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Supplements A Managed Care Perspective:Treatment of Idiopathic Pulmonary Fibrosis
Overview of Idiopathic Pulmonary Fibrosis (IPF) and Evidence-Based Guidelines
Roozbeh Sharif, MD, MEd, MSc
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Steven D. Nathan, MD
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Strategies to Manage Costs in Idiopathic Pulmonary Fibrosis
Gary M. Owens, M
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Strategies to Manage Costs in Idiopathic Pulmonary Fibrosis

Gary M. Owens, M
Idiopathic pulmonary fibrosis (IPF) is a diagnostically challenging disease. Clinicians are faced with the need to exclude alternative diagnoses, limited treatment and management guidelines, and few treatment options. Patients with IPF have significantly increased healthcare usage compared with similar patients without the disease. Medicare estimates for this disease are as high as $3 billion, not including cost of treatment. The disease, characterized by worsening dyspnea, declining lung function, nonspecific respiratory symptoms, and a varied clinical course randomly punctuated by episodes of acute exacerbations, is also accompanied by a host of comorbid conditions that contribute significantly to increased healthcare usage and cost. The comorbidities, which increase impairment and disability, and compromise patient quality of life and survival, include pulmonary and cardiac conditions, sleep apnea, gastroesophageal reflux disease, depression and anxiety, and lung cancer. Until recently, palliative care and lung transplant were the only options for management of IPF. Without a lung transplant, the median survival was estimated at 3 to 5 years from the initial diagnosis. Newer treatments, pirfenidone and nintedanib, demonstrate a modest effect on slowing decline in lung function in patients with IPF. Both were approved for the treatment of IPF in 2014. As potentially effective therapies emerge, attention should be given to healthcare resource usage and healthcare processes that ensure patient-centered management with sustainable, cost-effective, and quality care. As such, it is imperative that a structured, comprehensive, multidisciplinary management approach is used in the treatment and management of IPF and its associated comorbidities to limit costs and provide effective and quality healthcare.
Am J Manag Care. 2017;23:-S0
Idiopathic pulmonary fibrosis (IPF) is a complex, progressive disease, challenging to diagnose, due to the need to exclude alternative diagnoses, and challenging to manage.1,2 While it has a histopathologic pattern of usual interstitial pneumonia (UIP)—characterized by diffuse fibrosis and scarring of the interstitium—its etiology is unknown and its natural history is variable and unpredictable. IPF is characterized by worsening dyspnea, declining lung function, nonspecific respiratory symptoms, a wide array of associated multiple comorbidities, and a varied clinical course randomly punctuated by episodes of acute exacerbations.1,2 In most patients, the disease progresses with a gradual worsening of lung function over years. However, a minority of patients may remain stable or decline rapidly, with some experiencing episodes of acute respiratory worsening despite previous stability.1

IPF primarily impacts middle-aged to older adults, most with a history of cigarette smoking.1 The disease is typically fatal, with median survival estimated at 3 to 5 years from the initial diagnosis.3 However, male gender is associated with a higher incidence of disease, higher mortality, and shorter survival time after diagnosis. It is interesting to note that among newly diagnosed patients with Medicare, the majority tend to be white (91%) and female (54%).4,5 These data, compared with previous studies, showed an unusually higher proportion of female patients. This may be due to limitations in coding in the Medicare database. Over the past decade, Medicare data and death certificate data have also shown a trend toward increasing prevalence of IPF among Americans older than 65 years, with increasing survival.2,4,6 This trend may be partly attributed to the aging population, increased awareness of the disease, and improved guidelines in defining and diagnosing the disease.1,5-8

The rise in incidence is coupled with the usual high cost of treating chronic conditions and the comorbidities that follow, along with the typical health concerns that go along with aging. In the case of IPF, the complexity of reaching a confirmed diagnosis and the need for managing complications and concomitant comorbidities makes managing patients with IPF cost intensive and resource intensive.9,10 Additionally, IPH has 2 costly treatment options: lung transplant or a choice of 2 recently approved pharmacologic treatments for IPF.1,11 As such, it is important to understand the economic burden associated with the disease and understand the impact on budgets from the only approved pharmacologic treatments, with no generic substitutions available.

Cost of Care

An examination of health resource usage and costs indicates that patients with IPF have significantly increased healthcare usage compared with demographically matched controls and incur substantial costs to payers both before and after the time of diagnosis. As determined through administrative claims, the cost of managing the 158,000 patients with IPF covered by Medicare in 2011 was estimated at almost $3 billion, not including cost of drug treatment; $1.8 billion specifically was attributed to IPF and its associated comorbidities.9 Between 2000 and 2011, patients with IPF used hospitals and emergency departments almost twice as often with an 82% higher risk of hospitalization (28.8% vs 15.8%) and an 82% greater chance of an emergency department visit (23.9% vs 13.1%). Similarly, total healthcare costs were 72% higher ($10,124 vs $5888) compared with matched controls. One year after initial diagnosis, patients with IPF had a 134% higher risk of hospitalization (48.7% vs 20.8%) and a 126% higher chance of an emergency department visit (39.6% vs 17.5%), compared with the control group. The cost difference between the 2 groups nearly doubled in the first year after diagnosis, with patients with IPF incurring 134% higher total healthcare usage costs ($20,887 vs $8932), not including medication costs.9 Inpatient services accounted for half of the medical costs in patients with IFP, and these costs doubled in the first year after a diagnosis of IPF was confirmed.12 Similar results were found using US claims databases, with direct annual costs, not including medication costs, totaling $26,378 per patient with IPF compared with $12,124 per control patient.10

