Allocation system is the first since OPA issued policy clarification in November.
April 4, 2012—Drug manufacturer Eli Lilly and Co. is limiting sales of its widely used atypical antipsychotic Zyprexa (olanzapine) in light of the drug's 340B ceiling price falling to $0.01 under the Office of Pharmacy Affairs' (OPA) "penny pricing" policy.
The company notified OPA that it was instituting the purchasing limits in a March 28 letter that OPA posted on its home page on April 2. It marks the first time that a manufacturer has announced an allocation system for one of its products since OPA clarified its penny-pricing policy last November.
According to the IMS Institute for Healthcare Informatics, Zyprexa was the 17th top-selling drug in the United States in 2010, the most recent year for which data are available, with $3 billion in sales. Last October, the Food and Drug Administration (FDA) granted Teva Pharmaceuticals US and Dr. Reddy's Labs permission to manufacturer the first generic version of the drug.
Under OPA's penny-pricing policy, a drug's 340B ceiling price is $0.01 when its Medicaid unit rebate amount (URA) equals its average manufacturer price (AMP), a situation that otherwise would result in a price of zero. This typically occurs when a drug's AMP has risen faster than the rate of inflation, which triggers an increase in the drug's URA.
In its March 28 letter, Lilly told OPA "we anticipate that we may be unable to meet demand for Zyprexa because of increased ordering activity anticipated as a consequence of the penny price."The sales limit applies to all orders received on or after April 1 "and will limit the amount of Zyprexa any customer (340B and non-340B) may purchase to that customer's historical average ordering volume on a percentage basis applied to the then-current quarter's available supply." Lilly said it expects the limit will last "at least through the end of the second quarter of 2012."