February 20, 2014—Bayer HealthCare Pharmaceuticals has limited sales of its widely used, genetically engineered multiple sclerosis (MS) drug Betaseron due to inability to meet demand, effective with orders received on or after Jan. 1, the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) announced on its website today.[ms-protect-content id=”2799″]
Under HRSA policy, when a 340B covered outpatient drug is in short supply, its manufacturer must demonstrate that its allocation system treats 340B providers the same as non-340B providers. HRSA asks drugmakers to notify OPA at least four weeks in advance of altering its allocation procedures.
Betaseron (interferon beta-1b) was the first breakthrough treatment for MS symptoms. When it came on the market in 1993, demand was so extreme it was allocated to patients by lottery. It is the company’s top-selling drug globally, according to the company website.
Just this week, the newsletter Genetic Engineering & Biotechnology News reported that Betaseron was the fifth-best-selling MS drug in the U.S. last year, with $1.05 billion in sales. According to the Multiple Sclerosis Society website, only one other manufacturer is approved to market interferon beta-1b in the country (Novartis, under the brand name Extavia).
The letter from Bayer to OPA posted on the agency’s website does not explain the reasons for the shortage. “The risks imposed by anticipated unpredictability in demand are heightened by the critical role this drug plays in the lives of many patients with relapsing forms of MS,” the company wrote. “We anticipate that this limited distribution system will remain in place for the forseeable future and will best ensure that all patients of all providers have equal access to Betaseron.”
The company said it “will not require minimum purchase amounts per transaction, and importantly, a customer’s 340B participation status and the price a customer pays for Betaseron will not affect its quarterly allotment.”
Under the allocation system, Bayer will limit the number of Betaseron units available to each U.S. customer. The amount available to each customer will be limited to that customer’s average quarterly purchase volume in the third quarter of 2013 determined on a percentage basis and then applied to the current quarter’s available supply. New customers’ allocations will be based on similarly situated existing customer’s allocation percentages. Bayer will fill orders on a first-in, first-out basis, until a customer reaches its limit for the quarter, the company said.
Bayer limited the distribution of its second-highest-selling drug, the oral contraceptive Yaz, in 2007, 2008, and 2011, on occasions when it became subject to the 340B program’s “penny pricing” policy. [/ms-protect-content]