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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">An&#225;lisis del coste incremental por respondedor &#40;PASI75&#44; PASI90 y PASI100&#41; basado en un metaan&#225;lisis en red de tratamientos biol&#243;gicos para la psoriasis&#58; Espa&#241;a 2018</p><p id="par0010" class="elsevierStylePara elsevierViewall">Incremental Cost per Responder &#40;PASI-75&#44; PASI-90 and PASI-100&#41; Based on a Network Meta-Analysis of Biologic Therapies for Psoriasis&#58; Spain 2018</p><p id="par0015" class="elsevierStylePara elsevierViewall">Network meta-analysis&#44; which now has a well-established methodology&#44; provides information on the relative efficacy of a number of treatments using data from clinical trials that directly compare two or more drugs in addition to indirect comparisons based on data from different trials using the same comparator&#46; Variations between trials are adjusted to the reference arm response rates&#46; Meta-analysis results can be expressed as the differential response compared to placebo &#40;either as a percentage or its corresponding decimal value&#41; or as its inverse&#8212;the number needed to treat &#40;NNT&#41;&#44; that is&#44; the number of patients that must be treated to achieve a responder&#46; The NNT and the incremental cost per responder&#8212;calculated by multiplying the NNT for the drug by the cost for the period considered&#8212;provide reliable values that allow us to compare the expected effectiveness of different treatments at various response levels&#44; a datum with important clinical and economic implications for physicians and those responsible for making decisions on treatment funding and reimbursement&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The objective of the study in this issue<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a> was to evaluate the cost-effectiveness of ixekizumab as afirst-line biologic for the treatment of psoriasis and to compare it with that of other biologic agents based on data from a recently published network meta-analysis&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a> Employees of the company that markets ixekizumab were involved in carrying out the network meta-analysis&#46; The main interest of the article is that it is the first study to provide data on ixekizumab in Spain&#46; In addition to the information provided by the health technology agencies&#39; assessments&#44; a study similar to this one has recently been published in the United States&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">The methodology and results of the study are valid&#44; but the terminology used for the outcome of interest &#40;&#8220;cost per NNT&#8221;&#41; is debatable&#58; it would probably be preferable to use the expression &#8220;&#40;incremental&#41; cost per successfully treated patient&#8221;&#46; The cost per NNT values &#40;cost x NNT&#41; corresponding to each response level are calculated by multiplying the cost of treatment by the respective NNT value &#40;and the 95&#37; credible interval&#41;&#46; However&#44; by analogy with widely used concepts such as &#8220;cost per patient&#8221; or &#8220;cost per day&#8221;&#44; the term &#8220;cost per NNT&#8221; suggests that the NNT is dividing &#40;cost&#47;NNT&#41; rather than multiplying the cost&#46; The term <span class="elsevierStyleItalic">incremental</span> is not relevant in this particular case because the cost of placebo is considered to be zero&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">In the analysis by N&#250;&#241;ez et al&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a> the population corresponds to the Summaries of Product Characteristics&#44; in each case&#44; and treatment response is expressed as the percentage of reduction in the Psoriasis Area and Severity Index &#40;PASI&#41; with respect to baseline&#44; with 3 different levels of efficacy &#40;PASI 75&#44; PASI 90 and PASI 100&#41;&#46; The cost per responder is calculated by multiplying the annual cost &#40;or the cost up to the end of the comparative phase vs placebo&#44; the <span class="elsevierStyleItalic">endpoint</span> in the clinical trials&#41; by the NNT&#46; In the meta-analysis&#44; the authors assume that the efficacy at that point is the same as the short-term effectiveness maintained&#44; without loss&#44; for the whole year&#46; The 95&#37; credible interval is not given for most of the results reported in the article&#46; This decision may have been taken to improve readibility&#44; but the use of the &#34;greater than&#34; symbol &#40;&#62;&#41; for comparisons may lead to confusion&#58; although the incremental cost per responder central values differ numerically&#44; one cannot strictly talk about the superiority of one drug over another when their credible intervals overlap&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The model used does not address the response rate achieved by each biologic agent as a rescue treatment or possible differences in the response of patients with a history of prior exposure or treatment failure with other biologic agents &#40;generally unknown or assumed to be similar or inferior in a variable and drug-dependent percentage to the response of patients who have never received biologic therapy&#41;&#46; Neither does it take into account drop-out rates&#44; indirect treatment costs&#44; or possible complications&#46; The authors could also have included apremilast&#44; which&#44; while not a biologic agent&#44; has a similar acquisition cost&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">More complex models have been proposed based on periods of 52 weeks<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a> and 2 years&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> One difference between those 2 studies is the choice of rescue treatment for patients who experience treatment failure &#40;conventional systemic treatment