Dutasteride plus tamsulosin fixed-dose combination first-line therapy versus tamsulosin monotherapy in the treatment of benign prostatic hyperplasia: a budget impact analysis in the Greek healthcare setting.

BACKGROUND: The purpose of this study was to explore the budget impact of dutasteride plus tamsulosin fixed-dose combination (DUT + TAM FDC) versus tamsulosin monotherapy, in the treatment of patients with benign prostatic hyperplasia (BPH) from the perspective of the Greek healthcare insurance system. METHODS: A Microsoft Excel-based model was developed to estimate the financial consequences of adopting DUT + TAM FDC within the Greek healthcare setting. The model, compared six mutually exclusive health states in two alternative treatment options: current standard of care and the introduction of DUT + TAM FDC in the market. The model used clinical inputs from the CombAT study; data on resource use associated with the management of BPH in Greece were derived from expert panel, and unit cost data were derived from official reimbursement tariffs. A payer perspective was taken into account. As patient distribution data between public and private sectors are not available in Greece two scenarios were investigated, considering the whole eligible population in each scenario. A 4 year time horizon was taken into account and included treatment costs, number of transurethral resections of the prostate (TURPs) and acute urinary retention (AUR) episodes avoided. RESULTS: The clinical benefit from the market adoption of DUT + TAM FDC in Greece was 1,758 TURPs and 972 episodes of AUR avoided cumulatively in a four year period. The increase in total costs from the gradual introduction of DUT + TAM FDC to the Greek healthcare system ranges from €1.3 million in the first year to €5.8 million in the fourth year, for the public sector, and €1.2 million to €4.0 million, for the private sector. This represents an increase of 1.91% to 7.94% for the public sector and 1.10% 3.29% in the private sector, during the 4-year time horizon. CONCLUSIONS: Budget impact analysis (BIA) results indicated that the gradual introduction of DUT + TAM FDC, would increase the overall budget of the disease, however providing better clinical outcomes. DUT + TAM FDC drug acquisition cost is partly offset by the reduction in the costs associated with the treatment of the disease.

Cost-effectiveness of 13-valent pneumococcal conjugate vaccine: Germany, Greece, and The Netherlands.

BACKGROUND: Seven-valent pneumococcal conjugate vaccine (PCV7) had profound public-health impacts and is considered cost-effective and potentially cost saving. Two new PCVs have been launched, a 10-valent vaccine (PCV10) and a 13-valent vaccine (PCV13). We examined public-health and economic impacts of PCV pediatric national immunization programs (NIPs) in Germany, Greece, and the Netherlands. METHODS: A decision-analytic model was developed to estimate the impact of PCV13, PCV7, and 10-valent pneumococcal conjugate vaccine (PCV10) on invasive pneumococcal disease (IPD), pneumonia (PNE), and acute otitis media (AOM). Using epidemiological data, we calculated the cases of IPD, PNE, and AOM, using country-specific incidence, serotype coverage, disease sequelae, mortality, vaccine effectiveness, indirect effects, costs, and utilities. Direct effects for PCV13- and PCV10-covered serotypes were assumed similar to PCV7. PCV13 was assumed to confer an indirect effect, while PCV10 was not. Assumptions were tested in sensitivity analyses. RESULTS: In a NIP, PCV13 was estimated to eliminate 31.7%, 46.4%, and 33.8% of IPD in Germany, Greece, and the Netherlands, respectively. Compared with PCV7 and PCV10, PCV13 was found to be cost-effective or cost saving in all cases when PCV13 indirect effects were included. CONCLUSIONS: Pediatric NIPs with PCV13 in Europe are expected to have dramatic public-health impacts and be cost-effective or cost saving.

Costs and effects of paliperidone extended release compared with alternative oral antipsychotic agents in patients with schizophrenia in Greece: a cost effectiveness study.

