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Response to Orellano et al. regarding cost-utility analysis of dengue vaccination in a country with heterogeneous risk of dengue transmission
Vaccine 34 (2016) 3222
Contents lists available at ScienceDirect
Vaccine journal homepage: www.elsevier.com/locate/vaccine
Letter to the Editor Response to Orellano et al. regarding cost-utility analysis of dengue vaccination in a country with heterogeneous risk of dengue transmission Keywords: Dengue Dengue vaccines Cost-utility analysis Argentina
Orellano et al. recently reported the cost-effectiveness of dengue vaccination in a country with heterogeneous risk of dengue transmission like Argentina [1]. The incremental cost-effectiveness ratio (ICER) of the vaccination program was found to be US$ 5714 per DALY averted and the authors concluded that vaccination would be cost-effective. The study has several major limitations that make the results inconclusive. As Argentina is currently undergoing a dengue outbreak, these results could have a high impact not only on scientific spheres, but also on health decision makers, the media and civil society. These are the main reasons why we consider relevant the following clarifications. The analysis assessed the hypothetical vaccination of children of 2 years of age while the only licensed vaccine (CYD-TDV, Sanofi Pasteur) is recommended from 9 years of age based on efficacy and safety reasons [2]. Moreover, vaccine efficacy inputs were based on Villar et al. results, from Latin-American highly endemic countries, where 80% of participants were seropositive for dengue at baseline [3]. In that study, efficacy was much higher in children with baseline antibodies against dengue (83.7%, 95% CI, 62.2–93.7) than among children without evidence of immunity (43.2%, 95% CI, −61.5 to 80.0). In Argentina, viral circulation has a seasonal behavior, is extremely variable from year to year, and predominates in a limited number of provinces. So, it is expected that the majority of the population lack of a priming response against dengue. Thus, the pooled vaccine efficacy of 64.7% observed in that pivotal study, and used in the model, may not be reproducible in our country. Furthermore, the vaccine price per dose was estimated at US$ 0.58 based on production costs of a different vaccine, still under investigation [4]. The prices afforded by the Ministry of Health of Argentina to incorporate a new vaccine into the regular calendar usually exceed this value by more than 10–20 times. This was the
http://dx.doi.org/10.1016/j.vaccine.2016.03.099 0264-410X/© 2016 Elsevier Ltd. All rights reserved.
case, for instance, of pneumococcal conjugate vaccine, HPV and rotavirus vaccines. So, the maximum vaccine price per dose, of US$1.49 that the analysis proposes to the strategy still be considered cost-effective, would be far outweighed in a real-life scenario. Clearly, since the previously discussed variables were some of the most affecting ICER values in the sensitivity analysis, they should be the most accurate as possible. Local cost-effectiveness analyses are relevant as a tool for health decision making. However, it is crucial to incorporate the most realistic data into the model to return plausible results and not generate false expectations. This is relevant not only for Argentina but also for other countries that share a similar epidemiological situation. References [1] Orellano PW, Reynoso JI, Stahl H-C, Salomon OD. Cost-utility analysis of dengue vaccination in a country with heterogeneous risk of dengue transmission. Vaccine 2016;34:616–21. [2] Hadinegoro SR, Arredondo-García JL, Capeding MR, Deseda C, Chotpitayasunondh T, Dietze R, et al. Efficacy and long-term safety of a dengue vaccine in regions of endemic disease. N Engl J Med 2015;373(Sept 24):1195–206. [3] Villar L, Dayan G, Arredondo-García J, Rivera D, Cunha R, Deseda C, et al. Efficacy of a tetravalent dengue vaccine in children in Latin America. N Engl J Med 2015;372:113–23. [4] Mahoney RT, Francis DP, Frazatti-Gallina NM, Precioso AR, Raw I, Watler P, et al. Cost of production of live attenuated dengue vaccines: a case study of the Instituto Butantan, Sao Paulo, Brazil. Vaccine 2012;30:4892–6.