or phototherapy in the German model<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a>&#41;&#46; In the study that considers the perspective of the Spanish health system&#44;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> with a 2-year time horizon&#44; indirect costs were not taken into account and assumptions were made regarding the rates of treatment intensification and switches to other biologic treatments as well as the cost-effectiveness of these interventions&#46; The order of efficiency reported in that study differs from that reported in the study in this issue&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Despite its limitations&#44; which actually represent possible alternative approaches&#44; the study is interesting and informative&#46; The methodology is correct &#40;there is always room for debate about whether or not the last dose should be included in the calculation of the interval or apportioned&#41; and the inclusion of a sensitivity analysis based on the results corresponding to the endpoint for each drug &#40;ranging from 10 to 16 weeks&#41; is appropriate&#44; with the limitation of between-trial differences in the duration of that period&#46; The usefulness of this article could be greatly enhanced through the inclusion&#44; as an on-line supplement&#44; of an Excel sheet or a link where the reader could access or download a small Java&#44; Android or Apple application&#44; depending on the platform&#46; This application would enable clinicians or pharmacists to calculate the results for the specific situation of each hospital &#40;given the current highly variable and fluid pricing situation&#41; and to incorporate new drugs as they become available&#44; and even modify the NNT data as new meta-analyses are published&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of Interest</span><p id="par0050" class="elsevierStylePara elsevierViewall">L&#46; Puig has received fees as a consultant or lecturer and&#47;or has served as a researcher in clinical trials sponsored by&#58; Abbvie&#44; Almirall&#44; Amgen&#44; Baxalta&#44; Biogen&#44; Boehringer Ingelheim&#44; Celgene&#44; Gebro&#44; Janssen&#44; Leo-Pharma&#44; Lilly&#44; Merck-Serono&#44; MSD&#44; Mylan&#44; Novartis&#44; Pfizer&#44; Regeneron&#44; Roche&#44; Sandoz&#44; Samsung-Bioepis&#44; Sanofi and UCB&#46;</p></span></span>"
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Incremental Cost per Responder (PASI-75, PASI-90 and PASI-100) Based on a Network Meta-Analysis of Biologic Therapies for Psoriasis: Spain 2018
Análisis del coste incremental por respondedor (PASI75, PASI90 y PASI100) basado en un metaanálisis en red de tratamientos biológicos para la psoriasis: España 2018
L. Puig
Servicio de Dermatología, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
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        "titulo" => "An&#225;lisis del coste incremental por respondedor &#40;PASI75&#44; PASI90 y PASI100&#41; basado en un metaan&#225;lisis en red de tratamientos biol&#243;gicos para la psoriasis&#58; Espa&#241;a 2018"
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">An&#225;lisis del coste incremental por respondedor &#40;PASI75&#44; PASI90 y PASI100&#41; basado en un metaan&#225;lisis en red de tratamientos biol&#243;gicos para la psoriasis&#58; Espa&#241;a 2018</p><p id="par0010" class="elsevierStylePara elsevierViewall">Incremental Cost per Responder &#40;PASI-75&#44; PASI-90 and PASI-100&#41; Based on a Network Meta-Analysis of Biologic Therapies for Psoriasis&#58; Spain 2018</p><p id="par0015" class="elsevierStylePara elsevierViewall">Network meta-analysis&#44; which now has a well-established methodology&#44; provides information on the relative efficacy of a number of treatments using data from clinical trials that directly compare two or more drugs in addition to indirect comparisons based on data from different trials using the same comparator&#46; Variations between trials are adjusted to the reference arm response rates&#46; Meta-analysis results can be expressed as the differential response compared to placebo &#40;either as a percentage or its corresponding decimal value&#41; or as its inverse&#8212;the number needed to treat &#40;NNT&#41;&#44; that is&#44; the number of patients that must be treated to achieve a responder&#46; The NNT and the incremental cost per responder&#8212;calculated by multiplying the NNT for the drug by the cost for the period considered&#8212;provide reliable values that allow us to compare the expected effectiveness of different treatments at various response levels&#44; a datum with important clinical and economic implications for physicians and those responsible for making decisions on treatment funding and reimbursement&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The objective of the study in this issue<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a> was to evaluate the cost-effectiveness of ixekizumab as afirst-line biologic for the treatment of psoriasis and to compare it with that of other biologic agents based on data from a recently published network meta-analysis&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a> Employees of the company that markets ixekizumab were involved in carrying out the network meta-analysis&#46; The main interest of the article is that it is the first study to provide data on ixekizumab in Spain&#46; In addition to the information provided by the health technology agencies&#39; assessments&#44; a study similar to this one has recently been published in the United States&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">The methodology and results of the study are valid&#44; but the terminology used for the outcome of interest &#40;&#8220;cost per NNT&#8221;&#41; is debatable&#58; it would probably be preferable to use the expression &#8220;&#40;incremental&#41; cost per successfully treated patient&#8221;&#46; The cost per NNT values &#40;cost x NNT&#41; corresponding