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1.
J Eval Clin Pract ; 2020 Jan 31.
Artigo em Inglês | MEDLINE | ID: mdl-32003511

RESUMO

OBJECTIVES: Doctor shopping, double doctoring, and overlapping prescriptions are often used as synonyms for multiple physician appointments in the same disease episode. Such behaviours translate into poor patient satisfaction and patient-doctor communication as well as abuse or misuse of drugs, increasing health care costs and resulting in negative health consequences. This systematic review of the literature was conducted to identify factors that drive doctor-shopping behaviour in children's caregivers. METHODS: The search was conducted in PubMed and grey literature and was based on the following search terms: included doctor or physician shopping, drug seeking, double doctoring, children, and combinations of those. Overall, 500 records were identified, of which 11 were selected for qualitative synthesis. Data extracted considered definitions of doctor shopping, co-morbidities, and target population characteristics. RESULTS: Definitions of doctor shopping were inconsistent. The frequency of doctor shopping was high for acute illnesses and ranged from 53% in children with a fever in Hong Kong to 18% at an emergency department in Canada. The incidence of this phenomenon was low when taking into account addictive drugs and was rated at 0.02% to 0.3% in the full paediatric population. This phenomenon was more prevalent in children younger than 1 year, in children with attention-deficit hyperactivity disorder (ADHD) and co-morbid psychiatric conditions, and in those whose caregivers themselves had psychiatric conditions. It was more frequent in cases with an acute disease (eg, fever, gastroenteritis, and urinary tract infection) than a chronic disease (eg, asthma). CONCLUSIONS: The knowledge about doctor shopping by children's caregivers is limited, despite that this is a frequent behaviour. There is a need for further research covering a broader range of diseases. The causes and consequences of doctor shopping should be sought as well to investigate its relation to health care regulations and possibility to reduce unnecessary medical resource utilization.

2.
PLoS One ; 15(1): e0225301, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31978044

RESUMO

OBJECTIVE: The objective was to assess the real-world cost-effectiveness of rivaroxaban, versus vitamin K antagonists (VKAs), for stroke prevention in patients with atrial fibrillation (AF) from a French national health insurance perspective. METHODS: A Markov model was developed with a lifetime horizon and cycle length of 3 months. All inputs were drawn from real-world evidence (RWE) studies: data on baseline patient characteristics at model entry were obtained from a French RWE study, clinical event rates as well as persistence rates for the VKA treatment arm were estimated from a variety of RWE studies, and a meta-analysis provided comparative effectiveness for rivaroxaban compared to VKA. Model outcomes included costs (drug costs, clinical event costs, and VKA monitoring costs), quality-adjusted life-years (QALY) and life-years (LY) gained, incremental cost per QALY, and incremental cost per LY. Sensitivity analyses were performed to test the robustness of the model and to better understand the results drivers. RESULTS: In the base-case analysis, the incremental total cost was €714 and the total incremental QALYs and LYs were 0.12 and 0.16, respectively. The resulting incremental cost/QALY and incremental cost/LY were €6,006 and €4,586, respectively. The results were more sensitive to the inclusion of treatment-specific utility decrements and clinical event rates. CONCLUSIONS: Although there is no official willingness-to-pay threshold in France, these results suggest that rivaroxaban is likely to be cost-effective compared to VKA in French patients with AF from a national insurance perspective.

3.
J Mark Access Health Policy ; 7(1): 1667195, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31595183

RESUMO

Objectives: We aimed to conduct a modelling study to estimate and predict the economic burden of AD to support the healthcare management of AD in China. Methods: The economic burden of AD was estimated with an evaluation of the prevalence of AD patients and a simulation of annual resource use and cost per AD patient in China using a published model. Percentage of AD patients being treated was assumed to be 5% from 2010 to 2050, with three scenarios testing the value of this parameter of 10%, 20% and 40% throughout 2020 to 2050. Results: The costs of AD were estimated to be from around 91 billion RMB in 2010 to 332 billion in 2050. Most of the current burden was related to private caregivers paid by families. With the percentage of patients being treated changing from 5% to 40%, costs were estimated to double. This was related to more hospitalisations and more use of care facilities, while the burden for families would decrease. Conclusion: A high economic burden related to AD is predicted. The burden would be driven mainly by indirect costs related to the social support of the patients. Investment in improving awareness and care of AD patients is needed and worth it.

