The WellPoint health plan has lifted prior authorization requirements on oral asthma medications based on a comparative effectiveness analysis of claims data for oral and inhaled asthma medications.
Despite inhaled drugs' clinical superiority in controlled trials, the study, conducted by HealthCore (WellPoint's health outcomes research subsidiary), revealed that users of oral asthma controllers appeared to have better clinical outcomes than did the inhaled corticosteroid (ICS) group, as indicated by less use of short-acting beta-agonists and a smaller risk of inpatient and emergency department visits, according to the study authors.
The study came about, according to WellPoint's National Pharmacy and Therapeutics Committee, when it found that oral asthma medications were being used as front-line therapy, a use that either wasn't part of the drug's approved indication or didn't follow the National Heart, Lung, and Blood Institute's asthma treatment guidelines.
WellPoint said it was hearing anecdotal evidence that members did not like inhaled treatments or were struggling to take them, prompting the insurer to find out “which therapy was best for members in the real world and align our formulary appropriately.”
For the study, HealthCore examined the medical and pharmacy claims of more than 55,000 patients from eight health plans who had used at least one of six types of asthma controller medications between 2003 and 2005.
The data were integrated with quality of life surveys of more than 800 asthma patients from the same plans to evaluate potential differences in quality of life between the types of controller medication. The oral medications that patients in the study were using were the leukotriene modifiers zafirlukast (Accolate), montelukast (Singulair), and zileuton (Zyflo).
Lead author Hiangkiat Tan and colleagues suggested that the reason for the better outcomes among the oral medication users compared with the ICS users comes down to real-world usage patterns.
“This conflict could be due to the observation that the patients in this study were less adherent to an inhaled controller medication (inhaled cortico-steroid, long-acting beta-agonist) regimen than to an oral controller medication regimen,” the authors suggested. “This observation concurred with the findings of other studies, which indicated that adherence was poor for inhaled medications, both in general and in comparison with oral medications” (Mayo Clin. Proc. 2009;84:675-84).
“Only 3% of patients in the ICS monotherapy group were considered adherent, a finding that underlines the urgent need for a better understanding of the barriers to patient acceptance of the most proven and effective therapy,” the researchers added. “When ICS adherence cannot be achieved, our findings indicate that a [leukotriene modifier] may be a reasonable alternative, although at a higher cost.”
The investigators noted that among patients who adhered to their controller medication regimen, the risk of inpatient or emergency department visits was lower for patients receiving an ICS than for those taking an oral medication.
But the findings underscore a common theme that has surfaced in broader discussions regarding comparative effectiveness research: How an intervention is used in the real-world setting can differ from its use in the clinical trials that are used to determine a drug's safety and efficacy, with different results.
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