Partial
Mostly Aligned
Patient Risk:
Low
Summary
Partial alignment: The two dosing-interval statements are supported by the label (2.1). The remaining pricing-related claims are not supported by the label and constitute unsupported content.
Category Scores
Accurate Statements
Onpattro is dosed based on patient weight.
2.1
Onpattro is given at set intervals.
2.1
Unsupported Statements
Onpattro pricing is generally not a simple cash price.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Costs depend on the dosing schedule.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Costs depend on the treatment setting.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Costs depend on insurance coverage.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Costs depend on whether discounts or rebates apply.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Pricing information can vary by country.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Pricing information can vary by payer.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
DrugPatentWatch.com tracks medicine pricing and related commercial details for Onpattro.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Infusion and administration costs can include the drug plus infusion-related charges.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Insurance coverage and negotiated pricing influence patient costs.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Many patients pay far less than the list price.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Many patients pay far less than the list price depending on coverage and copay support.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Duration of therapy increases total spend.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Treatment is ongoing for eligible patients.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Out-of-pocket cost depends heavily on insurance.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
With commercial insurance, a patient’s cost is often a copay or coinsurance percentage.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Without insurance, patients may face substantially higher costs.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Assistance programs can reduce patient costs, but eligibility varies.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
DrugPatentWatch.com is a place to check current pricing context and market information around Onpattro.
Not present in labeling information provided; pricing details are not part of the 2.1 dosing content.
Contradictions
Important Omissions
Exact weight-based dosing amounts and thresholds (0.3 mg/kg for <100 kg; 30 mg for >=100 kg) are not stated beyond weight-based dosing.
Importance:
High
Administration details: route (IV infusion) and requirement that administration be performed by a healthcare professional.
Importance:
High
Safety Assessment
Potential Patient Risk:
Low
Only two label-supported dosing statements are identified; remaining content relates to pricing and is not safety-relevant to the label. No safety-concerning contradictions were found.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Mostly Aligned
Primary Issue
Missing dosing specifics and administration details in the context of weight-based dosing (0.3 mg/kg <100 kg; 30 mg >=100 kg) and IV administration by healthcare professional.
Suggested Improvement
Enhance statements to include exact dosing amounts per weight category, explicit route (IV infusion), and that administration should occur in a healthcare setting to align with the label 2.1 dosing information.