From Regulatory Approval to Subsidized Patient Access in the Asia-Pacific Region: A Comparison of Systems Across Australia, China, Japan, Korea, New Zealand, Taiwan, and Thailand

AbstractObjectivesTo compare processes and timings of regulatory and subsidized access systems for medicines across seven jurisdictions within the Asia-Pacific region.MethodsA questionnaire was developed focusing on regulatory and health technology assessment–based subsidized access processes and timings in each of the seven surveyant’s jurisdictions.ResultsAustralia and Thailand are the only two jurisdictions that formally allow the subsidized access evaluation process to be conducted in parallel with the regulatory evaluation process. Australian, Japanese, Korean, New Zealand, and Taiwanese systems afford broad coverage, whereas Chinese and Thai systems provide limited coverage for medicines under patent. Subsidized access systems for all jurisdictions except Thailand have an associated patient co-payment for each medicine/prescription. The biggest disparity across the study group relates to time from regulatory submission to subsidized access of patented medicines—ranging from just over 1 year (Japan) to a minimum of 5 years (China).ConclusionsThere is consistency across the seven jurisdictions studied in relation to regulatory and subsidized patient access processes—that is, regulatory approval is required before subsidized access review; subsidized access coverage is broad; and the cost of medicine subsidization is offset, in part, by patient co-payments. Although local differences will always exist in relation to budget and pricing negotiation, there may be efficiencies that can be applied across systems to improve time to subsidized access. Closer understanding of regulatory and subsidized access systems can lead to best-practice sharing and, ultimately, timely access and better health outcomes for patients

Fourth Annual Idaho Public Policy Survey 2019

The Fourth Annual Idaho Public Policy Survey was conducted December 10th to January 8th and surveyed 1,004 adults currently living in the state of Idaho. The sample is designed to be representative of the population, using a random-digit dialing sampling approach, with 60% of the respondents contacted on cell-phones to increase our coverage of the population. People were asked about their attitudes on the main issues and priorities facing the state, education, budget and taxes, criminal justice, and the environment. The sampling margin of error is 3.1%

Improved omit set displacement recoveries in dynamic analysis

Two related methods for improving the dependent (OMIT set) displacements after performing a Guyan reduction are presented. The theoretical bases for the methods are derived. The NASTRAN DMAP ALTERs used to implement the methods in a NASTRAN execution are described. Data are presented that verify the methods and the NASTRAN DMAP ALTERs

Potential health impacts of heavy metals on HIV-infected population in USA.

Noninfectious comorbidities such as cardiovascular diseases have become increasingly prevalent and occur earlier in life in persons with HIV infection. Despite the emerging body of literature linking environmental exposures to chronic disease outcomes in the general population, the impacts of environmental exposures have received little attention in HIV-infected population. The aim of this study is to investigate whether individuals living with HIV have elevated prevalence of heavy metals compared to non-HIV infected individuals in United States. We used the National Health and Nutrition Examination Survey (NHANES) 2003-2010 to compare exposures to heavy metals including cadmium, lead, and total mercury in HIV infected and non-HIV infected subjects. In this cross-sectional study, we found that HIV-infected individuals had higher concentrations of all heavy metals than the non-HIV infected group. In a multivariate linear regression model, HIV status was significantly associated with increased blood cadmium (p=0.03) after adjusting for age, sex, race, education, poverty income ratio, and smoking. However, HIV status was not statistically associated with lead or mercury levels after adjusting for the same covariates. Our findings suggest that HIV-infected patients might be significantly more exposed to cadmium compared to non-HIV infected individuals which could contribute to higher prevalence of chronic diseases among HIV-infected subjects. Further research is warranted to identify sources of exposure and to understand more about specific health outcomes

