Economic Analysis of the Immunostimulant OM-85 for the Prevention of Paediatric Recurrent Upper Respiratory Tract Infections

Ravasio, Roberto

doi:10.5301/grhta.5000200

Cited by 10 publications

(9 citation statements)

References 18 publications

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“…OM-85 was cost-effective in preventing ARI and also showed cost savings in over 70% of cases for direct costs with a reduction of 2.61 episodes of ARI during a follow-up of six months [ 18 ]. These results with OM-85 have been similar to those obtained in other countries such as France and Italy [ 17 , 19 , 20 ].…”

Section: Discussionsupporting

confidence: 89%

Podotimod in pediatric recurrent respiratory tract infections: a cost-utility analysis

2022

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Introduction Despite the growing evidence on efficacy, few economic evaluations have evaluated the cost-utility of Pidotimod (PDT) supplementation to decrease the probability of recurrent respiratory tract infections in children. This study aimed to determine the cost-utility of PDT to reduce the incidence rate of recurrent respiratory tract infections in children. Methods A decision tree model was used to estimate the cost and quality-adjusted life-years (QALYs) of PDT in a patient aged 1–6 with a history of recurrent respiratory tract infections. Multiple sensitivity analyses were conducted to evaluate the robustness of the model. Cost-effectiveness was evaluated at a willingness-to-pay (WTP) value of US$5180. Results The base-case analysis showed that compared with placebo, PDT was associated with lower costs and higher QALYs. The expected annual cost per patient with PDT was US$797 (CI 95% US$794- US$801) and with placebo was US$1175 (CI 95% US$1169- US$1181). The QALYs per person estimated with PDT was 0.95 (CI 95% 0.94–0.95) and with placebo was 0.94 (CI 95% 0.94–0.94). The NMB with PDT was US$ 4121 (CI 95% 4114–4127) and with placebo was US$ 3710 (CI 95% 3700–3720). This position of absolute dominance (PDT has lower costs and higher QALYs than placebo) of PDT it is unnecessary to estimate the incremental cost-effectiveness ratio. Conclusion In conclusion our study shows that PDT is a cost-effective strategy to reduce the incidence rate of recurrent respiratory tract infections in children. Our study provides evidence that should be used by decision-makers to improve clinical practice guidelines.

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Section: Discussionsupporting

confidence: 89%

Podotimod in pediatric recurrent respiratory tract infections: a cost-utility analysis

2022

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“…Previous pharmacoeconomic evaluations have studied immunostimulants for preventing pediatric ARTIs [20–22]. For example, Pessey 2003 [20] evaluated the pharmacoeconomic value of using OM-85 for the prevention of rhinopharyngitis in French children, based on the low efficacy reported in three European studies [11, 13, 16] and the cost structure of the French Social Security system.…”

Section: Discussionmentioning

confidence: 99%

“…They estimated that the use of OM-85 in ARTI prevention would be cost-effective, when more than 7% of upper ARTIs were prevented and the total cost of treating one upper ARTI was greater than €10.00. Another Italian pharmacoeconomic evaluation [22] estimated that a complete course of OM-85 would reduce the number of ARTIs by 1.2/pediatric patient in a six-month period. This would achieve a savings of €40.30/patient (2015 prices), from the perspective of the National Health Service, and the savings would be €182.99/patient, from the perspective of the community.…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness analysis of OM-85 vs placebo in the prevention of acute respiratory tract infections (ARTIs) in children that attend day-care centers

Berber¹,

Del-Río-Navarro

2019

Health Econ Rev

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BackgroundChildren that attend day-care centers frequently contract acute respiratory tract infections (ARTIs). ARTIs represent a burden for both children and parents. Systematic reviews on the use of immunostimulants for the prevention of juvenile recurrent ARTIs have provided moderate evidence of efficacy and safety. The aim of the study was to establish whether the immunostimulant, OM-85, was cost-effective in preventing ARTIs in children 2–6 years old that attended day-care centers or preschools in Mexico. We performed a systematic review to evaluate the efficacy of OM-85. For costs, we assumed an institutional perspective, which included the costs of care and supplies over a study period of six months, during the autumn-winter seasons. We created decision trees and constructed a model to identify pharmacoeconomic parameters. We generated 1000 estimations with the bootstrap method to calculate descriptive statistics of pharmacoeconomic parameters. We evaluated cost-effectiveness compared to treatment without immunostimulants.ResultsThe mean (SD) incidences of ARTIs were 5.59 ± 0.29 without immunostimulants and 2.97 ± 0.32 with OM-85, during the study period. The mean (25th, 75th percentile) direct costs of ARTIs were 57.04 (37.11, 76.39) US$ (US dollars) without immunostimulants and 48.53 (37.35, 58.93) US$ with OM-85, with a mean increment of − 8.51(− 17.08, 0.75) US$, and a mean cost-effectiveness of − 17.94 (− 36.48, 1.66) US$. The direct costs plus the cost of one parent missing work to care for the child with ARTI were 125.76 (102.83, 150.16) US$, without immunostimulant and 85.21 (72.15, 98.81) US$, with OM-85. The increment was − 40.55 (− 68.29, − 13.95) US$, and the cost-effectiveness was − 86.89 (− 142.37, − 29.34) US$.Part of the cost reduction was ascribed to the reduced use of medications, particularly antibiotics.ConclusionsOur results were consistent with previous clinical studies conducted in closed institutions in Mexico. OM-85 reduced the number of ARTIs and the frequency of antibiotics use. We concluded that OM-85 was cost-effective for preventing ARTIs in children that attended day-care centers, particularly when parental absenteeism was covered by the institutions.