to each response level are calculated by multiplying the cost of treatment by the respective NNT value &#40;and the 95&#37; credible interval&#41;&#46; However&#44; by analogy with widely used concepts such as &#8220;cost per patient&#8221; or &#8220;cost per day&#8221;&#44; the term &#8220;cost per NNT&#8221; suggests that the NNT is dividing &#40;cost&#47;NNT&#41; rather than multiplying the cost&#46; The term <span class="elsevierStyleItalic">incremental</span> is not relevant in this particular case because the cost of placebo is considered to be zero&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">In the analysis by N&#250;&#241;ez et al&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a> the population corresponds to the Summaries of Product Characteristics&#44; in each case&#44; and treatment response is expressed as the percentage of reduction in the Psoriasis Area and Severity Index &#40;PASI&#41; with respect to baseline&#44; with 3 different levels of efficacy &#40;PASI 75&#44; PASI 90 and PASI 100&#41;&#46; The cost per responder is calculated by multiplying the annual cost &#40;or the cost up to the end of the comparative phase vs placebo&#44; the <span class="elsevierStyleItalic">endpoint</span> in the clinical trials&#41; by the NNT&#46; In the meta-analysis&#44; the authors assume that the efficacy at that point is the same as the short-term effectiveness maintained&#44; without loss&#44; for the whole year&#46; The 95&#37; credible interval is not given for most of the results reported in the article&#46; This decision may have been taken to improve readibility&#44; but the use of the &#34;greater than&#34; symbol &#40;&#62;&#41; for comparisons may lead to confusion&#58; although the incremental cost per responder central values differ numerically&#44; one cannot strictly talk about the superiority of one drug over another when their credible intervals overlap&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The model used does not address the response rate achieved by each biologic agent as a rescue treatment or possible differences in the response of patients with a history of prior exposure or treatment failure with other biologic agents &#40;generally unknown or assumed to be similar or inferior in a variable and drug-dependent percentage to the response of patients who have never received biologic therapy&#41;&#46; Neither does it take into account drop-out rates&#44; indirect treatment costs&#44; or possible complications&#46; The authors could also have included apremilast&#44; which&#44; while not a biologic agent&#44; has a similar acquisition cost&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">More complex models have been proposed based on periods of 52 weeks<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a> and 2 years&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> One difference between those 2 studies is the choice of rescue treatment for patients who experience treatment failure &#40;conventional systemic treatment or phototherapy in the German model<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a>&#41;&#46; In the study that considers the perspective of the Spanish health system&#44;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> with a 2-year time horizon&#44; indirect costs were not taken into account and assumptions were made regarding the rates of treatment intensification and switches to other biologic treatments as well as the cost-effectiveness of these interventions&#46; The order of efficiency reported in that study differs from that reported in the study in this issue&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Despite its limitations&#44; which actually represent possible alternative approaches&#44; the study is interesting and informative&#46; The methodology is correct &#40;there is always room for debate about whether or not the last dose should be included in the calculation of the interval or apportioned&#41; and the inclusion of a sensitivity analysis based on the results corresponding to the endpoint for each drug &#40;ranging from 10 to 16 weeks&#41; is appropriate&#44; with the limitation of between-trial differences in the duration of that period&#46; The usefulness of this article could be greatly enhanced through the inclusion&#44; as an on-line supplement&#44; of an Excel sheet or a link where the reader could access or download a small Java&#44; Android or Apple application&#44; depending on the platform&#46; This application would enable clinicians or pharmacists to calculate the results for the specific situation of each hospital &#40;given the current highly variable and fluid pricing situation&#41; and to incorporate new drugs as they become available&#44; and even modify the NNT data as new meta-analyses are published&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of Interest</span><p id="par0050" class="elsevierStylePara elsevierViewall">L&#46; Puig has received fees as a consultant or lecturer and&#47;or has served as a researcher in clinical trials sponsored by&#58; Abbvie&#44; Almirall&#44; Amgen&#44; Baxalta&#44; Biogen&#44; Boehringer Ingelheim&#44; Celgene&#44; Gebro&#44; Janssen&#44; Leo-Pharma&#44; Lilly&#44; Merck-Serono&#44; MSD&#44; Mylan&#44; Novartis&#44; Pfizer&#44; Regeneron&#44; Roche&#44; Sandoz&#44; Samsung-Bioepis&#44; Sanofi and UCB&#46;</p></span></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Puig L&#46; An&#225;lisis del coste incremental por respondedor &#40;PASI75&#44; PASI90 y PASI100&#41; basado en un metaan&#225;lisis en red de tratamientos biol&#243;gicos para la psoriasis&#58; Espa&#241;a 2018&#46; Actas Dermosifiliogr&#46; 2019&#59;110&#58;517&#8211;518&#46;</p>"
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Article information
ISSN: 15782190
Original language: English
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Idiomas
Actas Dermo-Sifiliográficas
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