Purpose To estimate the cost-effectiveness of Nefecon in addition to the best supportive care (BSC) vs BSC in a hypothetical cohort of commercially insured adult patients with primary immunoglobulin A nephropathy (IgAN) from a United States (US) societal perspective. Methods A lifetime horizon, semi-Markov model was developed that consisted of nine health states: chronic kidney disease (CKD) stage 1, 2, 3a, 3b, 4, end-stage renal disease (ESRD) with dialysis, ESRD without dialysis, post-kidney transplant, and death. Health state occupancy was estimated from individual patient-level data from the Phase 3 randomized controlled trial NefIgArd Part A (NCT03643965). Additional scenarios evaluated the impact of varying the time horizon, discounting, costs included, rounds of treatment, and the method used to calculate transition probabilities. Results In the deterministic base case analysis over a lifetime horizon, Nefecon plus BSC (hereafter Nefecon) had an incremental cost of $3,810 vs BSC. Nefecon resulted in a mean survival gain of 0.247 quality-adjusted life years (QALYs), 0.195 life years (LYs), and 0.244 equal value life years (evLYs) vs BSC alone – this resulted in incremental cost-effectiveness ratios (ICERs) of $15,428 per QALY, $19,502 per LY, and $15,611 per evLY gained. Probabilistic sensitivity analyses estimated that with willingness to pay thresholds of $100,000, $150,000, and $250,000 per QALY gained, Nefecon would be cost-effective over BSC in 66.70%, 75.02%, and 86.82% of cases, respectively. In the scenario analysis, Nefecon remained cost-effective with 4 rounds of treatment. Conclusion Nefecon was associated with LY and QALY gains vs BSC, with an incremental cost of $3,810. Based on these values, with a willingness to pay threshold of $100,000 per QALY gained, Nefecon was found to be a cost-effective treatment for US adults with primary IgAN.

Objective: The analysis estimates projected population outcomes resulting from the introduction of a plant-derived influenza vaccine formulated as quadrivalent virus-like particles (QVLP) in Canada. Methods: Using Monte Carlo simulations, the number of influenza cases, general practitioner visits, inpatient admissions, intensive care unit (ICU) admissions, and deaths due to influenza-associated illness were estimated under no vaccination, plant-derived QVLP vaccines only, or egg-derived vaccines only. The base case analysis examined the adult Canadian population in two subgroups: 18-64 years of age during the 2017/18 season and 65+ years of age during the 2018/19 season. Efficacy data were obtained from QVLP clinical trials. Vaccine effectiveness data for egg-derived vaccines were calculated from observational studies from the corresponding influenza seasons. Scenario analyses examined the impact of varying absolute vaccine effectiveness or vaccination coverage from base case inputs. Results: In the base case analysis, plant-derived QVLP vaccines led to an additional reduction in the burden of influenza over egg-derived vaccines for both population subgroups. In the 18-64 subgroup, QVLP vaccines were associated with 2.63% (48,029; 95% credible interval [Crl]: 42,336) fewer influenza cases than egg-derived vaccines. In the 65+ subgroup, QVLP vaccines led to 4.82% (27,918; 95% Crl: 25,397) fewer influenza cases, and reductions in the number of inpatient admissions by 4.77% (1167; 95% CrI: 851-1483) and deaths by 4.75% (326; 95% CrI: 107-546) compared to egg-derived vaccines. Further reductions were observed in scenario analyses considering the potential increase in vaccine coverage. Conclusion: Use of plant-derived QVLP influenza vaccines may contribute to greater reductions in influenza cases and influenza-related outcomes, including inpatient admissions and deaths, compared to egg-derived vaccines currently available in Canada.