Principles of pharmacoeconomic analysis: the case of pharmacist-led interventions

In the past years, several factors such as evidence-based healthcare culture, quality-linked incentives, and patient-centered actions, associated with an important increase of financial constraints and pressures on healthcare budgets, resulted in a growing interest by policy-makers in enlarging pharmacists' roles in care. Numerous studies have demonstrated positive therapeutic outcomes associated with pharmaceutical services in a wide array of diseases. Yet, the evidence of the economic impact of the pharmacist in decreasing total health expenditures, unnecessary care, and societal costs relies on well-performed, reliable, and transparent economic evaluations, which are scarce. Pharmacoeconomics is a branch of health economics that usually focuses on balancing the costs and benefits of an intervention towards the use of limited resources, aiming at maximizing value to patients, healthcare payers and society through data driven decision making. These decisions can be guide by a health technology assessment (HTA) process that inform governmental players about medical, social, and economic implications of development, diffusion, and use of health technologies including clinical pharmacy interventions. This paper aims to provide an overview of the important concepts in costing in healthcare, including studies classification according to the type of analysis method (e.g. budget-impact analysis, cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis), types of costs (e.g. direct, indirect and intangible costs) and outcomes (e.g. events prevented, quality adjusted life year - QALY, disability adjusted life year - DALY). Other key components of an economic evaluation such as the models' perspective, time horizon, modelling approaches (e.g. decision trees or simulation models as the Markov model) and sensitivity analysis are also briefly covered. Finally, we discuss the methodological issues for the identification, measurement and valuation of costs and benefits of pharmacy services, and suggest some recommendations for future studies, including the use of Value of Assessment Frameworks

Costs and Factors Associated with Hospitalizations Due to Severe Influenza in Catalonia (2017–2020)

This study aimed to estimate the cost and factors associated with severe hospitalized patients due to influenza in unvaccinated and vaccinated cases. The study had a cross-sectional design and included three influenza seasons in 16 sentinel hospitals in Catalonia, Spain. Data were collected from a surveillance system of influenza and other acute respiratory infections. Generalized linear models (GLM) were used to analyze mean costs stratified by comorbidities and pregnancy. Multivariate logistic models were used to analyze bacterial coinfection, multi-organ failure, acute respiratory distress syndrome, death and ICU admission by season and by vaccination status. Costs of ICU, hospitalization and total mean costs were analyzed using GLM, by season and by vaccination status. All models were adjusted for age and sex. A total of 2742 hospitalized cases were included in the analyses. Cases were mostly aged ≥ 60 years (70.17%), with recommended vaccination (86.14%) and unvaccinated (68.05%). The ICU admission level was statistically significant higher in unvaccinated compared to vaccinated cases. Costs of cases with more than or equal to two comorbidities (Diff = EUR − 1881.32), diabetes (Diff = EUR − 1953.21), chronic kidney disease (Diff = EUR − 2260.88), chronic cardiovascular disease (Diff = EUR − 1964.86), chronic liver disease (Diff = EUR − 3595.60), hospitalization (EUR 9419.42 vs. EUR 9055.45), and total mean costs (EUR 11,540.04 vs. 10,221.34) were statistically significant higher in unvaccinated compared to vaccinated patients. The influenza vaccine reduces the costs of hospitalization. There is a need to focus strategies in recommended vaccination groups.This study was supported by the Programme of Prevention, Surveillance and Control of Transmissible Diseases (PREVICET), CIBER de Epidemiología y Salud Pública (CIBERESP, CB06/02/0076, CB16/02/00322 and CB16/02/00429), Instituto de Salud Carlos III, Madrid; and the Catalan Agency for the Management of Grants for University Research (AGAUR Grant Number 2017/SGR 1342)

Cost-effectiveness analysis of a multiple health behaviour change intervention in people aged between 45 and 75 years: a cluster randomized controlled trial in primary care (EIRA study)

