The association between insurance coverage for insulin pen needles and healthcare resource utilization among insulin-dependent patients with diabetes in China.

BACKGROUND: Pen needles are an important component of insulin delivery among patients with diabetes, but are not universally covered in China. We compared clinical and economic characteristics of insulin-dependent patients in China who have some level of pen needle (PN) reimbursement to those with no PN reimbursement. METHODS: A cross-sectional study was conducted among 400 insulin users with Type 1 or Type 2 diabetes treated in outpatient endocrinology units of four large tertiary care hospitals in Nanjing, Chongqing, Beijing and Zhengzhou. Demographics, medical history, healthcare resource utilization (RU), out-of-pocket costs, insurance and PN reimbursement status were surveyed. Unit costs were assigned to healthcare RU and compared using descriptive statistics and multivariate regression models. RESULTS: A total of 400 patients were analyzed; 142 (35.5%) with some level of PN coverage/reimbursement and 258 (64.5%) without. Patients without PN reimbursement had a higher prevalence of lipohypertrophy (59.3% vs. 40.7%, p = 0.0007), greater median PN reuse (12 vs. 7 times per needle, p < 0.0001), greater 6-month insulin costs (1591 vs. 1328 Renminbi [RMB], p = 0.0025) and total unadjusted 6-month expenditures (6433 vs. 4432 RMB, p < 0.0001), respectively. After controlling for clinical and demographic characteristics, patients without PN reimbursement had 4.6 times greater odds of high costs compared to those with PN reimbursement. CONCLUSIONS: Insulin users without PN reimbursement may pose a greater economic burden to China compared to those with PN reimbursement. Expansion of insurance coverage for insulin PNs can improve the quality of care and potentially help reduce the economic burden in this population.

The Comparative Burden of Chronic Widespread Pain and Fibromyalgia in the United States.

BACKGROUND/PURPOSE: Little information exists on the comparative patient and economic burden of chronic widespread pain (CWP) and fibromyalgia (FM) in the United States. METHODS: This multistage, observational study included an online screening survey of a large geographically diverse US sample to assess CWP status, a physician/site visit to determine FM diagnosis, and an online subject questionnaire to capture clinical characteristics, pain, health status, functioning, sleep, healthcare resource use (HRU), productivity, and costs. Based on the screener and physician evaluation, mutually exclusive groups of subjects without CWP (CWP-), with CWP but without FM (CWP+), and with confirmed FM were identified. RESULTS: Disease burden was examined in 472 subjects (125 CWP-, 176 CWP+, 171 FM). Age, race, and ethnicity were similar across groups. Mean body mass index and number of comorbidities increased from CWP- to CWP+ to FM (P = 0.0044, P < 0.0001, respectively). From CWP- to CWP+ to FM, there were reductions in health status (EQ-5D, SF-12) and sleep outcomes (MOS-SS, SSQ) (all P < 0.05). Pain severity, interference with function (BPI-SF), and overall work impairment (WPAI:SHP) increased from CWP- to CWP+ to FM (all P < 0.0001). Higher proportions of CWP+ (52.8%) and FM subjects (62.6%) were taking pain-related prescription medications relative to CWP- subjects (32.8%; P < 0.0001). Significant differences in total direct and indirect costs across the three groups (both P < 0.0001) were observed, with highest costs among FM subjects. CONCLUSION: Fibromyalgia subjects were characterized by the greatest disease burden with more comorbidities and pain-related medications, poorer health status, function, sleep, lower productivity, and higher costs.

Sphygmomanometry-evoked allodynia in chronic pain patients with and without fibromyalgia.