Another recent retrospective analysis looked at claims incurred between 2006 and 2011 from a national commercial claims database of 1735 patients with IPF. The analysis confirmed the need for appropriate management of episodes of IPF acute exacerbations to help slow disease progression, reduce associated morbidity and mortality, and mitigate costs.13 Based on the claims data, 38.6% of patients with IPF had at least 1 all-cause hospitalization, 10.8% had IPF-related hospitalizations, and 72.1% had suspected IPF exacerbations leading to urgent outpatient visits during the first year after an IPF diagnosis. The average cost per IPF-related hospitalization was $16,812, and the average cost per exacerbation requiring hospitalization was $14,731. Furthermore, the cumulative risk of each event occurring increased over time. In this group of patients, costs of exacerbations requiring hospitalization, amounting to $1.5 million per year, accounted for almost 46% of the total exacerbation-associated costs. However, the costs of exacerbation not requiring hospitalization, at $444 per event, totaled to 54% for a $1.7 million cost per year because of the high rate of exacerbation and occurrence. These data show the significant need to effectively define and identify acute exacerbations in IPF, and to distinguish these exacerbations from IPF-associated comorbidities to curtail the associated high cost of healthcare usage.13

Contributors to Cost

Several comorbidities are associated with IPF, and most patients with IPF will have at least 1 secondary complication that will increase their impairment and disability, resulting in further compromise to their quality of life and potentially impacting survival.14 A claims data study of Medicare beneficiaries (5%, 3.7 million people) from 2000 to 2011 found that, in the 1 year before diagnosis, patients with IPF (n = 7855) were more likely to suffer from other pulmonary conditions, such as chronic obstructive pulmonary disease (COPD) (41.0% vs 13.5%) and respiratory infections (33.1% vs 13.3%), compared with control patients (n = 38,856).9 In fact, all selected comorbidities were more common in the IPF group than in the control group (P <.01). Comorbidities with the highest comparative prevalence ratio (PR) included pulmonary hypertension (PR = 4.9), pneumonia (PR = 3.7), pulmonary embolism (PR = 3.1), COPD (PR = 3.0), lung cancer (PR = 2.8), sleep apnea (PR = 2.7), and congestive heart failure (CHF) (PR = 2.2).9

Some comorbidities, such as pneumonia, CHF, and pulmonary embolism, may present acutely and are often difficult to distinguish from an acute exacerbation of the disease.15 An acute exacerbation of IPF is an unexplained, sudden acceleration of the underlying fibrotic disease and unpredictable deterioration. Identifiable causes of deterioration, such as infection, pulmonary embolism, or heart failure, must be excluded.16 The exact frequency of exacerbations is unknown because of the lack of consensus in definitions and diagnostic criteria for these exacerbations. It is estimated that exacerbations occur in 5% to 15% of patients per year.17 One predictor of exacerbations in these patients is declining forced vital capacity (FVC). Also, acute infections may cause respiratory decline in patients with IPF that behaves similarly to an exacerbation. It is agreed that patients with acute exacerbations have an especially poor prognosis, with retrospective intensive care unit studies reporting mortality rates as high as 85%.13,15,18 The most commonly reported cause of mortality in patients with IPF is respiratory complications, usually because of an acute exacerbation.19

Other significant comorbidities associated with IPF include gastroesophageal reflux disease (GERD), present in up to 90% of patients with IPF, which is associated with a worsening or exacerbation of IPF.20 Depression and anxiety are observed in about a quarter of patients with IPF and are associated with increased dyspnea and pain, poor sleep quality, and reduced FVC. The use of antidepressants in this patient population is therefore widespread.21,22 Obstructive sleep apnea is reported in up to 88% of these patients.23 Patients with IPF have a 7-fold increase in the risk of developing lung cancer, with squamous cell carcinoma and adenocarcinoma being most common.22,24,25 Finally, venous thromboembolism occurs at an incidence 34% higher than in the general population and higher than disease-matched controls, with emphysema or lung cancer necessitating the use of anticoagulants and other medications to prevent or treat thromboembolic events.26 Other common comorbidities include pulmonary infection, bronchitis, asthma, heart disease (including heart failure, myocardial infarction, atrial fibrillation, and coronary artery disease), and cerebrovascular disease, among others. These comorbid conditions, along with cough and dyspnea, the most prominent symptoms of IPF, contribute significantly to the impairment and disability in patients with IPF, further compromising their survival and quality of life, and ultimately increasing the cost of treatment and care.14

Treatment of these comorbid conditions has not been well studied.14 However, appropriate identification and treatment of comorbidities may help result in improved survival and quality of life for selected comorbid conditions such as GERD. Unfortunately, there are limited data and guidance available on the management of comorbidities in patients with IPF. Because of the varied course of the disease and the presence of comorbidities and periods of adverse events that may necessitate aggressive treatment, there is no single central IPF treatment strategy. Often, the combination of comorbid conditions and patient health status requires an individualized approach to management.27 The high prevalence of comorbidities associated with IPF suggests that comorbidities are important contributors to the increased healthcare usage and cost associated with an IPF diagnosis. IPF management needs to continually evolve over the course of the disease to slow down disease progression and maximize quality of life and health status.

Cost-Effective Treatment

 
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