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Issues and Challenges for Managed Care in the Treatment of Asthma and Chronic Obstructive Pulmonary Disease
Shellie K. Schoening, MBA, PharmD, RPh

Issues and Challenges for Managed Care in the Treatment of Asthma and Chronic Obstructive Pulmonary Disease

Shellie K. Schoening, MBA, PharmD, RPh

Managed care organizations (MCOs) and payers have become increasingly aware of the impact of asthma and chronic obstructive pulmonary disease on healthcare expenditures. The prevalence and incidence of both conditions continue to increase, even as new therapeutic modalities enter the market to offer treatment alternatives for these conditions. Although viewed by most payers as long-term conditions with expenditures that will not diminish, MCOs and payers have become more concerned with controlling costs and ensuring appropriate utilization.

(Am J Manag Care. 2004;10:S158-S163)

Asthma and chronic obstructive pulmonary disease (COPD) may have traditionally been viewed as diseases that affect the elderly or those with a lower socioeconomic status. However, these conditions are becoming more common among the middle class.1,2 According to the National Health Interview Survey, between 1980 and 1996, self-reported asthma prevalence rose by the largest percentage in individuals aged 15 to 34 years than any other age group in the survey.3 The same survey also estimated that during 1994-1996, adults with asthma missed on average 2.5 work days per year because of asthma complications, which accounted for 14.5 million missed work days overall. In a retrospective study of patients entering the National Jewish Medical and Research Center disease state management program, Tinkelman and colleagues4 found that the stereotypical classification of the patient with COPD as elderly and unemployed may not apply to patients currently diagnosed with COPD. In fact, Tinkelman4 found that 49.7% of patients were younger than 65 years of age and 46.1% of patients were employed.

In many cases, the severity of the disease dictates resource utilization. Hilleman and colleagues5 conducted a retrospective cost-of-illness analysis on patients with COPD. The authors determined that healthcare resource utilization was highly correlated with disease severity, and as disease severity increased so did healthcare resource utilization. According to the American Thoracic Society6 COPD severity stages, stage I disease severity was found in this study to have $1681 per patient per year in healthcare resource expenditures, stage II was found to be $5037, and patients with stage III utilized on average $10 812 in healthcare resources per patient per year. In a cohort of 318 patients, Godard and associates also concluded that the overall costs of asthma (including individual direct costs, indirect costs, and intangible quality-of-life costs) are directly related to the severity of the disease.7

This is leading many MCOs and employers to take a harder look at disease management, risk avoidance, and early detection/identification.

Clinical Guidelines

Recognizing that these conditions cannot be cured, but rather managed, the development and use of clinical guidelines has assisted efforts to manage appropriate therapy. For COPD, the American Thoracic Society (ATS) guidelines6 were released in 1995 for the diagnosis and care of individuals with COPD. This was followed in 2001 by the World Health Organization and US Strategy for the Diagnosis, Management, and Prevention of Chronic Pulmonary Disease Report that has become known as the "GOLD Guidelines."8 Table 1 summarizes the goals of COPD therapy according to the GOLD guidelines. The ambulatory management of patients with COPD includes specific, symptomatic, and secondary therapy. Treatment may depend on severity. Staging of severity by the ATS is based on forced expiratory volume in 1 second (FEV1), which correlates best with morbidity and mortality in COPD. Table 2 summarizes the management strategies for COPD. However, appropriate outpatient management of COPD depends on prescription compliance and adherence to therapy.

The National Asthma Education and Prevention Program (NAEPP) first released guidelines on the management and treatment of asthma in 1991,9 followed by a release in 1997,10 and then an update on selected topics in 2002.11 Table 3 summarizes the goals of therapy according to the NAEPP guidelines. These guidelines help to categorize asthma based on severity of symptoms and provide treatment recommendations based on disease severity. The guidelines standardize care and promote the use of anti-inflammatory medications. Table 4 summarizes the treatment guidelines for asthma.

Despite the development and publication of clinical guidelines regarding these disease states, managed care organizations (MCOs) are still plagued with several challenges when it comes to appropriate therapy for asthma and COPD. Appropriate dosage, duration, and agent selection still remain major therapy hurdles. Many physicians have failed to adopt clinical guidelines in the treatment and management of their patients,12-14 leading to evidence that many patients have suboptimal therapy management for their disease conditions.15-17 Anis and colleagues18 found that excessive use of short-acting β-agonists and underuse of inhaled corticosteroids was a marker for poorly controlled asthma and excessive utilization of healthcare resources. Patients who were inappropriately managed received more prescriptions per year, visited their healthcare provider more frequently, were more likely to be admitted to the hospital, and were more likely to require an emergency department visit.

