The pattern of illness in the U.S. has shifted from mostly acute disease to one in which chronic conditions predominate. Although there are many diseases that can shorten life expectancy, it is more likely that a disease will have adverse health consequences that result in dysfunction and decreased well-being. Hence, patient self-reports of functioning and well-being, or health-related quality of life (HRQOL), are increasingly viewed as important measures of therapeutic outcome. Sanders and colleagues found that the reporting of quality-of-life therapeutic endpoints in randomized controlled trials increased more than 650% between 1980 and 1997.
As described by Badia and Herdman, the relative importance of HRQOL information depends on the type of condition (i.e., chronic or acute) and the type of treatment (i.e., preventive, curative, or palliative). In chronic conditions (e.g., osteoarthritis, angina, Parkinson’s disease), HRQOL might be a primary measure of therapeutic efficacy, whereas in acute conditions (e.g., community-acquired pneumonia, urinary tract infections), the primary goal is usually to cure the disease (i.e., infection eradication). Commonly measured dimensions of HRQOL include physical functioning, psychological/emotional functioning, social/role functioning, and perception of well-being.
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The pharmaceutical industry has been the principal driving force behind the recent expansion in the number and type of HRQOL instruments available to clinicians and researchers. Therapeutic areas receiving increased attention from the pharmaceutical industry include arthritis, asthma, cancer, diabetes, end-stage renal disease, HIV, hypertension, migraine headaches, and other chronic diseases. Information based on patient-reported perceptions of the impact of pharmaceuticals on HRQOL are beginning to be included in product labeling and promotional materials. This is likely to occur with increasing frequency as pharmaceutical firms look for ways to demonstrate value and differentiate their products from competing therapies.
Information regarding the impact of pharmacotherapy on HRQOL can provide additional data for making medication-use policy and formulary decisions. The use of formularies among managed care plans has been slowly increasing as more patients have access to pharmaceuticals as part of their basic health benefits. Numerous clinicians, researchers, and clinical practice organizations have recommended that HRQOL data be considered in formulary development.
However, the literature suggests that HRQOL data are not commonly included in the pharmaceutical formulary management process. The goal of this preliminary research was to investigate the role of HRQOL data in pharmaceutical coverage decisions within managed health care plans. The specific objectives were to assess, in a focus-group format, decision-makers’ perceptions regarding: 1) the relative importance and value of HRQOL data in the formulary management process and 2) the quality of HRQOL data available in the published literature and promotional materials.