On March 28, 2020, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the use of hydroxychloroquine and chloroquine for certain hospitalized patients diagnosed with coronavirus disease 2019 (COVID-19). 1 Hydroxychloroquine and chloroquine have long been approved for the prophylaxis and treatment of malaria, with the former also used in the treatment of systemic lupus erythematosus and rheumatoid arthritis. Although these drugs appear to inhibit coronavirus replication in vitro, at the time of the EUA, there was no reliable clinical evidence to support the use of these drugs to treat COVID-19 in patients.An EUA is an authorization for the use of unapproved medical products or unapproved uses of approved medical products during a public health emergency. The FDA Commissioner has the authority to issue EUAs after the Secretary of Health and Human Services declares a public health emergency. The EUA can only be issued for "serious or life-threatening" 2 conditions for which there are no alternative treatments available. The criteria require that "it is reasonable to believe that the product may be effective" given "the totality of scientific evidence" and that the "known and potential benefits…outweigh the known and potential risks of the product." 2 As of April 30, 2020, the FDA had issued 174 EUAs, of which 143 (82.2%) have been for diagnostic tests for disease outbreaks that have affected the US. Only 4 EUAs (2.3%) had been issued for therapeutics: separate EUAs each for oseltamivir, zanamivir, and peramivir for the treatment of the 2009 influenza A(H1N1), and an EUA for hydroxychloroquine and chloroquine (issued in the same EUA) for COVID-19.During the influenza A(H1N1) pandemic, all patients who were diagnosed early and were tested for susceptibility to existing influenza treatments showed susceptibility to oseltamivir and zanamivir. These medicines were approved for the treatment of influenza A (of which H1N1 is a subtype). They had promising susceptibility testing and established safety profiles. Coupled with a need to treat seriously ill patients, oseltamivir (an oral formulation) and zanamivir (an inhaled formulation) were authorized under EUAs for more expansive use outside their approved indications.Investigations of new, unapproved therapies for the treatment of influenza A(H1N1) continued given the need for an intravenous treatment for severely ill patients and increasing antiviral resistance. Peramivir emerged as a potential therapeutic with encouraging results. A phase 1 study demonstrated few safety concerns with peramivir. The FDA also evaluated 3 phase 2 and phase 3 trials VIEWPOINT
Purpose Liver diseases including non-alcoholic fatty liver disease (NAFLD) and ensuing alterations to the micro-environment may affect development of liver metastasis. Mirroring the rise in obesity rates, prevalence of NAFLD is increasing globally. Our objective was to examine the association between NAFLD and mortality in colorectal cancer patients. Methods Colorectal Cancer-Sarcopenia and Near-term Survival (C-SCANS) is a retrospective cohort study which included 3,262 stage I-III patients, aged 18–80 years, and diagnosed between 2006 and 2011 at Kaiser Permanente Northern California. Cox proportional hazards regression was used to calculate multivariable adjusted hazard ratios (HR) and 95% confidence intervals (CI). Results After up to 10 years of follow-up, 879 deaths, including 451 from CRC were identified. Cases diagnosed with NAFLD before and within 1 month after CRC diagnosis (pre-existing NAFLD; n = 83) had a HR of 1.64 (95% CI 1.06–2.54) for overall and a HR of 1.85 (95% CI 1.03–3.30) for CRC-specific mortality compared to those without NAFLD. Findings did not differ significantly by sex, stage, tumor location, and smoking status, and were also similar when restricted to obese patients only. Conclusions Independent of body mass index and prognostic indicators, CRC patients with pre-existing NAFLD had a worse prognosis than those without NAFLD.
This cross-sectional study examines the characteristics of prior authorization policies for new drugs in Medicare Part D to understand whether they are consistent with US Food and Drug Administration indications.
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