Chronic obstructive pulmonary disease is a challenging disease to treat, and at advanced stages of the disease, procedural interventions become some of the only effective methods for improving quality of life. However, these procedures are often very costly. This article reviews the medical literature on cost-effectiveness of lung volume reduction surgery and bronchoscopic valve placement for lung volume reduction. It discusses the anticipated costs and economic impact in the future as technique is perfected and outcomes are improved.
Key points
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Chronic obstructive pulmonary disease (COPD) is associated with a substantial burden to the health care system and society, as it relates to direct medical costs and indirect costs.
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In select patients with predominantly upper lobe disease and low exercise tolerance. lung volume reduction surgery can be a cost-effective procedure.
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In select patients without collateral ventilation bronchial valve, therapy can be a cost-effective procedure.
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As surgical and bronchoscopic techniques are refined, length of stay, complication rate. and correct patient selection will improve cost-effectiveness of these lung volume reduction procedures
Introduction
Chronic obstructive pulmonary disease (COPD) remains a leading cause of chronic morbidity and is the third leading cause of mortality within the United States. For heavy current or former smokers, the prevalence of COPD is approximately 20%, impacting at least 16 million people in the United States. It contributes to a significant reduction in quality of life with substantial economic, societal, and personal costs.
Prevention of COPD exacerbations and the high costs associated with hospital admission remain a major quality goal of the US health care system. For many patients, the disease can be well controlled with medications alone, while for patients with the most severe disease, lung transplant is an effective, although extremely expensive and highly resource-limited option. For patents with significant disease who are not candidates for transplant, treatments focused on reducing dead space and improving ventilation-perfusion matching have shown to be efficacious. This can be done surgically, by resecting the diseased lung, or via 1-way valves that prevent airflow into the diseased area but do allow air to return. These 2 procedures, lung volume reduction surgery (LVRS) and bronchoscopic lung volume reduction (BLVR), have different costs and effectiveness. The economic impacts of these therapies, relative to each other and to best medical practice, is the focus of this article.
Chronic obstructive pulmonary disease economic burden
COPD is associated with a substantial economic burden to the health care system and society as a whole. Understanding the cost of the disease is important for health care decision makers to inform policy and guide resource-allocation toward interventions that have the most impact on overall disease-related health care costs and the greatest improvement in patient quality of life. In 2009, US costs attributable to COPD totaled $50 billion, with direct cost estimated at $29.6 billion and indirect costs estimated at $20.4 billion.
Direct costs to the health care system include those related to the detection, treatment, prevention, and rehabilitation of the disease. The direct costs of COPD on the US health care system are substantial. The 2017 Agency for Healthcare Research and Quality group data report total expenditures of COPD at $79 billion, in comparison to cancer at $106 billion, diabetes at $104 billion, and hypertension at $46 billion. COPD consistently ranks among the top 5 most expensive chronic diseases.
Patients with poorly controlled disease have significantly higher costs because of more primary care interactions, more emergency room visits, and increased hospital and intensive care unit admissions. Although total treatment costs are highly correlated with disease severity, within each stage it is still hospitalization expenses that remain the highest portion of costs (see Table 1 for direct cost breakdown). Targeting interventions that reduce hospitalizations will therefore have the most impact on direct costs.