BACKGROUND: Fibromyalgia is a chronic pain syndrome that affects about 2% of the U.S. general population, with greater prevalence among women (3.5%) than men (0.5%). Previous research results suggest that the experience of pain (allodynia) upon sphygmomanometry may indicate the presence of fibromyalgia. OBJECTIVE: The aim of this study was to confirm these findings in patients with fibromyalgia and other chronic pain conditions and evaluate the use of sphygmomanometry as a potential screening tool for the identification of patients with fibromyalgia. METHODS: A total of 150 people participated in this multicenter, cross-sectional observational study. The study included a physician-conducted evaluation to determine if the participant met the American College of Rheumatology (ACR) 1990 diagnostic criteria for fibromyalgia. The presence of sphygmomanometry-evoked allodynia was assessed during a seated cuff pressure inflation that was repeated three times on each arm. Each site was provided a sphygmomanometer to ensure standardization, and the pressure of the cuff at the moment of pain initiation was recorded. If the patient did not indicate pain prior to 180 mmHg, then the inflation was stopped, a notation of no pain was made, and a cuff pressure of 180 mmHg was recorded. The mean of the six cuff pressure measurements was used for the analyses. Logistic regression was performed to analyze the relationship between sphygmomanometry-evoked allodynia and fibromyalgia. RESULTS: The evaluable sample was 148 (one participant had too large an arm circumference for the sphygmomanometer and another did not receive the clinician evaluation of ACR-determined fibromyalgia diagnosis). Over half of the participants were determined to have an ACR diagnosis of fibromyalgia. Of these, 71 (91%) were women and had an average age of 54 years. Of the 70 participants with no fibromyalgia diagnosis, 42 (60%) were women and also had an average age of 54 years. Sixty-one (78%) of the fibromyalgia participants, compared with 25 (36%) of those with no fibromyalgia diagnosis, reported sphygmomanometry-evoked allodynia. The participants with fibromyalgia reported pain ata lower cuff pressure compared with those without fibromyalgia (132 mmHg vs. 166 mmHg, p < .01). The logistic regression showed that sphygmomanometry-evoked allodynia predicted an ACR-determined FM diagnosis (χ(2) = 19.4, p < .01). DISCUSSION: These findings support previous research suggesting that patients who report pain upon sphygmomanometry may warrant further evaluation for the presence of fibromyalgia.

Societal and individual burden of illness among fibromyalgia patients in France: association between disease severity and OMERACT core domains.

BACKGROUND: Patients with fibromyalgia (FM) report widespread pain, fatigue, and other functional limitations. This study aimed to provide an assessment of the burden of illness associated with FM in France and its association with disease severity and core domains as defined by Outcome Measures in Rheumatology Clinical Trials (OMERACT) for FM. METHODS: This cross-sectional, observational study recruited patients with a prior diagnosis of FM from 18 community-based physician offices in France. Patients completed questions about FM impact (Fibromyalgia-Impact Questionnaire [FIQ]), core symptoms (defined by OMERACT), health-related quality of life (EQ-5D), current overall health status (rated on a scale from 0 to 100), productivity, treatment satisfaction, and out-of-pocket expenses related to FM. Site staff recorded patients' treatment and health resource use based on medical record review. Costs were extrapolated from 4-week patient-reported data and 3-month clinical case report form data and calculated in 2008 Euros using a societal perspective. Tests of significance used the Kruskal-Wallis test or Fisher's Exact test where P < 0.05 was considered significant. RESULTS: Eighty-eight patients (mean 55.2 y; female:male 74:14) were recruited. The majority of patients (84.1%) were prescribed medications for FM. Patients mainly described medications as a little/not at all effective (40.0%) or somewhat effective (52.9%). Current Overall Health rating was 52.9 (± 17.8) and FIQ total score was 54.8 (± 17.3). FIQ total score was used to define FM severity, and 17 patients scored 0- < 39 (mild FM), 33 patients 39- < 59 (moderate FM), and 38 scored 59-100 (severe FM). As FM severity level worsened, patients had poorer overall health status and perceived their prescription medications to be less effective. Average cost/FM patient was higher for severe (€10,087) vs. moderate (€6,633) or mild FM (€5,473); however, the difference was not significant. CONCLUSIONS: In a sample of 88 patients with FM from France, we found that FM poses a substantial economic and human burden on patients and society. FM severity level was significantly associated with patients' health status and core symptom domains.

The association of sleep difficulties with health-related quality of life among patients with fibromyalgia.

BACKGROUND: Difficulty sleeping is common among patients with fibromyalgia (FM); however, its impact on health-related quality of life (HRQoL) is not well understood. The aim of the current study was to assess the burden of sleep difficulty symptoms on HRQoL among patients with FM. METHODS: The current study included data from the 2009 National Health and Wellness Survey (N=75,000), which is a cross-sectional, Internet-based survey representative of the adult US population. The prevalence of sleep difficulty symptoms among patients with FM (n=2,196) were compared with matched controls (n=2,194), identified using propensity-score matching. Additionally, the relationship between the number of sleep difficulty symptoms (none, one, or two or more) and HRQoL (using the SF-12v2) was assessed using regression modeling, controlling for demographic and health history variables. RESULTS: Of the 2,196 patients with FM, 11.2% reported no sleep difficulty symptoms, 25.7% reported one sleep difficulty symptom, and 63.05% reported two or more sleep difficulty symptoms. The prevalence of sleep difficulty symptoms was significantly higher than matched controls. Patients with one and two sleep difficulty symptoms both reported significantly worse HRQoL summary and domain scores relative to those with no sleep difficulty symptoms (all p<.05). Further, the relationship between sleep difficulty symptoms and HRQoL was significantly different between those with FM than matched controls, suggesting a uniqueness of the burden of sleep difficulties within the FM population. CONCLUSIONS: Among the FM population, sleep difficulty symptoms were independently associated with clinically-meaningful decrements in mental and physical HRQoL. These results suggest that greater emphasis in the treatment of sleep difficulty symptoms among the FM population may be warranted.

