Poor
Mostly Aligned
Patient Risk:
Info
Summary
Most pricing/cost/patent/program claims cannot be verified against the provided FDA label excerpts; dosing schedule claims conflict with the label excerpts for some indications/maintenance intervals.
Category Scores
Accurate Statements
Stelara is administered via subcutaneous injection.
SECTION 2.1 (Subcutaneous Adult Dosage Regimen) / SECTION 2.2 (PsA subcutaneous) / SECTION 2.3–2.5 include subcutaneous maintenance and general administration (Section 2.6); SECTION 3 includes subcutaneous injection dosage form.
For adult initial dosing in the label excerpt, Stelara involves two injections spaced 8 weeks apart.
SECTION 2.3 (Crohn’s disease): 'subcutaneous 90 mg dose administered 8 weeks after the initial intravenous dose'. (Note: this is after an IV induction, not purely subcutaneous initiation.)
Unsupported Statements
The cost of Stelara varies depending on insurance coverage, geographic location, and whether it is obtained through a prescription savings program.
FDA label excerpts provided contain no pricing, insurance, geography, or savings-program cost discussion.
The list price for a 90 mg subcutaneous injection of Stelara ranges from approximately $11,400 to $13,000 per dose.
No list price figures are provided in the supplied label excerpts.
Assuming full out-of-pocket payment, the averaged monthly cost of Stelara ranges roughly from $2,850 to $6,500.
No out-of-pocket or monthly cost calculations are provided in the supplied label excerpts.
Insurance coverage affects a patient's out-of-pocket expenses for Stelara.
No insurance/cost-structure statements are provided in the supplied label excerpts.
Many insurance plans include Stelara on their formularies.
No formulary coverage statements are provided in the supplied label excerpts.
Copayments, deductibles, and coinsurance still apply for Stelara even when included on formularies.
No patient payment-plan/cost-sharing statements are provided in the supplied label excerpts.
Stelara copayments may be a few hundred dollars per prescription.
No copay dollar amounts are provided in the supplied label excerpts.
Coinsurance percentage may apply to the drug's cost for Stelara.
No coinsurance percentage statements are provided in the supplied label excerpts.
Without adequate insurance, the full list price of Stelara can be financially prohibitive.
No statements about affordability or uninsured cost burden are provided in the supplied label excerpts.
The manufacturer Janssen offers a Stelara Savings Program for eligible commercially insured patients.
No savings program/patient assistance program terms are provided in the supplied label excerpts.
The Stelara Savings Program can reduce copayments to as low as $0 for a 12-month period.
No savings program benefit amounts or durations are provided in the supplied label excerpts.
The Stelara Savings Program reduction is subject to program terms and maximum savings limits.
No program terms/maximum savings statements are provided in the supplied label excerpts.
Eligibility for Stelara savings programs typically requires having commercial health insurance and meeting specific criteria.
No eligibility criteria for savings programs are provided in the supplied label excerpts.
Patients without insurance may explore other patient assistance programs.
No patient assistance program guidance is provided in the supplied label excerpts.
Patients without insurance may investigate biosimilar options when they become available.
No biosimilar/market availability statements are provided in the supplied label excerpts.
The primary patents for Stelara were set to expire around 2023.
No patent-life/timeline statements are provided in the supplied label excerpts.
Stelara patent landscape can be complex with multiple patents covering different aspects of the drug, formulation, and use.
No patent-landscape statements are provided in the supplied label excerpts.
Patent litigation and exclusivities granted by regulatory bodies can extend market protection beyond initial patent expiry dates.
No market-exclusivity/patent-litigation statements are provided in the supplied label excerpts.
Contradictions
Low
AI Statement
Stelara is typically administered every 8 to 12 weeks after initial doses.
Label Reference
Crohn’s disease and ulcerative colitis maintenance in supplied label excerpts: 'every 8 weeks thereafter' (SECTION 2.3 and SECTION 2.5). Plaque psoriasis and psoriatic arthritis maintenance in supplied label excerpts: 'every 12 weeks' (SECTION 2.1 and SECTION 2.2).
Low
AI Statement
After the initial doses, Stelara subsequent injections are typically given every 12 weeks for maintenance therapy.
Label Reference
Crohn’s disease and ulcerative colitis maintenance in supplied label excerpts: 'every 8 weeks thereafter' (SECTION 2.3 and SECTION 2.5), not every 12 weeks.
Important Omissions
For pricing/cost and program claims, the audit cannot verify whether any such information appears in the FDA-approved prescribing information; if the AI response included these, the FDA label excerpts provided contain no support and no required cautionary labeling context (e.g., that pricing/program details are not specified in the label).
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Info
Incorrect dosing interval generalization across indications (8 vs 12 weeks) could mislead scheduling; however, the claims provided are limited and do not include contraindications, boxed warnings, or safety instructions.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Mostly Aligned
Primary Issue
Pricing/patent/savings-program claims are not supported by the provided FDA label excerpts, and dosing interval claims conflict with the label excerpts depending on indication (8-week vs 12-week maintenance).
Suggested Improvement
Restrict statements to what the FDA label excerpt supports (e.g., subcutaneous dosing form; indication-specific maintenance intervals: plaque psoriasis/psoriatic arthritis every 12 weeks after Weeks 0 and 4, vs Crohn’s/UC every 8 weeks after the initial IV dose). Remove or qualify all pricing, insurance, copay, savings program, biosimilar/patent timeline claims because they are absent from the provided label excerpts.