Cost-effectiveness analysis of onabotulinumtoxinA (BOTOX(®)) for the management of urinary incontinence in adults with neurogenic detrusor overactivity: a UK perspective.

OBJECTIVES: To evaluate the cost effectiveness of onabotulinumtoxinA (BOTOX(®), 200 units [200 U]) for the management of urinary incontinence (UI) in adults with neurogenic detrusor overactivity (NDO) due to subcervical spinal cord injury or multiple sclerosis that is not adequately managed with anticholinergic drugs (ACHDs). PERSPECTIVE: UK National Health Service (NHS) perspective. METHODS: A Markov state-transition model was developed, which compared onabotulinumtoxinA + best supportive care (BSC) with BSC alone (comprising behavioural therapy and pads, alone or in combination with clean intermittent catheterization and possibly with ACHDs). Non-responders were eligible for invasive procedures. Health states were defined according to the reduction in UI episodes. Efficacy data and estimates of resource utilization were pooled from 468 patients on onabotulinumtoxinA in two phase III clinical trials. Drug costs (2013) and administration costs (NHS Reference Costs 2011-2012) were obtained from published sources. The time horizon of the model was 5 years, and costs and benefits were discounted at 3.5%. Scenario, one-way and probabilistic sensitivity analyses (PSAs) were conducted to explore uncertainties around the assumptions. RESULTS: In the base case, treatment with onabotulinumtoxinA + BSC over 5 years was associated with an increase in costs of £1,689 and an increase in quality-adjusted life-years (QALYs) of 0.4, compared with BSC alone, resulting in an incremental cost-effectiveness ratio of £3,850 per QALY gained. Sensitivity analyses showed that utility values had the greatest influence on model results. PSA suggests that onabotulinumtoxinA + BSC had a 100 % probability of being cost effective at a willingness to pay of <£20,000. CONCLUSION: For adult patients with NDO who are not adequately managed with ACHDs, onabotulinumtoxinA + BSC appears to be a cost-effective use of resources in the UK NHS.

The use of immediate postoperative instillations of intravesical chemotherapy after TURBT of NMIBC among European countries.

PURPOSE: The aim of this study was to assess the use of immediate postoperative instillation of intravesical chemotherapy (IPOIC) after transurethral resection of bladder tumour (TURBT) of nonmuscle invasive bladder cancer (NMIBC) in Europe. METHODS: Urologists based in five European Union nations were asked to extract information from the records of patients with NMIBC-urothelial carcinoma who received at least one TURBT. Multivariate logistic regression models were developed to determine the significant predictors of IPOIC usage. Data were weighted to control for country-to-country and other differences. RESULTS: Overall, 324 urologists (58 France, 72 Germany, 62 Italy, 65 Spain, 67 United Kingdom) were involved; the participation rate was 55 %. Overall, 771 patients received 954 TURBTs (mean-1.2/patient), of which 413 of the TURBTs (43.3 %) were administered IPOIC . Sixty-six of the 413 IPOICs (16.0 %) were for a recurrent tumour. Five of the tested variables were significantly associated with a patient's likelihood of receiving IPOIC after TURBT. Variables in the order of significance are as follows: (1) country (United Kingdom, patients most likely to receive IPOIC; France, least likely); (2) progression risk (physician assessed) [lower-risk conditions (no CIS, tumour < 3 cm) or intermediate risk-more likely]; (3) whether urologist completed a uro-oncology fellowship (completed-more likely); (4) recurrence risk (physician assessed) [higher-risk conditions (≥T2, ≥3 cm, CIS)-more likely]; and (5) physician's NMIBC patients volume (higher volume-more likely). CONCLUSIONS: This study revealed wide practice variation and substantial noncompliance with European Association of Urology Guidelines on the use of IPOIC after TURBT for NMIBC.

Long-term patterns of use and treatment failure with anticholinergic agents for overactive bladder.