The comparative burden of mild, moderate and severe fibromyalgia: results from a cross-sectional survey in the United States.

BACKGROUND: Fibromyalgia (FM) is characterized by chronic, widespread pain, fatigue, and other symptoms; yet few studies have comprehensively assessed its humanistic burden. This observational study evaluates the impact of FM severity on patients' symptoms, health-related quality of life (HRQoL), and productivity in the United States. METHODS: 203 FM subjects were recruited from 20 physician offices. Subjects completed a questionnaire including the EuroQol 5D (EQ-5D), Fibromyalgia Impact Questionnaire (FIQ), Multidimensional Assessment of Fatigue (MAF), Medical Outcomes Study Sleep Scale (MOS-SS), and Hospital Anxiety and Depression Scale (HADS) and questions about demographics, pain and other symptoms, HRQoL and productivity. FIQ total scores were used to define FM severity, with 0- < 39, 39- < 59, and 59-100, representing mild, moderate, and severe FM, respectively. Sites recorded subjects' clinical characteristics and FM treatment on case report forms using medical records. Summary statistics were calculated for continuous variables and frequency distributions for categorical variables. Differences across FM severity groups were evaluated using the Kruskal-Wallis or Chi-square tests. Statistical significance was evaluated at the 0.05 level. RESULTS: Mean (SD) age was 47.9 (10.9); 95% were female. Most (92%) were prescribed medication for FM; 24% and 66% reported moderate and severe FM, respectively. Mean (SD) scores were: 6.3 (2.1) for pain intensity; 0.35 (0.35) for EQ-5D; 30.7 (14.2) for MAF; 57.5 (18.4) for MOS-SS Sleep Problems Index; 10.2 (4.8) for HADS anxiety and 9.4 (4.4) for HADS depression. Subjects with worse FM severity reported significantly increased pain severity, HRQoL, fatigue, sleep disturbance, anxiety and depression (p < 0.001). Overall, 50% of subjects reported some disruption in their employment due to FM; this differed across severity levels (p < 0.001). Employed subjects missed a mean (SD) of 1.8 (3.9) workdays during the past 4 weeks; this also differed across severity levels (p = 0.03). CONCLUSIONS: FM imposes a substantial humanistic burden on patients in the United States, and leads to substantial productivity loss, despite treatment. This burden is higher among subjects with worse FM severity.

Efficient practices associated with diagnosis, treatment and management of fibromyalgia among primary care physicians.

OBJECTIVES: To describe beliefs and practice patterns of primary care physicians (PCPs) providing fibromyalgia (FM) care, and to characterize differences between PCPs who report being able to provide timely and beneficial care versus the remaining PCPs. METHODS: A mixed-methods approach including surveys followed by semi-structured focus groups among United States-based PCPs in seven cities was used. Post hoc, a composite threshold of timely and beneficial care, defined as PCPs reports of at least one-half of their patients achieving an 'acceptable' quality of life within one to four office visits after diagnosis, was created to compare subgroups. RESULTS: Forty-six per cent of PCPs reported some uncertainty when diagnosing FM. PCPs reported personally treating approximately two-thirds of their patients (63%), and reported an average of three dosage titrations. In a post hoc exploratory analysis, 42.5% of PCPs met a composite threshold of self-reported timely and beneficial FM care. These PCPs reported fewer office visits to confirm an FM diagnosis (2.7 versus 4.0 visits [P<0.01]) and more patients with 'significant improvement' (38% versus 23% [P<0.01]) after six months of treatment compared with the remaining PCPs. CONCLUSIONS: Physicians self-reported an inadequacy in diagnosing, treating and managing patients with FM in current practice. A subset of PCPs, however, perceived an ability to reach a definitive diagnosis and initiate treatment plans relatively sooner than the other respondents. If the perception of this subset can be confirmed with objective clinical outcomes, and these behaviours modelled, steps could be taken to improve FM care within the broader PCP setting.

Retrospective evaluation of clinical characteristics, pharmacotherapy and healthcare resource use among patients prescribed pregabalin or duloxetine for diabetic peripheral neuropathy in usual care.