Background: Multiple health behaviour change (MHBC) interventions that promote healthy lifestyles may be an efficient approach in the prevention or treatment of chronic diseases in primary care. This study aims to evaluate the cost-utility and cost-effectiveness of the health promotion EIRA intervention in terms of MHBC and cardiovascular reduction. Methods: An economic evaluation alongside a 12-month cluster-randomised (1:1) controlled trial conducted between 2017 and 2018 in 25 primary healthcare centres from seven Spanish regions. The study took societal and healthcare provider perspectives. Patients included were between 45 and 75 years old and had any two of these three behaviours: smoking, insufficient physical activity or low adherence to Mediterranean dietary pattern. Intervention duration was 12 months and combined three action levels (individual, group and community). MHBC, defined as a change in at least two health risk behaviours, and cardiovascular risk (expressed in % points) were the outcomes used to calculate incremental cost-effectiveness ratios (ICER). Quality-adjusted life-years (QALYs) were estimated and used to calculate incremental cost-utility ratios (ICUR). Missing data was imputed and bootstrapping with 1000 replications was used to handle uncertainty in the modelling results. Results: The study included 3062 participants. Intervention costs were €295 higher than usual care costs. Five per-cent additional patients in the intervention group did a MHBC compared to usual care patients. Differences in QALYS or cardiovascular risk between-group were close to 0 (- 0.01 and 0.04 respectively). The ICER was €5598 per extra health behaviour change in one patient and €6926 per one-point reduction in cardiovascular risk from a societal perspective. The cost-utility analysis showed that the intervention increased costs and has no effect, in terms of QALYs, compared to usual care from a societal perspective. Cost-utility planes showed high uncertainty surrounding the ICUR. Sensitivity analysis showed results in line with the main analysis. Conclusion: The efficiency of EIRA intervention cannot be fully established and its recommendation should be conditioned by results on medium-long term effects. Trial registration: Clinicaltrials.gov NCT03136211. Registered 02 May 2017 – Retrospectively registered © 2021, The Author(s)

A qualitative emancipatory inquiry into relationships between people with mental disorders and health professionals

Introduction: A therapeutic alliance with people is essential for the efficacy of treatments. However, the traditional paternalistic values of the Mediterranean society may be incompatible with patient autonomy. Aim: To explore the therapeutic relationship from the perspective of people diagnosed with mental disorders with health professionals, including nurses. Methods: This emancipatory research was performed through focus groups, with people with mental disorders who had a variety of diagnoses and experiences of acute and community‐based mental health services and other healthcare services. Data were analysed using the content analysis method. Results: Four main themes emerged: stereotypes and prejudice; quality of interactions and treatment; emotional and behavioural impacts; and demands. Discussion: According to the participants' descriptions, health professionals are not exempt from prejudice against persons with psychiatric diagnoses. They reported experiencing abuse of power, malpractice, and overmedication. Thus, in the Mediterranean culture, professional attitudes may represent a barrier for an appropriate therapeutic alliance, and people with mental disorders do not feel involved in making decisions about their health. Implications for practice: Knowing how people with mental disorders perceive their interactions with health professionals and the effects is necessary to move the care model towards more symmetric relationships that facilitate a therapeutic alliance

Impact of the 13-valent conjugated pneumococcal vaccine on the direct costs of invasive pneumococcal disease requiring hospital admission in children aged < 5 years. A prospective study

