Evaluation of Progesterone Agent Utilization and Birth Outcomes in a State Medicaid Plan

An analysis of medication adherence and birth outcomes among members receiving progesterone for the prevention of preterm birth in a state Medicaid program. Data is also used to evaluate the association between member characteristics and medication adherence and birth outcomes as well as whether there was a change in the cost of care

Uptake of Direct Acting Antivirals for Hepatitis C Virus in a New England Medicaid Population, 2014-2017

Introduction Introduction of the direct acting antiviral (DAA) sofosbuvir (SOV) in 2013 offered significant improvement over previous options for hepatitis C virus (HCV) treatment. Initial uptake was low in Medicaid and other populations, perhaps in part due to high drug cost and prior authorization (PA) restrictions related to fibrosis stage, prescribing provider specialty, and sobriety. Both the subsequent introduction of ledipasvir/sofosbuvir (LDV/SOV), an all-oral regimen for most genotypes, and lifting of PA restrictions were expected to increase overall uptake, but little is known about recent prescribing patterns. We examined trends in DAA uptake in a Medicaid population and identified the effect of these two events on treatment initiation. Study Design An interrupted time series (ITS) design utilized enrollment, medical, and pharmacy claims from Medicaid enrollees in three New England states, 12/2013-12/2017. Trends in treatment uptake, defined as 1+ pharmacy claim for a DAA, were examined overall, by demographic characteristics, and prior to and after two time points: 10/2014 (LDV/SOV approval date) and 7/2016 (date PA restrictions affecting two-thirds of members were lifted). Chi-square evaluated demographic differences, segmented regression models examined trends. Study Population The population included members ages 18-64 years with HCV (2+ claims with ICD-9/10 code for HCV or 1+ claim for chronic HCV). Eligible individuals remained in the sample until treatment initiation or Medicaid disenrollment. Findings The analytic sample averaged 30,433 members with HCV per month, mean age 42.9 years, 60% male. In 2014 3.3% of eligible members initiated treatment, increasing to 7.7% in 2017 (p = Conclusion While initial uptake of DAAs was low in this multi-state Medicaid population, treatment initiation among eligible members increased through 2017. Introduction of new medications and lifting of PA restrictions led to an immediate increase in uptake followed by relatively flat monthly utilization. Policy implications Sharp increases in uptake after LDV/SOV introduction may indicate warehousing of members in anticipation of LDV/SOV approval; increases after PA restrictions were lifted indicates demand for treatment among those affected by restrictions. As a large percentage of the Medicaid HCV population remains untreated, planned provider interviews will help to understand barriers and facilitators of treatment for HCV

Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trial

Background—Children account for a substantial proportion of cases and deaths from Ebola virus disease. We aimed to assess the safety and immunogenicity of a two-dose heterologous vaccine regimen, comprising the adenovirus type 26 vector-based vaccine encoding the Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia Ankara vectorbased vaccine, encoding glycoproteins from the Ebola virus, Sudan virus, and Marburg virus, and the nucleoprotein from the Tai Forest virus (MVA-BN-Filo), in a paediatric population in Sierra Leone. Methods—This randomised, double-blind, controlled trial was done at three clinics in Kambia district, Sierra Leone. Healthy children and adolescents aged 1–17 years were enrolled in three age cohorts (12–17 years, 4–11 years, and 1–3 years) and randomly assigned (3:1), via computer-generated block randomisation (block size of eight), to receive an intramuscular injection of either Ad26.ZEBOV (5 × 1010 viral particles; first dose) followed by MVA-BN-Filo (1 × 108 infectious units; second dose) on day 57 (Ebola vaccine group), or a single dose of meningococcal quadrivalent (serogroups A, C, W135, and Y) conjugate vaccine (MenACWY; first dose) followed by placebo (second dose) on day 57 (control group). Study team personnel (except for those with primary responsibility for study vaccine preparation), participants, and their parents or guardians were masked to study vaccine allocation. The primary outcome was safety, measured as the occurrence of solicited local and systemic adverse symptoms during 7 days after each vaccination, unsolicited systemic adverse events during 28 days after each vaccination, abnormal laboratory results during the study period, and serious adverse events or immediate reportable events throughout the study period. The secondary outcome was immunogenicity (humoral immune response), measured as the concentration of Ebola virus glycoprotein-specific binding antibodies at 21 days after the second dose. The primary outcome was assessed in all participants who had received at least one dose of study vaccine and had available reactogenicity data, and immunogenicity was assessed in all participants who had received both vaccinations within the protocol-defined time window, had at least one evaluable post-vaccination sample, and had no major protocol deviations that could have influenced the immune response. This study is registered at ClinicalTrials.gov, NCT02509494. Findings—From April 4, 2017, to July 5, 2018, 576 eligible children or adolescents (192 in each of the three age cohorts) were enrolled and randomly assigned. The most common solicited local adverse event during the 7 days after the first and second dose was injection-site pain in all age groups, with frequencies ranging from 0% (none of 48) of children aged 1–3 years after placebo injection to 21% (30 of 144) of children aged 4–11 years after Ad26.ZEBOV vaccination. The most frequently observed solicited systemic adverse event during the 7 days was headache in the 12–17 years and 4–11 years age cohorts after the first and second dose, and pyrexia in the 1–3 years age cohort after the first and second dose. The most frequent unsolicited adverse event after the first and second dose vaccinations was malaria in all age cohorts, irrespective of the vaccine types. Following vaccination with MenACWY, severe thrombocytopaenia was observed in one participant aged 3 years. No other clinically significant laboratory abnormalities were observed in other study participants, and no serious adverse events related to the Ebola vaccine regimen were reported. There were no treatment-related deaths. Ebola virus glycoprotein-specific binding antibody responses at 21 days after the second dose of the Ebola virus vaccine regimen were observed in 131 (98%) of 134 children aged 12–17 years (9929 ELISA units [EU]/mL [95% CI 8172–12 064]), in 119 (99%) of 120 aged 4–11 years (10 212 EU/mL [8419–12 388]), and in 118 (98%) of 121 aged 1–3 years (22 568 EU/mL [18 426–27 642]). Interpretation—The Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen was well tolerated with no safety concerns in children aged 1–17 years, and induced robust humoral immune responses, suggesting suitability of this regimen for Ebola virus disease prophylaxis in children