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Tuesday, November 13, 2007

Asthma Inhaler Price Relief

The Only Cheap ($4/month) Asthma Quick Relievers Left in the United States

I just got back from an asthma conference in Phoenix, with 20 experts from around the United States. Dr. Stuart Stoloff, an active member of the committee which wrote the new EPR-3 asthma clinical practice guidelines, decried the lack of a generic asthma controller medication in the United States.

Sadly, as I’ve mentioned here before, the FDA and the inhaler manufacturers have worked together during the past couple of years to ensure that new patents for all asthma inhalers which contain an inhaled corticosteroid (ICS) will not expire for another 15 years. The prices of $100 to $300 per month for an ICS will be maintained since no generics will be introduced.

Another speaker, well connected with the FDA and major inhaler manufacturers, showed the expected FDA approval dates for about 8 new ICS or combination ICS plus LABA inhalers during the next 8 years. All of these are “me too” inhalers, with any differences between them and existing ICS or combo inhalers possibly exaggerated in an attempt to gain a slice of the $10 billion per year worldwide market for asthma and COPD inhalers. Of course, all of these new inhalers will be priced about the same as the existing ones ($100 to $300 per month). No truly innovative inhalers are “in the pipeline” (in phase II or III clinical trials). This is a sad situation for under-insured folks in the United States with asthma (or a child with asthma).

Okay, back to the title of this blog. Asthma drugs can generally be categorized into 1) controllers (which you take every day), and 2) quick relievers, which are bronchodilators which are to be used only to temporarily relieve asthma symptoms. Once inhaled, they “kick-in” in less than 5 minutes, and last about an hour or two. These puffers contain beta-2 agonists (aka short-acting bronchodilators); albuterol (called salbutamol outside of the U.S.) is the most popular. It’s available as a metered-dose inhaler (MDI, aka an asthma puffer), a solution to be placed in a nebulizer, and a pill. Albuterol MDIs are wildly popular because they are very small, take less than a minute to take a couple of puffs, and are relatively cheap. The albuterol solution is more cumbersome, since it must be placed in a nebulizer and takes 5-10 minutes to inhale the 2-3 milliliters of the liquid. Very few asthma experts ever use albuterol pills, because they are much more likely to cause side-effects (rapid heart rate, nervousness, and tremor), and they take 20-30 minutes to become effective.

Generic albuterol MDIs have been available in the U.S. for several years, and have cost as little as $6 each (less than most insurance copays). Sadly, the FDA has decreed that they be banned, starting in December, 2008. Already, it is rare to find them, as wholesale houses deplete their inventory and don’t buy more. The FDA also plans to ban Primatine Mist (quick relief) inhalers, which are currently over the counter (without a prescription) for about $16 each. The new branded HFA MDI inhalers (Ventolin, Proventil, ProAir, and Xopenex) now cost between $30 to $65 each. There is no convincing evidence that any of them are more effective or are less likely to cause side-effects when compared with each other or generic albuterol.

What’s left for poor folks? Wal-Mart, Target, and Dey Pharmaceuticals have “come to the rescue,” but their solutions (pun intended) are not ideal. Dey makes generic albuterol and generic ipratropium single dose vials with 2.5 mL of liquid to pour into a nebulizer, and Wal-Mart and Target pharmacies sell a “typical” one month supply of these vials (60-75) for only four dollars! Wow, that’s about one-tenth the price of the branded albuterol MDIs. What’s the catch? Well, you need to have a compressor which plugs into the wall ($20 to $120 each, depending whether you buy it at a local pharmacy or DME store versus Ebay) and some nebulizers ($3 to $30 each, again depending on the source). An alternative is a battery-powered, hand-held ultrasonic nebulizer, which cost from $30 to $150 each, depending on the source. These solutions require larger equipment when compared to an MDI and a handful of vials, and take longer to administer the drug, but silver lining is that the nebulizer+compressor combination is the same as the bronchodilator treatment you will get in most emergency rooms.

So what about the generic ipratropium solution from Dey, which was just added to Wal-Mart’s $4/month program? Ipratropium has been around for decades, branded by Boehringer (a German drug company) as Atrovent. Ipratropium has two major disadvantages as an asthma rescue medication when compared to albuterol: 1) it takes 45 minutes to an hour to take effect, and 2) it only works for a relatively small minority of children or young adults with asthma. However, ipratropium brings temporary relief of shortness of breath for about half of patients with COPD due to smoking. For those in whom it is effective, it lasts for 4 to 6 hours. The bronchodilator effect of ipratropium adds to the bronchodilator effect of albuterol, so many years ago, Boehringer introduced a combination MDI inhaler called Combivent. They apparently fell behind in the development of an HFA or DPI inhaler to replace the old CFC Combivent (and thus get another 15 year patent), so they have petitioned the FDA for an delay (beyond 2008) in the ban on CFC Combivent. Meanwhile, the Mothers of Asthmatics have attacked compounding pharmacies for substituting low cost generic combinations of ipratropium and albuterol solutions for the expensive Combivent brand name solution for nebulizers.

If you are concerned that the $4 per month generic short-acting bronchodilators may be less effective than the branded versions, get a peak flow meter (or even better a PiKo-1 pocket spirometer to measure your FEV1) and compare the improvement between the cheap and the expensive solutions (after ten minutes for albuterol and after 45 minutes for ipratropium or the combination. Of course, always, always work with your doctor when contemplating a change in your asthma treatments.

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Posted by: Paul Enright MD at 3:44 pm


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