OBJECTIVE: To evaluate treatment patterns and costs among patients with painful diabetic peripheral neuropathy (pDPN) newly prescribed pregabalin or duloxetine in usual care settings. METHODS: Using the PharMetrics® Database, patients with pDPN (ICD-9-CM codes 357.2 or 250.6x) newly prescribed pregabalin or duloxetine were identified. Patients initiated on duloxetine (n=713; mean age 55.4 ± 9.5 years) were propensity score-matched with patients initiated on pregabalin (n=713; mean age 56.3 ± 9.3 years). Prevalence of comorbidities, pain-related pharmacotherapy and healthcare resource use/costs (pharmacy, outpatient, inpatient, total) were examined during the 12 months preceding (pre-index) and following (follow-up) the date of the first pregabalin or duloxetine prescription. RESULTS: Both cohorts had multiple comorbidities and a substantial pain medication burden. Among pregabalin patients, use of other anticonvulsants (35.6% vs. 24.7%) and tricyclic antidepressants significantly decreased (18.2% vs. 13.7%) and serotonin-norepinephrine reuptake inhibitors (SNRIs) increased (7.9 % vs. 12.9%) in the follow-up period; all P values <0.05. Among duloxetine patients, use of other SNRIs (8.7% vs. 5.2%) and selective serotonin reuptake inhibitors decreased significantly (32.1% vs. 18.9%) in the follow-up period, but there were increases for anticonvulsants (42.1% vs. 48.4%), benzodiazepines (25.5% vs. 32%), and sedative/hypnotics (22.6% vs. 25.8%); all P values <0.05. Among pregabalin and duloxetine patients there were increases (P<0.05) in pharmacy, outpatient, and total healthcare costs from the pre-index to the follow-up period. Total medication costs in the follow-up period were significantly higher for duloxetine (median $6,763 [IQR $3,970-$10,914]) relative to pregabalin (median $6,059 [IQR $3,277-$9,865]); P=0.0017. CONCLUSIONS: Patients with pDPN prescribed pregabalin and duloxetine were characterized by a substantial comorbidity and pain medication burden. Although there were no differences in total healthcare costs, medication costs were significantly higher in the duloxetine cohort relative to the pregabalin cohort.

Clinical characteristics, pharmacotherapy, and healthcare resource use among patients with diabetic neuropathy newly prescribed pregabalin or gabapentin.

OBJECTIVE: To characterize comorbidities, pain-related pharmacotherapy, and healthcare resource use among patients with painful diabetic peripheral neuropathy (pDPN) newly prescribed pregabalin or gabapentin in clinical practice. METHODS: Using the LifeLink(™) Health Plan Claims Database, patients with pDPN (ICD-9-CM codes 357.2 or 250.6) newly prescribed (index event) gabapentin (n = 1,178; 56.9 ± 10.3 years old) were identified and propensity score-matched with patients initiated on pregabalin (n = 1,178; 56.4 ± 9.8 years old). Comorbidities, pain-related pharmacotherapy, and healthcare resource use/costs were examined during the 12-month pre-index and follow-up periods. RESULTS: Both cohorts were characterized by multiple comorbidities and substantial use of pain-related and adjunctive medications. In the pregabalin cohort, the use of tricyclic antidepressants significantly decreased (16.0% vs. 13.2%) and nonsteroidal anti-inflammatory drugs (30.8% vs. 34.8%), muscle relaxants (19.2% vs. 22.9%), anticonvulsants (14.4% vs. 18.1%), benzodiazepines (22.3% vs. 25.0%), and topical agents (7.0% vs. 9.8%) increased (P < 0.05) in the follow-up period. In the gabapentin cohort, there were significant increases (P < 0.05) in the use of short-acting (55.4% vs. 61.2%) and long-acting (9.4% to 12.8%) opioids, serotonin-norepinephrine re-uptake inhibitors (14.2% vs. 16.7%), anticonvulsants (7.1% vs. 19.2%), benzodiazepines (19.1% vs. 24.3%), sedative/hypnotics (14.9% vs. 18.0%), and tramadol (13.3% vs. 16.8%). There were significant increases (P < 0.05) in pharmacy, outpatient, and total costs in both cohorts and in costs of physician office visits in the gabapentin cohort. There was no difference in postindex median total costs between the pregabalin and gabapentin cohorts ($16,137 vs. $15,766). CONCLUSIONS: Patients with pDPN prescribed pregabalin and gabapentin had a substantial comorbidity and pain medication burden. Although healthcare costs increased in both groups, the increase in pain medication burden was higher in the gabapentin group. Direct medical costs were similar for both groups. Given the human and economic burden of pDPN, future research may benefit from a focus on efficacy parameters to further differentiate treatment options.

Comparison of antigen- and RT-PCR-based testing strategies for detection of SARS-CoV-2 in two high-exposure settings.

