The price of a 10-vial pack of an injectable medicine called dehydrated alcohol is expected to jump from about $1,300 to $10,000, according to STAT.
The drug, which has been available for years, is used to treat chronic pain or prevent infection in patients who need nutrients intravenously.
For years, hospitals were able to get the medication for much less money because older versions came before the enactment of strict FDA requirements and were never approved by the agency.
But in June 2018, Belcher Pharmaceuticals won approval for its version of the drug, Ablysinol, for use with a specific heart procedure.
In seeking approval for the drug, Belcher Pharmaceuticals pursued indication for treating hypertrophic obstructive cardiomyopathy, a rare cardiac illness. As a result, the drug won orphan designation, a special status given to drugs that treat rare diseases or conditions. As a result of the designation, which grants patent exclusivity, other drugmakers cannot market dehydrated alcohol until 2025.
Last year, Belcher launched its drug at $9,950 for a 10-pack of 5 ml vials. At the time, many didn't pay attention because it was less than the $1,295 charged for the same amount by two other drugmakers who manufactured the dehydrated alcohol injectable.
However, the price hike is now gaining attention because other manufacturers are no longer permitted to produce their versions of dehydrated alcohol. Wholesalers are also running out of their inventories of the old drug and are forced to stock Ablysinol.
Belcher Pharmaceuticals is standing behind the price hike, arguing it invested "multiple millions of dollars" to manufacture and launch the drug.
"Those other companies can charge whatever they want because they’re unapproved. They never did any studies. We had to develop the drug. We can't trust what’s unapproved," Labio Lanzieri, president of BPI Labs, a Belcher subsidiary, told STAT. "A drug that’s never been approved means nothing to me, because no test was done. You can’t prove safety and efficacy. We had to prove all that."
Access the full STAT article here.