The relevance of therapeutic positioning in the post-approval evaluation of new medicines.

The objective of regulatory authorities is to ensure a favorable risk-benefit balance for medicines in their licensed indication, without seeking to establish their place in the therapeutic armamentarium beyond that. The licensed indication covers heterogeneous subpopulations and often does not sufficiently specify the characteristics of the patients who may benefit. The regulatory information does not always show the benefit over the standard treatments; moreover, it only reacts to the conditions specified in the developer's application, and lacks an assessment of the clinical relevance of the benefit and its uncertainties.

Economic assessment of abemaciclib for the adjuvant treatment of luminal HER2- breast cancer from the perspective of the Spanish health system.

Introduction: Abemaciclib is an oral inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). Data from the clinical trial monarchE (2023) showed improved survival from invasive disease. The aim of the present article was to conduct an economic assessment of adjuvant treatment with abemaciclib in women with luminal, HER2- and node-positive breast cancer.

Economic evaluation of adjuvant therapy with osimertinib in patients with early-stage non-small cell lung cancer and mutated EGFR.

Purpose: The ADAURA trial demonstrated the superiority of osimertinib over a placebo with regard to disease-free survival, showing it to be indicated as an adjuvant therapy for treatment of non-small cell lung cancer with mutated epidermal growth factor receptor (EGFR). The aim of the present study was to conduct a cost-utility analysis and an analysis of the budgetary impact of adjuvant therapy with osimertinib in patients with non-small cell lung cancer with mutated EGFR who had undergone resection surgery with curative intent.

Methods: Analyses were based on the outcomes of the ADAURA clinical trial and were conducted through a Spanish National Health Service perspective.

Abemaciclib as adjuvant treatment for high-risk early breast cancer.

Objective: To adapt the GHEMA report of abemaciclib, an inhibitor of cyclin-dependent kinases 4 and 6. European Medicines Agency authorisation (April 2022) includes, in combination with endocrine therapy, the adjuvant treatment of adult patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, node-positive, early breast cancer at high risk of recurrence.

Method: The efficacy and safety of abemaciclib were evaluated in a randomized, open-label and multicenter phase III study.

Systematic review and meta-analysis of interleulin-6 inhibitors in reducing mortality for hospitalized patients with COVID-19.

Objective: One year after the declaration of the SARS-CoV-2 pandemic, only  dexamethasone has clearly shown a reduction in mortality for COVID-19  hospitalized patients. For interleukin-6 inhibitors, results are variable and  nclear. The objective was to review and analyze the effect of tocilizumab and  sarilumab on survival in this setting.

Factors associated with mortality in patients hospitalized for COVID-19 in Spain. Data from the RERFAR registry.

Objective: To determine the baseline characteristics associated with higher  mortality at 42 days in patients hospitalized for COVID-19 in Spain.

Method: The study analyzed a prospective cohort of hospitalized COVID-19  patients. The dependent variable was 42-day mortality.

Daratumumab-based therapies in transplant-ineligible patients with untreated multiple myeloma and hepatic dysfunction: A systematic review of subgroup analyses.

Introduction: There is subgroup analysis suggesting a lack of benefit of daratumumab use in multiple myeloma (MM) and hepatic disease (HD). The objectives of this study were to conduct a systematic review and interpretation of daratumumab-based regimen efficacy in transplant-ineligible patients with untreated MM and HD.

Methods: A systematic search in Pubmed database about randomized clinical trials (RCTs) with subgroup analysis regarding hepatic function for overall survival (OS) or progression-free survival (PFS) were developed.

Use of docetaxel in low- and high-burden metastatic hormone-sensitive prostate cancer: A systematic review and assessment of subgroup analyses.

Background: Use of docetaxel in low- and high-burden metastatic hormone-sensitive prostate cancer presents considerable controversy. There is literature suggesting lack of benefit for low-volume of metastases.

Objective: The study aims to develop a systematic review and methodological assessment of subset analysis about use of docetaxel in metastatic hormone-sensitive prostate cancer regarding volume of metastatic disease.

Cost-utility of talazoparib monotherapy treatment for locally advanced or metastatic breast cancer in Spain.

Breast cancer is one of the most frequent malignancies. The aim of the article is to analyse the cost-utility ratio and budgetary impact of talazoparib treatment for patients with locally advanced or metastatic gBRCA + breast cancer from the perspective of the Spanish National Health System. Analyses were based on the EMBRACA clinical trial and the model was constructed according to "partitioned survival analysis".

Drug evaluation is also a clinical activity.

