The 340B drug discount program lets certain hospitals and clinics buy medications at reduced prices, but a long-standing exclusion for orphan-designated drugs can block those savings even when the drug is prescribed for a common condition. A Nebraska pharmacist argues this is unfair and legally outdated, pointing out that Crohn's disease is not juvenile idiopathic arthritis, yet policy treats them the same.
The author explains that Rinvoq, approved for Crohn's disease, also carries orphan designations for juvenile idiopathic arthritis and giant cell arteritis. Because manufacturers can apply the orphan exclusion at the molecule level, his pharmacy sometimes sells the drug at a loss for Crohn's patients. Federal courts struck down HRSA's attempts to limit the exclusion to actual orphan use, saying only Congress can change the statute.
The article notes a new HRSA rebate pilot starting in 2027, where covered entities pay full price and seek rebates. The pilot is narrow and voluntary for manufacturers, and the author worries it shifts financial risk to pharmacies. He suggests adding a data field to track indication could make the system work, but the law still needs to catch up.