Posted December 2, 2008
It's a good time to be an asthma patient - if you can afford it.
With asthma rates climbing worldwide, pharmaceutical companies are galloping light speed to find the cause and innovative therapies for this highly complex disease. The competition has led to drugs so effective they can treat 90% of asthma cases.
"Hardly a week goes by when something new shows up," said Alfred Munzer, MD, director of pulmonary medicine at Washington Adventist Hospital in Takoma Park, Md., and past president of the American Lung Association.
As of last year, 22.9 million Americans had asthma, of which 6.8% are children, according to the American Lung Association.1 This translates to a $13 billion to $14 billion industry in the United States alone.1,2 The yearly cost to treat an asthma patient in the United States is $1,102, according to the Agency for Healthcare Research and Quality (AHRQ), a division of the U.S. Department of Health and Human Services.2
The rising costs in asthma care are fueled largely by increases in prescription prices. The phaseout of chlorofluorocarbon (CFC) metered-dose inhalers in a few weeks will raise some patients' copays for the medications from $5 to $45.
In addition, patients are shifting their perspectives. Asthma no longer is seen as an episodic, reversible condition. Patients are learning that it is a chronic disease requiring long-term management, which means more medication and higher costs.
Spending for asthma care is reaching a breaking point, and fears are beginning to surface that cost-control measures by insurance companies and the government could hamper future innovation, said Mark W. Millard, MD, medical director at Martha Foster Lung Care Center at the Baylor University Medical Center in Dallas. "The asthma industry is brewing in a cauldron of conflicting priorities," he said.
U.S. residents spent $2.1 billion in office-based care related to asthma in 2005, the most recent figures available from the AHRQ. In addition, they spent $1.7 billion for inpatient hospitalizations, $0.7 billion for emergency room visits, $7.4 billion for prescribed medications, and $1.5 billion for home health care. Medicaid and private insurance paid for two-thirds of these costs, while patients paid 20% out of pocket. Medicare contributed 8% to the asthma health care bills.
The asthma industry comprises hospitals, home health care, prescription and over-the-counter drugmakers, and the manufacturers of such equipment as peak flow meters, spirometry and nebulizers. At least 70 companies worldwide offer asthma medications and equipment, making competition keen.3
Important innovations over the last several years include dose counters on inhalers, nonstatic holding chambers in hydrofluoroalkane (HFA) inhalers that prevent the medication and propellants from sticking to the sides, inhaled corticosteroids without excipients and surfactants, and at least one inhaled steroid that uses no propellant. Other advances such as leukotriene inhibitors look at asthma as an inflammatory disorder. Leukotriene inhibitors are oral medications that block the immune reaction pathways causing bronchospasms.
Patent laws are driving much of this innovation. "Companies have to come up with new medications," Millard said. "Otherwise, everything goes generic, and their profits go down."
But coming up with novel drugs is a challenge because the current drugs are so effective. Millard predicts patients will start seeing once-a-day combinations instead of twice-a-day. Drugmakers are pouring money into understanding asthma's genetic origins and the signaling that takes place in the airways, giving rise to inflammation and wheezing. Other areas of focus include preventing asthma from developing in the first place.
By and large, the most critical issue facing the asthma industry is the shift to HFA inhalers from CFC inhalers. CFC albuterol inhalers will be phased out after December, Munzer said. No generic HFA medications currently are on the market.
Not only are patients paying higher copays, but hospitals also will see costs rise. Hospitals have been using metered-dose inhalers with generic albuterol because they are as effective as nebulizers but less expensive, Millard said. Faced with paying for more expensive HFAs, hospitals likely will go back to administering fast-relief bronchodilators with nebulizers.
"There's been an economic impact right up front," Millard said.
The transition has been costly for pharmaceutical companies, said Nancy Sander, founder and president of the Allergy and Asthma Network Mothers of Asthmatics. Pharmaceutical companies had to redesign the canisters, change their assembly lines and test the drugs.
"They had to sell down CFCs and step up HFAs in a way that patients would not run out of medication," she said. "I'm pleased with the way pharmaceutical companies tackled this difficult task in as seamless a way as possible."
One benefit of the transition is that all patients will have to go into their health care provider's office to get their new prescriptions, Sander said. This presents an opportunity to re-educate patients with asthma, give them pulmonary function tests and look at their inhalation techniques.
Patients now can choose among four FDA-approved HFA albuterol inhalers. "If patients don't like one, they can choose another," said Sander, who has asthma.
Providers will have to make sure patients do not become confused by their options, Munzer said. One problem, he pointed out, is that patients may receive in-office demonstrations on an inhaler, only to find their insurance does not cover it, and they will have to use an alternative brand.
Insurers are struggling with higher asthma costs, and as a result are scaling back coverage for these drugs by moving them to lower tiers in their preferred drug lists. UnitedHealthcare moved Advair, a combination long-acting beta2-agonist and inhaled corticosteroid, to its third tier most expensive list, saying it was being used inappropriately.
"That's really a ruse for they don't like the cost of it," Millard said.