| Price | |
|---|---|
| Intensive care unit (ICU) stay | $1446/d |
| Non-ICU stay | $626/d |
| General practitioner visit | $54/visit |
| Emergency room visit | $123/visit |
| Specialist visit | Varies |
| Oxygen | $383/month |
| Medications | $1175 |
| Rehabilitation | $56/outpatient |
| Mean hospitalization for exacerbation (in the United States) | $18,120 |
When considering the economic impact of disease on society, it is also important to understand the indirect costs of the disease. Indirect costs are those costs borne by the patient and society because of the disabling effects of the disease and include loss of productivity, loss of salary, caregiver time and lost productivity, and use of disability benefits. As work productivity and disability benefits are among the largest drivers of indirect costs, the percentage of patients who are working age has a large impact on the societal burden of the disease. In the Confronting COPD in North America and Europe survey, researchers found 82% of COPD patients in the United States are of working age. Patients of working age were asked how often their COPD affected their capacity to work. The results found a dramatic impact on productivity, with over 50% of the population reporting that the disease affected their work productivity. Thirty-five percent of respondents were completely prevented from working during the previous year; 18% were limited in the work they were able to do, and an additional 5% had absences from work. The Health and Retirement Study evaluated the impact of the COPD on Americans older than 50 years with regards to employment status and the collection of disability benefits. These researchers found having COPD resulted in a 9% decrease in likelihood of being employed, a 3.9% increase in probability of collecting Social Security Disability Insurance (SSDI), and a 1.7% increase in likelihood of collecting Supplemental Security Income (SSI). This negative impact on employment exceeds nearly all other major chronic health conditions including heart disease, cancer, hypertension, and diabetes. Only stroke patients experience a comparable decline in employment productivity. Moreover, the associations of COPD with collecting SSDI and SSI are the largest of any of the chronic disease conditions evaluated. At the time of this study, the average wage loss was $38,844, SSDI average annual benefit $14,507, and SSI average annual benefit $6008, for a total societal economic loss of nearly $60,000 per patient. Further compounding the issue is that these are almost certainly underestimates of the broader societal and patient impact, as many indirect costs are difficult to capture. In many cost-effectiveness studies, these costs described previously, as well as costs of out-of-pocket expenses such as nonprescription medication, travel costs to and from health care visits, economic value of the care provided by family members, and time spent by the patient receiving treatment, are not included. Overall, this may lead to potential underestimation of the total economic burden.
History of lung volume reduction surgery and costs
LVRS was first described in 1957, when Brantigan and colleagues , reported their initial results with multiple wedge resections of emphysematous lung. The procedure showed promise of significant functional improvement, but was abandoned due to perioperative mortality that approached 20%. In 1995 and 1996, Cooper and colleagues reported their results, demonstrating an initial 82% improvement in forced expiratory volume in 1 second (FEV1) with significant symptomatic improvement, with a 90-day mortality of only 4%. Despite these promising results, in 1995, Medicare made the decision not to reimburse LVRS.
The denial of coverage in light of the promising data from Cooper and colleagues is what ultimately led to the National Emphysema Treatment Trial (NETT). This trial confirmed a significant improvement in quality of life and survival for certain subgroups undergoing LVRS, while also identifying patients for whom the procedure was harmful. For non-high-risk patients, there was an improvement in survival, exercise capacity, and quality of life, with the greatest benefit seen in those patients with upper lobe predominant disease and low exercise capacity. As a result of the NETT data, LVRS achieved limited approval by the Centers for Medicare and Medicaid Services (CMS) for select hospital programs and specific patient populations.
Cost-Effectiveness
As part of the NETT report, a companion study evaluating cost-effectiveness was performed. The study included both the direct costs, specifically surgical costs, hospital days, and medications, along with indirect costs such as transportation and time spent by patients and family members related to the care of their disease. Table 2 shows the breakdown of costs of LVRS compared with best medical care. The study found that after excluding the highest risk patients, who were unlikely to benefit from surgery, the incremental cost-effectiveness ratio (ICER) for LVRS was $190,000 per quality-adjusted life year gained (QALY). With statistical modeling to 10 years, the ratio decreased to $53,000 per QALY gained. The patients with upper lobe predominant disease with low exercise capacity had overall greatest improvement in survival and quality of life, with projected 10-year cost of $21,000 per QALY gained.
