Patient-reported barriers to osteoporosis therapy

This study was designed to assess patients’ reasons for non-treatment of osteoporosis among patients who were never treated and reasons for discontinuation of osteoporosis therapy among those who had been treated previously. Currently and previously treated patients were older, more frequently had drug coverage through insurance, and reported better general health and fewer days of poor physical or mental health during the past 30 days than never-treated patients. These results are consistent with a US retrospective analysis that found that older age, better physical functioning, and prescription insurance coverage were among the patient characteristics associated with receiving osteoporosis therapy [13].

Among patients never treated for osteoporosis in the current study, the highest ranking reasons for non-treatment were the use of alternative treatments such as over-the-counter vitamins/supplements and the fear of side effects. The latter result agrees with the findings of Yu et al., who found that among US osteoporotic women aged 55 and older, the primary reason for not initiating osteoporosis therapy was concern over side effects (77.3 % of survey respondents) [4]. Similarly, in a survey that analyzed factors associated with the decision of US women to initiate osteoporosis therapy, respondents who did not initiate prescription medication for osteoporosis were more likely to worry about the side effects of taking osteoporosis medication and more likely to agree with the statement, “I can take care of my osteoporosis without medication” [14]. In addition, respondents who initiated osteoporosis prescription medication believed more strongly in the effectiveness of medication, while non-initiators reported having more distrust of medications [14]. In our analysis, fear of side effects was the most frequently first-ranked reason for non-treatment (see Fig. 1), and this fear may have acted as a driver for women to try alternative therapies, thus resulting in our finding that over half of the women included in this study preferred taking over-the-counter vitamins and supplements for osteoporosis.

The results of our survey show that the cost of medication is a barrier to initiating osteoporosis therapy among 24.1 % of the surveyed population. These results are consistent with those of Yu et al. Among the surveyed women, 34.1 % cited the cost of medication as their reason for not initiating treatment [4]. In addition, in a study of osteoporotic US women aged 40 and older, out-of-pocket spending on prescriptions as a proportion of income was found to be a significant predictor of receiving a prescription therapy for osteoporosis or osteopenia (P = 0.01) [13].

In the current survey, the most frequent reasons for discontinuation among previously treated patients included the direction of the physician, concerns about long-term safety, and the experience of side effects. The fact that some physicians are directing their patients to discontinue treatment is consistent with national guidelines that allow for a drug holiday [9], or it may be that physicians incorporate flexibility into the regimens of patients experiencing medication-related adverse effects. Experiencing side effects is a commonly cited reason for discontinuing osteoporosis therapy, as shown by health care and claims database analyses [6, 7] and telephone and questionnaire-based surveys [8, 15]. Regarding long-term safety profiles, patients taking bisphosphonates may be aware of reports of infrequent occurrences of renal toxicity, atypical subtrochanteric and femoral shaft fractures, osteonecrosis of the jaw, and, with intravenous formulations, influenza-like symptoms [16, 17]. An additional reason for discontinuation reported in this study was the cost of medication. This result is consistent with the findings of an Italian survey of postmenopausal women in which roughly 10 % of participants reported cost as a reason for discontinuation [18].

In the current study, 65.2 % of patients (195 of the 299 who answered this survey question) were somewhat to extremely willing to restart therapy. This value is higher than the rates of reinitiation reported in other observational studies [5, 6, 10, 11], perhaps because there is a difference between willingness to restart therapy and actually filling a prescription. Our results showed that patients not willing to restart osteoporosis treatment were more likely to have discontinued because of side effects and concerns about safety, compared to patients who were willing to restart therapy. These findings provide a link between reasons for discontinuation and predictors of reinitiation and offer insight into the known correlates of reinitiation of therapy. For example, women with side effects and women concerned about the long-term safety of their treatment will likely discontinue sooner, and early discontinuation is predictive of a lack of reinitiation of therapy [5, 10].

These findings have implications for insurance coverage of osteoporosis therapy. In order to manage pharmacy costs, managed care organizations may implement step-therapy restrictions in which patients are required to try generic, payer-preferred treatments before being reimbursed for a more expensive or branded medication. In many cases, this may mean that patients need to restart their previous medication in order to get a different prescription. Our study shows that treatment side effects may affect patient’s willingness to participate in the step-therapy process.

The primary limitation of this study is its potential lack of generalizability, because the survey population was derived from a consumer panel and may differ from patient populations derived from clinics or claims databases. In addition, the survey was conducted online which may also impact the generalizability. The cross-sectional survey design is limited by the accuracy of patient recall and reporting bias. For example, the diagnosis of osteoporosis in this study was based on self-report and not confirmed by medical records or physician contact and thus was subject to error. The lack of precision regarding the diagnosis of osteoporosis may explain why one quarter of patients included in our survey believed that osteoporosis was not serious enough to require a prescription medication. In addition, when participants were asked if they had ever had a BMD test or DEXA scan, recall bias and lack of knowledge of terminology could have impacted their response to this question. Also, in classifying patients as never treated, there was no distinction between patients who never received a prescription and those who received one but did not fill it. In this survey, no distinctions were made between types of osteoporosis treatments, so we could not determine whether patients taking oral versus injectable therapies or bisphosphonates versus non-bisphosphonates would have had substantially different results. In addition, we did not collect data on the time from osteoporosis diagnosis to medication initiation. This data may have helped determine whether patients that were never treated were simply not yet treated. Finally, the effect of confounders on the willingness to restart therapy was not assessed in this study.