4.
J Mark Access Health Policy ; 7(1): 1648973, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31489150

RESUMO

Background and Objectives: Utility elicitation studies for schizophrenia generate different utility values for the same health states. We reviewed utility values used in schizophrenia pharmacoeconomic evaluations and evaluated the impact of their selection on the incremental cost-effectiveness ratio (ICER). Methods: A systematic search was performed in Medline and Embase. Health state definitions, associated utility values, elicitation studies, and value selection processes were extracted. Sets of utility values for all schizophrenia health states were used in a cost-effectiveness model to evaluate the ICER. Results: Thirty-five cost-utility analyses (CUAs) referring to 11 utility elicitation studies were included. The most frequent health states were 'stable' (28 CUAs, 7 utility elicitation studies, 10 values, value range 0.650-0.919), 'relapse requiring hospitalisation' (18, 5, 7, 0.270-0.604), 'relapse not requiring hospitalisation' (18, 5, 10, 0.460-0.762), and 'relapse only' (10, 5, 6, 0.498-0.700). Seventeen sets of utility values were identified with difference in utility values between relapse and stable ranging from -0.358 to -0.050, resulting in ICERs ranging from -56.2% to +222.6% from average. Conclusion: The use of utility values for schizophrenia health states differs among CUAs and impacts on the ICER. More rigorous and transparent use of utility values and sensitivity analysis with different sets of utility values are suggested for future CUAs.

5.
J Mark Access Health Policy ; 7(1): 1650596, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31489151

RESUMO

Background: The Trump administration's 'American Patients First' blueprint proposes to reduce drug prices in the USA by increasing drug prices abroad, ex USA. The possibility of the Trump administration to raise drug prices ex USA through legal action via the WTO and bilateral negotiations with foreign trade partners was reviewed. Methods: A literature review was conducted through PUBMED, EMBASE, Media and grey literature to consolidate publications of the Trump administrations' policies and strategies towards foreign countries and drug prices. Results: The Trump administration has withdrawn from and halted major multilateral agreements including the TPP, Paris Agreement, TTIP, UNESCO, NAFTA (now USMCA), and NATO. The Trump administration has been successful in bilateral negotiations for pharmaceuticals' pricing, as seen with Japan, South Korea, Germany, and Mexico and Canada. Conclusion: The objective of raising prices abroad is attainable. Action through the WTO is unlikely, due to its nondiscriminatory principle. Bilateral trade negotiation have proven more promising. In this bilateral framework, financial security and military protection are strong assets for the USA to levy higher drug prices abroad. Although raising drug prices ex USA is possible, further questions as to whether this will directly translate into lower drug prices for American patients are raised.

6.
BMC Infect Dis ; 19(1): 655, 2019 Jul 23.
Artigo em Inglês | MEDLINE | ID: mdl-31337339

RESUMO

BACKGROUND: Although significant improvement in efficacy measured by a sustained virological response, the high acquisition costs of direct-acting antivirals limit the access for patients and influence the costs of healthcare resource utilisation in hepatitis C. It is important to have the latest estimates of prevalence, especially in high-risk groups, for cost of illness, cost-effectiveness and budget impact studies. METHODS: Original studies on the estimates of the prevalence among general and high-risk groups in the European Union/European Economic Area (EU/EEA) were retrieved from Medline and Embase for the period from 2015 to 2018. All included studies were evaluated for risk of selection bias and summarised together in a narrative form. Results from previous reviews and updated searches were compared per country among different populations, respectively. RESULTS: Among the 3871 studies identified, 46 studies were included: 20 studies were used for the estimate of the general population; 3 for men who have sex with men (MSM); 6 for prisoners; and 17 for people who inject drugs (PWID). Compared with the results reported in previous systematic reviews, the updated estimates were lower than previously in most available countries. Anti-HCV general population prevalence estimates ranged from 0.54 to 1.50% by country. The highest prevalence of anti-HCV was found among PWID (range of 7.90-82.00%), followed by prisoners (7.00-41.00%), HIV-positive MSM (1.80-7.10%), HIV-negative MSM (0.20-1.80%), pregnant women (0.10-1.32%) and first-time blood donors (0.03-0.09%). CONCLUSIONS: Our study highlights the heterogeneity in anti-HCV prevalence across different population groups in EU/EEA. The prevalence also varies widely between European countries. There are many countries that are not represented in our results, highlighting the need for the development of robust epidemiological studies.


