These results are exploratory and are limited by the small number of participants and managed care organizations represented. No attempt was made to obtain a random or representative sample of managed care decision-makers, so the findings cannot be generalized beyond the study participants. However, a number of the findings are consistent with results reported by other investigators.
Focus group participants reported that only when other more important factors (i.e., acquisition cost, safety and efficacy) were equal was HRQOL information of value in the formulary management process. This finding was not surprising because other authors have reported that decision-makers placed less value on HRQOL data than other data in the decision-making process. Even if all the proposed steps were taken to enhance the usefulness of HRQOL data in formulary/pharmacy benefit decision-making, it is unlikely that HRQOL data would move up appreciably in relative importance in this context.
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Participants reported that they were, in general, untrained in the analysis and interpretation of HRQOL data. HRQOL data might not be used to formulate policy decisions because the consequences and impact of a medication on patients’ self-reported HRQOL is not readily understood or appreciated by them. Although survey data indicate that decision-makers are familiar with pharmacoeconomic analyses, only a small percentage reported that they had completed training (e.g., certification) in pharmacoeconomics beyond individual continuing education programs. It is likely that even fewer of them have an adequate grasp of HRQOL assessment and its application.
Most HRQOL data were generally unavailable when the formulary decisions were being made and were not applicable to the managed care patient population for which the decisions were being made, according to participants. In addition, there was concern that HRQOL studies might be designed (e.g., in the selection of comparators) by sponsors to reflect most favorably upon their products. The fact that participants perceived HRQOL data from RCTs to be of lesser value was somewhat puzzling because they did not report that safety and efficacy data from RCTs was not applicable to their patient populations. However, these findings might reflect the respondents’ relative comfort level with their ability to evaluate different types of RCT data (efficacy vs. HRQOL) and/or their recognition that most RCTs are designed to evaluate clinical efficacy as the primary endpoint and that HRQOL, if measured, would be secondary.
Participants believed that, to enhance the usefulness of HRQOL data in health care decisions, consumers and purchasers/payers must be better informed about the role of HRQOL data in demonstrating the overall value of medications. In addition, participants agreed that health care professionals must be trained in the interpretation and application of HRQOL data. These findings support the position of other authors who have asserted that the education of health care consumers and the training of health care professionals in HRQOL assessment must be improved before HRQOL data is widely accepted in the formulary management process.
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Although HRQOL information is seen as increasingly important in documenting therapeutic outcomes, it does not appear to be a significant factor in formulary/pharmacy benefit decision-making at this time. This might be caused by the lack of relevance and/or value attributed to it by decision-makers. Patients might be the more receptive consumers of HRQOL information, a concept that has not been lost on the producers of direct-to-consumer advertisements (DTCAs) for prescription medications. Most of the current DTCAs are presenting an implicit or explicit HRQOL message. Although it is hard to obtain precise data on the actual demand created by DTCAs of this type, there is no doubt that managed care organizations are dealing with the effect of medication-related HRQOL information, one way or another.