Surveillance testing for infectious disease is an important tool to combat disease transmission at the population level. During the SARS-CoV-2 pandemic, RT-PCR tests have been considered the gold standard due to their high sensitivity and specificity. However, RT-PCR tests for SARS-CoV-2 have been shown to return positive results when performed to individuals who are past the infectious stage of the disease. Meanwhile, antigen-based tests are often treated as a less accurate substitute for RT-PCR, however, new evidence suggests they may better reflect infectiousness. Consequently, the two test types may each be most optimally deployed in different settings. Here, we present an epidemiological model with surveillance testing and coordinated isolation in two congregate living settings (a nursing home and a university dormitory system) that considers test metrics with respect to viral culture, a proxy for infectiousness. Simulations show that antigen-based surveillance testing coupled with isolation greatly reduces disease burden and carries a lower economic cost than RT-PCR-based strategies. Antigen and RT-PCR tests perform different functions toward the goal of reducing infectious disease burden and should be used accordingly.

Evaluation of the impact of fibromyalgia on patients' sleep and the content validity of two sleep scales.

BACKGROUND: Disturbed sleep is commonly reported in fibromyalgia (FM). Both the Sleep Quality Numeric Rating Scale (NRS) and the Medical Outcomes Study Sleep Scale (MOS-Sleep) have demonstrated positive psychometric properties in patients with FM. However, these assessments were developed prior to the current recommendation to include patient input during the concept elicitation or item generation phases. Therefore, the objective of this study was to evaluate the impact of FM on participants, including their sleep, and to test the content validity of these two sleep measures in FM patients. METHODS: Qualitative interviews were conducted in Raleigh, North Carolina and Detroit, Michigan with 20 adults who reported a physician diagnosis of FM. Sixteen participants were female, 13 were white, and the average age was 50 years. Two researchers conducted all interviews using a structured guide. RESULTS: Participants consistently reported that FM had a debilitating impact on their lives and their sleep, particularly getting to sleep and staying asleep. Participants responded positively to the Sleep Quality NRS as an assessment of their sleep. The majority of participants stated that they would not change the response numbering or wording of the item's anchors. Participants also responded positively to the 24-hour recall period of the Sleep Quality NRS. Participants found the 12-item MOS-Sleep to be appropriate and relevant; 19 participants indicated the measure captured all of their sleep-related symptoms. However, areas for potential modification were identified, such as the need to separate the item regarding awakening short of breath and awakening with a headache into two separate questions. Participants also questioned the relevance of the snoring and awakening short of breath items to FM. Half of participants expressed a preference for a daily rather than a weekly recall period. CONCLUSION: This study demonstrates the significant impact that FM has on patients' lives, particularly sleep. While patients with FM were not part of the development of the generic sleep assessments that were evaluated, this study provides evidence of their content validity, supporting their use in FM studies. Modifications to the MOS-Sleep may improve the psychometric properties and relevance to patients with FM.

Lipohypertrophy in China: Prevalence, Risk Factors, Insulin Consumption, and Clinical Impact.

BACKGROUND: Lipohypertrophy (LH) is a complication of insulin therapy. We assessed LH prevalence, risk factors, insulin usage, and clinical and health economic effects in China. METHODS: In four cities, 401 adult patients injecting insulin ≥1 year were surveyed for diabetes/insulin injection history and practices, pen needle reimbursement (PNR), and health resource utilization, followed by structured examination and HbA1c testing. Differences between those with and without LH were evaluated by Student's t-test or the Wilcoxon rank sum test. Insulin costs were calculated. RESULTS: Patients were 59.6 ± 11.5 years old; 50% male; 93.5% type 2 diabetes. LH prevalence was 53.1%. Compared to those without LH, patients with LH had higher body mass index (BMI; 26 vs. 24.8 kg/m2) and HbA1c (8.2% vs. 7.7% [66 vs. 61 mmol/mol]), took 11 IU (0.13 IU/kg or 31.7%) more insulin costing $1.4 versus $1.0 (RMB 9.5 vs. 6.8) daily, reused PNs more times, and had less PNR (all P ≤ 0.003). LH patients correctly rotated injection sites less often (67.6% vs. 92.3%, P < 0.0001). By stepwise logistic regression, BMI, needle reuse frequency, and PNR remained modestly associated with LH prevalence (odds ratios [OR] <1.9; P ≤ 0.03); weight-adjusted insulin dose and incorrect site rotation showed ORs of nearly 7 and 8.4, respectively (P ≤ 0.001). Extrapolated to 9 million insulin-injecting patients in China and adjusted for therapy adherence, LH-related excess annual insulin consumption cost is estimated at nearly $297 million (RMB 2 billion). CONCLUSIONS: LH is common in China and associated with worse glycemic control, despite nearly one-third greater insulin consumption, with large cost implications. Proper injection technique education may reduce LH prevalence.

Medication usage, treatment intensification, and medical cost in patients with type 2 diabetes: a retrospective database study.