Assuntos
Hepatite C/epidemiologia , Adulto , Doadores de Sangue/estatística & dados numéricos , Europa (Continente)/epidemiologia , União Europeia , Feminino , Anticorpos Anti-Hepatite C/sangue , Homossexualidade Masculina , Humanos , Masculino , Gravidez , Complicações Infecciosas na Gravidez/epidemiologia , Complicações Infecciosas na Gravidez/virologia , Gestantes , Prevalência , Prisioneiros/estatística & dados numéricos , Minorias Sexuais e de Gênero/estatística & dados numéricos
7.
Curr Med Res Opin ; 35(11): 1867-1872, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31328580

RESUMO

Objective: The aim of this study was to investigate the impact of methodological choices in a meta-analysis of real-world evidence (RWE) comparing three non-vitamin-K antagonist oral anticoagulants with vitamin K antagonists (VKAs) for the treatment of patients with non-valvular atrial fibrillation (NVAF). Methods: The meta-analysis was based on a systematic review of RWE studies enrolling incident and prevalent patients aged ≥18 years with NVAF and receiving either rivaroxaban, dabigatran, apixaban or a VKA. Five different scenarios were considered to explore the impact of the initial meta-analysis assumptions: (1) using studies that involved only incident patients; (2) excluding studies that only reported crude values and did not consider any adjustment; (3) including all studies independently of possible database overlap; (4) using studies with data on different dosages for rivaroxaban and dabigatran; and (5) assigning quality weights to studies to assess quality of reporting. These scenarios were run on three outcomes: ischemic stroke (IS), myocardial infarction (MI) and intracranial hemorrhage (ICH). Results: Across all scenarios, rivaroxaban was associated with significantly lower risks of IS and ICH than VKAs. In most scenarios, dabigatran was associated with significantly lower risks of IS and ICH. In all scenarios, apixaban was associated with a significantly lower risk of ICH. Conclusions: Sensitivity analyses showed the impact of similar assumptions was different depending on the outcome and the drug considered. The development of recommendations and guidelines for the inclusion of RWE in meta-analyses could prove useful in evaluating the effectiveness of health care interventions.

8.
J Mark Access Health Policy ; 7(1): 1618661, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31156762

RESUMO

The importance of understanding the impact of disease and treatment on children's Health-Related Quality of Life (HRQoL) has given rise to an increasing use of child self-report and observer or proxy instruments. In this article, we review the status quo and challenges of HRQoL measurement specific to children under five. A number of HRQoL questionnaires exist for use with children and/or proxies, and both guidelines and reviews have been published on paediatric HRQoL. However, none address the challenges of measurement for children under five, for whom proxy measures should be used. In reality, there is significant heterogeneity in the cut-off age for self-report questionnaires. Recommendations are that proxies should be used for observable concepts, but not for concepts that require interpretation. Some research has been undertaken on dimensions/concepts in paediatric HRQoL questionnaires. However, no HRQoL models have been developed specifically for children, and heterogeneity in questionnaire dimensions underlines that there is no clear grasp of what HRQoL means in paediatric populations. There is a need to carry out research in order to develop theoretical models of HRQoL that are specific to children at different developmental stages, in order to evaluate and support new and existing measures for paediatric HRQoL and their use in clinical practice as well as clinical trials.

9.
Value Health ; 22(6): 661-668, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-31198183

RESUMO

The concept of a reference case, first proposed by the US Panel on Cost-Effectiveness in Health and Medicine, has been used to specify the required methodological features of economic evaluations of healthcare interventions. In the case of gene therapy, there is a difference of opinion on whether a specific methodological reference case is required. The aim of this article was to provide a more detailed analysis of the characteristics of gene therapy and the extent to which these characteristics warrant modifications to the methods suggested in general reference cases for economic evaluation. We argue that a completely new reference case is not required, but propose a tailored checklist that can be used by analysts and decision makers to determine which aspects of economic evaluation should be considered further, given the unique nature of gene therapy.