BACKGROUND: To compare the costs and effects of paliperidone extended release (ER), a new pharmaceutical treatment for the management of schizophrenia, with the most frequently prescribed oral treatments in Greece (namely risperidone, olanzapine, quetiapine, aripiprazole and ziprasidone) over a 1-year time period. METHODS: A decision tree was developed and tailored to the specific circumstances of the Greek healthcare system. Therapeutic effectiveness was defined as the annual number of stable days and the clinical data was collected from international clinical trials and published sources. The study population was patients who suffer from schizophrenia with acute exacerbation. During a consensus panel of 10 psychiatrists and 6 health economists, data were collected on the clinical practice and medical resource utilisation. Unit costs were derived from public sources and official reimbursement tariffs. For the comparators official retail prices were used. Since a price had not yet been granted for paliperidone ER at the time of the study, the conservative assumption of including the average of the highest targeted European prices was used, overestimating the price of paliperidone ER in Greece. The study was conducted from the perspective of the National Healthcare System. RESULTS: The data indicate that paliperidone ER might offer an increased number of stable days (272.5 compared to 272.2 for olanzapine, 265.5 f risperidone, 260.7 for quetiapine, 260.5 for ziprasidone and 258.6 for aripiprazole) with a lower cost compared to the other therapies examined (euro 7,030 compared to euro 7,034 for olanzapine, euro 7,082 for risperidone, euro 8,321 for quetiapine, euro 7,713 for ziprasidone and euro 7,807 for aripiprazole). During the sensitivity analysis, a +/- 10% change in the duration and frequency of relapses and the economic parameters did not lead to significant changes in the results. CONCLUSION: Treatment with paliperidone ER can lead to lower total cost and higher number of stable days in most of the cases examined.

Medical resource utilisation and cost of care for women seeking treatment for urinary incontinence in an outpatient setting. Examples from three countries participating in the PURE study.

OBJECTIVE: To describe the medical resource use and direct costs of treatment for women with urinary incontinence (UI) in European countries. DESIGN: PURE is a non-interventional, observational study of patients seeking treatment for UI in an outpatient setting. SETTING: Investigators being either general practitioners (GPs) and/or specialists, i.e. urologists and gynaecologists, in 14 European countries participated in PURE. The results for medical resource use and cost of treatment in Germany, Spain and the UK/Ireland recorded retrospectively at the enrolment visit for the preceding 12 months are presented here. SUBJECTS: Treatment-seeking women aged over 18 years who were under treatment or seeking treatment for UI, and who presented within the normal course of care for UI were enrolled in the 6 months study. MEASUREMENTS: Information on the incontinence resource use was gathered on standard data collection forms. The direct medical costs were calculated by attaching the unit costs from the perspective of the relevant health insurance in each country to the country-specific resource use. Furthermore, the contribution of patients to the costs of pads, or any treatment for UI was assessed. RESULTS: Variation in medical resource use and cost of treatment between the three countries was observed, reflective of the differences in the healthcare systems and whether specialists and/or GPs provided the care. We found that women in Spain and Germany are more likely to have consulted a specialist for their UI symptoms, which had implications for utilisation of diagnostic procedures. Conservative treatment, particularly pelvis floor muscle exercises, was more common in patients in the UK/Ireland treated in primary care by GPs. In all three countries most of the women had used protective pads, which more than half the patients paying for them out-of-pocket, despite potential healthcare reimbursement schemes. Mean total UI-related costs per year ranged from 359 in the UK/Ireland for patients predominantly treated in the GP setting to 515 in Germany and 655 in Spain for patients treated by specialists and GPs. CONCLUSIONS: Our study provides an estimation of resource use and costs associated with UI in treatment-seeking European women, exemplified here in three countries.

A description of health care provision and access to treatment for women with urinary incontinence in Europe -- a five-country comparison.

