ABSTRACT
Introduction: Black and Latinx patients bear a disproportionate burden of asthma-related morbidity partly due to inadequate healthcare access. Telehealth could improve access, but its impact on asthma outcomes compared to in-person visits in these populations is unknown. Method(s): Black and Latinx adults with moderate-severe asthma were recruited from US clinics, including Puerto Rico for the PREPARE trial. For this ancillary study, 7/19 sites had available EMR data on asthma care appointment setting (telehealth vs. in-person). Participants whose asthma care included telehealth (TH) vs. those with exclusively in-person visits (IP) starting at COVID-19 pandemic onset (3/2020, greater telehealth prevalence) through 4/2021 (last PREPARE exit) were included if 2+ monthly PREPARE surveys were available for the post-index visit period. Asthma control (ACT) and asthma-related quality of life (ASUI) were compared between TH vs. IP. Result(s): Data were available for n=62 TH and n=36 IP participants, with comparable duration of follow-up (6.36 vs. 6.42 months, respectively). TH were more likely Latinx, from the Northeast, employed, only use inhaled corticosteroids as controller therapy, lower BMI, and lower self-reported asthma therapy adherence compared to IP. Before and after adjustment for these baseline differences and for PREPARE treatment assignment and baseline ACT and ASUI scores, TH and IP had comparable follow-up asthma control (ACT 18.43 vs. 18.93, respectively, p=0.519) and asthma-related quality of life (ASUI 0.79 vs. 0.84, respectively, p=0.163). Conclusion(s): Asthma control and asthma-related quality of life were comparable between TH and IP after adjustment. TH may represent a valuable asthma care option for Black and Latinx patients. Copyright © 2022
ABSTRACT
Objectives: To review and analyze the new early access authorization program in France launched in July 2021. Method(s): Treatments that were processed under the early access authorization program between July 2021 and June 2022 were analyzed. The assessments were examined for therapy area, processing timeline, and data used in the evaluation. Result(s): As of 30 June 2022, 55 of the 66 decisions (83%) that have been published by HAS were granted early access, and 11 (17%) applications were refused. Among those granted early access, 37 (67%) already had a marketing authorization (MA), of which 25 (68%) had conditional MA and 11 (30%) were granted orphan status;18 (33%) applied to the program before obtaining regulatory approval (pre-MA). Among the treatments granted early access after MA, one received ASMR II, 15 received ASMR III, 2 Received ASMR IV, 5 received ASMR V rating, and 13 had not been evaluated for the indication. The average time taken for the processing of all applications (receipt of complete file to date of adoption) was 65 days (range, 1-121);mean time for ANSM opinion on the product's presumed efficacy and safety in the absence of MA was 55 days (range, 4-112). Oncology drugs accounted for 21 (39%) of applications. Most decisions were based on phase 2-3 clinical data for technologies with or without MA. Only two positive, pre-MA early access authorization requests used phase 1 clinical data for treatments indicated in pre-exposure prophylaxis of coronavirus 2019 and unresectable or metastatic triple-negative breast cancer. Contributions from stakeholders, including patient and user groups, were involved in 39 (59%) applications (both pre-MA and post-MA). Conclusion(s): Overall, the time taken to evaluate the early access applications is significantly lower compared with the 3-month examination period stipulated by the program, facilitating a quick access to patients with high unmet need. Copyright © 2022