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

Managed care organizations (MCOs) and payershave become increasingly aware of the impact ofasthma and chronic obstructive pulmonary diseaseon healthcare expenditures. The prevalence and incidenceof both conditions continue to increase, evenas new therapeutic modalities enter the market tooffer treatment alternatives for these conditions.Although viewed by most payers as long-term conditionswith expenditures that will not diminish, MCOsand payers have become more concerned with controllingcosts and ensuring appropriate utilization.

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

Asthma and chronic obstructive pulmonarydisease (COPD) may havetraditionally been viewed as diseasesthat affect the elderly or those with a lowersocioeconomic status. However, these conditionsare becoming more common amongthe middle class.^1,2 According to the NationalHealth Interview Survey, between 1980 and1996, self-reported asthma prevalence roseby the largest percentage in individuals aged15 to 34 years than any other age group inthe survey.³ The same survey also estimatedthat during 1994-1996, adults with asthmamissed on average 2.5 work days per yearbecause of asthma complications, whichaccounted for 14.5 million missed work daysoverall. In a retrospective study of patientsentering the National Jewish Medical andResearch Center disease state managementprogram, Tinkelman and colleagues⁴ foundthat the stereotypical classification of thepatient with COPD as elderly and unemployedmay not apply to patients currentlydiagnosed with COPD. In fact, Tinkelman⁴found that 49.7% of patients were youngerthan 65 years of age and 46.1% of patientswere employed.

In many cases, the severity of the diseasedictates resource utilization. Hilleman andcolleagues⁵ conducted a retrospective cost-of-illness analysis on patients with COPD.The authors determined that healthcareresource utilization was highly correlatedwith disease severity, and as disease severityincreased so did healthcare resource utilization.According to the American ThoracicSociety⁶ COPD severity stages, stage I diseaseseverity was found in this study to have$1681 per patient per year in healthcareresource expenditures, stage II was found tobe $5037, and patients with stage III utilizedon average $10 812 in healthcare resourcesper patient per year. In a cohort of 318patients, Godard and associates also concludedthat the overall costs of asthma (includingindividual direct costs, indirect costs, andintangible quality-of-life costs) are directlyrelated to the severity of the disease.⁷

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

Clinical Guidelines

Recognizing that these conditions cannotbe cured, but rather managed, the developmentand use of clinical guidelines hasassisted efforts to manage appropriate therapy.For COPD, the American ThoracicSociety (ATS) guidelines⁶ were released in1995 for the diagnosis and care of individualswith COPD. This was followed in 2001 bythe World Health Organization and USStrategy for the Diagnosis, Management, andPrevention of Chronic Pulmonary DiseaseReport that has become known as the"GOLD Guidelines."⁸ Table 1 summarizesthe goals of COPD therapy according to theGOLD guidelines. The ambulatory managementof patients with COPD includes specific,symptomatic, and secondary therapy.Treatment may depend on severity. Stagingof severity by the ATS is based on forcedexpiratory volume in 1 second (FEV₁),which correlates best with morbidity andmortality in COPD. Table 2 summarizes themanagement strategies for COPD. However,appropriate outpatient management ofCOPD depends on prescription complianceand adherence to therapy.

The National Asthma Education andPrevention Program (NAEPP) first releasedguidelines on the management and treatmentof asthma in 1991,⁹ followed by a release in1997,¹⁰ and then an update on selected topicsin 2002.¹¹ Table 3 summarizes the goals oftherapy according to the NAEPP guidelines.These guidelines help to categorize asthmabased on severity of symptoms and providetreatment recommendations based on diseaseseverity. The guidelines standardize careand promote the use of anti-inflammatorymedications. Table 4 summarizes the treatmentguidelines for asthma.

