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FDA is considering doing away with albuterol metered-dose inhalers that use chlorofluorocarbons as propellents
Get ready for a new generation of albuterol metered-dose inhalers. They look like today's MDIs and deliver the same dose of the same medication. But they are not identical. Patients report a slightly different taste from the new MDIs. And the albuterol blast is not as cold or as forceful as patients are accustomed to.
That's because the new MDIs use a new propellanthydrofluoroalkane, or HFA. The familiar propellant, chlorofluorocarbon (CFC), could be out of production by the end of 2005 because of environmental concerns. The problem is that replacement inhalers powered by HFA cost more. In mid-July, Drugstore.com listed generic 17-gm albuterol MDIs for $14. A similar Proventil (Schering-Plough) MDI listed for $38 and Proventil HFA for $40. Prices for Ventolin (GlaxoSmithKline) MDIs were similar.
"The change is mandated by law and by international treaty. Timing is the only real question," said Leslie Hendeles, professor of pharmacy practice at the University of Florida and member of the Food & Drug Administration's Pulmonary-Allergy Drugs Advisory Committee (PADAC).
PADAC recommended banning further production of CFC-based inhalers in December 2005. That would give manufacturers time to increase production. It would also give the FDA time to approve pending approval applications for new HFA-based inhalers. U.S. patients currently use about 50 million MDI canisters annually, Hendeles added.
CFCs have already been banned from almost all other uses around the world. The 1987 Montreal Protocol called for the elimination of products such as CFCs that contribute to ozone depletion.
The treaty made an exception for uses such as asthma inhalers in which CFCs are essential, but only until replacements became available. With two HFA-powered albuterol inhalers on the market and a third from IVAX moving through toward approval, the FDA is considering removing CFC-powered inhalers from the market. The agency's proposed rule to remove the essential-use designation for CFC-based albuterol MDIs was published in the Federal Register on June 16. Comments are being accepted until Aug. 16.
The American Association for Respiratory Care (AARC) also supports the switch to HFA. But the group sees price increases as a potential access and compliance problem. "Price is something we watch out for in the hospital environment," said AARC spokesman Tom Kallstrom, director of respiratory care services at Fairview Hospital in Cleveland. "So do our patients. My concern is that price will be higher and patients will just go to the drugstore and buy Primatene Mist. That is hardly a first-line medication for asthma and COPD [chronic obstructive pulmonary disease]."
PADAC member Fernando Martinez, M.D., director of the University of Arizona's Arizona Respiratory Center, warned that higher prices would reduce access for a significant number of patients. The problem is that HFA inhalers are recently approved as new drugs. The first patents do not expire until 2010, noted Dennis Williams, Pharm.D., associate professor at the University of North Carolina School of Pharmacy. "Non-CFC inhalers are equally effective," he said. "But I am worried about the cost issue. We need a moderate approach, not an immediate ban." Generics now fill more than 90% of the albuterol MDI market, he said, but generic competition would disappear for years once CFC-powered inhalers are off the market.
Hendeles is not convinced that today's three-fold price differential would remain. IVAX typically prices its branded products about 50% below the competition, he noted. If the company follows the same pattern, its HFA inhaler would enter the market at around $20. That's a 50% jump over currently available generic albuterol MDIs. But until, or if, generic-like pricing hits the HFA inhaler market, R.Ph.s and patients can expect sticker shock as CFC products disappear.
"HFA inhalers are two to three times more expensive," said Page Dunlap, co-owner of Fowler Pharmacy near Birmingham, Ala. "That must be passed on to the payer, be it the patient or a third party. We expect to see some patients stop buying." Patient assistance programs will help bridge the financial gap, she said, but not all needy patients qualify. And not all patients or R.Ph.s realize that assistance programs exist for front-line medications such as albuterol.
The FDA expects to publish a final rule on the phase-out of CFC-based inhalers by the summer of 2005.
Fred Gebhart. Are albuterol inhaler costs expected to rise?
Aug. 9, 2004;148:13.