˜ a,∗ Analía Uruena Carla Vizzotti a Jorge A. San Juan b a Dirección Nacional de Control de Enfermedades Imunoprevenibles, Ministerio de Salud de la Nación, Av Rivadavia 875 1◦ P(C1002AAG) , Ciudad Autónoma de Buenos Aires, Argentina b Dirección Nacional de Epidemiología y Riesgos, Ministerio de Salud de la Nación, Av 9 de Julio 1925 (C1073ABA) , Ciudad Autónoma de Buenos Aires, Argentina ∗ Corresponding author. E-mail address: [email protected] ˜ (A. Uruena)
Contents lists available at ScienceDirect
Vaccine journal homepage: www.elsevier.com/locate/vaccine
Letter to the Editor Response to Orellano et al. regarding cost-utility analysis of dengue vaccination in a country with heterogeneous risk of dengue transmission Keywords: Dengue Dengue vaccines Cost-utility analysis Argentina
Orellano et al. recently reported the cost-effectiveness of dengue vaccination in a country with heterogeneous risk of dengue transmission like Argentina [1]. The incremental cost-effectiveness ratio (ICER) of the vaccination program was found to be US$ 5714 per DALY averted and the authors concluded that vaccination would be cost-effective. The study has several major limitations that make the results inconclusive. As Argentina is currently undergoing a dengue outbreak, these results could have a high impact not only on scientific spheres, but also on health decision makers, the media and civil society. These are the main reasons why we consider relevant the following clarifications. The analysis assessed the hypothetical vaccination of children of 2 years of age while the only licensed vaccine (CYD-TDV, Sanofi Pasteur) is recommended from 9 years of age based on efficacy and safety reasons [2]. Moreover, vaccine efficacy inputs were based on Villar et al. results, from Latin-American highly endemic countries, where 80% of participants were seropositive for dengue at baseline [3]. In that study, efficacy was much higher in children with baseline antibodies against dengue (83.7%, 95% CI, 62.2–93.7) than among children without evidence of immunity (43.2%, 95% CI, −61.5 to 80.0). In Argentina, viral circulation has a seasonal behavior, is extremely variable from year to year, and predominates in a limited number of provinces. So, it is expected that the majority of the population lack of a priming response against dengue. Thus, the pooled vaccine efficacy of 64.7% observed in that pivotal study, and used in the model, may not be reproducible in our country. Furthermore, the vaccine price per dose was estimated at US$ 0.58 based on production costs of a different vaccine, still under investigation [4]. The prices afforded by the Ministry of Health of Argentina to incorporate a new vaccine into the regular calendar usually exceed this value by more than 10–20 times. This was the
http://dx.doi.org/10.1016/j.vaccine.2016.03.099 0264-410X/© 2016 Elsevier Ltd. All rights reserved.
case, for instance, of pneumococcal conjugate vaccine, HPV and rotavirus vaccines. So, the maximum vaccine price per dose, of US$1.49 that the analysis proposes to the strategy still be considered cost-effective, would be far outweighed in a real-life scenario. Clearly, since the previously discussed variables were some of the most affecting ICER values in the sensitivity analysis, they should be the most accurate as possible. Local cost-effectiveness analyses are relevant as a tool for health decision making. However, it is crucial to incorporate the most realistic data into the model to return plausible results and not generate false expectations. This is relevant not only for Argentina but also for other countries that share a similar epidemiological situation. References [1] Orellano PW, Reynoso JI, Stahl H-C, Salomon OD. Cost-utility analysis of dengue vaccination in a country with heterogeneous risk of dengue transmission. Vaccine 2016;34:616–21. [2] Hadinegoro SR, Arredondo-García JL, Capeding MR, Deseda C, Chotpitayasunondh T, Dietze R, et al. Efficacy and long-term safety of a dengue vaccine in regions of endemic disease. N Engl J Med 2015;373(Sept 24):1195–206. [3] Villar L, Dayan G, Arredondo-García J, Rivera D, Cunha R, Deseda C, et al. Efficacy of a tetravalent dengue vaccine in children in Latin America. N Engl J Med 2015;372:113–23. [4] Mahoney RT, Francis DP, Frazatti-Gallina NM, Precioso AR, Raw I, Watler P, et al. Cost of production of live attenuated dengue vaccines: a case study of the Instituto Butantan, Sao Paulo, Brazil. Vaccine 2012;30:4892–6.
˜ a,∗ Analía Uruena Carla Vizzotti a Jorge A. San Juan b a Dirección Nacional de Control de Enfermedades Imunoprevenibles, Ministerio de Salud de la Nación, Av Rivadavia 875 1◦ P(C1002AAG) , Ciudad Autónoma de Buenos Aires, Argentina b Dirección Nacional de Epidemiología y Riesgos, Ministerio de Salud de la Nación, Av 9 de Julio 1925 (C1073ABA) , Ciudad Autónoma de Buenos Aires, Argentina ∗ Corresponding author. E-mail address: [email protected] ˜ (A. Uruena)