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Albuterol is a short acting beta agonist (SABA) used to treat or prevent bronchospasm in patients with reversible obstructive airway disease commonly caused by chronic bronchitis, as well as to prevent exercise-induced bronchospasm (asthma). Bronchospasms are the tightening and narrowing of the airways in the lungs causing difficulty in breathing. Exercise and other physical activity can bring on these symptoms in most people who have asthma and may occur either during or right after being active. Asthma causes recurring wheezing episodes. Asthma is a chronic disease that affects more than 26 million people in the US, 7 million of them are children. Uncontrolled asthma costs over the next 20 years will approach $1 billion dollars in the United States. Asthma attacks can lead to death but can be avoided with proper treatment and care. Albuterol inhalers are an important pharmacologic therapy used to treat asthma symptoms and to ease breathing by opening airways during an asthma attack.

For many years Proair HFA, Ventolin HFA and Proventil HFA were the three branded albuterol products that have dominated the SABA class. According to IPD Analytics, they account for over 3 billion in US sales annually. However, we have seen many new developments in the SABA space this past year and a half that impacted both supply and management strategies.

First came the AG (authorized generic) launches. In January 2019, we saw two AGs launched. GSK launched an AG for Ventolin HFA, which is manufactured by GSK and distributed by Prasco. Then an AG for ProAir HFA was launched, which is manufactured and distributed by Teva. In April 2019, we saw the launch of the AG for Proventil HFA which is manufactured by Merck and distributed by Endo.

Then in early 2020, we experienced shortages of albuterol inhalers in different parts of the country due to the COVID-19 pandemic. Several factors contributed to this shortage including the easing of refill restrictions and the increased usage in hospitals. In order to prevent spreading COVID-19, hospitals moved away from using nebulizers, and were using albuterol inhalers as the treatment of choice to manage respiratory issues that are common in COVID-19 patients. Key stakeholders in the supply chain responded to these initial albuterol shortages by reducing barriers to access so that patients can have access to this vital drug.

A couple of generic launches in early 2020 have helped alleviate some of the shortage. The FDA approved the first AB-rated generic for ProAir HFA in February 2020. Soon after in April 2020, an AB-rated generic for Proventil HFA was approved.

The ProAir Digihaler was recently launched in July 2020 at a significantly higher price when compared to the approved brand and generics. The Digihaler contains built-in sensors to monitor and record inhaler usage though a mobile app. This new technology will allow healthcare providers to have easier access to data that can help manage and assess the patient’s condition. This may be useful in some patients as they transition to Telehealth services due to the COVID 19 pandemic. The list price of the Digihaler is $146.67 compared to the ProAir HFA inhaler at $66.88 and the new AB generic which costs $35.98.

How have these generic launches impacted the rescue inhaler category? For one, it has helped alleviate some of the shortages experienced during the early phases of the pandemic. As the FDA is interested in maintaining the albuterol inhaler supply throughout the continuing pandemic, we expect to see more generic albuterol inhaler approvals in the near future.  This will not only help with supply but will drive down costs as more generics enter the market. In terms of cost savings, the generic launches have not driven down costs significantly. Part of the reason is 3 of the 5 albuterol generics in the market today are AGs.

Payors and health plans will need to monitor the generic pipeline and pricing as strategy may evolve because of the changing landscape. There are many factors to consider when developing and executing a management strategy. If the branded albuterol inhaler is the lower net cost option, one must look at how long the net cost of generic inhaler prices will be higher than the brand. State regulations and member pushback are other factors that need to be considered. Branded albuterol inhalers are a heavily rebated class and if prices are not expected to come down significantly for more than a year , there may be an opportunity for a brand over generic strategy. If the net cost of the generic albuterol HFA is less than the brand, different formulary management strategies will need to be implemented. In developing your management strategy understanding the albuterol inhaler class and close monitoring of the generic pipeline will be needed to come up with an effective strategy for this class. It’s also important to understand benefit design as well as the net cost of branded products (after rebates) and how brand manufacturers use AGs to compete with other brands in the albuterol inhaler category in order to lower cost. 

To understand some of the complexities of generic and AG strategy, here is a link to another RemedyOne article:

https://remedy-one.com/navigating-the-complex-world-of-generics-and-authorized-generics/are

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