BACKGROUND: Female urinary incontinence is a prevalent condition, but only about one-third of women seek treatment. OBJECTIVES: To describe the health care provision for women with urinary incontinence from a European perspective, selecting France, Germany, Spain, Sweden, and the United Kingdom as examples, and to investigate whether specific barriers for treatment exist. METHODS: Available health care system information, a literature review and clinical expert information identified patterns of treatment provision. RESULTS: In Spain, Sweden, and the UK, access to medical care in general is primarily through the general practitioners. However, in Spain and Sweden, women with urinary incontinence can directly visit specialists. In France and Germany, women have equal access to either general practitioners or specialists. Aside from general practitioners, gynaecologists play a major role in urinary incontinence care in all countries except the UK. In Germany, urologists are also involved in initial female urinary incontinence care; however, only in about 16% of women. There are no waiting lists in France and Germany for appointments with physicians or procedures, contrary to Spain, which has long waiting lists. Access to general practitioners in the UK is unrestricted whereas advanced diagnosis and treatment in secondary care requires long waits. A specific Swedish policy mandates that no woman is required to wait longer than 3 months for incontinence visits and related surgery. In Sweden and the UK, specialist nurses and other health care workers provide incontinence services. Almost all treatment options for urinary incontinence are at least in part reimbursed. However, various co-payments and fees in France, Germany, Spain and Sweden exist and constitute out-of-pocket expenses for women if no complementary additional private health insurance is available. In some countries, financial incentives for physicians to provide incontinence services are low, raising concerns about their interest to engage in continued patient care. CONCLUSIONS: Information about service provision in Europe for women with urinary incontinence is limited and makes it difficult to understand barriers to treatment seeking. A broad European perspective may promote optimised treatment access in the future for this widespread and under-recognised condition.

Patient-reported impact of urinary incontinence--results from treatment seeking women in 14 European countries.

OBJECTIVES: To describe the patient-reported impact of urinary incontinence (UI) in treatment-seeking women in Europe. DESIGN: PURE was a non-interventional, observational study, which aimed to describe the direct costs of treatment for European women seeking treatment for UI. A secondary study objective was to describe the impact of UI on health-related quality of life (HRQoL) by UI subtype and severity of disease. This paper presents the results from quality of life assessments as well as bothersomeness and interference with daily activities from the first study observation. SUBJECTS: Nine thousand four hundred and eighty-seven European women who had UI symptoms in the last 12 months were enrolled. Their UI symptoms were frequently those defined as mixed urinary incontinence (MUI) and were moderate to severe in nature. MEASUREMENTS: HRQoL was assessed at the first observation using the urinary Incontinence-specific Quality of Life Questionnaire (I-QOL) and the EQ-5D, a generic quality of life questionnaire. Data collected from EQ-5D provided insight into the patients' general health perception, while the I-QOL data indicated how affected the women were about their UI symptoms. Higher EQ-5D and I-QOL scores represent better quality of life. Patients were asked to indicate how much UI symptoms limited selected activities and to indicate the degree to which they found their symptoms to be bothersome. RESULTS: Overall, the median self-rated health status on the EQ-5D visual analogue scale (VAS) was 70.0 and the median EQ-5D health state index was 0.85, with small but noticeable differences observed between countries. Of the five health dimensions of the EQ-5D, patients' self-care appeared to be the least affected by UI, with fewer than 10% of the women reporting that they had some problems. Between 20 and 40% of patients had some problems with their mobility and usual activities, or had pain/discomfort or anxiety/depression. However, the impact of existing co-morbidity was not assessed and may have affected some women's scoring of the EQ-5D domains. The mean total I-QOL score overall was 57.7 and of the three subscales of the I-QOL, psychosocial impact had the highest overall scores, representing fewer problems, with lower scores observed for the avoidance and limiting behaviour subscale, and even lower scores for the social embarrassment subscale. The greatest patient-reported impact of UI symptoms on activities was on exercise, with more than 45% of patients moderately to totally limited in this activity. In most of the countries, more than 60% of the women reported that they were moderately to extremely bothered by their UI symptoms. CONCLUSIONS: There was considerable impact of UI on HRQoL in a treatment seeking population, as demonstrated by the disease-specific quality of life scale and by the high percentage of patients who were bothered by their symptoms.

Characteristics of female outpatients with urinary incontinence participating in a 6-month observational study in 14 European countries.

