The manufacturer of Nulibry, a recently approved, first-of-its-kind injectable treatment for a very rare, often fatal genetic disorder that typically appears soon after birth, has posted details about the limited distribution network for the drug on the U.S. Health Resources and Services Administration’s (HRSA) 340B program website.
The manufacturer, Origin Biosciences, said it is limiting distribution to hospital inpatient facilities and just one specialty pharmacy, Biologics by McKesson. It said it doing so because it makes Nulibry in small quantities, the drug requires “stringent conditions” for cold storage, and dispensing pharmacists need special training.
“Covered entities may access Nulibry at the 340B ceiling price through contract pharmacy arrangements with Biologics,” the company said.
“Origin is committed to compliance with all aspects of the 340B Drug Discount Program,” it said. “By this notice, we want to make clear how 340B covered entities may access Nulibry at the statutory 340B ceiling price.”