To obtain the target of 10 focus group participants, 29 prospective participants from the conference pre-registrant list were identified and contacted. Although eight men and three women met the inclusion criteria and agreed to participate, three of them were unable to attend, leaving a total of eight (i.e., six men and two women) focus group participants. These participants were on P&T committees that made pharmaceutical benefit decisions for over 500,000 enrolled lives.
Participants described HRQOL as an evaluative tool that includes the patient’s acceptance and tolerance of a medication as well as the convenience associated with the use of a medication. Furthermore, they described HRQOL as a measure of patients’ involvement in activities of daily living and physical functioning. They also perceived it to be implicit that all pharmacotherapy is designed to improve HRQOL (e.g., “the goal of drug therapy is to allow patients to live their lives to the fullest”). Table 2 provides the importance ratings for the drug coverage decision-making factors on a scale from 1 (“not important”) to 5 (“very important”). Of the eight factors, participants rated “efficacy of the drug” and “consumer demand for the drug” the most and least important factors in drug coverage decision-making, respectively. “Health-related quality-of-life effects of the drug” was rated at approximately the midpoint (i.e., 3.2) of the importance scale.
Table 2 Importance* of Specific Factors in Drug Coverage Decisions
|Factor Mean Rating RangeEfficacy of the drug 4.9 4-5 Cost-effectiveness of the drug 4.4 4-5 Cost of the drug 4.0 3-5 Safety of the drug 4.0 2-5 Physician demand for the drug 3.4 2-4 Health-related quality-of-life
effects of the drug 3.2 2-4 Rebate arrangements affecting the drug 2.9 1-5 Consumer demand for the drug 2.4 2-3
Four dominant themes emerged from the analysis of the discussions: 1) although the quality of HRQOL data in the literature or in promotional material is perceived to be good, the data are not routinely applicable to the formulary decision-making process; 2) formulary decision-makers are not trained to interpret HRQOL data; 3) HRQOL data is valuable only when other more important factors are equal; and 4) the usefulness of HRQOL data can be enhanced, but it will take a concerted effort on the part of health care professionals.
Applicability of HRQOL Data
Participants were in agreement that HRQOL data appearing in scientific/clinical literature and promotional material based on RCTs could be of good quality, but that data from effectiveness studies that were performed in a managed care setting would be preferable. Participants did not perceive that HRQOL information based on effectiveness trials was readily available (“you don’t generally see effectiveness trials with HRQOL as an endpoint”). Participants’ overall perceptions of HRQOL data from RCTs were that the data were: 1) incomplete, because not all comparable drugs were tested (“they pick and choose the drugs they want to compare so that theirs will look better”), and based on short durations of follow-up (“our patients are with us longer than a six-month follow-up”) and 2) not applicable, because the subjects in RCTs were not similar to their managed care patient populations (“they pick and choose their subjects; we have to care for all of our subscribers”). In addition, participants perceived HRQOL data from post-marketing studies as lacking timeliness (“Information on drugs changes every three months; most of these trials are a couple of years old.” “[We] have to wait for phase IV trial results and they aren’t ready until at least a year after the drug is released”).
Interpretation of HRQOL Data
Participants described themselves and their formulary decision-making colleagues as unsophisticated in the understanding and interpretation of HRQOL data—as one participant said, “our P&T committee has no HRQOL ‘expert’ to help us interpret the data.” Participants described P&T committee members (e.g., physicians and pharmacists) as untrained in relating HRQOL data to clinical significance (“physicians on P&T committees rely on their personal experience to make decisions”). Some participants verbalized their perception that larger organizations (e.g., Kaiser, the Blues, etc.) had staff trained in HRQOL interpretation. Participants from large organizations did not corroborate this perception.
Value of HRQOL Data
Gauging the importance of data to formulary decision-makers on a scale from 1 to 5, participants, on average, rated data regarding the HRQOL effects of a medication at the midpoint. Although no tests of statistical significance were performed, this rating was numerically lower than average ratings for data on the medication’s efficacy, cost, cost-effectiveness, physician demand, or safety. Only data on consumer demand and on rebate arrangements of the medication were rated lower in importance than HRQOL data (“Other factors besides HRQOL] weigh more heavily”). Participants were in agreement that when it came to making formulary decisions, safety, efficacy, and cost were the primary factors in their decisions (“Only when other more important factors [costs and efficacy] are equal do we consider HRQOL”).
Participants did not perceive a demand from consumers or third-party payers to include HRQOL in the formulary decision-making process (“Payers don’t see the value in it [HRQOL data].” “Babyboomers want it [HRQOL data] included but employers don’t see the value”). Participants were unsure of any health plan that required submission of HRQOL data as part of the dossier for formulary decisions.
Participants were in agreement that appeal mechanisms are in place so that decisions regarding the use of non-formulary, HRQOL-enhancing medications can be made at the patient level. Participants wondered what value HRQOL data will provide in the future as managed care organizations shift from closed formularies to multi-tiered co-pays (“its value may be only for high-profile drugs”).
Enhancing the Usefulness of HRQOL Data
Participants agreed that to enhance the usefulness of HRQOL data in the formulary management, employer groups and health care consumers must first be convinced of the value of HRQOL data. They also stated that health care professionals need to be trained in the use and interpretation of HRQOL data before it will be widely accepted as a factor in formulary decision-making (“Health care professionals need to be educated on the value of this data [HRQOL] from the start of their training”).
To increase the use of HRQOL data in the formulary decisionmaking process, participants recommended that: 1) HRQOL data need to be made available in a more timely manner (“data needs to be available when decisions are being made”); 2) HRQOL data from effectiveness studies, as opposed to RCTs, would be more accepted by decision makers (“Data from studies in naturalistic settings is more relevant to me than data from RCTs.” “Sample sizes of the studies need to be large”); 3) a standardized system of reporting HRQOL data needs to be established (“Every study uses a different [HRQOL] instrument; it’s hard to compare one study to the next”); and 4) presentation of HRQOL data needs to be improved (“HRQOL scores can be confusing; the data needs to be presented more visually”).