Recommendations on chronic diseases management emphasise the need to consider patient perspectives and shared decision-making. Discrepancies between patients and physicians' perspectives on treatment ...objectives, disease activity, preferences and treatment have been described for immune-mediate inflammatory diseases. These differences could result on patient dissatisfaction and negatively affect outcomes. To describe the degree of patient-physician discrepancy in three chronic immune-mediated inflammatory diseases (rheumatoid arthritis RA, psoriatic arthritis PsA and psoriasis Ps), identifying the main areas of discrepancy and possible predictor factors. Qualitative systematic review of the available literature on patient and physician discrepancies in the management of RA, PsA and Ps. The search was performed in international (Medline/PubMed, Cochrane Library, ISI-WOK) and Spanish electronic databases (MEDES, IBECS), including papers published from April 1, 2008 to April 1, 2018, in English or Spanish, and conducted in European or North American populations. Study quality was assessed by the Oxford Centre for Evidence-Based Medicine criteria. A total of 21 studies were included (13 RA; 3 PsA; 4 Ps; 1 RA, Ps, and Axial Spondyloarthritis). A significant and heterogeneous degree of discrepancy between patients and physicians was found, regarding disease activity, treatment, clinical expectations, remission concept, and patient-physician relationship. In RA and PsA, studies were mainly focused on the evaluation of disease activity, which is perceived as higher from the patient's than the physician's perspective, with the discrepancy determined by factors such as patient's perception of pain and fatigue. In Ps, studies were focused on treatment satisfaction and patient-physician relationship, showing a lower degree of discrepancy in the satisfaction regarding these aspects. There is a significant degree of patient-physician discrepancy regarding the management of RA, PA, and Ps, what can have a major impact on shared decision-making. Future research may help to show whether interventions considering discrepancy improve shared decision-making.
ObjectiveTo conduct a cost-effectiveness analysis from the perspective of the Spanish National Health System (NHS) comparing ixekizumab versus secukinumab.DesignA Markov model with a lifetime horizon ...and monthly cycles was developed based on the York model. Four health states were included: a biological disease-modifying antirheumatic drug (bDMARD) induction period of 12 or 16 weeks, maintenance therapy, best supportive care (BSC) and death. Treatment response was assessed based on both Psoriatic Arthritis Response Criteria (PsARC) and ≥90% improvement in the Psoriasis Area Severity Index score (PASI90). At the end of the induction period, responders transitioned to maintenance therapy. Non-responders and patients who discontinued maintenance therapy transitioned to BSC. Clinical efficacy data were derived from a network meta-analysis. Health utilities were generated by applying a regression analysis to Psoriasis Area Severity Index and Health Assessment Questionnaire‒Disability Index scores collected in the ixekizumab SPIRIT studies. Results were subject to extensive sensitivity and scenario analysis.SettingSpanish NHS.ParticipantsA hypothetical cohort of bDMARD-naïve patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis was modelled.InterventionsIxekizumab and secukinumab.ResultsIxekizumab performed favourably over secukinumab in the base-case analysis, although cost savings and quality-adjusted life-year (QALY) gains were modest. Total costs were €153 901 compared with €156 559 for secukinumab (difference −€2658). Total QALYs were 9.175 vs 9.082 (difference 0.093). Base-case results were most sensitive to the annual bDMARD discontinuation rate and the modification of PsARC and PASI90 response to ixekizumab or secukinumab.ConclusionIxekizumab provided more QALYs at a lower cost than secukinumab, with differences being on a relatively small scale. Sensitivity analysis showed that base-case results were generally robust to changes in most input parameters.Trial registration numberSPIRIT-P1: NCT01695239; Post-results, SPIRIT-P2: NCT02349295; Post-results.
Objective
To assess the burden of hypoglycemia in patients with diabetes mellitus (DM) in Spain, including epidemiological data and information relating to healthcare resource utilization (HRU) and ...costs, and patients’ quality of life (QoL).
Methods
A systematic literature review (SLR) was conducted to identify studies that included original information on epidemiology, HRU and costs, and/or QoL associated with hypoglycemia in patients with DM in Spain, published in either Spanish or English, between January 2007 and April 2017.
Results
Fifteen articles, involving 14 studies, were identified in the SLR and included in the analysis. The estimated rate of severe hypoglycemia (SH) events per patient per year ranged from 0.90 to 1.50 in patients with type 1 DM (T1DM) and from 0.30 to 0.63 in patients with type 2 DM (T2DM). The data on HRU differed extensively between studies, making it difficult to draw a conclusion. Total costs per SH event ranged from €409.97 in patients with T1DM to €713.10 in patients with DM. Work absence was reported in 11.80–18% of the working patients. Further, patients who experienced hypoglycemic events expressed a higher fear and had a poorer QoL than those who did not report these events.