The lack of invasive pneumococcal disease (IPD) cost studies may underestimate the effect of pneumococcal polysaccharide conjugated vaccines (PCV). The objective of this study was to estimate the direct costs of hospitalized IPD cases. A prospective study was made in children aged <5 years diagnosed with IPD in two high-tech hospitals in Catalonia (Spain) between 2007-2009 (PCV7 period) and 2012-2015 (PCV13 period). Costs were calculated according to 2014 Catalan Health Service rates using diagnostic-related groups. In total, 319 and 154 cases were collected, respectively. Pneumonia had the highest cost (65.7% and 62.0%, respectively), followed by meningitis (25.8% and 26.1%, respectively). During 2007-2015, the costs associated with PCV7 serotypes (Pearson coeffcient (Pc) = 0.79; p = 0.036) and additional PCV13 serotypes (Pc = 0.75; p = 0.05) decreased, but those of other serotypes did not (Pc = 0.23 p = 0.62). The total mean cost of IPD increased in the PCV13 period by 31.4% (¿3016.1 vs. ¿3963.9), mainly due to ICU stay (77.4%; ¿1051.4 vs. ¿1865.6). During the PCV13 period, direct IPD costs decreased due to a reduction in the number of cases, but cases were more severe and had a higher mean cost. During 2015, IPD costs increased due to an increase in the costs associated with non-PCV13 serotypes and serotype 3 and this requires further investigation

Multiple health behaviour change primary care intervention for smoking cessation, physical activity and healthy diet in adults 45 to 75 years old (EIRA study): a hybrid effectiveness-implementation cluster randomised trial

Background: This study aimed to evaluate the effectiveness of a) a Multiple Health Behaviour Change (MHBC) intervention on reducing smoking, increasing physical activity and adherence to a Mediterranean dietary pattern in people aged 45–75 years compared to usual care; and b) an implementation strategy. Methods: A cluster randomised effectiveness-implementation hybrid trial-type 2 with two parallel groups was conducted in 25 Spanish Primary Health Care (PHC) centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention was based on the Transtheoretical Model and focused on all target behaviours using individual, group and community approaches. PHC professionals made it during routine care. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR). Data were analysed using generalised linear mixed models, accounting for clustering. A mixed-methods data analysis was used to evaluate implementation outcomes (adoption, acceptability, appropriateness, feasibility and fidelity) and determinants of implementation success. Results: 14.5% of participants in the intervention group and 8.9% in the usual care group showed a positive change in two or all the target behaviours. Intervention was more effective in promoting dietary behaviour change (31.9% vs 21.4%). The overall adoption rate by professionals was 48.7%. Early and final appropriateness were perceived by professionals as moderate. Early acceptability was high, whereas final acceptability was only moderate. Initial and final acceptability as perceived by the participants was high, and appropriateness moderate. Consent and recruitment rates were 82.0% and 65.5%, respectively, intervention uptake was 89.5% and completion rate 74.7%. The global value of the percentage of approaches with fidelity =50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five corresponding to the Inner Setting domain. Conclusions: Compared to usual care, the EIRA intervention was more effective in promoting MHBC and dietary behaviour change. Implementation outcomes were satisfactory except for the fidelity to the planned intervention, which was low. The organisational and structural contexts of the centres proved to be significant determinants of implementation effectiveness. Trial registration: ClinicalTrials.gov, NCT03136211. Registered 2 May 2017, “retrospectively registered”. © 2021, The Author(s)

Impact of the mass media OBERTAMENT campaign on the levels of stigma among the population of Catalonia, Spain

AbstractReducing public stigma could improve patients’ access to care, recovery and social integration. The aim of the study was to evaluate a mass media intervention, which aimed to reduce the mental health, related stigma among the general population in Catalonia (Spain). We conducted a cross-sectional population-based survey of a representative sample of the Catalan non-institutionalized adult population (n = 1019). We assessed campaign awareness, attitudes to people with mental illness (CAMI) and intended behaviour (RIBS). To evaluate the association between campaign awareness and stigma, multivariable regression models were used. Over 20% of respondents recognized the campaign when prompted, and 11% when unprompted. Campaign aware individuals had better attitudes on the benevolence subscale of the CAMI than unaware individuals (P = 0.009). No significant differences in authoritarianism and support for community mental health care attitudes subscales were observed. The campaign aware group had better intended behaviour than the unaware group (P &lt; 0.01). The OBERTAMENT anti-stigma campaign had a positive impact to improve the attitudes and intended behaviour towards people with mental illness of the Catalan population. The impact on stigma was limited to attitudes related to benevolence. A wider range of anti-stigma messages could produce a stronger impact on attitudes and intended behaviour.</jats:p

