Latest articles in this journal
AboutOpen, Volume 7, pp 9-15; doi:10.33393/abtpn.2020.2104
Introduction: Pharma companies deal with the same important challenges that humans face: to grow and stay healthy. The crucial role of pharma companies in preserving health would suggest that they might rank highly in the reputation indexes. However, this does not seem to be the case. Our aim was to collect, cluster and analyse the words used by pharma companies in their mission, vision and value statements as a base to identify areas of improvement in their corporate communication. Methods: A total of 97 multinational pharma companies were selected based on their size and presence within major markets. Mission, vision and company values were captured from company websites and analysed. Word clouds were built to analyse the frequency of words in the statement. The influence of company size and location was also analysed. Results: Most companies (90.7%) have a mission and 54.6% have a clearly stated vision statement, 71.4% mention values. “Life/lives” “patients”, “innovative”, “people/persons” are the most frequently used words. “Innovation” and “integrity” are by far the most common values, followed by “respect”, “ethics”, “responsibility” and “passion”. References to healthcare professionals, access to treatment and sustainability, open science, transparency and care for the environment are more scanty. Conclusions: Most, but not all, pharma companies provide comprehensive statements focussing mostly on the innovation and its impact on patients. Topics such as role of health care professionals, economic sustainability and care for the environment are rarely listed. An in-depth analysis of their alignment with key needs and trending topics is warranted to further engage customers and build reputation and value.
AboutOpen, Volume 7, pp 1-3; doi:10.33393/abtpn.2020.2029
AboutOpen, Volume 7, pp 4-8; doi:10.33393/abtpn.2020.2030
Introduction: Granulocyte-colony stimulating factors (G-CSFs) can significantly reduce the risk of febrile neutropenia (FN) among certain patients receiving chemotherapy. FN is associated with significant clinical and nonclinical complications. At present, the patent protection of pegfilgrastim (Neulasta®) has expired, and a biosimilar (Ziextenzo®) has been approved. Since the biosimilar price is expected to be lower as compared with the originator’s, the present Drug Budget Impact analysis tries to evaluate whether and how much profitable the biosimilar availability will be for the Italian NHS, in terms of cost containment (savings). Methods and Results: The model time horizon extends to five years. The initial overall number of treatments with pegfilgrastim is estimated based on the number of pegfilgrastim packages (assuming a recommended dose of 6 mg is administered after each cytotoxic chemotherapy) and kept constant in time. The model assumes that, year by year, the number of treatments with the originator will partly switch to the biosimilar (according to an uptake rate assumed). The results show that the availability of the biosimilar would provide an €6.4 million cumulated savings to the NHS in the five years. Conclusions: According to the present analysis, the availability of the biosimilar would generate cumulated savings (in five years) as high as €6.4 million for the Italian NHS.
AboutOpen, Volume 6, pp 86-89; doi:10.33393/abtpn.2019.300
Bedside measurement of respiratory mechanics allows to closely monitor the lung function in critically ill patients. The two fundamental parameters describing the respiratory system mechanics are resistance and compliance. Resistance of the respiratory system describes the opposition to gas flow during inspiration. During volume-controlled ventilation, resistance can be calculated as the ratio between the peak to plateau pressure drop and the resulting flow rate. Compliance describes the elastic property of the respiratory system, comprising the lung and the chest wall. It is the ratio between a change in volume (i.e. tidal volume) and the corresponding change in pressure, calculated as the difference between plateau pressure and total positive end-expiratory pressure, measured by end-inspiratory and end-expiratory manual occlusion, respectively. In this review, we describe how to measure respiratory mechanics at the bedside, starting from the physiological background of the equation of motion of the respiratory system. (Intensive care)
AboutOpen, Volume 6, pp 78-85; doi:10.33393/abtpn.2019.302
Introduction: Multicriteria Decision Analysis (MCDA) provides a framework that enhances transparency and repeatability of decisions taken on a multicriteria basis. Objective: This analysis aims at assessing obinutuzumab compared to rituximab used as a first-line treatment for Follicular Lymphoma (FL) in the Italian health care system, using an MCDA approach. Materials and Methods: We used the EVIDEM V10 MCDA framework and a Delphi approach to scrutinize the views of a panel of physicians, payers and patients on value domains and their application to our research target. Results: All stakeholders attached medium-high scores to FL severity (patients at higher risk of relapsing), unmet needs, obinutuzumab clinical benefit and evidence quality, and lower scores to organizational impact and, except for payers, to costs. The comparative analysis highlighted positive scores for the domains “incremental efficacy” (2.6: range −5/+5) and “incremental patient benefit” (1.5: range −5/+5) of obinutuzumab compared to rituximab. A slight increase of severe adverse events (≥3) for obinutuzumab was estimated by the panellists. Obinutuzumab compared to rituximab received a neutral evaluation for costs and for organizational impact. Conclusion: This study reveals that MCDA could be a useful framework for evaluating a drug and it can be used to elicit the views of different stakeholder groups (as patients). The key criteria driving the value of obinutuzumab
AboutOpen, Volume 6, pp 76-77; doi:10.33393/abtpn.2019.297
AboutOpen, Volume 6, pp 70-75; doi:10.33393/abtpn.2019.294
On 26 May 2017, the Medical Devices Regulation (MDR 2017/745) was published, with the aim of replacing the current Medical Devices Directive (MDD 93/43/EC). Following a transition period of 3 years, this regulation will be applied in full from 26 May 2020. This article describes and discusses the impact of MDR on the clinical evaluation and gives advice to manufacturers on the preparation, planning and implementation of processes to support compliance with the new regulation. (HTA & Market Access)
AboutOpen, Volume 6, pp 55-61; doi:10.33393/abtpn.2019.287
A meta-analysis is a statistical technique used to assess the data of independent studies concerning the same clinical scenario, in order to synthesize results that are reported as effect estimate. The strength of a meta-analysis lies in its potential to combine the results of studies characterized by different size and that may have been underpowered to answer clinically relevant questions. Furthermore, meta-analyses can be used to clarify questions for which large randomized controlled trials have not led to consensus within the scientific community. The effect estimate resulting from a meta-analysis should be interpreted both from a statistical and clinical point of view. The clinical interpretation of the effect estimate must take into consideration the minimal clinically important differences compared to the comparator, which may be placebo and/or other active treatments. In this review we consider the key points needed to correctly and critically interpret the current meta-analyses, and to assess how reliable are the results from a statistical and clinical point of view.