Comparison of Healthcare Costs for Women with Treated Versus Untreated Vasomotor Symptoms Due to Menopause.

INTRODUCTION: The study objective was to estimate all-cause healthcare resource utilization (HCRU) and medical and pharmacy costs for women with treated versus untreated vasomotor symptoms (VMS) due to menopause. METHODS: A retrospective study was conducted using US claims data from Optum Research Database (study period: January 1, 2012-February 29, 2020). Women aged 40-63 years with a VMS diagnosis claim and ≥ 12 and ≥ 18 months of continuous enrollment during baseline and follow-up periods, respectively, were included. Women treated for VMS were propensity score matched 1:1 to untreated controls with VMS. Standardized differences (SDIFF) ≥ 10% were considered meaningful. A generalized linear model (gamma distribution, log link, robust standard errors) estimated the total cost of care ratio. Subgroup analyses of on- and off-label treatment costs were conducted. RESULTS: Of 117,582 women diagnosed with VMS, 20.5% initiated VMS treatment and 79.5% had no treatment. Treated women (n = 24,057) were matched to untreated VMS controls. There were no differences in HCRU at follow-up (SDIFF < 10%). Pharmacy ($487 vs $320, SDIFF 28.4%) and total ($1803 vs $1536, SDIFF 12.6%) costs were higher in the treated cohort. Total costs were 7% higher in the treated cohort (total cost ratio 1.07, 95% CI 1.05-1.10, P < 0.001). The on-label treatment pharmacy costs ($546 versus $315, SDIFF 38.6%) were higher in the treated cohort. Off-label treatment had higher medical costs ($1393 versus $1201, SDIFF 10.4%). CONCLUSIONS: Most women with VMS due to menopause were not treated within 6 months following diagnosis. While both on- and off-label treatment increased the total cost of care compared with untreated controls, those increases were modest in magnitude and should not impede treatment for women who report symptom improvement as a result of treatment.

Incremental direct and indirect costs of untreated vasomotor symptoms.

OBJECTIVE: Most women with moderate to severe vasomotor symptoms (VMS) are untreated. This retrospective matched-cohort study aims to evaluate the healthcare resource utilization, work loss, and cost burden associated with untreated VMS. METHODS: Health insurance claims (1999-2011) were used to match (1:1) women with untreated VMS with control women using propensity score. Healthcare resource utilization, work productivity loss (disability + medically related absenteeism), and associated costs were compared between cohorts. RESULTS: During the 12-month follow-up, women with untreated VMS (n = 252,273; mean age, 56 y) had significantly higher healthcare resource utilization than women in the control cohort: 82% higher for all-cause outpatient visits (95% CI, 81-83; P < 0.001) and 121% higher (95% CI, 118-124; P < 0.001) for VMS-related outpatient visits. Mean direct costs per patient per year were significantly higher for VMS women (direct cost difference, US$1,346; 95% CI, 1,249-1,449; P < 0.001). VMS women had 57% (95% CI, 51-63; P < 0.001) more indirect work productivity loss days than controls, corresponding to an incremental indirect cost per patient per year associated with untreated VMS of US$770 (95% CI, 726-816; P < 0.001). CONCLUSIONS: This study shows that untreated VMS are associated with significantly higher frequency of outpatient visits and incremental direct and indirect costs.

Effective and cost-effective clinical trial recruitment strategies for postmenopausal women in a community-based, primary care setting.

INTRODUCTION: Little evidence exists to guide investigators on the effectiveness and cost-effectiveness of various recruitment strategies in primary care research. The purpose of this study is to describe the effectiveness and cost-effectiveness of eight clinical trial recruitment methods for postmenopausal women in a community-based setting. METHODS: A retrospective analysis of the yield and cost of eight different recruitment methods: 1) family physician (FP) recruiters, 2) FP referrals, 3) community presentations, 4) community events, 5) newsletters, 6) direct mailings, 7) posters, and 8) newspaper advertisements that were used to recruit postmenopausal women to a randomized clinical trial (RCT) evaluating the effectiveness of gabapentin in treating hot flashes. RESULTS: We recruited 197 postmenopausal women from a total of 904 screened, with 291 of the remainder being ineligible and 416 declining to participate. Of the 904 women screened, 34 (3.8%) were from FP recruiters and 35 (3.9%) were from other FP referrals while 612 (67.7%) resulted from newspaper advertisements. Of the 197 women enrolled, 141 (72%) were from newspaper advertisements, with 26 (13%) following next from posters. Word of mouth was identified as an additional unanticipated study recruitment strategy. Metropolitan newspaper advertising at $112.73 (Canadian) per enrolled participant and posters at $119.98 were found to be cost-effective recruitment methods. CONCLUSION: Newspaper advertisements were the most successful method to recruit postmenopausal women into a community-based, primary care RCT.

