Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease: Clinical, Economic, and Budget Impact Analysis
From CADTH Technology Overviews, Volume 1, Issue 4, December 2010
[Adapted from: Hailey D, Jacobs P, Stickland M, Chuck A, Marciniuk DD, Mayers I, Mierzwinsky-Urban M. Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease: Clinical, Economic, and Budget Impact Analysis (Technology report; no.126). Ottawa: Canadian Agency for Drugs and Technologies in Health; 2010.]
Introduction
Chronic obstructive pulmonary disease (COPD) causes disability and impaired quality of life. In 2006, more than 10% of all hospitalizations in Canada were due to COPD. For many patients, an option for optimizing the non-pharmacologic management of COPD is pulmonary rehabilitation (PR).1
PR is a program of care designed to reduce symptoms, optimize functional status, increase participation, and reduce health care costs through stabilizing or reversing systemic manifestations of the disease. Comprehensive PR programs include patient assessment, exercise training, education, and psychosocial support.2
The use of PR has been shown to improve functional exercise capacity and quality of life, while reducing acute exacerbations and hospitalizations.3 With concomitant pharmacotherapy, it has been shown to be a more effective therapeutic strategy for improving health outcomes in COPD compared with traditional pharmacological management with inhaled bronchodilators,3,4 and has emerged as a recommended standard of care for patients with chronic lung disease.3
In Canada, there is poor access to PR because of limited program capacity. Policy-makers and health care providers need advice to help with decision-making about the future establishment and use of PR programs. Information on the cost-effectiveness, budget impact, and operational needs of PR programs and the impact of program elements on clinical outcomes would be helpful for decision-makers.
Objectives
The objectives of this assessment are to evaluate the effect of PR programs for COPD on clinical and economic outcomes, and to assess their health services impact.
The research questions are:
- What is the clinical effectiveness of PR and pharmacotherapy (together) compared with pharmacotherapy alone for adults with COPD?
- What is the effectiveness of specific elements of PR programs for adults with COPD?
- What is the cost-effectiveness of PR and pharmacotherapy compared with pharmacological therapy alone in adults with COPD?
- What is the health services impact of implementing PR for adults with COPD in Canada?
- What are the recommendations for the use of PR in current COPD clinical practice guidelines that are relevant to the Canadian context?
Methods
Literature searches were conducted to obtain clinical and economic data using bibliographic databases and grey literature sources. Systematic reviews of clinical and economic literature were undertaken. Recommendations and judgments on evidence were extracted from relevant clinical practice guidelines.
A cost-effectiveness analysis was undertaken to compare the costs and health outcomes of usual care (pharmacotherapy) with the costs and health outcomes of usual care plus PR. PR consisted of three sessions per week at 2.5 hours per session over six weeks. A health system perspective was taken.
In the budget impact analysis, COPD prevalence data were used to estimate the number of patients recommended to receive PR. The desired capacity for PR in each year is estimated as current capacity plus the number of additional persons served each year. The budget impact of the additional services was estimated by multiplying the unit cost of PR by the additional persons served per year. A time horizon of 10 years was used.
Results
Clinical
The studies that are included in this review showed that, when compared with the usual care (pharmacotherapy) of patients with stable COPD, PR plus usual care is effective in the short term (up to three months), as indicated by improvement in exercise capacity, health-related quality of life (HRQL), and mental health.5-16 In some studies, however, the improvements in outcomes were below the minimal clinically important differences. Some longer-term studies found that the benefits from the use of PR disappeared in 12 months or less.17,18 Others found that the benefits were sustained for two to three years.19,20 Reductions in health care utilization, as indicated by the number of hospital admissions or the length of stay, were reported in studies of variable quality. 11,21-24
The findings suggested that patients with COPD can benefit from the use of PR regardless of age, 25-27 sex,28,29 and disease severity.28,30-32 Home-based PR programs provided similar benefits to those obtained from hospital outpatient PR programs. 24,33 The appropriate duration and content of PR programs is unclear. Information on comparisons of PR with other treatments and on the effectiveness of components of PR programs was limited. Four clinical practice guidelines were identified as being relevant to Canada.1,3,34-36 Common themes included support for the use of PR for patients with COPD who have dyspnea and reduced exercise capacity, and the inclusion of education as a component of PR.
Economic Analysis
If the duration of efficacy of PR is 18 months, the incremental cost-effectiveness ratio of usual care plus PR compared with usual care is $27,924 per additional quality-adjusted life-year gained.
Health Services Impact
If it is assumed that only the moderate and severe cases of COPD need PR, then 1,505 additional persons would be served annually in Canada over a 10-year period for an added annual cost of $1.8 million. If 25% of persons with COPD need PR, this cost would rise to $33.9 million annually for 100% uptake or $19 million if 67% of those who are in need used the services. If all persons with COPD needed PR, the additional annual cost would be $168 million.
Limitations
Weaknesses in the assessment were mainly linked to limitations in the primary data. The studies that were included in the clinical review related to PR programs that varied in components, duration, and patient populations. The selected studies used several methods to assess the outcomes of PR, which contributed to heterogeneity. Consequently, the derivation of summary statistics was considered to be unrealistic, and a series of narrative reviews were prepared. Many of the papers presented findings on outcomes with reference to P values and did not give confidence intervals. In the economic review, the variation in PR design and measured outcomes between studies meant that an integrative analysis could not be developed, because there was no standard cost measure.
The generalizability of studies reporting longer-term outcomes is not entirely clear. Sustained benefits from PR have been achieved in some settings but not in others, and more work seems to be needed to confirm factors that contribute to longer-term success.
There is a need for better information on patient characteristics and the optimum structure and operation of PR programs. The approaches vary between programs. Limited information was obtained in the clinical review on the efficacy of individual components of PR. The same can be said for the economic review. Given the lack of longer-term data on outcomes, we need information on the decay of benefits and the possible need for boosters. While the short-term benefits of PR are established, the extent of these benefits may be unclear because many studies excluded patients with comorbidities and those who had recent exacerbations.
Conclusions
The use of PR improves short-term exercise capacity, HRQL, and mental health outcomes for patients with COPD. The use of PR may also be associated with reductions in hospitalization, but better-quality studies are needed. There is evidence that, in some settings, the benefits of PR can be sustained in the longer term, but at other centres the benefits decline over six to 18 months after the completion of rehabilitation. More work is needed to confirm the factors that contribute to the successful long-term management of COPD after PR. There is limited information on the effectiveness of elements of PR programs. Issues that relate to patient characteristics and the operation of PR and maintenance programs need to be considered by those who establish and provide these services.
If the duration of effectiveness of PR is 18 months, as in some of the studies from the clinical literature, the incremental cost-effectiveness ratio of usual care plus PR compared with usual care is $27,924 per additional quality-adjusted life-year gained. This is within the range of acceptability according to current thresholds, and the results are not highly sensitive to variations in the values of the model variables.
The estimates of additional costs of PR services in Canada ranged from $1.8 million to $168 million annually. In the most likely scenario, corresponding to 25% of persons with COPD needing PR and a 67% uptake, another $19 million would be needed annually.
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