Examining new and emerging therapies to meet the unmet needs of patients with asthma.
Approximately 23.3 million Americans have asthma, with costs in 2010 estimated at $5.5 billion for hospital care, $5.9 billion for prescription care, and $4.2 billion for physicians’ services.1 Part of the high costs are due to the fact that each patient with asthma has a unique set of symptoms, triggers, comorbidities, and treatment preferences. The immunologic pathophysiology of asthma is very complex, and it is difficult to know which factors or combination of factors will trigger an exacerbation or worsen symptoms. Similarly, asthma treatment is very complicated; asthma control should be regarded as a long-term process.
A measurement of asthma control along with tailored asthma management strategies can be found in the guidelines developed by the National Asthma Education and Prevention Program (NAEPP).2 These evidence-based guidelines are the third report written by the NAEPP’s expert panel and they provide a solid foundation to help clinicians and managed care providers develop treatment plans to control asthma. Control of asthma should be the goal of treatment. If control is not achieved, future asthma control can be impeded. Poor asthma control also impacts medical costs and health-related quality of life.3,4
A key factor to obtaining asthma control is good adherence to the treatment plan. Unfortunately, poor adherence to treatment is common in asthma,5 and suboptimal adherence is linked with suboptimal asthma control.6 Numerous factors, including sex, age, and disease severity, are associated with poor patient adherence to treatment (
).7 Asthma control and adherence to treatment, however, are not the sole responsibility of the patient. Other people involved in the treatment plan, such as pharmacists, physicians, family members, and managed care representatives, can have tremendous influence on how well treatment proceeds. The article will review the current NAEPP guidelines and discuss how pharmacists and managed care professionals can help patients adhere to those guidelines.
Review of Asthma Treatment Guidelines
In 1991, the National Heart, Lung, and Blood Institute (NHLBI) wrote its first NAEPP guidelines.8 These guidelines have been updated several times, with the most recent version published in 2007; it is commonly referred to as Expert Panel Report 3 (EPR-3).2 The EPR-3 lists 4 components of asthma management: (1) assessment and monitoring; (2) education; (3) controlling environmental and comorbid conditions; and (4) pharmacologic therapy. Pharmacists and managed care professionals can help in all 4 of these components.
Assessment and Monitoring 2
Assessment and monitoring tools can be used to determine asthma severity, patients’ control of asthma, and responsiveness to treatment. Both impairment (ie, symptom severity and function limitations) and risk (of future exacerbations, declining lung function, and/or medication side effects) are key factors to assess and monitor. Pharmacists can help monitor adherence by canister use and reiterating asthma treatment plans during refills. Managed care professionals can make sure that time is allocated at each visit to properly assess and monitor the patient.
Patient Education 2
Most asthma treatment is self-administered by the patient. Therefore, the patient should have a fairly good knowledge of the pathophysiology of asthma and how poor adherence to treatment can worsen symptoms. Asthma self-management education is essential to control asthma and improve outcomes. Education requires repetition and reinforcement. It is encouraged that patients be provided with a written action plan that includes 2 aspects: (1) daily management; and (2) how to recognize and handle worsening asthma. Managed care professionals should make sure that any plan includes allotment of time for clinicians and pharmacists to educate patients repeatedly.
Control of Environmental Factors and Comorbid Conditions 2
It is well established that asthma is associated with an immune response. As such, patients need to be educated on methods to reduce exposure to known allergens (
).2 This aspect of the treatment plan can easily be overlooked by all parties involved and result in poor asthma control. Equally important, comorbid conditions can also impact asthma symptoms and asthma treatment.
