Summary
No claims align with FDA-approved labeling. All claims concern non-label information about patient assistance programs and are not described in the drug's label.
Category Scores
Accurate Statements
Unsupported Statements
Yervoy discounts from Bristol Myers Squibb's patient assistance programs, copay cards, or commercial rebates cannot be applied retroactively to past claims or purchases.
Not present in FDA-approved labeling.
These programs require enrollment and validation before treatment, with savings applied at the point of sale or reimbursement.
Not present in FDA-approved labeling.
BMS OneONCOLOGY Copay Program offers up to $25,000 in annual copay support for eligible commercially insured patients.
Not present in FDA-approved labeling.
It is activated via a card at pharmacies or infusion centers.
Not present in FDA-approved labeling.
Enrollment must occur prior to service; retroactive claims are not processed.
Not present in FDA-approved labeling.
Uninsured patients may qualify for free drug through the BMS Access Support program.
Not present in FDA-approved labeling.
Only for future fills after approval.
Not present in FDA-approved labeling.
Medicare Part D patients cannot use manufacturer copay cards due to federal anti-kickback rules.
Not present in FDA-approved labeling.
Retroactive discounts are prohibited for Medicare Part D patients.
Not present in FDA-approved labeling.
Low-income subsidies (LIS) or Extra Help provide prospective relief but do not reimburse prior costs.
Not present in FDA-approved labeling.
State programs like patient assistance foundations review eligibility upfront.
Not present in FDA-approved labeling.
Pharmacies or providers can sometimes adjust claims for errors within payer-specific windows (e.g., 60-180 days for some insurers), but this does not involve manufacturer discounts.
Not present in FDA-approved labeling.
Appeals to Bristol Myers Squibb for denied future assistance rarely extend to past expenses.
Not present in FDA-approved labeling.
Patients report success requesting one-time grants from independent foundations like PAN Foundation, though these are not guaranteed or retroactive.
Not present in FDA-approved labeling.
Contact your pharmacy/insurer first.
Not present in FDA-approved labeling.
Request a reversal or good-faith credit within their policy timeline.
Not present in FDA-approved labeling.
Independent charities: PAN or CancerCare may cover out-of-pocket costs post-treatment with proof of financial need.
Not present in FDA-approved labeling.
Tax deductions: Unreimbursed medical expenses exceeding 7.5% of AGI qualify for IRS deductions.
Not present in FDA-approved labeling.
Future planning: Enroll in BMS programs before next cycle to cap costs at $0-$5 per dose for eligible patients.
Not present in FDA-approved labeling.
Contradictions
Important Omissions
No FDA-labeled content covers patient assistance program specifics; labeling focuses on clinical safety, indications, dosing, and risk information. The response includes non-label information about assistance programs which is not supported by the label.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
Content is non-clinical program information; no direct safety risk identified.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Not Aligned
Primary Issue
Claims describe non-label information (patient assistance programs) not present in FDA-approved labeling.
Suggested Improvement
Limit content to FDA-approved labeling information (indication, dosing, contraindications, warnings, adverse reactions, administration, monitoring, and storage). Clearly separate any non-label patient assistance information as a distinct non-label resource.