S43abstraction was done to capture deidentified patient characteristics, treatment decisions, and clinical events. ReSultS: Our research found that prior to 2014 only 14% of mCRPC patients received newer treatment options (abiraterone, enzalutamide, sipuleucel-T) as first-line treatment. Between 2015 and 2016, 37% of the patients received newer treatment options, and by 2016 and later this number rose to 77% of the patients. ConCluSionS: Though these results demonstrated the rapid adoption of newer treatment options in areas of high unmet needs like mCRPC, they also highlighted the need for continued physician education as nearly 25% of patients did not receive recommended newer options as their first-line treatment since 2016. +Cancer Facts & Figures 2017. American Cancer Society.
The increasing proportion of women conceiving later in life, associated with the higher probability of contracting a chronic disease, highlights an increasing need to understand the impact of drug use for chronic diseases pre- and postpartum. In this study, the authors report the results of systematic reviews of drug use during pregnancy by focusing on pregnant women with a chronic disease, specifically, epilepsy, rheumatoid arthritis (RA), or schizophrenia. The authors studied the clinical impact of drug use in these chronic diseases on the mother and fetus, as well as the ethical issues and socioeconomic impact of drug use during pregnancy for women with these conditions. The results indicate that treatment discontinuation in epilepsy and schizophrenia can lead to serious adverse effects, whereas pregnancy can have an ameliorating effect on RA symptoms. Delivery and neonatal complications were associated with the use of older generation drugs across the 3 diseases. Newer generation drugs were deemed safer but more expensive. Ethical considerations for physicians and patients involved mainly the potential risks of drug use for the fetus. In conclusion, treatment guidelines need to be developed in the future; additionally, better insight into the economics of pregnancy for women with chronic diseases will improve value for money in obstetric care.
Objectives: Regulators and HTA bodies are increasingly promoting early access to medicines for the treatment of diseases with unmet clinical need. A variety of different early access pathways have emerged across settings. A global survey was undertaken to identify, map, and differentiate early access pathways. MethOds: Two survey tools were developed to map early access pathways across 25 countries. The first tool included 28 questions on different types of accelerated marketing authorisation, and was distributed to a selection of contacts from a number of regulatory bodies (n= 12) . The second tool included 15 questions on the use of medicines prior to marketing authorization (MA) and was distributed to HTA agencies from a number of countries (n= 25). Both survey tools were available in English via Qualtrics from May 2017. Results: Preliminary results from the survey (n= 17) suggest that early access schemes can be grouped in four different pathways: a) MA with faster review time (n= 3), b) MA with lower evidence thresholds (n= 2), c) MA based on approval in other settings (n= 2), and d) access to medicines prior to MA (n= 14). Five regulatory bodies (EMA, FDA, MEDSAFE, PMDA, and HSA) reported some type of accelerated MA procedure. Fourteen countries
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