Asthma medications are classified as long-term control medications or quickrelief medications. Most long-term controllers are taken daily on a long-term basis to maintain or develop control of persistent asthma. Long-term controller medication classes include inhaled corticosteroids (ICSs), cromolyn sodium and nedocromil, long-acting beta2-agonists (LABAs), sustained-release theophyllines, leukotriene modifiers, and anti-immunoglobulin E (IgE) agents. ICSs are the most potent and effective anti-inflammatory medications currently on the US market.9 They block late-phase reactions to allergens, reduce airway hyperresponsiveness, and inhibit inflammatory cell migration and activation. Selection of long-term controllers is usually based on the severity of asthma; a step-wise approach to treatment is advised (
).2 For more severe asthma, an ICS is often combined with a LABA10-12; however, LABAs are contraindicated in asthma patients not using an asthma controller medication, such as an ICS.13 LABAs should be used for the shortest duration of time to achieve control of symptoms and discontinued (if possible) when control can be sustained without LABAs. This recommendation is based on analyses of data by the US Food and Drug Administration which suggested that LABAs were associated with an increased risk for severe exacerbation of asthma symptoms. Other long-term controller options include sustained release theophyllines, leukotriene modifiers, and omalizumab. Quick-relief medications consist of short-acting beta2-agonists, anticholinergics, and oral or systemic corticosteroids. Short-acting beta2-agonists are the therapy of choice for relief of acute asthma symptoms and prevention of exercise-induced bronchospasm.2
Disease Management Programs and Improving Asthma Care
Numerous studies have evaluated the clinical and economic aspects of asthma interventions and policies. The general consensus is that appropriate use of ICSs is cost-effective.14 Further, appropriate use of the combination of an ICS plus a LABA is also considered costeffective.15-17 In addition, the use of omalizumab in patients with severe, uncontrolled allergic asthma may be cost-effective.18
Adherence to treatment has long been a problem with asthma management. Poor adherence, however, is not solely due to the patient forgetting to take their morning inhalant. Poor adherence also includes missing followup appointments, not removing known allergy trigger factors, neglecting to record symptoms, and not having regular reviews. This is why it is important for all parties involved in the treatment plan to be familiar with the guidelines and follow an evidence-based treatment plan that is designed to improve and sustain control.
Managed care plans can help asthma control indirectly by providing all parties with the time and opportunity needed to use the guidelines appropriately. Bahadori et al noted that the large variation in asthma control can be partly explained by differences in guideline adherence to medication use and deficits in patient management.19 Insurance companies and managed care providers can help in this process by providing management plans that promote adherence to an evidence-based treatment plan. As stated above, pharmacologic therapy is only 1 component of the treatment plan. Constant monitoring, education, and removal of environmental triggers are also important to asthma management success. Managed care providers should allow physicians, pharmacists, nurses, and all those involved in asthma care the time necessary to ensure that these components of the treatment plan are properly addressed.
Among other factors, the definition and implementation of an optimal asthma management program likely depends on the patient population and the medical care setting. Dall et al noted that one model of an asthma managed care plan can provide: (1) less utilization of emergency and hospital services; (2) increased appropriate use of medical exams and pharmaceuticals; (3) reduced annual per capita medical expenditures for targeted audiences; and (4) overall satisfaction with the program. The perception of the Dall et al program helped increase patients’ understanding of their asthma, self-management skills, and quality of life.20
Whatever plan is developed, it should be one that promotes education to reduce asthma-related impairment and risks that in turn may reduce total costs.21
New and Emerging Therapeutic Options in Asthma
Managed care plans must also be flexible to new treatments if evidence supports their clinical and economic value. Asthma encompasses a large array of morbidity and symptoms, and new treatment options are needed to improve outcomes in some patients.
Many medications in combination with ICSs have shown promise in clinical trials. For example, the leukotriene inhibitor montelukast, normally recommended for patients with mild asthma, may be effective for some patients with severe asthma when combined with an ICS.22
The combination of tiotropium plus an ICS may be another option for patients with uncontrolled asthma; it was associated with improved asthma control in clinical trials.23 This anticholinergic drug is currently approved only for the treatment of chronic obstructive pulmonary disorder. Patients with asthma may also benefit from the combination of an ICS plus the monoclonal anti-IgE agent omalizumab.18,24 Various cytokine inhibitors are being studied as monotherapy for asthma. These include the interleukin (IL)-5 antagonist mepoluzimab for patients with eosinophilic asthma25,26; daclizumab, a monoclonal antibody that binds to IL-2, for moderate-to-severe asthma27; and the tumor necrosis factor antagonists etanercept28 and infliximab.29
Phosphodiesterase type 4 inhibitors (eg, roflumilast)30,31 and oligonucleotides32,33 are also promising therapeutic options based on recent clinical trial data. Managed care plans should also be flexible to include nonpharmacologic therapies, such as bronchial thermoplasty, 34 if they are shown to be beneficial and cost-effective.
The NAEPP has developed an evidence-based treatment program to improve asthma control. These guidelines are comprehensive and well designed. However, the challenge remains in translating population-based guidelines into patient-level management and clinical decision making. Adherence to these guidelines will most likely ensure that patients on average have better control of asthma. Optimal adherence to a management plan is often difficult to achieve due to a myriad of factors. Managed care providers can help patients adhere to treatment by providing opportunities for all parties involved, including giving the time necessary to look at all aspects of the treatment plan, not just the medicines being prescribed.
Most well-designed, education-based interventions are considered good value for money, but such policy interventions may be difficult to put into practice.30 Managed care providers should examine these programs to better understand the time commitment needed to educate health professionals and patients on the best methods to control asthma in a cost-effective way.