Asthma Drug Spending Soars in U.S.

According to new government figures U.S. spending on asthma drugs more than quadrupled in the 10 years from 1998 to 2008.  During that time, annual costs rose from $527 million to $2.5 billion.

Many of the reasons are clear.  Firstly, the the number of people diagnosed with asthma grew by 4.3 million between 2001 to 2009. Asthma rates rose 50% among black children during that time.  And the problem is still growing. The U.S. Centers for Disease Control and Prevention (CDC) estimates that 7 million kids and nearly 17.5 million adults suffer from asthma.

Secondly, the proportion of children who used a prescribed drug to treat their asthma doubled from 29% between 1997-1998 to 58% between 2007-2008.  Overall, spending on drugs to control asthma grew from $280 million in the late 1990s to $2.1 billion by 2008. In that same period, spending on drugs to relieve immediate symptoms grew from $222 million to $352 million.

Thirdly, annual spending on older, less expensive drugs such as oral corticosteroids has fallen, while newer more expensive medications have taken their place.  Examples of more expensive medications include,  inhaled corticosteroids which prevent inflammation and control asthma; reliever drugs such as short-acting beta-2 agonists (SABA’s) that make breathing easier and leukotriene receptor antagonists which help prevent asthma symptoms from occurring in the first place.

Over the past decade there has been a 25% rise in the number of patients using inhaled corticosteroids, a 10% rise in the use of beta agonists and a 31% rise in leukotriene receptor agonists such as Montelukast (sold as Singulair®) and Zafirlukast (sold as Accolate®).

Do these spiraling costs take your breath away or suggest that asthma is being better controlled?  Let us know your thoughts.

FDA Gets Tough on Asthma Drugs

The U.S. Food and Drug Administration (FDA)  has ordered four drug manufacturers to conduct additional post-marketing clinical trials of their long-acting beta-agonists (LABAs).  LABAs to be studied are AstraZeneca’s Symbicort, GlaxoSmithKline’s Advair Diskus, Merck and Co.’s Dulera, and Novartis AG’s Foradil.

The clinical trials will examine the use of LABAs when used in combination with inhaled steroids. Each of the LABAs plus a corticosteroid will be compared with the steroid alone in patients 12 years of age and older. A total of 46,800 patients will be studied.  Another trial will include 6,200 younger patients, aged 4 to 11, using Advair Diskus.

Last June, the FDA issued warnings on LABAs, saying they should never be used on their own to treat asthma. Although LABAs relax the muscles of the airway to help patients breathe easier, they can cause an increased risk of asthma symptoms that can lead to hospitalizations and death.

The studies will begin later this year, but results are not expected until 2017.

The huge size of the studies signals that FDA wants to be completely sure about the safety profile of these drugs as they are used so widely.

Clearly however, such large study populations might pose financial challenges for the manufacturers.

As of now, Word on Health has heard that Glaxo plans to fully comply with the requirement and Astra Zeneca is finalizing their study protocol with the agency.

Novartis said it was still reviewing the post-marketing requirements issued by the FDA, while Merck said it would have a comment shortly.

We’ll of course bring you updates as they occur.