Assuntos
Tomada de Decisões , Terapia Genética/economia , Análise Custo-Benefício , Terapia Genética/tendências , Humanos , Anos de Vida Ajustados por Qualidade de Vida
10.
J Mark Access Health Policy ; 7(1): 1603538, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31044055

RESUMO

Background: The relative efficacy and safety can vary among drugs over time. Sumatriptan, a first choice drug for acute migraine, can illustrate this phenomenon. Objective: To assess the evolution of the relative efficacy and tolerability of oral sumatriptan against placebo between its approval in 1991 and 2006. Methods: A systematic literature review of randomized controlled trials (RCTs) of adults suffering from acute migraine episodes was performed using Medline. Meta-analyses estimated odds ratios of the occurrence of pain-free at 2 hours and of any adverse event. Results: Out of the 67 RCTs identi.fied, pain-free at 2 hours and adverse events were reported in 25 and 28 studies, respectively. For pain-free, the relative effect of sumatriptan increases considerably over time, despite an increase in the absolute placebo effect. The odds ratio (95% CI) equaled 3.13 (1.67-5.86) around approval (1991-1994) and increased up to 4.14 (3.67-4.67) on the following decade. No specific variation was observed in the relative tolerability effect of sumatriptan over placebo over time. Conclusions: The relative effect of sumatriptan evolved substantially over time. This phenomenon may impact the results of network meta-analysis and indirect comparisons performed to evaluate the potential of a new drug, compared to widely prescribed older drugs.

11.
J Med Econ ; 22(8): 760-765, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30969801

RESUMO

Aims: Non-vitamin K antagonist oral anticoagulants (NOACs) and vitamin K antagonists (VKAs) are used to prevent stroke in patients with atrial fibrillation (AF). This paper aimed to evaluate the clinical efficacy and safety of NOACs when compared to VKAs by calculating the number needed to treat (NNT) at 2 years using incidence rates and hazard ratios (HRs) derived from a meta-analysis of studies conducted in real-world settings. Materials and methods: HRs were sourced from a published systematic literature review and a meta-analysis of real-world evidence on the use of NOACs vs VKAs. Rivaroxaban, dabigatran, and apixaban vs VKAs were investigated. The efficacy outcomes included: a composite of ischaemic stroke and systemic embolism (IS/SE), ischaemic stroke (IS), and all-cause mortality. The safety analysis assessed major bleeding and intracranial haemorrhage (ICH). Results: Superiority of NOACs vs VKAs was observed in 10/15 comparisons. Treating patients with rivaroxaban and dabigatran was associated with a reduced risk of IS and all-cause mortality compared to VKAs, with one death prevented every 22 and 32 patients, respectively, and one IS prevented every 206 and 166 patients, respectively. Rivaroxaban was significantly associated with a reduced risk of IS/SE compared to VKA (NNT: 107). No significant differences were observed between apixaban and VKAs. Dabigatran and apixaban were associated with a reduced risk of major bleeding compared to VKA (NNT: 59 and 38, respectively). No significant difference was observed between rivaroxaban and VKAs regarding major bleeding. Rivaroxaban, dabigatran, and apixaban were significantly associated with a reduced risk of ICH (NNT: 205, 115, and 108, respectively). Limitations: Heterogeneity in definitions of major bleeding across studies. Conclusions: The NNT calculation, when approached and interpreted properly, is a practical measure of the effectiveness of a treatment. The calculation based on HRs showed that NOACs are safe and effective alternatives to VKAs in real life.


Assuntos
Anticoagulantes/administração & dosagem , Anticoagulantes/classificação , Fibrilação Atrial/tratamento farmacológico , Acidente Vascular Cerebral/prevenção & controle , Administração Oral , Anticoagulantes/uso terapêutico , Antitrombinas/uso terapêutico , Embolia/mortalidade , Embolia/prevenção & controle , Inibidores do Fator Xa/uso terapêutico , Humanos , Tamanho da Amostra , Acidente Vascular Cerebral/mortalidade , Vitamina K/antagonistas & inibidores , Varfarina/uso terapêutico
12.
J Mark Access Health Policy ; 7(1): 1595953, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30956784

RESUMO

Objective: Doctor-shopping has significant consequences for patients and payers and can indicate misuse of drugs, polypharmacy, less continuity of care, and increased medical expenses. This study reviewed the literature describing doctor-shoppers in the adult population. Methods: A systematic literature review was performed in PubMed and supplemented by a Google search of grey literature. Overall, 2885 records were identified; 43 papers served as a source of definition of a doctor-shopper, disease, treatment, patient characteristics, patient special needs, country. Results: Definitions of doctor-shopping were heterogeneous. Overall, 40% of studies examined the use of opioids, antidepressants, or psychoactive drugs, while the others focused on chronic or frequent diseases. Most studies were conducted in countries with easy access to healthcare resources (USA, France, Taiwan, Hong Kong). The prevalence of doctor-shopping ranged from 0.5% among opioid users in the USA to 25% of patients registered at general practices in Japan. Comorbidities, active substance abuse, greater distance from healthcare facility, younger age, longer disease and poor patient satisfaction increased doctor-shopping. Conclusions: Knowing the characteristics of doctor-shoppers may help identify such patients and reduce the associated waste of medical resources, but concerns about the misuse of drugs or healthcare resources should not prevent proper disease management.