OBJECTIVE: The goal of this study was to describe medication usage patterns in patients with type 2 diabetes mellitus (T2DM) initiating treatment with non-insulin antidiabetic drugs (NIADs), basal insulin, or prandial/mixed insulin using real-world data. RESEARCH DESIGN AND METHODS: A retrospective analysis using the Truven Health MarketScan Research Databases was conducted to identify adults (≥18 years) with T2DM from 2006 to 2012. Patients were categorized into four cohorts based on diabetes treatment. Cohort 1 (n=597 664) consisted of newly diagnosed patients who did not receive any treatment, cohort 2 (n=342 511) included NIAD initiators, cohort 3 (n=99 578) included basal insulin initiators, and cohort 4 (n=62 876) included prandial/mixed insulin initiators. Patients transitioned out of a cohort once they met the criteria for the next one. RESULTS: Patients in cohort 2 were younger (56.2 years, SD±12.1) than patients in cohorts 1, 3, and 4 (58 years, SD±0.75). Metformin was the most commonly prescribed drug in cohort 2 patients. Basal insulin usage decreased from 71% in year 1 to 47% in year 4, in cohort 3 patients. Approximately one-third of these patients switched to prandial/mixed insulin each year. In cohort 4, the usage of prandial/mixed insulin decreased to 61% by year 4. Use of basal insulin and NIAD remained common in this group. Mean glycosylated hemoglobin (HbA1c) values decreased by ∼1% for each of the treatment cohorts following treatment initiation and remained stable during follow-up. All-cause and diabetes-related medical costs were highest for patients in cohorts 3 and 4. CONCLUSIONS: Overall, our findings demonstrate that treatment intensification was low in all study cohorts despite elevated HbA1c levels during preindex and follow-up period.

Adherence to Insulin Pen Therapy Is Associated with Reduction in Healthcare Costs Among Patients with Type 2 Diabetes Mellitus.

BACKGROUND: Type 2 diabetes mellitus is a chronic metabolic disorder that poses a significant economic burden on the US healthcare system associated with direct and indirect medical costs, loss of productivity, and premature mortality. OBJECTIVES: To determine whether increased adherence to therapy among patients with type 2 diabetes who use an insulin pen is associated with reduced healthcare costs, and to describe the overall healthcare costs of patients with type 2 diabetes. METHODS: This retrospective claims database analysis used the Truven Health MarketScan Commercial and Medicare Supplemental databases to identify patients diagnosed with type 2 diabetes with at least 1 insulin pen prescription claim between January 2006 and September 2010. Insulin pen adherence was measured using the medication possession ratio (MPR). The cost outcomes included all-cause and type 2 diabetes-related costs by type of service (ie, inpatient, outpatient medical, outpatient pharmacy), which were calculated in 2011 US dollars. Insulin adherence and overall healthcare costs were evaluated over the 12-month postindex period. RESULTS: A total of 32,361 patients met the study inclusion criteria, with an average MPR of 0.63 (standard deviation [SD], 0.29). Overall, patients with type 2 diabetes who used an insulin pen had an average annual healthcare cost of $19,612, which was driven by inpatient costs (37.2%) and outpatient pharmacy costs (24.4%). There is a significant difference in the average annual per-patient healthcare expenditures between the least adherent group (MPR <0.20; 11.0% of patients) and the most adherent group (MPR >0.80; 34.6% of patients) $26,310 versus $23,839, respectively (P = .007). Patients with the greatest insulin adherence had higher overall pharmacy costs than patients with the lowest insulin adherence ($10,174 vs $5395, respectively; P <.001). CONCLUSIONS: The total healthcare expenditures of patients with type 2 diabetes who utilized insulin pens decreased with improvement in adherence, suggesting that higher rates of medication adherence may present an opportunity to curb healthcare costs in insulin pen users. The average sample MPR for our study population was 0.63 (SD, 0.29), indicating that insulin adherence continues to be a challenge for successful diabetes management. More research is needed to better characterize the relationship between medication adherence and healthcare costs among insulin users with type 2 diabetes and to identify the key drivers of adherence among this patient group.

Bazedoxifene/conjugated estrogens for managing the burden of estrogen deficiency symptoms.

The bothersome vasomotor and vaginal symptoms and bone loss that accompany the menopausal transition are associated with significant direct costs due to physician visits and medication, as well as indirect costs from reduced health-related quality of life (HRQoL) and work productivity. With life expectancies increasing, the number of postmenopausal women is also increasing, and more women are remaining in the workforce. These factors have led to an increased burden of menopausal symptoms on healthcare systems. Hormone therapy (HT) has been shown to effectively reduce menopausal symptoms and significantly increase quality-adjusted life years in postmenopausal women, particularly in women experiencing severe symptoms. However, many women discontinue use of HT before their symptoms have dissipated due to safety and tolerability concerns. The tissue selective estrogen complex (TSEC) that pairs bazedoxifene (BZA) with conjugated estrogens (CE) has been developed to provide relief of menopausal symptoms and prevent bone loss without stimulating the breast or endometrium, and to have improved tolerability compared with HT. In this context, BZA 20mg/CE 0.45 and 0.625 mg were shown to prevent bone loss and effectively treat menopausal symptoms in postmenopausal women with an intact uterus, while also demonstrating a favorable safety/tolerability profile. BZA 20mg/CE 0.45 and 0.625 mg were further associated with clinically significant improvements in HRQoL, sleep, and treatment satisfaction. Taken together, the reduction in menopausal symptoms, improvement in HRQoL, and favorable safety/tolerability profile associated with BZA/CE suggest that it is a cost-effective alternative to HT for managing the burden of menopausal symptoms.

Evaluation of the fibromyalgia diagnostic screen in clinical practice.

RATIONALE, AIMS AND OBJECTIVES: Fibromyalgia (FM) is challenging to diagnose, especially in primary care settings. The Fibromyalgia Diagnostic Screen was developed to facilitate the diagnosis of FM in clinical practice. The objectives of this study were to assess the performance of the Fibromyalgia Diagnostic Screen in primary care and specialty clinics, using the 1990 American College of Rheumatology (ACR) diagnostic criteria as the gold standard, and comparing the Fibromyalgia Diagnostic Screen with the London Fibromyalgia Epidemiology Study Screening Questionnaire (LFESSQ) and the modified 2010 ACR Fibromyalgia Diagnostic Criteria (ACR-FDC). METHODS: This multicenter, cross-sectional study included 150 adult chronic pain patients who underwent a physician-administered structured history and physical exam and completed the Fibromyalgia Diagnostic Screen, the LFESSQ and the modified ACR-FDC. The analyses determined the predictive ability of the Fibromyalgia Diagnostic Screen for FM. RESULTS: Item-level analyses provided support for the response categories and predictive ability of most of the Fibromyalgia Diagnostic Screen items. Additionally, the evaluation of the Fibromyalgia Diagnostic Screen scoring models demonstrated the greatest accuracy in predicting an FM diagnosis with a combination of patient items and clinician items that included an abbreviated tender point exam (sensitivity 0.68, specificity, 0.82). Sensitivity of the modified ACR-FDC and the LFESSQ was 0.87 and 0.86, respectively, with specificity 0.62 and 0.49, respectively. CONCLUSIONS: The Fibromyalgia Diagnostic Screen is a useful new clinical tool to aid in the evaluation of FM in clinical practice.

The costs associated with sleep symptoms among patients with fibromyalgia.

AIMS: To assess the costs associated with sleep symptoms among patients with fibromyalgia (FM). PATIENTS & METHODS: Patients reporting physician-diagnosed FM from the National Health and Wellness Survey were categorized into three groups based on the number of sleep symptoms reported: two or more sleep symptoms (n = 1353), one sleep symptom (n = 574) and no sleep symptoms (n = 269). Annual direct and indirect costs were compared among the groups controlling for relevant confounders. RESULTS: After adjusting for demographic and health characteristics, patients with FM with one, two or more sleep symptoms had higher annual physician costs (US$12,328 and US$12,261, respectively) and higher annual emergency room visit costs (US$846 and US$729, respectively) than patients with FM without any sleep symptoms (physician visit costs: US$9845; emergency room visit costs: US$527; all p < 0.05). Similarly, both patients with one (US$18,100) and two or more sleep symptoms (US$18,428) reported higher total indirect costs compared with those without any sleep symptoms (US$14,711; p < 0.05). CONCLUSIONS: Among the FM population, sleep symptoms were prevalent and associated with higher direct and indirect costs, suggesting improved management may have long-term cost savings.

Estimating the economic benefits of positive shifts in fibromyalgia severity: an exploratory analysis based on modeling of clinical trial data of pregabalin.

OBJECTIVE: To estimate the annualized differences in direct medical and indirect costs associated with improvement in fibromyalgia (FM) severity among pregabalin-treated patients. METHODS: Data from three clinical trials of pregabalin in patients with FM were modeled; efficacy results were extrapolated. Mean annual costs (direct and indirect) were assigned based on FM severity levels (mild: $10,219; moderate: $26,217; severe: $42,456). FM severity levels were defined using established cut-points on the Fibromyalgia Impact Questionnaire (FIQ). Mean annualized costs at end-point were estimated for all patients within each cohort and the mean differences in costs were compared using a regression model. RESULTS: Relative to placebo, there was a significantly higher proportion of subjects with mild FM at end-point with pregabalin 450 mg and a significantly lower proportion of subjects with severe FM. Mean total costs were lower with pregabalin (300 mg, $25,721; 450 mg, $24,103) than placebo ($26,162). The difference in mean annual costs was $2059 lower for pregabalin 450 mg (p = 0.003) and $441 lower for pregabalin 300 mg (p = 0.52). Mean direct medical costs were higher with pregabalin (300 mg, $4962; 450 mg, $4820) than placebo ($4364). The difference in mean annual direct medical costs was significantly higher for pregabalin 450 mg by $456 (p < 0.0001) and by $599 for pregabalin 300 mg (p < 0.0001). Mean indirect costs for pregabalin (300 mg, $20,783; 450 mg, $19,306) were lower than placebo ($21,735). The difference in mean annual indirect costs for pregabalin 450 mg was lower by $2429 (p < 0.0001); pregabalin 300 mg was lower by $951 (p = 0.12). LIMITATIONS: Use of 13-week end-point data from clinical trials to extrapolate to annual costs and an assumption of continuous therapy over the course of 1 year. CONCLUSIONS: Improvements in FM severity were associated with overall reductions in cost. Reductions in indirect costs may offset the costs of treatment with pregabalin.

Burden of vasomotor symptoms in France, Germany, Italy, Spain, and the United Kingdom.

BACKGROUND: Several studies have documented a significant association between vasomotor symptoms (VMS) and a decrement in health outcomes among postmenopausal women, but these studies have mostly focused on the US. The aim of the current study was to broaden this investigation by examining the burden of VMS symptoms in the European Union with respect to both humanistic and economic outcomes. METHODS: All women aged 40-75 years who completed the 2010 5EU (France, Germany, Italy, Spain, and the UK) National Health and Wellness Survey were identified as potential respondents and invited to participate in an additional cross-sectional, Internet-based survey. Only postmenopausal women from 5EU were included in the current analyses (n = 3801). VMS was assessed using the Menopausal Rating Scale, and was used in multiple regression models as the primary predictor of health status (EQ-5D-3L), work productivity loss, and the number of physician visits due to menopause. RESULTS: Over half (50.3%) of postmenopausal women experienced either mild (24.6%), moderate (17.6%), or severe (8.1%) VMS. Controlling for confounding variables, mild (b = -0.03, P < 0.05), moderate (b = -0.07, P < 0.05), and severe VMS (b = -0.17, P < 0.05) were each associated with worse health utilities relative to women without VMS. Similarly, increased resource use (b = 1.04-2.39, all P < 0.05), overall work impairment (b = 8.71-19.69, all P < 0.05), and activity impairment (b = 11.22-24.54, all P < 0.05) were also observed as VMS severity increased (with each b representing the difference between each level of severity and the reference category). CONCLUSION: These results suggest a high prevalence of VMS in Western Europe. These symptoms are also associated with both humanistic and economic outcomes. Improved management of VMS may be able to increase the health status and ability to work productively as well as reduce societal direct costs.

Health-resource use and costs associated with fibromyalgia in France, Germany, and the United States.

BACKGROUND: Fibromyalgia (FM) is a chronic disorder characterized by widespread, persistent pain. Prospective and retrospective studies have demonstrated substantial health-care costs associated with FM in a number of countries. This study evaluated and compared health-resource use (HRU) and associated costs related to FM in routine clinical practice across the US, France, and Germany. METHODS: Two separate, cross-sectional, observational studies of subjects with FM were conducted: one in the US and one in France and Germany. HRU related to prescription medication, physician office visits, diagnostic tests, and hospitalizations was abstracted from chart review; patient out-of-pocket costs and lost productivity were collected via subject self-report. Costs were assigned to HRU based on standard algorithms. Direct and indirect costs were evaluated and compared by simple linear regression. RESULTS: A total of 442 subjects (203 US, 70 France, 169 Germany) with FM were analyzed. The mean (standard deviation) age in the US, France, and Germany was 47.9 (10.9), 51.2 (9.5), and 49.2 (9.8), respectively (P = 0.085). Most subjects were female (95% US, 83% France, 80% Germany) (P < 0.001). Adjusted annual direct costs per subject for FM were significantly higher in the US ($7087) than in France ($481, P < 0.001) or Germany ($2417, P < 0.001). Adjusted mean annual indirect costs per subject for FM were lower in the US ($6431) than in France ($8718) or Germany ($10,001), but represented a significant proportion of total costs in all countries. CONCLUSION: The significant HRU and costs associated with FM in the US, France, and Germany documented in this study highlight the substantial global economic burden of FM. Indirect costs represented a significant proportion of the total costs, particularly in Europe. Comparisons between the three countries show differences in HRU, with significantly higher direct costs in the US compared with France and Germany.