OBJECTIVE: To describe the characteristics of women seeking treatment for symptoms of urinary incontinence (UI) in European countries. DESIGN: Prospective urinary incontinence research (PURE) was a 6-month, observational, pan-European study, primarily aimed at determining the direct costs of urinary incontinence treatment. The secondary objectives of PURE were to describe the impact of UI on health-related quality of life (HRQoL) in treatment seeking patients and to illustrate the treatment patterns for UI in Europe. SETTING: One thousand and Fifty-five physicians from 14 European countries, including general practitioners (GPs), gynaecologists, urologists and geriatricians, observed women seeking treatment for their UI and recorded data at the first observation and then prospectively at 3 and 6 months after the first observation during the normal course of therapy. SUBJECTS: Women of at least 18 years of age who had experienced urinary leakage in the 12 months prior to enrolment in the study, who were seeking treatment or under treatment for UI and who presented within the normal course of UI care were included in the 6 months study. The first observation characteristics of the patients are described here. METHODS: Demographic characteristics, as well as disease and treatment status at first observation were explored using descriptive summary statistics to gain an understanding of the population studied. RESULTS: In total, 9487 women took part in PURE, with the largest patient groups from Germany, Spain and the UK/Ireland. The majority of women were post-menopausal and had a mean age of 60.7 years, were not current smokers and tended to be overweight (BMI > 25.0). Overall, mixed UI symptoms were more common than SUI and UUI, as defined by clinical opinion (SUI 38%, MUI 42% and UUI 18%), and by a two-item questionnaire, the S/UIQ (SUI 29%, MUI 58% and UUI 13%). Around half of the patients (48%) suffered from their symptoms for less than 2 years before consulting a physician; 28% delayed seeking treatment for 3-5 years, with 13% waiting for 6-10 years and the remaining 11% waiting for 11 or more years. CONCLUSIONS: Some of the described patients' characteristics may provide important information to clinicians to enable them to take a more active approach to case-finding, which will ultimately benefit the incontinent patient.

Assessment of bothersomeness and impact on quality of life of urinary incontinence in women in France, Germany, Spain and the UK.

OBJECTIVE: To assess the bothersomeness and impact on quality of life (QoL) of urinary incontinence in community-dwelling women in France, Germany, Spain and the UK. SUBJECTS AND METHODS: A detailed follow-up questionnaire was mailed to 2960 randomly-selected women who had reported symptoms of urinary incontinence in an earlier survey of 29,500 representative households in four European countries. In the second questionnaire, women were asked about the severity of their symptoms, the impact of urinary incontinence on their QoL, and how bothersome their incontinence was. RESULTS: A total of 1573 women responded to the follow-up questionnaire, of which >80% reported that their urinary incontinence symptoms were bothersome. The greatest negative effect appeared to be on physical activities, confidence, self-perception and social activities, with a statistically significant correlation between an increase in bothersomeness and an increase in severity of symptoms. Similarly, a negative impact on QoL was associated with an increase in severity of incontinence. The variables: country, urinary incontinence type, severity, age, number of medical conditions and number of leakages had a statistically significant influence on the bother and the validated incontinence QoL (I-QoL) questionnaire scores. CONCLUSION: The extent to which women are bothered by their urinary incontinence and report that their symptoms have a negative impact on their QoL is largely subjective. In determining the most appropriate management, physicians should consider the experience of being incontinent as unique to each individual.

EMEA and the evaluation of health-related quality of life data in the drug regulatory process.

OBJECTIVES: This study reviewed the European guidelines of the Committee for Proprietary Medicinal Products (CPMP) on how health-related quality of life (HRQOL) research should be conducted in clinical trials. Published product-level information was also reviewed to investigate the actual role of HRQOL data in the European regulatory process. METHODS: All disease-specific notes for guidance and concept papers on clinical investigations, development and evaluation of human medicinal products, as well as the European Public Assessment Reports (EPAR) of all approved drugs published on the European Agency for the Evaluation of Medicinal Products (EMEA) Web site were evaluated for their HRQOL recommendations. RESULTS: Only twenty of the fifty CPMP guidance notes for clinical investigation of pharmaceutical products in specific disease areas included a reference to HRQOL. Most of the recommendations were generic and vague, and the terminology used was inconsistent across documents. The EPAR provided nonspecific information about HRQOL and contradictory conclusions on the effect of a drug on HRQOL sometimes occurred in different documents. The criteria used by the CPMP to assess the HRQOL data could not be identified due to an ad hoc approach to the inclusion of data in the EPAR. CONCLUSIONS: A more systematic approach is needed on the way health outcomes data are considered, reviewed, and interpreted by the regulatory authorities. For this to be achieved, CPMP should develop general guidelines on the importance of HRQOL and how research should be conducted if data are to be included in the registration process.