Recognizing the need for performance monitoring, the National Committee for Quality Assurance (NCQA) developed a set of guidelines to benchmark health plan performance measures in asthma therapy management.19 The NCQA Health Employer Data and Information Set provides minimally acceptable therapy measures for asthma that addresses minimally acceptable primary medications for treatment. It is important to note that the NCQA criteria vary from the NAEPP treatment recommendations and should not be viewed as a treatment or a therapy guide, but rather a quality and performance measure guide for MCOs to follow to assist in their efforts to monitor the quality of care for these patients.

Although clinical guidelines have been developed to address patient identification and decisions for treatment, clinical guidelines are slow to incorporate new drug treatments into the therapeutic regimen. These therapies often fall subject to managed care review measures, such as step therapy or prior authorization criteria, before access to coverage is provided. It is a difficult challenge for MCOs to provide a fair balance between cost control and ensuring quality of care for the patient.

Therapy Choice

The ultimate choice of therapy for a patient is a critical factor in determining the success rate that the patient will have in controlling their disease state. Other factors such as trigger exposure, medication adherence, and self-management education also play a major role in determining the success of a patient in disease state control. Clinical guidelines should assist physicians in prescribing the correct agents and/or combination of agents to target the patient's needs based on their disease severity. However, managed care formularies also play a role in determining which particular therapeutic agent a patient may be started on. Many MCOs have adopted formulary review measures that focus on evidence-based clinical guidelines; however, a struggle that MCOs face is the lack of data on comparative efficacy of the available agents. According to the Asthma Committee of the Canadian Thoracic Society's Canadian Asthma Consensus Conference Summary of Guidelines,20 in asthma therapy, 12% or more improvement in FEV1 after administration of a β2-agonist is considered significant, whereas the use of oral corticosteroids for more than 1 week or the use of inhaled corticosteroids for 2 or more weeks should produce an increase of 20% in a patient's FEV1 response. This presents a challenge to MCOs. How many agents are reviewed on their ability to provide this level of relief and response for patients? Direct comparative data are often sparse and difficult to obtain to conduct a thorough comparative efficacy analysis. Pharmacoeconomic models and analytical decision models need to be developed to support the decision-making processes of comparing new and existing treatments.21 MCOs are then faced with the challenge of providing and proving the clinical and economic outcomes of therapy choices in formulary decisions regarding asthma and COPD medications.

Disease State Management Programs

Outcomes are one of the key challenges for all medical care. All outcomes need to be assessed to ensure a properly designed program. In the short term, an asthma or COPD management program may actually increase pharmaceutical product costs in cases in which patients are receiving suboptimal therapy because of the need for additional therapies. However, long-term outcomes of decreased hospitalizations and emergency department visits need to be carefully monitored for impact. In addition, reductions in indirect costs due to missed work and school are important to patients and employers.

Patient education can be one of the most successful management techniques for asthma and COPD. A lack of understanding of the patient's disease state can lead to noncompliance or exacerbation of symptoms. Just as the etiology of asthma is multimodal, its management encompasses nonpharmacologic, pharmacologic, and educational components. A broad-based educational platform that includes an overview of the disease state, recognition of triggers and symptoms, an action plan to handle exacerbations, and education on proper inhaler techniques and spacer devices, if needed, are cornerstones of any program. The use of peak flow meters can assist patients in recognizing airway obstruction and then developing an action plan to help control their symptoms and identify triggers. A properly structured asthma and/or COPD education program should take various forms and be administered in many mediums to provide repetition for increased patient comprehension and compliance. Patient engagement of asthma and COPD begins with the recognition that many changes must take place before the trends of increasing morbidity and mortality can be reversed.

Risk modeling and targeting have also become important techniques for MCOs to aid in targeting early interventions to avoid future expenditures. Risk models can satisfactorily predict future patient outcomes in asthma when models take into account risk factors for disease progression based on patient demographics, symptom severity, comorbid conditions, and concurrent medication usage.22

MCOs have proved to be successful at implementing therapy compliance programs that monitor patient medication compliance ratios or engage in refill reminder programs.23 Disease state management programs need to be designed to ensure ease of patient access to care, ensure dose and duration appropriateness of pharmacologic agents, and include a management program that incorporates pharmacologic treatment and institutes ongoing monitoring of patient outcomes. MCOs have the daunting challenge of developing asthma and COPD management programs that minimize costs and maximize the quality of care for the patient.

Preventive Care Measures

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