Despite the development and publicationof clinical guidelines regarding these diseasestates, managed care organizations (MCOs)are still plagued with several challengeswhen it comes to appropriate therapy forasthma and COPD. Appropriate dosage,duration, and agent selection still remainmajor therapy hurdles. Many physicianshave failed to adopt clinical guidelines in thetreatment and management of theirpatients,^12-14 leading to evidence that manypatients have suboptimal therapy managementfor their disease conditions.^15-17 Anisand colleagues¹⁸ found that excessive use ofshort-acting β-agonists and underuse ofinhaled corticosteroids was a marker forpoorly controlled asthma and excessive utilizationof healthcare resources. Patientswho were inappropriately managed receivedmore prescriptions per year, visited theirhealthcare provider more frequently, weremore likely to be admitted to the hospital,and were more likely to require an emergencydepartment visit.

Recognizing the need for performancemonitoring, the National Committee forQuality Assurance (NCQA) developed a setof guidelines to benchmark health plan performancemeasures in asthma therapy management.¹⁹ The NCQA Health EmployerData and Information Set provides minimallyacceptable therapy measures for asthmathat addresses minimally acceptable primarymedications for treatment. It isimportant to note that the NCQA criteriavary from the NAEPP treatment recommendationsand should not be viewed as atreatment or a therapy guide, but rather aquality and performance measure guide forMCOs to follow to assist in their efforts tomonitor the quality of care for thesepatients.

Although clinical guidelines have beendeveloped to address patient identificationand decisions for treatment, clinical guidelinesare slow to incorporate new drug treatmentsinto the therapeutic regimen. Thesetherapies often fall subject to managed carereview measures, such as step therapy orprior authorization criteria, before access tocoverage is provided. It is a difficult challengefor MCOs to provide a fair balancebetween cost control and ensuring quality ofcare for the patient.

Therapy Choice

The ultimate choice of therapy for apatient is a critical factor in determining thesuccess rate that the patient will have incontrolling their disease state. Other factorssuch as trigger exposure, medication adherence,and self-management education alsoplay a major role in determining the successof a patient in disease state control. Clinicalguidelines should assist physicians in prescribingthe correct agents and/or combinationof agents to target the patient's needsbased on their disease severity. However,managed care formularies also play a role indetermining which particular therapeuticagent a patient may be started on. ManyMCOs have adopted formulary review measuresthat focus on evidence-based clinicalguidelines; however, a struggle that MCOsface is the lack of data on comparative efficacyof the available agents. According tothe Asthma Committee of the CanadianThoracic Society's Canadian AsthmaConsensus Conference Summary ofGuidelines,²⁰ in asthma therapy, 12% ormore improvement in FEV₁ after administrationof a β₂-agonist is considered significant,whereas the use of oral corticosteroids formore than 1 week or the use of inhaled corticosteroidsfor 2 or more weeks should producean increase of 20% in a patient's FEV₁response. This presents a challenge toMCOs. How many agents are reviewed ontheir ability to provide this level of relief andresponse for patients? Direct comparativedata are often sparse and difficult to obtainto conduct a thorough comparative efficacyanalysis. Pharmacoeconomic models andanalytical decision models need to be developedto support the decision-makingprocesses of comparing new and existingtreatments.²¹ MCOs are then faced with thechallenge of providing and proving the clinicaland economic outcomes of therapychoices in formulary decisions regardingasthma and COPD medications.

Disease State Management Programs

Outcomes are one of the key challengesfor all medical care. All outcomes need to beassessed to ensure a properly designed program.In the short term, an asthma orCOPD management program may actuallyincrease pharmaceutical product costs incases in which patients are receiving suboptimaltherapy because of the need foradditional therapies. However, long-termoutcomes of decreased hospitalizations andemergency department visits need to becarefully monitored for impact. In addition,reductions in indirect costs due to missedwork and school are important to patientsand employers.

Patient education can be one of the mostsuccessful management techniques for asthmaand COPD. A lack of understanding ofthe patient's disease state can lead to noncomplianceor exacerbation of symptoms.Just as the etiology of asthma is multimodal,its management encompasses nonpharmacologic,pharmacologic, and educationalcomponents. A broad-based educationalplatform that includes an overview of thedisease state, recognition of triggers andsymptoms, an action plan to handle exacerbations,and education on proper inhalertechniques and spacer devices, if needed,are cornerstones of any program. The use ofpeak flow meters can assist patients in recognizingairway obstruction and then developingan action plan to help control theirsymptoms and identify triggers. A properlystructured asthma and/or COPD educationprogram should take various forms and beadministered in many mediums to providerepetition for increased patient comprehensionand compliance. Patient engagement ofasthma and COPD begins with the recognitionthat many changes must take placebefore the trends of increasing morbidityand mortality can be reversed.

