Asthma's New Expense
Phaseout of inhaler leaves patients gasping with sticker shock
More than 22 million Americans have the chronic airway inflammation known as asthma, with episodes of wheezing, coughing, and breathlessness. Each year, asthma causes 1.8 million emergency room visits, nearly 500,000 hospitalizations, and more than 4,000 deaths. Albuterol was a breakthrough for quelling asthma attacks when it debuted in 1981. But today, doctors emphasize the need for corticosteroids to reduce swelling long term and head off most acute episodes. No drug, however, wipes out the risk of attacks. So asthma patients keep albuterol close at hand, no matter how well their condition is controlled. "It is an incredibly important drug in the asthma market, because all patients—from those with mild intermittent to severe persistent cases—need it," says Vickie Lai, an analyst for the consulting firm Decision Resources.
After the FDA approved generic albuterol in 1995, that low-cost alternative came to dominate the market. Such is the well-worn drug industry story line. But a rare plot twist came with the FDA's 2005 ozone move. Medical inhalers have been one of the few remaining uses of CFCs, eliminated from refrigerants and sprays years ago under the Montreal Protocol. The FDA has a duty to finger the therapies involving CFCs that are no longer medically necessary. It decided albuterol, the only inhaled asthma drug sold generically, would be the first to go. The amount of CFCs released from albuterol inhalers in the United States was small—about 1,200 tons per year, a tiny fraction of the 1.8 million tons of ozone-depleting substances emitted into the atmosphere prior to the treaty. But there's been an alternative since 1996, when Schering-Plough introduced Proventil HFA, which contains the ozone-benign propellant hydrofluoroalkane.
Proventil HFA and GlaxoSmithKline's Ventolin HFA, introduced in February 2002, lagged far behind the cheaper generic CFC albuterol in sales. So the FDA took action, saying: "This regulation is necessary because private markets are very unlikely to preserve levels of stratospheric ozone sufficient to protect the public health."
Two big patient advocacy groups, the American Lung Association and Allergy and Asthma Network Mothers of Asthmatics, support the FDA decision—and in fact helped spur it by filing a 2003 petition requesting CFC withdrawal. Both groups undertook CFC public awareness programs sponsored by drug companies. The ALA's "Time to Make the Switch" campaign was underwritten with $1 million from Teva, maker of ProAir HFA. The AANMA promotes "Smart Moves to an HFA Inhaler," sponsored by Sepracor. That company sells the albuterol-like drug levalbuterol as Xopenex HFA.
The groups maintain that patient concerns were foremost in their advocacy and that, in any case, dwindling global production of medical-grade CFCs would have sharply driven up the cost of CFC-based inhalers. "The fact we all have to face is that the CFC inhalers are going away," says Nancy Sander, AANMA's president and founder, who has owned Sepracor stock.
Alfred Munzer, a former ALA president and director of pulmonary medicine at Washington Adventist Hospital in Takoma Park, Md., says that competition among branded inhalers may soon begin to drive prices down. Indeed, Teva, known mainly as a generics firm, introduced ProAir HFA just prior to the FDA decision, pricing it slightly below Ventolin HFA and Proventil HFA. According to figures from IMS Health, a healthcare information company, ProAir HFA leapt to No. 1, with a 37.4 percent market share in early 2007. Munzer says negotiations between insurers and drug companies also will make a difference. For example, the nation's second-largest health insurer, UnitedHealth Group, in April struck a deal with Sepracor that moves Xopenex HFA from Tier 3 to Tier 1. That can shave the copayment from as much as $50 to $10, the same low sum patients previously paid for generic albuterol. The competing drugs remain in Tier 3.