Executive Summary:

• On January 8th, 2024 the Senate Committee on Health, Education, Labor, and Pensions (HELP) sent letters to the CEOs of the four largest manufacturers of inhalers sold in the United States (AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline (GSK), and Teva) launching an investigation into the high price of inhalers used for Asthma and Chronic Obstructive Pulmonary Disease (COPD). Subsequently, two manufacturers have imposed self-pay caps at $35 per inhaler.  
• Between 2013 and 2018 the average cash price of inhalers increased about 35 percent from around $208 in 2013 to more than $380 in 2018; price increases could be market responses to drug shortages, manufacturing issues, and environmental regulations.  
• With the possibility of other inhaler manufacturers self-imposing price caps or more burdensome regulations being enforced, policymakers should consider the unique dynamics of the inhaler market before mandating new pricing requirements.  

Introduction:

On January 8th, 2024 the Senate Committee on Health, Education, Labor, and Pensions (HELP) sent letters to the CEOs of the four largest manufacturers of inhalers sold in the United States (AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline (GSK), and Teva) launching an investigation into the high price of inhalers used for Asthma and Chronic Obstructive Pulmonary Disease (COPD). This has led to AstraZeneca and Boehringer Ingelheim self-implementing a $35 price cap on inhalers beginning in Summer of 2024. The out-of-pocket price of an inhaler has increased from about $10 to nearly $100 over the last 15 years. Environmental concerns, drug shortages and manufacturing discontinuation has contributed to this price increase, and while price caps on inhalers may see like a win for the consumer, these caps may be stifling innovation and competition in an already struggling market.  

Asthma Demographics:

Asthma impacts about 24.9 million, or around 1 in 12, people in the United States. Asthma prevalence is higher in adults (8.0 percent) than in children (6.5 percent) and higher in female adults (9.7 percent) than male adults (6.2 percent). Asthma rates are highest in Indigenous and Black American Adults. Further, around 40.7 percent of adults diagnosed with asthma report experiencing an asthma attack within the past year. In 2020, 4,145 people died from to an asthma attack or complications due to asthma, with the highest death rate being in those over 65. 

Changing Landscape:

In the Annals of the American Thoracic Society, asthma is described as a costly condition for many Americans, with the average cost of asthma care per person being around $3,266 a year, with $1,830 of that total being contributed strictly to prescriptions. Between 2013 and 2018 the average cash price of inhalers increased about 35 percent from around $208 in 2013 to more than $380 in 2018, and these prices have only continued to increase over the past few years.   

Advair HFA 

Advair HFA is a commonly prescribed bronchodilator inhaler for those suffering from asthma and COPD. The average cash price for one unit of Advair HFA has increased from $316 in 2013 to $496 in 2018, which is almost a 56 percent increase in price. Currently, the average cash price estimated for one unit of Advair HFA is around $472. For Medicare beneficiaries, there has been a 1.2 percent annual change in the growth rate in average spending per dosage unit of Advair HFA. Total Medicare spending in 2022 for Advair HFA was $384,716,839 with beneficiaries paying an average of $2,224 a year for their Advair HFA prescriptions.  

Flovent HFA 

Flovent HFA is a commonly prescribed steroid inhaler used to prevent asthma attacks. Between 2013 and 2018 the average cash price of Flovent HFA increased from $207 to $292, almost a 41 percent increase. Currently, the estimated average cash price for one unit of Flovent HFA is around $389. For Medicare beneficiaries there has been a 3.7 percent increase in spending per dosage per unit for Medicare beneficiaries and a 3.3 percent increase in the average spending growth rate per unit of Flovent HFA. In 2022, the average spending on Flovent HFA for Medicare beneficiaries was around $941. Total Medicare spending on Flovent HFA was $445,083,268 in 2022.  

Possible Reasons for Increase: 

There are various reasons for the increase in prices for inhalers, including environmental concerns, regulatory burdens and drug shortages. These unique predicaments over a long length of time have contributed to the high cash prices we are currently seeing for inhalers.  

Arguably, one of the most influential moments in inhaler pricing was in 2008 when affordable and effective inhalers that contained chlorofluorocarbons (CFC) were banned due to the Montreal Agreement, an agreement focused on protecting the ozone layer. In 2009, CFC inhalers were officially phased out and replaced with hydrofluoroalkane (HFA) inhalers, and while HFA inhalers are more environmentally friendly, they are much pricier. In fact, a 2015 study found that for insured patients the out-of-pocket cost for an albuterol inhaler increased from $13.60 per unit in 2004 to $25 per unit directly after the 2008 ban. 

Further, an increase in shortages of inhalers due to discontinuation by the manufacturer has contributed to the increasing price of inhalers. Perrigo discontinued its Albuterol HFA inhaler in 2020 due to possible clogging of the device, leading to inaccurate dispensing of the medication. Next, Merck, a drug manufacturer in West Point, Pennsylvania discontinued its Proventil HFA inhaler in September of 2021. There was no reason listed for the discontinuation. Finally, on October 1^st, 2022, Teva announced that they would be discontinuing ProAir HFA inhalation aerosol.  

What’s Next?

On 8th, January 2024 the Senate Committee on Health, Education, Labor, and Pensions (HELP) sent letters to the CEOs of the four largest manufacturers of inhalers sold in the United States (AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline (GSK), and Teva) launching an investigation into the high price of inhalers used for Asthma and Chronic Obstructive Pulmonary Disease (COPD). Following these letters, as of March 18th, 2024, both AstraZeneca and Boehringer Ingelheim voluntarily capped their out-of-pocket costs for inhalers at $35 a month in the United States. Seven Boehringer Ingelheim inhalers and four AstraZeneca inhalers are affected by the price cap, which will go into effect on June 1st, 2024. The price caps will be implemented at retail pharmacies and will apply to those who are uninsured or underinsured.  

Conclusion:

Getting inhalers to patients who need them is vital and, potentially, manufacturers’ limiting out-of-pocket costs may be the beginning of a longer collaboration between industry and policymakers. Regardless, with the discontinuation of many inhalers as well as different manufacturers pulling out of the market, further analysis into the lack of competition in the inhaler space is needed. Policymakers should consider solutions to support a robust inhaler marketplace rather than impose new pricing regulations on a limited number of products.