Risk modeling and targeting have alsobecome important techniques for MCOs toaid in targeting early interventions to avoidfuture expenditures. Risk models can satisfactorilypredict future patient outcomes inasthma when models take into account riskfactors for disease progression based onpatient demographics, symptom severity,comorbid conditions, and concurrent medicationusage.²²

MCOs have proved to be successful atimplementing therapy compliance programsthat monitor patient medication complianceratios or engage in refill reminder programs.²³ Disease state management programsneed to be designed to ensure ease of patientaccess to care, ensure dose and durationappropriateness of pharmacologic agents,and include a management program thatincorporates pharmacologic treatment andinstitutes ongoing monitoring of patient outcomes.MCOs have the daunting challenge ofdeveloping asthma and COPD managementprograms that minimize costs and maximizethe quality of care for the patient.

Preventive Care Measures

Prevention is one of the best opportunitiesfor MCOs to make an impact on conditionssuch as asthma and COPD. Maternalsmoking during pregnancy is a proposed riskfactor for asthma development in children,as well as active smoking in adolescents andyoung adults.²⁴ Smoking cessation is extremelyimportant to prevent disease exacerbationand potential development of COPD.Multitargeted strategies are most effective;establishment of a quit date, behavior modificationtechniques, group sessions, and nicotinetherapy are useful. After smokers give uptheir smoking habit, their FEV₁ increasesslightly for a few years, then follows a pathsimilar to that of nonsmokers. Of course, thisdepends on when they quit and how muchthey smoked. After smoking cessation,cough and expectoration diminish over afew months; sputum may become more viscid.Lost lung function is not regained, butsmoking cessation delays the onset of exertionaldyspnea and decreases the risk ofdeveloping or dying from COPD.

The fear for MCOs and payers is that theinclusion of coverage for smoking cessationprograms would increase budgets and drugspending. Although the benefits of long-termsmoking cessation are well documented, theshort-term benefits may not be as recognizable for MCOs and payers. A study conductedby Ringen and colleagues25 on a subset ofblue collar workers found the costs associatedwith a smoking cessation program to be$1025.28 per smoker who quit or $11.78 perfull-time equivalent employee per year.²⁵ Theoverall savings in healthcare resource utilizationwas expected to be 15 times the cost ofthe program, yielding an annual return oninvestment of 27.6%.

Preventive care measures can be one ofthe most cost-effective measures for MCOs.Some causes of COPD, such as smoking, aretargeted. For example, environmental irritantsin the workplace or elsewhere may beevaluated, and patients would then beadvised of ways to avoid them. Influenzavaccine should be given annually becausethe risk of serious complications frominfluenza is greater in these patients.¹⁹Pneumococcal vaccine should be given onceand may be repeated after 5 to 10 years inhigher-risk patients.²⁰

Although the benefits seem obvious, thechallenge for MCOs is to encourage employeradaptation of smoking cessation and preventivecare programs for their workforce.Many strategies can be employed; however,support from the employer is key to the successof any work-site smoking cessation orpreventive care program.

Summary

MCOs and payers face many unique challengesin the management and treatment ofasthma and COPD, such as clinical guidelineacceptance and use, clinical and economictherapy choices, outcomes measurementand assessment, as well as incorporation ofpreventive care measures. Although newerpharmacologic treatment modalities arebecoming available, and even newer agentsare on the horizon, MCOs face the toughchallenge of balancing access and cost driversto ensure optimal patient outcomes. Toreverse the increase in morbidity and mortality,and overall healthcare resource utilization,a paradigm shift needs to occur inthe management of asthma and COPD. Thefocus needs to shift to early detection, diseaseprevention, adherence to medicationtherapy, and the use of evidence-based clinicalguidelines for pharmacotherapy.

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