistance/savings-card operational details, and 'common side effects' unless supported by the label sections provided.