BACKGROUND: Overactive bladder (OAB) involves a complex set of symptoms with a lifetime prevalence of any symptom in ~30% of women and 20% of men. Anticholinergic agents are associated with poor medication persistence in OAB treatment. OBJECTIVE: This study evaluated the long-term patterns of use and treatment failure in patients prescribed anticholinergic agents for OAB. METHODS: This was a nonexperimental, retrospective cohort study. Medical, pharmacy, and eligibility data from the IMS LifeLink Health Plans Claims Database were used. Men and women aged ≥18 years were eligible for inclusion with an International Classification of Diseases, Ninth Revision, Clinical Modification, diagnosis of OAB in any field during the patient study period from January 2005 to June 2010. First documentation of a prescription filled between July 2005 and June 2008 for an anticholinergic agent was defined as the index prescription. Other inclusion criteria were: ≥1 pharmacy claim for an anticholinergic drug between July 2005 and June 2008; continuous enrollment 6 months before the index date, during which no anticholinergic drugs were filled; and 24 months of follow-up from the index prescription. Study outcomes were treatment failure, discontinuation, switch, reinitiation, and adherence. Treatment failure was defined as having a treatment discontinuation (ie, treatment gap of ≥45 days) or switching anticholinergic therapy. RESULTS: The analytic cohort comprised 103,250 patients with a mean age of 58.7 years. A majority were female (73%) and privately insured (75%). The vast majority of patients (91.7%) failed to meet their treatment goals with their index anticholinergic agent over the 24-month follow-up period. Of these, 5.8% switched, 51.3% permanently discontinued all anticholinergic agents, and 34.6% reinitiated treatment sometime after 45 days. The mean (SD) time to treatment failure was 159 (216.0) days, with a mean of 1.3 (0.5) unique anticholinergic agents per patient. Forty-eight percent of patients demonstrated appropriate adherence as determined by a medication possession ratio ≥80%. CONCLUSIONS: This study provides real-world data on treatment patterns over 2 years in a large cohort of patients diagnosed with OAB. Despite the potential for better adherence with some anticholinergic agents, these analyses suggest that such benefits have not yet been realized, and many patients end up without effective pharmacotherapy. Thus, there is a need for new therapies and strategies to increase persistence and adherence to improve outcomes in OAB.

Records linkage of electronic databases for the assessment of adverse effects of antiretroviral therapy in sub-Saharan Africa.

PURPOSE: In 2009, the Ministry of Health and Social Services in Namibia decided to conduct a confirmatory assessment of the risk of anemia associated with zidovudine (AZT)-based highly active antiretroviral therapy (HAART) using records contained in three electronic databases. These records did not share a unique identifying number. The first step was to apply probabilistic record linkage methods to link records in the three databases. METHODS: Records of persons, aged 19-65 years, newly initiated on HAART between January 2007 and June 2008, were selected from a pharmacy electronic dispensing tool (EDT) and linked to an electronic medical records database (ePMS) and a laboratory database (MEDITECH). Using the paper-based clinical record as the gold standard, we measured the sensitivity of the starting HAART regimen, that is, proportion of AZT users in the clinical record correctly identified in electronic record, and specificity of severe anemia, that is, proportion of non-cases of severe anemia in the clinical records correctly identified in the electronic record. Kappa and intraclass correlation coefficients were used to determine reliability. RESULTS: A total of 12 358 records were selected from EDT. Seventy-six percent and 58% of EDT records were linked to ePMS and MEDITECH, respectively. The sensitivity of the starting HAART regimen was 98%, whereas specificity of severe anemia was 100%. The reliability scores for variables including weight, hemoglobin, and CD4 counts were moderate to perfect and ranged from 0.59 to 0.99. CONCLUSION: Probabilistic record linkage methods were effective for records linkage in this sub-Saharan African setting.

Genital ulcer disease treatment policies and access to acyclovir in eight sub-Saharan African countries.

BACKGROUND: Herpes simplex virus-2, the most common cause of genital ulcer disease (GUD) globally, is a cofactor in human immunodeficiency virus type-1 (HIV-1) acquisition and transmission. Current World Health Organization guidelines for sexually transmitted infections recommend acyclovir as first-line syndromic treatment of GUD in countries with high herpes simplex virus-2 prevalence (> or =30%). OBJECTIVE: To assess the extent of adoption of acyclovir as syndromic treatment for GUD, and describe procurement, distribution, and cost of acyclovir in the public and private sectors of 8 sub-Saharan African countries. METHODS: We conducted standardized interviews with Ministry of Health (MoH) officials, pharmacists, and other pharmacy workers based in the public and private sectors. Interviews were conducted in Botswana, Kenya, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe. Price comparisons were conducted using the 2007 median international reference price (IRP) for acyclovir. RESULTS: Of the 8 African countries, 4 surveyed had adopted acyclovir as first-line syndromic GUD treatment in both their essential medical lists and sexually transmitted infection guidelines. Country-specific acquisition prices for acyclovir 200 mg were comparable to the median IRP and ranged from 0.74 to 1.95 times the median IRP. The median retail cost of acyclovir in the private sector ranged from 5.85 to 9.76 times the median IRP. Public health facilities faced cost and regulatory barriers that impeded the requisitioning of acyclovir from the central medical stores. CONCLUSIONS: Systems for drug procurement, distribution, and access in sub-Saharan African countries need strengthening for a GUD treatment policy using acyclovir to be effective.