The addition of a fourth year to the hospital pharmacy residency program has allowed trainees to rotate through various inpatient clinical  units where they can, under the supervision of a specialist pharmacist,  work shoulder to shoulder with other healthcare providers to ensure that  patients receive the care they need. In addition to sharing their  pharmacotherapeutic and pharmacokinetic knowledge (among others) with their colleagues, hospital pharmacists can and should contribute with their  expertise in the areas of drug evaluation, selection and positioning. As no  other healthcare professional masters like a pharmacist the intricacies of  treatment efficacy or effectiveness, or of therapeutic safety, conveying this knowledge is yet another of the many clinical activities a hospital  pharmacist must perform as a member of a multidisciplinary team, while  assisting fellow-team members in deciding what medications are best  suited to each patient.

Remdesivir and mortality reduction in COVID-19 patients: a systematized subgroup analysis of clinical trials.

Objective: Remdesivir has not shown survival benefit for patients with severe COVID-19. However, subgroup analysis of ACTT-1 Study Group showed an apparent reduction in mortality for patients who required non‑high-flow oxygen. Presentation of SOLIDARITY study results were associated by a meta-analysis combining mortality results by subsets rom randomized clinical trials.

Network meta-analysis of first-line treatments in transplant-ineligible multiple myeloma patients.

Objectives: Multiple myeloma (MM) is a complex disease. Lack of direct comparisons among treatments and incorporation of new alternatives make it necessary to perform studies that allow for clinical decision-making. A network meta-analysis (NMA) was developed to evaluate the comparative efficacy among different therapeutic alternatives in newly diagnosed transplant-ineligible MM patients.

Checklist for clinical applicability of subgroup analysis.

What Is Known And Objective: Subgroup analysis plays an important role in clinical decision-making. Correct management of subgroup analysis is necessary to optimize effectiveness, safety and efficiency of treatments. No homogeneous criteria have been developed for interpretation of subgroup analysis.

Economic evaluation and budgetary burden of mepolizumab in severe refractory eosinophilic asthma.

Objective: Mepolizumab is indicated as an additional treatment of severe refractory eosinophilic asthma. The observed differences in  population subgroups according to plasma eosinophil count, the  existence of patients with high levels of immunoglobulin E who are  candidates of omalizumab and mepolizumab, as well as mepolizumab's  economic impact, lead to make efficient economic studies for clinical  decision making. The aim was to analyze mepolizumab's cost-efficacy  and budget impact.

[Risk of medicines in pregnancy: a problem of knowledge transfer with ethical implications].

Drug use in pregnancy is essential and beneficial, but it is needed to check their safety. Available scientific evidence is poor and difficult to interpret. Risk classifications (FDA, ADEC) have shown to be too simple and categorical; they lead to inaccurate perceptions of risk and unfortunate decisions, such as interrumption of medication, or abortion.

Cost-effectiveness of lenalidomide maintenance in patients with multiple myeloma who have undergone autologous transplant of hematopoietic progenitor cells.

The objective of this article is to analyze the ratio of cost-effectiveness and budgetary impact of lenalidomide treatment in patients with multiple myeloma who have undergone autologous transplant in Spain. The analyses were based on clinical trials CALGB 100104 and IFM 2005-02, from the perspective of the National Health System. The alternatives compared were the treatment with lenalidomide against maintenance without treatment (MwT).

Cost-effectiveness and Budget Impact of Treatment with Evolocumab Versus Statins and Ezetimibe for Hypercholesterolemia in Spain.

Introduction And Objectives: To analyze the cost-effectiveness ratio and budget impact of treatment with evolocumab (PCSK9 inhibitor) for patients in secondary prevention in the Spanish National Health System.

Methods: A budget impact analysis, decision tree and Markov models were designed under the public health system perspective, based on the only study with morbidity and mortality data (FOURIER). The alternatives compared were evolocumab vs statins, and dual therapy with ezetimibe in 5% of the population.

Docetaxel in hormone-sensitive advanced prostate cancer; GENESIS-SEFH evaluation reporta.

Prostate cancer (PC) is the most common urogenital malignancy in older men and the second leading cause of death by cancer in men in Europe. Current therapeutic practice considers Androgen Deprivation Therapy (ADT) as first line treatment for clinically localized prostate cancer at high-risk, either locally advanced or metastatic. ADT can be achieved through orchiectomy (surgical castration), luteinizing hormone-releasing hormone (LHRH) agonists, or through complete androgen blockade (LHRH agonist combined with an anti-androgen).