Cost-utility analysis and budget impact of benralizumab as add-on therapy to standard care for severe eosinophilic asthma in Colombia.

INTRODUCTION: Benralizumab, amonoclonal antibody for human interleukin-5, has been associated with adecrease in asthma exacerbations. The introduction of this drug raises concerns about the economic impact in scenarios with constraints. This study aimed to estimate the cost-utility of benralizumab plus standard care (SoC) vs. SoC alone in adults with severe uncontrolled asthma with evidence of eosinophilic phenotype. METHODS: We constructed aMarkov model with three health states (asthma on benralizumab and SOC, asthma on SOC alone, and death) from ahealthcare system perspective over alifetime horizon. The model was populated using local costs while utilities were derived from international literature. Cost and transition probabilities were obtained from amixture of Colombian-specific and internationally published data. RESULTS: The incremental cost-effectiveness ratio (ICER) per patient peryear was $US 42,746per QALY gained. Benralizumab treatment would be cost-effective at the recommended societal US 18,000 WTP threshold if the cost of benralizumab is reduced by 41% more than the base case value. CONCLUSION: Benralizumab is not cost-effective using WTP of US$18,000per QALY threshold in Colombia. Our study provides evidence that should be used by decision-makers to improve clinical practice guidelines.

[Predictors of hospitalization plus airway support among infants with recurrent wheezing in the emergency department].

OBJECTIVE: Most patients with recurrent wheezing are infants under 2 years of age. Clinical prediction models of the risk of receiving airway support during the hospital stay in this population have been poorly studied in tropical countries. This study aimed to evaluate the clinical predictors of hospitalization plus airway support among infants with recurrent wheezing evaluated in the emergency department in Colombia. METHODS: A retrospective cohort study was performed. This study included all infants with two or more wheezing episodes who were younger than two years old in two tertiary centers in Rionegro, Colombia, between January 2019 and December 2019. The primary outcome measure was hospitalization plus any airway support. A multivariable logistic regression model was used to identify factors independently associated with hospitalization plus any airway support. RESULTS: A total of 85 infants were hospitalized plus any airway support, of whom 34(40%) were treated with high flow nasal canula, 2(2%) received non-invasive ventilation, 6(7%) were mechanically ventilated, and 43 (51%) received conventional oxygen therapy. The multivariable logistic regression model showed that predictors of hospitalization plus airway support included prematurity (OR=1.79, 95%CI: 1.04-3.10), poor feeding (OR=2.22, 95%CI: 1.25-3.94), nasal flaring and/or grunting (OR=4.27, 95%CI: 2.41-7.56), and previous wheezing episodes requiring hospitalization (OR=3.36, 95%CI: 1.86-7.08). The model has a high specificity (99.6%) with acceptable discrimination and an area under the curve of 0.70(95%CI: 0.60-0.74). CONCLUSIONS: The present study shows that prematurity, poor feeding, nasal flaring and/or grunting, and more than one previous episode of wheezing requiring hospitalization are independent predictors of hospitalization plus airway support in a population of infants with recurrent wheezing in the emergency department. More evidence must be collected to examine the results in other tropical countries.

Implications of global pricing policies of pharmaceuticals for access the innovative drugs: the case of trastuzumab in seven Latin American countries

Background: Differential pricing (DP) on the basis of countries' purchasing power has been recommended by the WHO to secure more affordably priced medicines. However, in developing counties (DC) many innovative drugs have similar or even higher prices than in high-income countries (HIC). We conducted a cost-effectiveness (CE) analysis to estimate the impact of this pricing policy on the CE of trastuzumab in Latin-America (LA). Methods: Model structure and a common methodology for identifying costs and resource use were agreed with country teams. A Markov model was designed to evaluate life years (LY), quality adjusted life years (QALYs) and costs \r\nfrom a health care sector perspective. A systematic search on effectiveness, local epidemiology and costs studies was undertaken to populate the model. A base case scenario using transition probabilities from trastuzumab clinical trials, and two alternative scenarios with transition probabilities adjusted to reflect breast cancer epidemiology in each country, were built to better fit local cancer prognosis. Findings: Incremental discounted benefits and costs of the trastuzumab strategy ranged from 0·87 to 1·00 LY, 0·51 to 0·60 QALY and $24,683 to $60,835 (2012 US dollars). Incremental CE ratios ranged from $42,104 to $110,283 per QALY, equivalent to 3·6 gross domestic products per capita (GDPc) per QALY in Uruguay to up to 35·5 GDPc per QALY in Bolivia. The probabilistic sensitivity analysis showed a 0% probability that trastuzumab is CE if the willingness-to-pay (WTP) threshold is one GDPpc per QALY, and remains 0% at a WTP threshold of three GDPc except in Chile and Uruguay (probability 4·3% and 26·6% respectively). Conclusion: Despite its proven CE in other settings, trastuzumab was not CE in LA at its current price. Better cooperation between the public and private sectors is still needed to make innovative drugs available and affordable in DC.