Rhinal cortex asymmetries in patients with mesial temporal sclerosis

SummaryPurposeThe rhinal cortex, comprising the entorhinal (ErC) and perirhinal (PrC) cortices, is one component of the limbic system that may be affected in patients with epilepsy and other temporal lobe pathologies. This study extended quantitative examination of the limbic system through development and validation of volumetric protocols to measure the ErC and PrC.MethodsVolumes were calculated from MRI studies using ANALYZE 7.5 and based on detailed anatomical definitions developed for the study. Subjects were 61 temporal lobe epilepsy patients with mesial temporal sclerosis (MTS: 33 left, 28 right) and 20 neurologically normal controls. Inter-rater reliabilities for the ErC and PrC volume protocols were found to be high (range 0.86–0.92).ResultsIpsilateral hippocampal volume was reduced in patients with MTS, while contralateral volume did not differ significantly from controls. In the patients, rhinal cortex volumes were reduced as a function of laterality of disease. The pattern of correlations between ErC and PrC differed between disease groups. Hippocampal and rhinal cortex volumes were not significantly correlated. A significant four-way interaction was found between side of MTS, hemisphere, structure and handedness.ConclusionsThis quantitative study demonstrates reliable in vivo evidence of morphometric changes in ErC and PrC in a substantial number of patients with unilateral MTS. The relationship observed between handedness, structure and disease status may suggest a role for cerebral dominance in modulating the expression of MTS

Intercomparison of remote and balloon-borne sensors operated at JAPE-91

In recent years, there has been an increased availability of different types of remote sensors for measuring atmospheric parameters. With the introduction of remote sensors into field operation, questions have arisen as to their accuracy and precision. An attempt was made to address this issue by analyzing and intercomparing sets of wind and temperature data obtained during the Joint Acoustic Propagation Experiment (JAPE-9l) conducted at White Sands Missile Range, New Mexico, in Jul. and Aug. 1991. The remote sensing systems that were deployed included a 924 MHz wind profiler, two Doppler acoustic sodars, and a Radio Acoustic Sounding System (RASS). In situ measurements of wind, temperature, and humidity were also obtained from radiosondes. Individual system characteristics and the results of intercomparing the derived wind and temperature data from each of the systems are presented

A linguistic ethnography of theatre production

Voices and Practices in Applied Linguistics comprises a selection of original applied linguistics-based research on the theme of the diversity of Applied Linguistics and in Applied Linguistics. It is a unique collection of reflections and cutting-edge research relating to academic, policy and professional fields of Applied Linguistics, featuring chapters written by founders of the field, established researchers, and rising stars. This accessible, eclectic and forward-looking volume is significant both for research and practice. It highlights current globalised perspectives on diversity in language use and communication, across a variety of contexts, and with a rich mix of frameworks, methodologies and participants. Compiled and edited by a team of academic experts in the field, this edited collection will be of interest to established and emerging researchers in Applied Linguistics globally. It will also be relevant to language professionals, practitioners, and policy makers. The volume draws together papers from the 2017 British Association for Applied Linguistics (BAAL) conference, marking the 50th anniversary of its inaugural meeting. Founded in the mid-1960s, this UK-based professional association provides a forum for Applied Linguistics and its annual meeting brings together researchers and language professionals from across this field

Putative Auditory-Evoked Neurophonic Measurements Using a Novel Signal Processing Technique: A Pilot Case Study

With changes to cochlear implant candidacy and improvements in surgical technique, there is a need for accurate intraoperative assessment of low-frequency hearing thresholds during cochlear implantation. In electrocochleography, onset compound action potentials (CAPs) typically allow estimation of auditory threshold for frequencies above 1 kHz, but they are less accurate at lower frequencies. Auditory nerve neurophonic (ANN) waveforms, on the other hand, may overcome this limitation by allowing phase-locked neural activity to be tracked during a prolonged low-frequency stimulus rather than just at its onset (Henry, 1995). Lichtenhan et al. (2013) have used their auditory nerve overlapped waveform (ANOW) technique to measure these potentials from the round windows of cats and guinea pigs, and reported that in guinea pigs these potentials originate in the cochlear apex for stimuli below 70 dB SPL (Lichtenhan et al., 2014). Human intraoperative round window neurophonic measurements have been reported by Choudhury et al. (2012). We have done the same in hearing impaired awake participants, and present here the results of a pilot study in which we recorded responses evoked by 360, 525, and 725 Hz tone bursts from the cochlear promontory of one participant. We also present a modification to the existing measurement technique which halves recording time, extracting the auditory neurophonic by recording a single averaged waveform, and then subtracting from it a 180° group-delayed version of itself, rather than using alternating condensation and rarefaction sound stimuli. We cannot conclude that the waveforms we measured were purely neural responses originating from the apex of the cochlea: as with all neurophonic measurement procedures, the neural responses of interest cannot be separated from higher harmonics of the cochlear microphonic without forward masking, regardless of electrode location, stimuli or post-processing algorithm. In conclusion, the extraction of putative neurophonic waveforms can easily be incorporated into existing electrocochleographic measurement paradigms, but at this stage such measurements should be interpreted with caution