Who Suffers From Pharmaceutical Poverty and What Are Their Needs? Evidence From a Spanish Region

Altres ajuts: CIBERESP (Centro de Investigación Biomedica en Red de Epidemiología y Salud Pública, CB16/02/00322); Fondo Europeo de Desarrollo Regional (FEDER); Institut Català de la Salut (7Z20/028).Background: Pharmaceutical poverty occurs when a patient cannot afford the cost of prescribed medication and/or medical products. Nonprofit organizations are covering the cost of medication to those patients in some contexts. The aim of the study was to describe the population of beneficiaries of the PB, a nongovernmental organization based on the primary healthcare system, which provides free-of-charge access to medicines and their utilization pattern of medicines and healthcare products. Methods: This was an observational study using PB beneficiary data collected between November 2017 and December 2018 in Catalonia. The Catalan Health Service provided information from the general population. A descriptive analysis of the beneficiaries' characteristics was conducted and compared to the general population. Results: The beneficiaries (N = 1,206) were mainly adults with a low level of education, unemployed, with functional disability, and with ≥1 child. Compared with the general population, the beneficiaries were older, had a lower level of education, showed a higher prevalence of functional disability, were less likely to be Spanish, and were more likely to be divorced and unemployed. The beneficiaries were polymedicated, and most were using medication related to the nervous (79%), musculoskeletal (68%), and cardiovascular system (56%) and alimentary tract and metabolism (68%). Almost 19% of beneficiaries used healthcare products. Female beneficiaries were older and more likely to be divorced or widowed, employed, and with children. Compared to men, women were more likely to use medicines for pain and mental disorders. The pediatric group used medications for severe, chronic conditions (heart diseases, autoimmune diseases, conduct disorders, and attention deficit hyperactivity disorder). Conclusion: Patients with severe, chronic, and disabling conditions are affected by pharmaceutical poverty. While the system of copayment remains unchanged, family physicians and pediatricians should explore economic barriers to treatment and direct their patients to resources that help to cover the cost of treatment

Pediatric Medication Noninitiation in Spain.

OBJECTIVES: To estimate medication noninitiation prevalence in the pediatric population and identify the explanatory factors underlying this behavior. METHODS: Observational study of patients (<18 years old) receiving at least 1 new prescription (28 pharmaceutical subgroups; July 2017 to June 2018) in Catalonia, Spain. A prescription was considered new when there was no prescription for the same pharmaceutical subgroup in the previous 6 months. Noninitiation occurred when a prescription was not filled within 1 month or 6 months (sensitivity analysis). Prevalence was estimated as the proportion of total prescriptions not initiated. To identify explanatory factors, a multivariable multilevel logistic regression model was used, and adjusted odds ratios were reported. RESULTS: Overall, 1 539 003 new prescriptions were issued to 715 895 children. The overall prevalence of 1-month noninitiation was 9.0% (ranging from 2.6% [oral antibiotics] to 21.5% [proton pump inhibitors]), and the prevalence of 6-month noninitiation was 8.5%. Noninitiation was higher in the youngest and oldest population groups, in children from families with a 0% copayment rate (vulnerable populations) and those with conditions from external causes. Out-of-pocket costs of drugs increased the odds of noninitiation. The odds of noninitiation were lower when the prescription was issued by a pediatrician (compared with a primary or secondary care clinician). CONCLUSIONS: The prevalence of noninitiation of medical treatments in pediatrics is high and varies according to patients' ages and medical groups. Results suggest that there are inequities in access to pharmacologic treatments in this population that must be taken into account by health care planners and providers