Conclusion
Although the data included in the SLR were difficult to synthesize due to heterogeneity of the study designs and patient characteristics in the 14 studies, our search identified a high burden associated with hypoglycemic events in terms of HRU and costs, and patients’ QoL. Further research is recommended to reach a consensus on hypoglycemia definition and study design to provide robust evidence on the burden of hypoglycemia and to accurately weigh the impact of this acute complication in Spain.
Funding
Eli Lilly and Company.
Although the choice of the comparator is one of the aspects with a highest effect on the results of cost-effectiveness analyses, it is one of the less debated issues in international methodological ...guidelines. The inclusion of an inappropriate comparator may introduce biases on the outcomes and the recommendations of an economic analysis. Although the rules for cost-effectiveness analyses of sets of mutually exclusive alternatives have been widely described in the literature, in practice, they are hardly ever applied. In addition, there are many cases where the efficiency of the standard of care has never been assessed; or where the standard of care has demonstrated to be cost-effective with respect to a non-efficient option. In all these cases the comparator may lie outside the efficiency frontier, so the result of the CEA may be biased. Through some hypothetical examples, the paper shows how the complementary use of an independent reference may help to identify potential inappropriate comparators and inefficient use of resources.
Highlights • This is the first study to estimate the social costs associated with familial (informal) caregiving of children with type 1 diabetes mellitus. • Children with an HbA1c level lower than ...7.5% consume significantly less healthcare resources and have a significantly lower cost than children with an HbA1c level of 7.5% or over. • Children who do not have complications associated with type 1 diabetes consume significantly less healthcare resources and have a significantly lower cost than children with complications. • The time that families devote to diabetes surveillance, glucose control, and other diabetes related care, represents the largest component of the total socioeconomic cost associated with type 1 diabetes in children.
Introduction
To evaluate clinical inertia in patients with type 2 diabetes mellitus (T2DM), obesity and poor glycaemic control in routine clinical practice.
Methods
This was a retrospective, ...observational study based on the analysis of medical records from the BIG-PAC® database. Subjects who required medical care in 2013 with the following characteristics were enrolled in the study: age ≥ 30 years, diagnosis of T2DM, glycosylated haemoglobin (HbA1c) ≥ 8%, obesity (body mass index BMI ≥ 30 kg/m
2
) and treatment with ≥ 2 oral antidiabetic drugs (OADs). Inertia was evaluated by time (days) to the first intensification during the period while HbA1c levels were ≥ 8% and percentage of patients whose treatment was not intensified at 6 months, 1, 2 and 3 years and the end of follow-up. The minimum length of follow-up was 4 years. Descriptive analyses and Kaplan–Meier survival curves were performed.
Results
A total of 13,824 patients with T2DM receiving ≥ 2 OADs were identified; of these 2709 (19.6%) had HbA1c ≥ 8% and BMI ≥ 30 kg/m
2
, thus fulfilling the inclusion criteria. Of these 2709 patients, the mean age was 65.5 (standard deviation SD 12.0) years; 54.9% were male, mean HbA1c level was 9.2% (SD 1.3%); mean BMI was 32.1 (SD 0.9) kg/m
2
; and mean time from diagnosis was 8.2 (SD 3.0) years. HbA1c remained ≥ 8% for a median of 440 (95% confidence interval CI 421–459) days. The median time to first intensification was 456 (95% CI 429–483) days. No intensification had occurred in 77.8, 59.5, 41.5, 28.1 and 22.4% of patients at 6 months, 1, 2, 3 years and the end of follow-up, respectively.
Conclusions
The patients with T2DM analysed in this study had a mean HbA1c of 9.2% at baseline, and this remained at ≥ 8% for > 1 year. The time to the first treatment intensification was longer than that recommended by guidelines. Treatment was not intensified in a large percentage of patients, with almost 60% of patients not receiving intensification at 1 year of follow-up.
Attention Deficit/Hyperactivity Disorder (ADHD) is a neurobehavioural disorder, affecting 3-6% of school age children and adolescents in Spain. Methylphenidate (MPH), a mild stimulant, had long been ...the only approved medication available for ADHD children in Spain. Atomoxetine is a non-stimulant alternative in the treatment of ADHD with once-a-day oral dosing. This study aims to estimate the cost-effectiveness of atomoxetine compared to MPH. In addition, atomoxetine is compared to 'no medication' for patient populations who are ineligible for MPH (i.e. having stimulant-failure experience or co-morbidities precluding stimulant medication).