13.
J Med Econ ; 22(6): 545-553, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30816067

RESUMO

Objectives: Real-world evidence (RWE) may provide good estimates of absolute event probabilities and costs in patients in actual clinical practice, but their use in decision-analytic models poses many challenges. A literature review based on a systematic search was conducted to summarize the limitations of using RWE in decision-analytic modeling reported in the literature, but also to identify existing recommendations about real-world modeling. Methods: A literature search was performed on Medline and Embase databases, as well as relevant websites. No restrictions in language or geographical scope were imposed. Results: A total of 14 references were included. RWE is recognized as a valuable source of data for market access and reimbursement, and as a complement to clinical trial evidence for treatment pathways, resource use, long-term natural history, and effectiveness. The main limitations identified in the literature were: confounding bias, missing data, lack of accurate data related to drug exposure and outcomes, errors during the record-keeping process, protection of private data, and insufficient numbers of patients. Although most submission guidelines recognized the potential biases associated with RWE, guidance on the appropriate methods to deal with these biases, and approaches to review different relevant evidence to inform model development, were scarce. Several initiatives have attempted to provide guidance on the use of RWE in decision-modeling. Conclusions: RWE is likely to be particularly valuable for informing healthcare policy-makers when formulating appropriate treatment pathways, encouraging the optimal allocation of scarce resources, and improving aggregate patient outcomes. However, little guidance is available on the relative merits of using efficacy and/or effectiveness evidence in Health Technology Appraisal submissions. Further research is needed to better understand these methods and their potential applications in a broader range of scenarios and simulation studies, and their impact on economic modeling.


Assuntos
Análise Custo-Benefício/organização & administração , Modelos Econômicos , Avaliação da Tecnologia Biomédica/organização & administração , Viés , Análise Custo-Benefício/normas , Confiabilidade dos Dados , Guias como Assunto , Humanos , Avaliação da Tecnologia Biomédica/normas
14.
Psychol Med ; : 1-9, 2019 Mar 08.
Artigo em Inglês | MEDLINE | ID: mdl-30846005

RESUMO

BACKGROUND: The interaction between positive, negative and depressive symptoms experienced by people with schizophrenia is complex. We used longitudinal data to test the hypothesis that depressive symptoms mediate the links between positive and negative symptoms. METHODS: We analyzed data from the European Schizophrenia Cohort, randomly sampled from outpatient services in France, Germany and the UK (N = 1208). Initial measures were repeated after 6 and 12 months. Depressive symptoms were identified using the Calgary Depression Scale for Schizophrenia (CDSS), while positive and negative symptoms were assessed with the Positive and Negative Syndrome Scale (PANSS). Latent variable structural equation modelling was used to investigate the mediating role of depression assessed at 6 months in relation to the longitudinal association between positive symptoms at baseline and negative symptoms at 12 months. RESULTS: We found longitudinal associations between positive symptoms at baseline and negative symptoms at 12 months, as well as between both of these and CDSS levels at 6 months. However depression did not mediate the longitudinal association between PANSS scores; all the effect was direct. CONCLUSIONS: Our findings are incompatible with a mediating function for depression on the pathway from positive to negative symptoms, at least on this timescale. The role of depression in schizophrenic disorders remains a challenge for categorical and hierarchical diagnostic systems alike. Future research should analyze specific domains of both depressive and negative symptoms (e.g. motivational and hedonic impairments). The clinical management of negative symptoms using antidepressant treatments may need to be reconsidered.

15.
J Mark Access Health Policy ; 7(1): 1579597, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30863516

RESUMO

Background: Drug prices in the United States are the highest in the world, restricting access to the domestic lower income population. President Trump campaigned heavily on promises to reduce drug prices.Methods: A literature review was conducted through PUBMED, EMBASE, Media and grey literature to consolidate and analyze publications addressing President Trump's promises from the campaign trail as well as the shortcomings and achievements of the Trump administration.Results: Major promises ranged from repealing and replacing Obamacare, expanding coverage, allowing cross-state insurance purchasing, and reducing drug prices. Main accomplishments of the Trump administration have been two executive orders (13765 and 13813), the proposition of the American Health Care Act, and the passing of the Tax Cuts and Jobs Act of 2017. The American Patients First blueprint further revealed the administration's strategies for lowering drug prices. The administration has also engaged in unconventional strategies, such as via bilateral leverage directly with trade partners.Conclusion: The Trump administration has not yet been able to fulfill the major campaign promises, primarily the ones requiring legislative and/or administrative action. If enough legislative action is accomplished to implement the Trump administration's promises, the effects on the pharmaceutical industry could be direct, yet minimal, unless Medicare can directly negotiate with manufacturers.

16.
J Mark Access Health Policy ; 7(1): 1564506, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30788086

RESUMO

Background: Little is known about the costs associated with vitamin K antagonist (VKA) treatment in patients with non-valvular atrial fibrillation (NVAF) in France. Objectives: To evaluate monthly per-patient costs attributable to VKA treatment in NVAF patients from a French societal perspective. Study design: Retrospective data were obtained from 7 international normalised ratio (INR) monitoring centres in France. Patients older than 18 years of age with NVAF treated with VKA were recruited. Additional patient-level data assessing resource use corresponding with VKA treatment were collected via self-completed questionnaires. Unit costs applicable to 2015 were multiplied by resource use and summed to generate VKA treatment costs. Results: 363 patients were included; 53% were men. The majority of patients received fluindione (72%). The number of INR tests per patient per month was 1.69 (95% CI, 1.59-1.80). The monthly patient cost was €39.72 (€36.23-43.21) from the French societal perspective. Direct medical costs comprised 76% of overall costs, with drug costs representing 7.4% (€2.4); direct non-medical and indirect costs comprised 10% and 14% respectively. Conclusions: Costs associated with VKA treatment in NVAF cannot be estimated only with drug costs. When direct and indirect attributable costs associated with VKA treatment are considered, the VKA treatment costs are more substantial.

17.
J Mark Access Health Policy ; 7(1): 1574541, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30774786

RESUMO

Introduction: Numerous real-world studies have compared non-vitamin K antagonist oral anticoagulants (NOACs) with vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF). A meta-analysis was performed to synthesize the available evidence. Methods: Systematic searches were performed through 12/2016 to identify non-randomized NVAF studies comparing NOACs with VKAs, and reporting effectiveness, safety, or persistence. Results: Of 562 citations identified, 49, 79, and 18 compared rivaroxaban, dabigatran, and apixaban, respectively, with VKAs and were included. Compared with VKAs, rivaroxaban was associated with a reduced risk of ischemic stroke (IS) (hazard ratio [HR] = 0.83, 95% confidence interval [CI] = 0.75-0.93), intracranial haemorrhage (ICH) (HR = 0.69, 95% CI = 0.52-0.90), and non-persistence (HR = 0.62, 95% CI = 0.60-0.65). Dabigatran was associated with a significantly lower risk of IS (HR = 0.80, 95% CI = 0.65-0.98) and ICH (HR = 0.45, 95% CI = 0.36-0.58), but not for non-persistence (HR = 0.91, 95% CI = 0.53-1.55), compared with VKAs. Apixaban was associated with a lower risk of ICH than VKAs (HR = 0.41, 95% CI = 0.28-0.60), but was not different to VKAs in terms of IS (HR = 1.01, 95% CI = 0.87-1.17) or non-persistence (HR = 1.08, 95% CI = 0.81-1.45). Conclusion: NOACs appear to be at least as effective and safe as VKAs for stroke prevention in patients with NVAF.

18.
Curr Med Res Opin ; 35(5): 785-792, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30681007

RESUMO

OBJECTIVES: Understanding inhaler preferences may contribute to improving adherence in COPD patients and improving long-term outcomes. This study aims to identify and quantify preferences for convenience-related inhaler attributes in French moderate-to-severe COPD patients, with discrete choice experiment (DCE) methodology. METHODS: Attributes were defined from a literature search, clinician and patient interviews: shape, dose insertion, dose preparation, dose release, dose confirmation, dose counter and reusability. An online DCE was conducted in respondents with self-reported COPD stage 2-4 recruited through a panel. The study questionnaire included twelve choice scenarios per respondent and questions on patient characteristics, treatment and disease severity. Statistical analyses used a mixed logit regression model with random effects. Utility scores were estimated for four types of inhalers: Inhaler A - soft mist inhaler; Inhaler B - reusable soft mist inhaler; Inhaler C - multi-dose dry powder inhaler; and Inhaler D - single dose dry powder inhaler. RESULTS: The study was completed by 153 patients (50 females); respondents were 50.4 years old on average; 13 different inhaler devices were reported. The most preferred inhaler is L-shaped, has dose preparation with capsule insertion and a dose counter, and is reusable. Inhaler profiles A and B had the highest utilities (mean of 1.2533 and 0.9578 respectively) compared to inhaler C (0.6315) and D (0.2200). CONCLUSIONS: This study showed statistically significant results that the strongest drivers of preference in French users of inhalation devices for COPD are shape, dose counter and reusability. Convenience-related characteristics are important to patients and should be taken into account by clinicians prescribing these devices.

19.
BMC Health Serv Res ; 19(1): 22, 2019 Jan 09.
Artigo em Inglês | MEDLINE | ID: mdl-30626376

RESUMO

BACKGROUND: Diabetic macular oedema (DMO) may lead to visual loss and blindness. Several pharmacological treatments are available on the National Health Service (NHS) to United Kingdom patients affected by this condition, including intravitreal vascular endothelial growth factor inhibitors (anti-VEGFs) and two types of intravitreal steroid implants, releasing dexamethasone or fluocinolone acetonide (FAc). This study aimed to assess the value for money (cost-effectiveness) of the FAc 0.2 µg/day implant (ILUVIEN®) in patients with chronic DMO considered insufficiently responsive to other therapies. METHODS: We developed a Markov model with a 15-year time horizon to estimate the impact of changes in best-corrected visual acuity in DMO patients on costs and quality-adjusted life years. The model considered both eyes, designated as the "study eye", defined at model entry as phakic with an ongoing cataract formation or pseudophakic, and the "fellow eye". The model compared the FAc 0.2 µg/day implant with a 700 µg dexamethasone implant (pseudophakic patients only) or with usual care, defined as a mixture of laser photocoagulation and anti-VEGFs (phakic and pseudophakic patients). Costs were estimated from the perspective of the NHS and Personal Social Services; full NHS prices were used for drugs. RESULTS: In patients who were pseudophakic at baseline, at 36 months, the FAc implant provided an additional gain of 4.01 and 3.64 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with usual care and the dexamethasone implant, respectively. Over the 15-year time horizon, this translated into 0.185 additional quality-adjusted life years (QALYs) at an extra cost of £3066 compared with usual care, and 0.126 additional QALYs at an extra cost of £1777 compared with dexamethasone. Thus, incremental cost-effectiveness ratios (ICERs) were £16,609 and £14,070 per QALY gained vs. usual care and dexamethasone, respectively. In patients who were phakic at baseline, the FAc 0.2 µg/day implant provided an additional gain of 2.96 ETDRS letters at 36 months compared with usual care, which, over 15 years, corresponded to 0.11 additional QALYs at an extra cost of £3170, resulting in an ICER of £28,751 per QALY gained. CONCLUSION: The FAc 0.2 µg/day implant provided good value for money compared with other established treatments, especially in pseudophakic patients.


Assuntos
Retinopatia Diabética/tratamento farmacológico , Fluocinolona Acetonida/administração & dosagem , Glucocorticoides/administração & dosagem , Edema Macular/tratamento farmacológico , Análise Custo-Benefício , Retinopatia Diabética/economia , Retinopatia Diabética/fisiopatologia , Implantes de Medicamento , Fluocinolona Acetonida/economia , Glucocorticoides/economia , Humanos , Edema Macular/economia , Edema Macular/fisiopatologia , Anos de Vida Ajustados por Qualidade de Vida , Reino Unido
20.
J Mark Access Health Policy ; 7(1): 1545514, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30479703

RESUMO

Non-profit drug research and development (R&D) has the potential to deliver innovative treatments at affordable prices. Using the case study methodology, we discuss some ethical and economic issues, including the possible impact of non-profit companies on innovation efforts from for-profit firms. Like other non-profits, Genethon is willing to adopt an ethical attitude toward their donors by pricing their products affordably. It remains to be seen if the approach to internalize the marketing authorization, manufacturing and distribution activities prove to be efficient and sustainable. Also, the firm faces an ethical dilemma because lower prices of innovative drugs can dry the for-profit R&D in the area and prevent patient access to future innovations.

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