When Sanofi said it’d stop making a bladder cancer drug in 2016, one expert predicted there’d be shortages. Fast forward to today, and Merck says it’s done it’s best to ensure global supply, but as the lone manufacturer, it’s having trouble keeping up.
As a result, Merck is forced to restrict shipments to countries around the world based on their historical ordering averages. Merck said “at no point” has it considered profitability in the decision.
Merck says it's been the sole supplier of TICE BCG, an important bladder cancer med, since 2012 after Sanofi and another drugmaker ran into manufacturing problems. Sanofi never reintroduced its drug, Merck says. In 2016, Sanofi confirmed it was exiting the market.
Intermittent availability of the drugs has been of grave concern to patients with bladder cancer because the alternative to treatment with BCG can mean partial removal of the bladder or a radical cystectomy in which the bladder and most of the sexual organs are removed.
As the lone supplier, Merck says it has expanded production by more than 100% and cut 40% off its manufacturing time. It’s now at full capacity, producing 600,000 to 870,000 vials annually.
Still, Merck can't quite keep up. Demand is growing around the world, and Merck still sometimes suffers from issues in a “lengthy and complex” manufacturing process. In January, the company started “proportionally allocating the medicine across countries where the company is the sole or primary supplier, including the United States” based on historical averages.
Merck expects the limited shipments to continue throughout this year and after. The company noted it doesn’t decide where shipments go within the U.S. Instead, that decision is for wholesalers and distributors.
Supply shortfalls for BCG have grabbed headlines for years as Sanofi struggled with manufacturing problems. According to a letter Sanofi sent to doctors in 2016 that urologic oncologist Benjamin Davies covered in Forbes, the the French drugmaker said it “spent considerable time and effort on a formal process to find another company to manufacture and commercialize” the drug, but that no other drugmakers would commit.