The Impact on Patients and Payers of Designating Albuterol a Non-Essential Use of an Ozone Depleting Substance
9 September 2003
By Dr. Richard Rozek with former NERA Consultant Emily Bishko Radel
For over 20 years, patients with asthma and chronic obstructive pulmonary disease (COPD) have used albuterol chlorofluorocarbon (CFC) metered-dose inhalers (MDIs) as a rescue medication. However, the CFC propellant haa been identified as an ozone depleting substance (ODS), which causes environmental harm. As a result, the US entered into the Montreal Protocol, an international agreement to phase out ODSs, including CFCs. While most consumer products have been phased out since January 1996, products designated as medically essential, such as albuterol CFC MDIs, are exempt until sufficient alternatives are developed.
Similarly, they calculated the average daily increase in costs to the US healthcare system during the first year after the FDA designates albuterol CFC MDIs non-essential to be:
On average, there is an increase in costs for albuterol. However, there are established public and private patient assistance and discount programs to ensure that patients unable to afford albuterol will have access to treatment. Moreover, there are offsetting savings in healthcare costs due to reduced expenditures for diseases such as cataracts and skin cancer associated with ozone depletion. Patients will be adequately served with the FDA designates albuterol CFC MDIs non-essential.
The Montreal Protocol created incentives for pharmaceutical companies to invest resources in R&D for alternative delivery technologies. Two non-CFC, albuterol-based MDIs have been developed and approved for patients. Given that these alternatives exist, the FDA is considering designating CFC MDIs non-essential. This action would eliminate sellers of albuterol CFC MDIs and raise the cost to the US healthcare system.
The authors prepared a comprehensive economic analysis to determine whether patients would continue to be adequately served when the FDA changes the status of albuterol CFC MDIs.
They estimated the average increase in total costs per MDI to be $9.87 where:
