The Drug Burden Index and Level of Frailty as Determinants of Healthcare Costs in a Cohort of Older Frail Adults in New Zealand.

OBJECTIVES: Frailty is common in older people and is associated with increased use of healthcare services and ongoing use of multiple medications. This study provides insights into the healthcare cost structure of a frail group of older adults in Aotearoa, New Zealand. Furthermore, we investigated the relationship between participants' anticholinergic and sedative medication burden and their total healthcare costs to explore the viability of deprescribing interventions within this cohort. METHODS: Healthcare cost analysis was conducted using data collected during a randomized controlled trial within a frail, older cohort. The collected information included participant demographics, medications used, frailty, cost of service use of aged residential care and outpatient hospital services, hospital admissions, and dispensed medications. RESULTS: Data from 338 study participants recruited between 25 September 2018 and 30 October 2020 with a mean age of 80 years were analyzed. The total cost of healthcare per participant ranged from New Zealand $15 (US dollar $10) to New Zealand $270 681 (US dollar $175 943) over 6 months postrecruitment into the study. Four individuals accounted for 26% of this cohort's total healthcare cost. We found frailty to be associated with increased healthcare costs, whereas the drug burden was only associated with increased pharmaceutical costs, not overall healthcare costs. CONCLUSIONS: With no relationship found between a patient's anticholinergic and sedative medication burden and their total healthcare costs, more research is required to understand how and where to unlock healthcare cost savings within frail, older populations.

National Patterns of Filled Prescriptions and Third-Line Treatment Utilization for Privately Insured Women With Overactive Bladder.

OBJECTIVE: The aim of this study was to evaluate national patterns of care for women with overactive bladder (OAB) in an administrative data set and identify potential areas for improvement. METHODS: We performed an analysis using the OptumLabs Data Warehouse, which contains deidentified administrative claims data from a large national US health insurance plan. The study included women, older than 18 years, with a new OAB diagnosis from January 1, 2007, to June 30, 2017. We excluded those with an underlying neurologic etiology, with interstitial cystitis/painful bladder syndrome, were pregnant, or did not have continuous enrollment for 12 months before and after OAB diagnosis. Trends in management were assessed via the Cochran-Armitage test. Time to discontinuation among medications was compared using t test. RESULTS: Of 1.4 million women in the database during the study time frame, 60,246 (4%) were included in the study. Median age was 61 years [interquartile range (IQR), 50-73], and median follow-up was 2.6 years (IQR, 1.6-4.2). Overall, 37% were treated with anticholinergics, 5% with beta-3 agonists, 7% with topical estrogen, and 2% with pelvic floor physical therapy; 26% saw a specialist; and 2% underwent third-line therapy. Median time to cessation of prescription filling was longer for beta-3 agonists versus anticholinergics [median, 4.1 months (IQR, 1-15) vs 3.6 months (IQR, 1-10); P < 0.0001]. Use of third-line therapies significantly increased over the study time frame, from 1.1% to 2.2% (P < 0.0001). CONCLUSIONS: Most of the patients do not continue filling prescriptions for OAB medications, and a minority of patients were referred for specialty evaluation. Although third-line therapy use is increasing, it is used in a small proportion of women with OAB. Given these patterns, there may be underutilization of specialist referral and other OAB therapies.

Cost-Effectiveness Analysis of Anticholinergics Versus Botox for Urgency Urinary Incontinence: Results From the Anticholinergic Versus Botox Comparison Randomized Trial.

OBJECTIVES: This study aimed to compare the cost-effectiveness of Botox and anticholinergic (AC) medications for the management of urgency urinary incontinence (UUI). METHODS: Cost and effectiveness data were analyzed from participants in the Anticholinergic versus Botox Comparison randomized trial of daily AC medication versus 100 U of intradetrusor Botox injection. Societal costs included the following: treatment costs, patient costs, and medical and nonmedical utilization during the 6-month trial. Quality-adjusted life-years (QALYs) were calculated based on questionnaire-derived utility measures and annualized based on data collected at baseline through 6 months. We also estimated the average direct costs for each treatment through 9 months - the duration of time when approximately half the Botox participants maintained adequate symptom control. RESULTS: Data were analyzed on the 231 women who completed a 6-month follow-up in the Anticholinergic versus Botox Comparison trial (119 AC and 112 Botox). The mean reduction in UUI episodes per day was not significantly different per group. The cumulative mean direct costs through the first 6 months also were similar: $1339 for the AC group and $1266 for the Botox group with AC costs exceeding Botox costs after 5 months. Both groups had considerable QALY gains. Annualizing the 6-month trial results to a 12-month measure, the AC and Botox groups averaged 0.702 and 0.707 QALYs, respectively. Estimates through 9 months favored Botox, showing that AC participants incurred a higher cost per month of adequate symptoms control ($305) compared with Botox participants ($207). CONCLUSIONS: Botox and AC medications have similar costs and effectiveness in the first 6 months of UUI treatment. If costs and outcomes are considered through 9 months, Botox may have significantly lower costs but similar UUI symptom control as AC.

A US database study characterizing patients initiating a budesonide-formoterol combination versus tiotropium bromide as initial maintenance therapy for chronic obstructive pulmonary disease.

OBJECTIVE: To compare clinical and demographic characteristics, resource utilization and costs of chronic obstructive pulmonary disease (COPD) patients prior to initiating budesonide-formoterol combination (BFC) or tiotropium-maintenance therapy. MATERIALS AND METHODS: This cross-sectional study used claims-based diagnosis to identify COPD patients in the HealthCore Integrated Research Database who initiated BFC or tiotropium therapy between March 1, 2009 and January 31, 2012 (intake period); the index date was defined as the initial prescription fill for either agent. Patients diagnosed with respiratory tract cancer or receiving inhaled corticosteroids/long-acting ß2-adrenergic agonists or tiotropium in 12 months prior to index date were excluded. Categorical variables were evaluated with χ(2) tests; mean cost differences were evaluated using γ-regression. RESULTS: Overall, 6,940 BFC and 10,831 tiotropium patients were identified. The BFC group was younger (mean age 64 versus 67 years), with a greater proportion of females (54% versus 51%). BFC-treated patients had more comorbid respiratory conditions, including asthma (25% versus 13%), but fewer comorbid cardiovascular conditions, including atherosclerosis (7% versus 10%) and myocardial infarction (4% versus 6%). A greater proportion of BFC patients received prior respiratory medication, including oral corticosteroids (46% versus 35%) and short-acting ß2-agonists (44% versus 35%). Tiotropium-treated patients had a greater mean number of COPD-related outpatient visits (4.6 versus 4.1). BFC-treated patients had lower total all-cause ($17,259 versus $17,926) and COPD-related ($1,718 versus $1,930) health care costs, driven by lower all-cause and COPD-related inpatient expenditures. CONCLUSION: Initiators of BFC or tiotropium showed differences in clinical and demographic characteristics and health care utilization and costs prior to starting COPD maintenance therapy.

Reducing inappropriate, anticholinergic and psychotropic drugs among older residents in assisted living facilities: study protocol for a randomized controlled trial.

BACKGROUND: Use of inappropriate drugs is common among institutionalized older people. Rigorous trials investigating the effect of the education of staff in institutionalized settings on the harm related to older people's drug treatment are still scarce. The aim of this trial is to investigate whether training professionals in assisted living facilities reduces the use of inappropriate drugs among residents and has an effect on residents' quality of life and use of health services. METHODS AND DESIGN: During years 2011 and 2012, a sample of residents in assisted living facilities in Helsinki (approximately 212) will be recruited, having offered to participate in a trial aiming to reduce their harmful drugs. Their wards will be randomized into two arms: one, those in which staff will be trained in two half-day sessions, including case studies to identify inappropriate, anticholinergic and psychotropic drugs among their residents, and two, a control group with usual care procedures and delayed training. The intervention wards will have an appointed nurse who will be responsible for taking care of the medication of the residents on her ward, and taking any problems to the consulting doctor, who will be responsible for the overall care of the patient. The trial will last for twelve months, the assessment time points will be zero, six and twelve months. The primary outcomes will be the proportion of persons using inappropriate, anticholinergic, or more than two psychotropic drugs, and the change in the mean number of inappropriate, anticholinergic and psychotropic drugs among residents. Secondary endpoints will be, for example, the change in the mean number of drugs, the proportion of residents having significant drug-drug interactions, residents' health-related quality of life (HRQOL) according to the 15D instrument, cognition according to verbal fluency and clock-drawing tests and the use and cost of health services, especially hospitalizations. DISCUSSION: To our knowledge, this is the first large-scale randomized trial exploring whether relatively light intervention, that is, staff training, will have an effect on reducing harmful drugs and improving QOL among institutionalized older people. TRIAL REGISTRATION: ACTRN12611001078943.

Anticholinergic drugs for adult neurogenic detrusor overactivity: a systematic review and meta-analysis.

CONTEXT: There is a lack of evidence about the efficacy and safety of anticholinergic drugs and about the optimal anticholinergic drug, if any, for the treatment of adult neurogenic detrusor overactivity (NDO). OBJECTIVE: Review the current evidence on the efficacy, safety, and tolerability of anticholinergic drugs in the treatment of adult NDO. EVIDENCE ACQUISITION: A literature search was conducted from 1966 to May 2011. Meta-analysis of all published randomised controlled trials (RCTs) comparing anticholinergic drugs with placebo and comparing different types, doses, and routes of administration of anticholinergic drugs, in adults with NDO, was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. The primary outcome was patient-reported cure/improvement of overactive bladder symptoms. Secondary outcomes were quality of life (QoL) changes, bladder diary events, urodynamic outcomes, adverse events, and costs to health services. EVIDENCE SYNTHESIS: A total of 960 patients from 16 RCTs with mean follow-up of 3.8 wk were included. Anticholinergic drugs were associated with statistically significantly better patient-reported cure/improvement (risk ratio: 2.80; 95% confidence interval [CI], 1.64 to 4.77), higher maximum cystometric capacity (weighted mean difference [WMD]: 49.49; 95% CI, 15.38 to 84.20), higher volume at first contraction (WMD: 49.92; 95% CI, 20.06 to 79.78), and lower maximum detrusor pressure (WMD: -38.30; 95% CI, -53.17 to -23.43) when compared with placebo. The dry-mouth rates were statistically significantly higher with anticholinergics, with no difference in withdrawals because of adverse events. There was no statistically significant difference in any of the outcomes between oxybutynin and other anticholinergics or among different doses and preparations of anticholinergic drugs. No study reported QoL changes or costs to health services. CONCLUSIONS: Compared with placebo, anticholinergic treatment in patients with NDO is associated with better patient-reported cure/improvement and significant reduction of maximum detrusor pressure; however, there is a higher incidence of adverse events. None of the anticholinergic drugs or different dosages assessed in this review was superior to another.

Effects of prescription coinsurance and income-based deductibles on net health plan spending for older users of inhaled medications.

BACKGROUND: Health plans that increase prescription cost-sharing for their patients may increase overall plan costs. We analyzed the impact on health plan spending of a switch in public drug insurance from full coverage to a prescription copayment (copay), and then to income-based deductibles plus coinsurance (IBD). METHODS: We studied British Columbia residents 65 years of age or older who were dispensed inhaled steroids, beta2 agonists or anticholinergics on or after January 1996. Multivariable linear regression was used to estimate health plan costs for the population using inhalers by the Ministry of Health (MOH) during the copay and IBD policies. We estimated costs for excess physician visits and emergency hospitalizations based on data from a previously published cohort study and cost data from the MOH. We estimated the net change in MOH spending as the sum of changes in spending for inhalers, physician visits, hospitalizations, and policy administration costs. RESULTS: Net health plan spending increased by C$1.98 million per year during the copay policy [95% confidence interval (CI): 0.10-4.34], and C$5.76 million per year during the first 10 months of the IBD policy (95% CI: 1.75-10.58). Out-of-pocket spending by older patients increased 30% during the copay policy (95% CI: 24-36) and 59% during the IBD policy (95% CI: 56-63). CONCLUSIONS: British Columbia's experience indicates that cost containment focused on cost-shifting to patients may increase net expenditures for the treatment of some diseases. Health plans should consult experts to anticipate the potential cross-program impacts of policy changes.

Electromotive drug-administration: a pilot study for minimal-invasive treatment of therapy-resistant idiopathic detrusor overactivity.

INTRODUCTION: Electromotive drug-administration (EMDA) represents a minimal-invasive method of intravesical instillation of therapeutic agents. We examined the therapeutic effect of EMDA in patients suffering from therapy-resistant idiopathic detrusor overactivity (IDO) with respect to urodynamics, micturition charts and quality of life (Kings Health Questionnaire). METHODS: Patients suffering from urge syndrome with and without urge incontinence and non-responding to oral anticholinergic drugs underwent EMDA therapy (2000 mg lidocaine-HCl 4% (50 ml), 2 mg epinephrine [1:1000] (2 ml), 40 mg dexamethason-21-dihydrogen phosphat (10 ml) in a total volume of 100 ml). Over a 27 months period, 84 patients (median age 63.1 years; 72 female, 12 male) with urge syndrome and urodynamically-proven idiopathic detrusor overactivity (IDO) were treated with EMDA. Following urodynamic measurements, quality of life (QoL) was evaluated using Kings Health Questionnaire (KHQ) and a micturition chart over 48 h, EMDA was performed once in four weeks for a period of three months. Patients continued to document drinking and micturition data during this time. Before each EMDA session urodynamic examination and KHQ were repeated. RESULTS: All treated patients suffered from urge syndrome (25.6% OAB wet, 20.0% OAB dry and 54.4% mixed urinary incontinence). Mean daytime frequency (DF) was 14.1 +/- 7.7 per day and nocturia (N) 5.1 +/- 5.1 per night before EMDA. After two EMDA sessions, daytime frequency (DF) decreased to 9.4 +/- 6.2 per day (P < 0.0001) and 2.5 +/- 2.4 per night (P = 0.035). The use of pads could be lowered from 4.5 +/- 4.1 per 24 h to 1.8 +/- 2.4 (P < 0.0074). The first desire to void volume (FDV) assessed by urodynamics started at 94.0 +/- 60.5 ml before treatment and changed to 142.2 +/- 79.6 ml (P = 0.0064) after two sessions. Strong desire to void volume (SDV) was noticed at 155.6 +/- 84.8 ml filling of the bladder; after two EMDA sessions at 199.5 +/- 97.3 ml (P = 0.001). Uninhibited detrusor contractions (UIC) were seen in all patients before treatment and were reduced to 46.4% after two EMDA sessions (P < 0.001). Maximal cystometric bladder capacity (MCBC) increased from 192.3 +/- 106.6 ml to 239.6 +/- 114.9 ml (P = 0.018). Patient-documented bladder capacity (BC) as micturition volume increased from 186.0 +/- 108.7 ml to 234.2 +/- 134.2 ml (P = 0.043). A reduction of impact of Quality of Life (QoL) was observed from 11.8 +/- 0.4 to 7.0 +/- 0.3 (P < 0.001) during treatment. A fraction of 53.6% (45/84) of all patients reported a completely withdrawal of symptoms and 28.6% (24/84) indicated a remarkable reduction. Only 10.7% (9/84) of patients did not continue therapy after two sessions. CONCLUSION: EMDA significantly improves urodynamic parameters, QoL and pad usages in patients with urge syndrome and therapy-resistant IDO. Therefore we offer EMDA therapy as an alternative treatment modality to the standard approaches.

Characteristics of chronic obstructive pulmonary disease in Spain from a gender perspective.

BACKGROUND: The objective of this study was to analyze the clinical and management characteristics of chronic obstructive pulmonary disease (COPD) in men and women, to determine possible gender-associated differences between the two groups of patients. METHODS: An observational and descriptive epidemiological study (EPIDEPOC study). The study included patients with stable COPD and aged >or= 40 years, evaluated in primary care. Data were collected relating to sociodemographic variables, clinical characteristics, quality of life (SF-12), severity of disease and treatment. The results obtained in men and women were compared. RESULTS: A total of 10,711 patients (75.6% males and 24.4% females) were evaluated. Significant differences were found between males and females in relation to the following parameters: age (67.4 +/- 9.2 years in men vs 66.1 +/- 10.8 in women, p < 0.05), smoking (91.9% of the men were smokers or ex-smokers vs 30% of the women), comorbidity (the frequency of hypertension, diabetes, anxiety and depression was greater in women, while ischemic heart disease was more common in men), mental component of quality of life (49.4 +/- 10.3 in men vs 44.6 +/- 11.9 in women, p < 0.05) and severity of disease (56.5 +/- 13.3% in men vs 60.7 +/- 3.2 in women, p < 0.05). As regards treatment, the percentage use of long-acting b2-adrenergic agonists, anticholinergic agents, theophyllines and mucolytic agents was significant greater in men. The total annual cost of COPD was greater in males than in females (1989.20 +/- 2364.47 euro vs 1724.53 +/- 2106.90, p < 0.05). CONCLUSION: The women with COPD evaluated in this study were younger, smoked less and have more comorbidity, a poorer quality of life, and lesser disease severity than men with COPD. However, they generated a lesser total annual cost of COPD than men.

Impact of two sequential drug cost-sharing policies on the use of inhaled medications in older patients with chronic obstructive pulmonary disease or asthma.

BACKGROUND: Evaluations of drug cost-sharing policies within the same population are needed for a fair comparison of different options. OBJECTIVE: The aim of this work was to analyze the impact of 2 changes in a public drug insurance plan on the use of inhaled medications in British Columbia (BC), Canada. METHODS: Data for the period from 1997 to 2004 were used to assess whether changes in the use of steroid, beta2-agonist, and anticholinergic inhalers were associated with insurance-plan changes in a large, natural experiment involving all BC residents aged>or=65 years. The 3 sequential policies included full coverage, fixed copayments at the beginning of 2002, and 25% coinsurance with an income-based deductible beginning May 1, 2003. Linkable prescription, physician billing, hospitalization, and mortality records were obtained from the BC Ministry of Health Services. From the total population of residents aged>or=65 years, we extracted data for all patients to whom inhaled steroids, beta2-agonists, or anticholinergics were dispensed on or after January 1, 1997. Multivariable linear regression was used to estimate inhaler use during a 60-month baseline period and during implementation of the subsequent copayment and coinsurance plus deductible policies. We used logistic regression to identify predictors of initiation and cessation use of inhaled medications among older patients. RESULTS: Use declined for inhaled steroids (-12.3%; P<0.001), inhaled anticholinergics (-12.2%; P<0.001), and inhaled beta2-agonists (-5.8%; P<0.001). Patients with new diagnoses of asthma or chronic obstructive pulmonary disease were 25% (95% CI, 14%-31%) less likely to initiate treatment with inhaled steroids when covered by the copayment or coinsurance plus deductible policies than when they had full coverage. Chronic users of inhaled steroids were 47% (95% CI, 40%-55%) more likely to cease treatment when they were covered by the copayment policy and 22% (95% CI, 15%-29%) more likely to cease when covered by the coinsurance plus deductible policy than when they had full coverage. CONCLUSIONS: The copayment and coinsurance plus deductible policies were associated with significant reductions in use of inhaled medications, mostly due to decreased initiation and increased cessation rates. However, the consequences of these policies on health outcomes have not yet been determined.