Cost-effectiveness of hormone therapy in the United States.

OBJECTIVE: To estimate the cost-effectiveness of 5 years of treatment with hormone therapy (HT) compared with no treatment for women with menopausal symptoms in the United States. METHODS: A Markov cohort simulation model was used with tunnel techniques to assess the cost-effectiveness of HT in women aged 50 years, based on a societal perspective. Clinical data, where possible, used results taken from the Women Health Initiative (WHI). The model had a lifetime horizon with cycle lengths of 1 year and contained the following disease states: hip fracture, vertebral fracture, wrist fracture, breast cancer, colorectal cancer, coronary heart disease, stroke, and venous thromboembolic events. An intervention was modelled by its impact on the disease risks during and after stopping treatment. The model required data on clinical effects, risks, mortality rates, quality of life weights, and costs. The main outcome of the model was cost per quality-adjusted life-year (QALY) gained on HT compared with no treatment. RESULTS: The results indicated that it was cost-effective to treat women with menopausal symptoms with HT in the United States. The severity of menopausal symptoms was the single most important determinant of cost-effectiveness, but HT remained cost-effective even where symptoms were mild or effects on symptom relief were small. CONCLUSIONS: Treatment of women with menopausal symptoms with HT is cost-effective.

Costs of hormonal and nonhormonal prescription medications for hot flashes.

Hot flashes are the cardinal symptom of menopause and can be treated with hormonal and nonhormonal prescription medications. However, considering that 6000 women enter menopause daily in the USA, and many of these women are symptomatic, the costs of these treatments can be a significant public health issue. We evaluated annual individual and population costs of hormonal and nonhormonal prescription treatments for hot flashes. Cost information may be helpful to clinicians and consumers in making treatment decisions.

Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review.

Many women experience vasomotor symptoms at or around the time of menopause. Hot flushes and night sweats are considered primary menopausal symptoms that may also be associated with sleep and mood disturbances, as well as decreased cognitive function. All of these symptoms may lead to social impairment and work-related difficulties that significantly decrease overall quality of life. Hot flushes have shown a great deal of variability in their frequency and severity in women. In some women, hot flushes persist for several months; in others, they may last for more than 10 years. Traditionally vasomotor symptoms were reported to begin 5 to 10 years prior to the cessation of the final menstrual cycle, corresponding with the initial decline in circulating gonadal hormones; however, night sweats in particular most often begin in perimenopause. The pathogenesis of hot flushes has not yet been fully elucidated, but the circuitry involving estrogen and neurotransmitters, norepinephrine and serotonin specifically, are hypothesized to play a major role in the altered homeostatic thermoregulatory mechanisms underlying these events. Menopause-associated vasomotor symptoms are associated with significant direct and indirect costs. Overall costs of traditional pharmacotherapy or complementary and alternative medicine modalities, including over-the-counter treatments and dietary supplements, for managing menopause-related vasomotor symptoms are substantial and include initial and follow-up physician visits and telephone calls. Additional costs include laboratory testing, management of adverse events, loss of productivity at work, and personal and miscellaneous costs. Pharmacoeconomic analyses, including those that consider risks identified by the Women's Health Initiative, generally support the cost-effectiveness of hormonal therapy for menopause-associated vasomotor symptoms, which have been the mainstay for the management of these symptoms for more than 50 years. However, because many women now want to avoid hormone therapy, there is a need for additional targeted therapies, validated by results from controlled clinical trials that are safe, efficacious, cost-effective, and well tolerated by symptomatic menopausal women.