| Lung Volume Reduction Surgery | Best Medical Care | ||
|---|---|---|---|
| Surgery (including bronchoscopy and tracheostomy) | $4882 | $0 | |
| Index hospitalization | Length of stay | 30,248 | 0 |
| Total index hospitalization | 35,130 | 0 | |
| 2 y of follow up costs | Hospitalizations | 7509 | 12,670 |
| Rehabilitation | 3616 | 2759 | |
| Oxygen | 2899 | 4125 | |
| Medications | 1225 | 1459 | |
| Outpatient visits | 1589 | 1561 | |
| Total follow-up costs | 16, 838 | 22,574 | |
| Total Costs | $51, 968 | $22,574 |
In 2006, the data from the multicenter Canadian randomized controlled trial comparing LVRS versus best medical care were published. The researchers found that the LVRS group had a 0.21 improvement in QALY compared with best medical care, and the cost difference was $28,119. For the 2-year study period data, ICER was $133,900 per QALY gained.
Drivers of Cost-Effectiveness
Although the authors from the NETT group looked at direct and indirect costs, it was the direct cost that overwhelmingly drove the cost of care, and of direct costs, number of hospitalization days was the single largest cost driver. The surgery group has 23.3 days in the hospital in the first 6 months, compared with 3 days for the medical group, with an associated total direct medical cost per patient in the surgery group of $62,753 in the first 12 months, compared with $12,932 over the first year per patient in the medical group. These numbers reversed in year 2, with the medical group having higher costs and more hospital days. Further reducing perioperative morbidity and postsurgical length of stay could thus improve the cost-effectiveness ratio for surgery patients, especially the upper lobe-predominant, lower exercise capacity group.
Surgical Approach and Cost
Among the NETT surgical patients, both median sternotomy and video-assisted thoracoscopic surgery (VATS) approaches were utilized; although sternotomy was the dominant approach (359 sternotomy vs 152 VATS). In a nonrandomized comparison of these 2 cohorts, there was no difference in perioperative morbidity or mortality, but there was a shorter length of stay, earlier return to independent living, and overall lower cost for the VATS group. As hospitalization is the largest cost, understanding the main determinants of length of stay is key to reducing the costs associated with LVRS. Although the largest driver of length of stay (LOS) in both groups was air leaks, the rates of air leak at 7 days between the 2 groups were similar (46% sternotomy vs 49% VATS). In a randomized cohort comparing the groups, VATS patients had a median LOS of 6 fewer days than sternotomy patients (9 days vs 15 days). Finally, within the randomized cohort, total cost for VATS was $6500 less per patient over the first 6 months compared with sternotomy.
Improvement in Long-Term Outcomes
Apart from lowering costs, improvements in effectiveness also significantly impact the cost-effectiveness ratio. The NETT follow-up was a median of 2.4 years, , and the long-term projections assumed that the differences in outcomes persisted to 3 years. However, in 2006, a long-term analysis of the outcomes found that the benefits persisted for up to 5 years. Excluding high-risk patients, there was an 18% relative risk reduction of death for LVRS patients at 5 years, and 15% of LVRS patients had a clinically significant improvement in quality of life at 5 years compared with only 7% of medical patients. Among upper lobe-predominant, low-exercise participants, there was a 43% reduction in mortality at 5 years, while 19% had a clinically significant quality-of-life improvements, compared with 0% of the medically treated patients. For the upper lobe-predominant high exercise capacity subgroup, there was a significant palliative benefit, with 23% of LVRS patients having significant quality-of-life improvements persisting to 5 years, compared with only 13% of the medical subgroup.
Utilizing an additional 2 years of data, Ramsey and colleagues performed an updated cost-effectiveness analysis to NETT cost analysis. They found that the 5-year cost for LVRS patients compared with medical patients was $140,000 per QALY gained, which compared favorably with the $190,000 per QALY based on observed 3-year data. For the upper-lobe, low exercise capacity group, the ratio improved from $98,000 per QALY to $77,000 per QALY gained. The other groups also showed improved ICERs. See details in Table 3 .
