Survey on the Situation of Medical Departments in the Pharmaceutical Industry in Spain.

INTRODUCTION: Medical departments have evolved from a position of support to one of strategic leadership. The number of tasks and the complexity of interactions in which they are involved is increasing. However, the spectrum of their activity in the sector differs significantly from one company to another. Therefore, the aim of this study was to describe their situation within the pharmaceutical industry, analyzing the positions, functions, and profiles of their professionals. METHODS: This study consisted of an online survey containing 25 questions grouped into four blocks (structure, medical direction, training, and activities and responsibilities). Medical departments in the Spanish pharmaceutical industry of different sizes and scope were invited to participate. The survey took place in 2021, with a designated response period of three months. It is important to note that all responses collected during this time were treated as anonymous. RESULTS: Thirty companies participated. A total of 93.3% of respondents worked for an international laboratory, with a size of 0-5 or 11-20 people (20.7%). For 27.6% of the companies, the number of medical advisors per medical department was 1 or 4, with varying numbers of medical scientific liaisons (1, 6-10, and > 20). A total of 56.7%, 33.3%, and 6.7% indicated that the country manager, head of regional medical affairs, and head of global medical affairs, respectively, had a solid-line reporting relationship with the medical directorate. Medical directors were mostly graduates in medicine (86.2%) with a doctorate (34.5%), and medical managers were mainly graduates in medicine (77.8%) and pharmacy (66.7%). CONCLUSIONS: This study reveals that respondents predominantly work in internationally focused laboratories, with professionals ranging from experienced medical directors to managers with 6-20 years of experience, each with distinct roles.

Clinical Experience on the Use of a Single-day, Two-injection Start Initiation Regimen of Aripiprazole Once Monthly in Patients With Schizophrenia in Spain: SaTISfy Study.

OBJECTIVE: The two-injection start (TIS) initiation regimen was recently approved for aripiprazole once monthly 400 mg (AOM400), with potential benefits in adherence. The SaTISfy study described in this article analyzed Spanish psychiatrists' perspectives on hospitalization lengths of stay, schizophrenia management, and the use of AOM400-TIS. METHODS: The authors describe an ecological study of aggregated data collected using a 41-question survey. Fifty psychiatrists were asked to provide their perceptions of their patients with schizophrenia and treatment with AOM400. RESULTS: The psychiatrists reported that lack of treatment adherence was the main reason for hospitalization for 58.3% of their patients diagnosed with schizophrenia. Aripiprazole, in any formulation, was the most commonly prescribed therapeutic option, being prescribed for a mean (SD) of 2.5 (0.9) out of 5 patients, while 98% of psychiatrists chose AOM400-TIS for patients who failed to adhere to previous treatments. Patients with schizophrenia, regardless of their treatment, were hospitalized for an average of 17.7 (3.93) days versus patients with schizophrenia treated with AOM400-TIS, who were hospitalized for an average of 14.2 (4.18) days, a reduction of 3.5 (3.86) days. Patients treated with AOM400-TIS showed a reduction of 5 (4.18) days compared with the mean national duration of hospitalization for acute patients in psychiatry units in Spain (19.18 d). The surveyed psychiatrists reported that AOM400-TIS improved safety and tolerability. Most of the psychiatrists were satisfied with the administration and results of AOM400-TIS. Most of the psychiatrists (90%) also reported that fewer health care resources were consumed with AOM400-TIS, mainly due to a reduction in hospitalization days and in the use of concomitant medications. CONCLUSIONS: AOM400-TIS was considered to have a positive impact on the duration of hospitalization and thus on the use of health care resources. There was a positive perception of adherence, safety, and tolerability with the use of AOM400-TIS in patients with schizophrenia.

Healthcare resource use and costs reduction with aripiprazole once-monthly in schizophrenia: AMBITION, a real-world study.

Objective: This study aims to compare the hospitalization rate in individuals with schizophrenia who started their treatment with aripiprazole once monthly (AOM400) or atypical oral antipsychotics (OA) in Spain. Methods: This is an observational and retrospective study based on the electronic medical records from the BIG-PAC database. The study population consisted of individuals diagnosed with schizophrenia who initiated their treatment with AOM400 (AOM cohort) or atypical OA (OA cohort) from 01/01/2017 to 31/12/2019. A 1:1 propensity score matching (PSM) procedure was conducted to match individuals of both cohorts. The number and duration of hospitalizations, persistence to treatment, healthcare resources use, and costs were analyzed after 12 months. Results: After the PSM, 1,017 individuals were included in each cohort [age: 41.4 years (SD: 10.6); males: 54.6%]. During the follow-up period, the AOM cohort had a 40% lower risk of hospitalization than the OA group [HR: 0.60 (95% confidence interval, CI: 0.49-0.74)]. The median time to the first hospitalization was longer in individuals with AOM400 compared to those with OA (197 days compared to 174 days; p < 0.004), whereas hospital admissions were shorter (AOM400: 6 compared to OA: 11 days; p < 0.001). After 12 months, individuals receiving AOM400 were more persistent than those with OA (64.9% compared to 53.7%; p < 0.001). The OA cohort required more healthcare resources, mainly visits to primary care physicians, specialists, and emergency rooms than those receiving AOM400 (p ≤ 0.005 in all comparisons). AOM400 reduced the costs of hospitalizations, and emergency room, specialist and primary care visits by 50.4, 36.7, 16.1, and 10.9%, respectively, in comparison to the treatment with atypical OA. AOM400 led to annual cost savings of €1,717.9 per individual, from the societal perspective. Conclusion: Aripiprazole once monthly reduces the number and duration of hospitalizations, together with the treatment costs of schizophrenia, as it reduces the use of healthcare resources and productivity losses in these individuals.

Cost-effectiveness of memantine in community-based Alzheimer's disease patients: An adaptation in Spain.

Several clinical trials have demonstrated the efficacy and safety of the NMDA antagonist memantine in moderately severe to severe Alzheimer's disease (AD) patients. A 28-week pharmacoeconomic study conducted in the US also showed a reduction of total healthcare costs and informal care compared to placebo. Long-term implications of memantine treatment were modelled in the UK and Finland and revealed reductions in dependency, institutionalization and costs. However, these conclusions were not directly applicable to the Spanish setting where patients are mainly treated within the community. The objective of this study was to estimate the long-term implications in terms of costs and health benefits of memantine therapy compared to standard care using a Spanish adaptation of previous models over a 2-year time horizon. As in previous adaptations, Markov health states were defined as a combination of severity (mild-moderate, moderately severe, severe) and dependency plus death as the absorbing state. Spain-specific data (costs, mortality and epidemiological data) were obtained from local and recently published cohorts of AD patients. Data on the effectiveness of memantine were derived from a randomized double-blind placebo-controlled clinical trial of 252 moderately severe to severe AD patients. Effectiveness was measured as the time spent in a non-dependent health state. The evaluation was conducted over 2 years, while the efficacy of memantine was applied for 1 year only in order to ensure a conservative approach. The robustness of the model was tested by conducting stochastic analyses and various sensitivity analyses on the key assumptions. Patients receiving standard care were estimated to spend 6 months in a non-dependent state and to incur average total costs of Euro 24,700 over 2 years. The memantine strategy was associated with an additional 2.5 months in a non-dependent state and a Euro 700 cost reduction. Monte-Carlo simulations and sensitivity analyses supported these findings. Memantine appears to be cost-effective compared with standard care in moderately severe to severe AD patients in a Spanish setting. The prolonged independence provided by memantine treatment translated into cost reductions which offset drug costs and resulted in overall cost-savings.