What Effect Will The Removal Of CFC Inhalers Have On The Health Care Market?

Implications: The transition from albuterol inhalers containing CFC propellants to those containing HFA propellants has certain ramifications for the health care market. The phaseout of existing generic albuterol inhalers has caused a constriction in the market and an increase in the cost of these products. Newer ozone-friendly products represent a significantly higher cost of therapy for patients. Some patients may cut back on the use of these products or forgo their use altogether. This may lead to more severe acute asthma attacks, more emergency room visits and hospitalizations, and increased health care costs.

Analysis: September 16th marked the celebration of the 20th anniversary of the signing of the Montreal Protocol,  and the observance of International Ozone Day for the Preservation of the Ozone Layer 2007.

The conversion of albuterol CFC inhalers to albuterol HFA inhalers in the United States is nearing completion. The FDA has mandated that by December 31, 2008 the production and sale of single-ingredient albuterol metered-dose inhalers (MDI's) must stop, by removing the essential use designation for albuterol MDI's which was granted in the EPA's Clean Air Act.

Since the phaseout began, the number of manufacturers of generic albuterol CFC inhalers has dwindled to one. Correspondingly, the average price for these inhalers has nearly quadrupled.

With the advent of the introduction, and subsequent mandate of the sale of albuterol HFA inhalers exclusively, the price of albuterol therapy will continue to rise. The average wholesale acquisition cost of one of the the currently available albuterol HFA inhalers is over $30.00 while the average cost of the currently available albuterol CFC inhaler is approximately $12.00

With the price of albuterol products increasing so drastically, the potential for a decrease in patient adherence is a real concern, especially in the case of uninsured patients.

While albuterol is typically not a drug used on a prophylactic basis in the treatment of asthma or COPD, many patients rely on it due to its heretofore low cost. Even patients with prescription drug insurance often cannot afford the higher copayments for the more expensive branded pharmaceuticals used to treat asthma and related conditions.

If patients discontinue the use if their albuterol inhalers and are not well-controlled on other forms of therapy, there undoubtedly will be an increase in acute asthma attacks, emergency room and urgent care visits, and hospitalizations. The cost to the health care system could be significant.

The bottom line is that as albuterol products increase in price it is inevitable that their use will decrease. One option would be for health plans to treat the new albuterol HFA inhalers like they would a generic product and place them in a preferred or "first tier" position on their drug formularies. This would afford the patients lower copayments and may increase utilization. Unfortunately, this does nothing to help those patients without health insurance or prescription drug coverage.

We have a year left before the change takes place. Hopefully there will be some constructive dialogue between the health care community and the payers, that can result in a reasonable solution. The outcome remains to be seen.