Monday, March 25, 1996
When Eli Lilly launched ReoPro just over a year ago, the slow ramp up of Centocor Inc.'s anti-platelet antibody caught many on Wall Street by surprise. A number of analysts had predicted first year sales for the drug in the range of $70-$150 million. Instead, Lilly's ReoPro sales for 1995 totalled $22.8 million.
The picture brightened over the year. After beginning marketing in February, sales increased every quarter, from $1 million in the first quarter, to $3 million in the second, $6.5 million in the third and $12.3 million in the fourth. By the end of 1995, ReoPro had received formulary approval at more than 70 percent of the Tier I, II and III hospitals that account for 80 percent of the angioplasties in the U.S., according to CNTO President and CEO David Holveck.
Still, the drug ran into resistance on several of fronts, among them the increasing use of stents and the bleeding issues associated with use of ReoPro and heparin. In addition, the some hospitals resisted the up front-costs of ReoPro because they would be unable to capture the presumed cost savings from the drug's effect on complications from angioplasty procedures, which would come downstream (see BioCentury, April 24, 1995).
A year later, cardiologists have more experience working with the GPIIb/IIIa inhibitor, and CNTO and Lilly have more selling. Most importantly, the companies now have data from two clinical trials that were halted early because of positive outcomes - the EPILOG all comers angioplasty trial and the CAPTURE refractory unstable angina study (see BioCentury Extras, Dec. 15 and Dec. 21, 1995). Those trials have added important information on how to control bleeding by administering lower doses of weight-adjusted heparin with ReoPro, which both should improve patient outcomes and shift the cost/benefit toward the drug.
In addition, the CAPTURE data provide a rationale for extending use of ReoPro from the catheterization lab into community hospitals, where non-interventional cardiologists would use the drug to stabilize patients with unstable angina.
New economic model
CNTO hasn't recalculated the economic model that came out of the original EPIC study. Based on that model, ReoPro saved $1,100-$1,200 per patient at six months, while the drug costs $1,350. By reducing the need for transfusions and extra time in the hospital to manage bleeding, the company expects that the cost advantage has been tilted in favor of ReoPro, Holveck said. The company expects to submit its economic analysis of the EPILOG data to the FDA by the end of the year, he said.
The key pharmacoeconomic battle isn't over the savings at six months, but on the savings in the acute setting, he said. "So a good portion of the economic sales pitch in reality has been focused on the drug's effectiveness in getting patients in and out of the cath lab." Part of the savings comes by eliminating the need for pretreating patients with one or two days of heparin or with ticlopidine, a platelet mediator, Holveck said. ReoPro also saves time during procedures by eliminating or reducing the need to fight thrombus, which means more patients can be moved through the cath lab, he said. Finally, with fewer adverse events after procedures, patients can get out of the hospital faster.