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“…Therefore the described pre-clinical observations explain the clinical efficacy of OM-85 BV in the prevention of RTIs in children and adolescents, the reduction of symptoms severity and duration, as well as of missed days of school, as it is shown in systematic reviews and meta-analysis [ 15 , 16 , 18 , 21 ]. The reduction of bacterial complications that are associated with higher morbidity, antibiotic prescription, referral visits to a specialist, and hospitalizations, can also contribute to the control of health care costs [ 41 ].…”

Section: Discussionmentioning

confidence: 99%

“…Considering the recent insights challenging the role of viral versus viral-bacterial co-infections [ 41 – 46 ] in the origin and the pathogenesis of RTI diseases (namely COPD and asthma), the dual and potentially “synergistic” immune response exemplified by OM-85 in these various studies may bring one more additional layer of its mode of action. Since both viruses and bacteria are involved in the pathogenesis of acute and recurrent RTIs, the combined action of OM-85 against both type of pathogens described in the present post-hoc analysis may contribute to explain the positive clinical results obtained in the prevention these common disorders [ 47 ].…”

Section: Discussionmentioning

confidence: 99%

Evidence that a primary anti-viral stimulation of the immune response by OM-85 reduces susceptibility to a secondary respiratory bacterial infection in mice

et al. 2018

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BackgroundViral respiratory infections may promote bacterial super-infection decreasing the host immune response efficiency. However, using a mice model we recently demonstrated that preventive treatment with the bacterial extract OM-85 reduces the susceptibility to a secondary Streptococcus (S.) pneumoniae infection after influenza virus (I.V.) challenge.MethodsTo better characterize the efficacy of OM-85 against S. pneumoniae super-infection, a post-hoc analysis was conducted, comparing efficacy (survival) and morbidity signs (clinical score, body temperature and weight loss) in the OM-85 and the control (BLANC) groups of mice after: a) I.V. infection; b) primary S. pneumoniae infection and c) post-I.V. S. pneumoniae super-infection.ResultsAfter a sublethal I.V. dose, all mice stayed alive at day 5 and no differences in morbidity signs were detected between the OM-85 and the BLANC groups. However, OM-85 pretreatment led to a significantly reduction of the viral load in the lung on day 5 post viral infection and, on day 10, reduced neutrophilic inflammation while increasing influenza-specific CD8 + T-cell proportion in the airways. Conversely to viral infection, exposure to S. pneumoniae induced a dramatic reduction of survival, with no mice surviving on day 3 post infection in the BLANC group, whereas a partial protective effect was observed in OM-85 pre-treated mice (20% of mice surviving at day 3, and 10% at day 4 and 5). The morbidity data substantiated the survival results. Interestingly, in the “super-infection” study, when mice were exposed to a sublethal I.V. dose followed by a secondary S. pneumoniae infection, all mice died by day 4 in the BLANC group. In contrast, in the OM-85 treated group, the survival rate was 70% at day 4 and still 50% at day 5, with positive effects on the clinical scores and on the body temperature already detectable at days 1 and 2.ConclusionsThe efficacy of OM-85 pre-treatment against S. pneumoniae super-infection reflects a strong and immediate immune reaction from the host, an event that can be explained in part by a “non-specific” activation of the immune system, a positive “immune effect” of the general OM-85- induced immune response against I.V.

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Economic Analysis of the Immunostimulant OM-85 for the Prevention of Paediatric Recurrent Upper Respiratory Tract Infections

Cited by 10 publications

References 18 publications

Podotimod in pediatric recurrent respiratory tract infections: a cost-utility analysis

Podotimod in pediatric recurrent respiratory tract infections: a cost-utility analysis

Cost-effectiveness analysis of OM-85 vs placebo in the prevention of acute respiratory tract infections (ARTIs) in children that attend day-care centers

Evidence that a primary anti-viral stimulation of the immune response by OM-85 reduces susceptibility to a secondary respiratory bacterial infection in mice

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