Women In Drugs Outcomes Research and Policies: 2021

The opinion manuscript selected, by Sarri, focuses on the value of real-world evidence to inform health-care decisions. It provides a good overview of how data generated in a real-world environment can offer complementary evidence to randomized clinical trials, particularly by offering additional information such as longer-term effects of technologies, but also by leveraging clinicians' expectations on the real risk-benefit ratio of these technologies when used in nontargeted populations. Sarri also challenges us to reflect about the role of real-world designs to collate evidence about the experiences faced by disadvantaged population and the extent to which barriers in access to healthcare may impact on the true value of technologies. The expansion of the traditional cost-effectiveness models is proposed to quantify health equality impacts (1).The collection somehow aims to mimic the drug cycle, from the development of clinical trials to market entry until drug use, covering prescription, dispensing and patient utilization.Zhao and colleagues analyzed 72 registered clinical drug trials comprising pregnant women in China and reported these focused on three indications, osteoporosis, cancer and assisted reproduction, highlighting a significant shortage in safety trials of pregnancy-related drugs (2). The findings from this original research reinforce the points presented by Sarri on the need for real-world evidence to overcome shortfalls in information about medicines at the time of market approval (1). Daly et al reviewed economic models used in NICE's Technology Appraisals and used therapies for diabetes as an example. Through the analysis of ten Technology Appraisals pertaining to treatments of diabetes, they have concluded that there is scarce robust data informing risk equations to enable the derivation of transition probabilities. Although economic models are essential to support market entry decisions, key structural and methodological issues often impede or limit their value (3). HTA that foresees a component of re-appraisal seems therefore essential to base reimbursement decisions and make use of real-world evidence that may be generated after market entry.Moreira and colleagues explored the evolution of chemotherapy over 13 years and reported an increased consumption of over 50%, the highest contribution deriving from the use of oral forms and by the approval of 40 new cancer medications with higher costs (4). Using an alternative metric to drug consumption, they explored the varying impact on specific cancer sites, highlighting non-small cell lung cancer as an important driver of costs, aside with innovative therapies for advanced breast cancer. These authors conclude that the growing use of oral chemotherapy calls for investments in supporting patients in managing medication adherence and adverse events, which require changes in healthcare system organization.Aspects of health care functioning and the importance of interprofessional collaboration, aside with health information sharing platforms, is introduced by Costa and colleagues (5). These authors report on the cost-effectiveness and cost-utility of a collaborative care model to manage hypertension and hyperlipidemia involving pharmacies and primary care units. Even though the probability of the intervention to be cost-effective is below 30%, the innovative nature of the model established, calls for additional research in creating more sustainable solutions for primary care. A person-centered approach prioritizing investments in primary care somehow aligns with the conclusions drawn by Moreira et al (4). The Astana declaration, signed in 2018, calls for action in strengthening primary health care as the most inclusive and efficient approach to peoples' health and wellbeing (6).The high quality of the published papers in this collection demonstrates the capabilities of women researchers in this field and calls for more support to be available to them to continue their valuable contributions.