An economic model with Markov processes was developed to estimate the costs and benefits of atomoxetine versus either MPH or 'no medication'. The incremental cost per quality-adjusted life-year (QALY) was calculated for atomoxetine relative to the comparators. The Markov process incorporated 14 health states, representing a range of outcomes associated with treatment options. Utility values were obtained from the utility valuation survey of 83 parents of children with ADHD. The clinical data were based on a thorough review of controlled clinical trials and other clinical literature, and validated by international experts. Costs and outcomes were estimated using Monte Carlo simulation over a 1-year duration, with costs estimated from the perspective of the National Health Service in Spain.
For stimulant-naive patients without contra-indications to stimulants, the incremental costs per QALY gained for atomoxetine were euro 34,308 (compared to an immediate-release MPH) and euro 24,310 (compared to an extended-release MPH). For those patients who have stimulant-failure experience or contra-indications to stimulants, the incremental costs per QALY gained of atomoxetine compared to 'no medication' were euro 23,820 and euro 23,323, respectively.
The economic evaluation showed that atomoxetine is an effective alternative across a range of ADHD populations and offers value-for money in the treatment of ADHD.
The objective of this study was to conduct a cost-effectiveness evaluation of pemetrexed compared to docetaxel in the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) for ...patients with predominantly non-squamous histology in the Spanish healthcare setting.
A Markov model was designed consisting of stable, responsive, progressive disease and death states. Patients could also experience adverse events as long as they received chemotherapy. Clinical inputs were based on an analysis of a phase III clinical trial that identified a statistically significant improvement in overall survival for non-squamous patients treated with pemetrexed compared with docetaxel. Costs were collected from the Spanish healthcare perspective.
Outcomes of the model included total costs, total quality-adjusted life years (QALYs), total life years gained (LYG) and total progression-free survival (PFS). Mean survival was 1.03 years for the pemetrexed arm and 0.89 years in the docetaxel arm; QALYs were 0.52 compared to 0.42. Per-patient lifetime costs were 34677 euros and 32343 euros, respectively. Incremental cost-effectiveness ratios were 23967 euros per QALY gained and 17225 euros per LYG.
Pemetrexed as a second-line treatment option for patients with a predominantly non-squamous histology in NSCLC is a cost-effective alternative to docetaxel according to the 30000 euros /QALY threshold commonly accepted in Spain.
Health economics: the start of clinical freedom Sacristán, José Antonio; Costi, María; Valladares, Amparo ...
BMC health services research,
06/2010, Letnik:
10, Številka:
1
Journal Article
Recenzirano
Odprti dostop
Since Professor Hampton announced the death of clinical freedom in 1983, the increasing influence of Evidence-based Medicine and Health Technology Assessment has contributed to augment the feeling ...that clinicians have a secondary role in the therapeutic decision-making process.
This article constitutes a reflection on how clinicians may use the results of economic evaluations in their daily clinical practice, making decisions about cost-effectiveness on a case by case basis, and addressing both the patient's and society's needs. To that end, some illustrating examples are taken from the literature to show there are factors with great impact on cost-effectiveness results that can be easily identified and modified by clinicians.
The evolution of the discipline and the trend towards a tailored therapy suggest that health economics is not the end of clinical freedom but the start of it.
Adherence to therapy is defined as the extent to which a person’s behavior in taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a ...healthcare provider. Patients presenting with type 2 diabetes mellitus are initially encouraged to maintain a healthy diet and exercise regimen, followed by early medication that generally includes one or more oral hypoglycemic agents and later may include an injectable treatment. To prevent the complications associated with type 2 diabetes, therapy frequently also includes medications for control of blood pressure, dyslipidemia and other disorders, since patients often have more than three or four chronic conditions. Despite the benefits of therapy, studies have indicated that recommended glycemic goals are achieved by less than 50% of patients, which may be associated with decreased adherence to therapies. As a result, hyperglycemia and long-term complications increase morbidity and premature mortality, and lead to increased costs to health services. Reasons for nonadherence are multifactorial and difficult to identify. They include age, information, perception and duration of disease, complexity of dosing regimen, polytherapy, psychological factors, safety, tolerability and cost. Various measures to increase patient satisfaction and increase adherence in type 2 diabetes have been investigated. These include reducing the complexity of therapy by fixed-dose combination pills and less frequent dosing regimens, using medications that are associated with fewer adverse events (hypoglycemia or weight gain), educational initiatives with improved patient–healthcare provider communication, reminder systems and social support to help reduce costs. In the current narrative review, factors that influence adherence to different therapies for type 2 diabetes are discussed, along with outcomes of poor adherence, the economic impact of nonadherence, and strategies aimed at improving adherence.
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