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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0010" class="elsevierStylePara elsevierViewall">The Spanish guidelines for the treatment of psoriasis recommend that drug choice should be guided by the criteria established in the Summary of Product Characteristics &#40;SPC&#41; for each agent and that decisions should be made on a case-by-case basis and take into account economic considerations&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> Since the introduction of biologic agents&#44; several authors have studied their cost-efficacy&#46;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#8211;4</span></a> However&#44; none of these studies present an overall view of the results at clinically significant evaluation time points&#46; The equation used for cost-effectiveness analysis&#44; which can support therapeutic decisions&#44; is the incremental cost effectiveness ratio &#40;ICER&#41;&#58; ICER&#160;&#61;&#160;&#40;C1&#8211;C2&#41;&#47;&#40;E1&#8211;E2&#41;&#44; where C1 and E1 are the cost and effect in the treatment group and C2 and E2 are the cost and effect in the control group&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">The present analysis is intended to provide useful information to guide clinical practice based on the results of a recent meta-analysis&#44;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> evaluating the most important variables at each time point&#46; The outcomes and time points used were as follows&#58; a 50&#37; reduction in PASI score &#40;PASI 50&#41; at the time point the SPC recommends assessment of response in order to identify primary treatment failure&#44; and PASI 50 and PASI&#160;75 responses at week 24 &#40;the end of the induction phase&#41;&#46; The cost of each treatment was calculated on the basis of the pharmaceutical company&#39;s sale price as of January 2014 less the mandatory deduction under Spanish law &#40;Real Decreto 08&#47;2010&#41; plus VAT&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> In the case of infliximab&#44; the cost was calculated for a patient weighing 80&#160;kg and included the additional expense of intravenous infusion at the updated price published by the SOIKOS-OBLIKUE program for 2014 &#40;&#8364;254&#46;68&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> No other additional costs were included in the analysis&#46; The ICER was calculated by dividing the cost of treatment up to the time point when response should be assessed by the mean incremental efficacy &#40;drug minus placebo&#41;&#46; ICER 95&#37; CI were calculated using the lower and upper 95&#37; CI limits of the incremental efficacy values published in the meta-analysis&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Analysis of incremental cost-effectiveness for PASI 50 at the time point recommended in the SPC for treatment response assessment to identify nonresponders &#40;week 12 for etanercept&#44; week 16 for adalimumab&#44; week 22 for infliximab&#44; and week 28 for ustekinumab&#41; shows that the drug with the lowest ICER is adalimumab &#40;&#8364;7076&#41;&#44; followed by etanercept &#40;&#8364;8818&#41;&#44; ustekinumab 45&#160;mg &#40;&#8364;10&#160;916&#41;&#44; infliximab &#40;&#8364;13&#160;172&#41;&#44; and ustekinumab 90&#160;mg &#40;&#8364;21&#160;777&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#46;&#41;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0020" class="elsevierStylePara elsevierViewall">While the analysis was carried out at the time point recommended in the SPC for the assessment of primary response&#44; the treatment had not&#44; in some cases&#44; reached maximum efficacy&#46; Owing to this difference in time to maximum response and the large differences in the number of weeks specified before treatment response assessment for each drug &#40;16 weeks between ustekinumab and etanercept&#44; assessed at week 28 and 12&#44; respectively&#41;&#44; imputing the cost-efficacy of treatments at these very different time points does not result in an equitable analysis&#46; The same reasoning can be applied to the analysis of the ICER for the time point at which the PASI&#160;75 response is assessed to provide registry data for each drug&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">The assessment of PASI response at week 24 is a very useful variable in clinical practice because the decision concerning the success or failure of treatment can be made at that time&#46; By week 24&#44; the induction phase has been completed in all the biologic agents and efficacy tends to have reached a plateau&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> Moreover&#44; analysis at this time implies calculating the cost of treatment at the same point for all the drugs&#46; The ICER results for a PASI&#160;50 response at week 24 are as follows&#58; ustekinumab 45&#160;mg &#40;&#8364;9703&#41;&#44; followed by adalimumab &#40;&#8364;10&#160;384&#8364;&#41;&#44; etanercept &#40;&#8364;12&#160;735&#8364;&#41;&#44; infliximab &#40;&#8364;13&#160;536&#41;&#44; and ustekinumab 90&#160;mg &#40;&#8364;19&#160;674&#160;&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46; As shown in <a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#44; the 95&#37; CIs of the ICERs for etanercept and infliximab overlap considerably&#44; both one with another and with adalimumab&#46; It is therefore not possible to establish any significant differences&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">The results for a PASI 75 response at week 24 show that the treatment with the lowest ICER is ustekinumab 45&#160;mg &#40;&#8364;10&#160;371&#41;&#44; followed by adalimumab &#40;&#8364;10&#160;549&#160;&#41;&#44; infliximab &#40;&#8364;14&#160;514&#160;&#8364;&#41;&#44; etanercept &#40;&#8364;16&#160;080&#160;&#41;&#44; and ustekinumab 90&#160;mg &#40;&#8364;20&#160;880&#160;&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a>&#41;&#46; In this case&#44; the 95&#37; CIs for ustekinumab 45&#160;mg and adalimumab almost overlap&#44; and both are significantly favorable compared to infliximab&#44; etanercept&#44; and ustekinumab 90&#160;mg&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">To stratify the data on treatment with ustekinumab&#44; we used the weight distribution of patients with psoriasis in the Spanish BIOBADADERM registry&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a>According to this data&#44; 9&#46;25&#37; of these patients weigh over 100&#160;kg&#46; If we estimate that half of these patients are treated with ustekinumab 45&#160;mg and half with ustekinumab 90&#160;mg &#40;in some regions this regimen is not reimbursed&#41;&#44; the ICER values at week 24 for ustekinumab adjusted for weight distribution would be as follows&#58; PASI&#160;50&#44; &#8364;10&#160;189 and PASI&#160;75 &#8364;10&#160;994&#46; When the ICER for PASI&#160;50 at week 24 is evaluated&#44; ustekinumab adjusted for weight distribution is still the most cost-effective treatment&#44; while in the case of PASI&#160;75 it is the second most cost-effective treatment&#44; coming after adalimumab&#46; In both cases&#44; the 95&#37; CI for ustekinumab adjusted for weight distribution overlaps that of adalimumab&#44; meaning that the numerical differences would not be significant&#46; In all cases&#44; the calculations performed represent an extrapolation which&#44; despite its limitations&#44; approximates routine clinical practice&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">As psoriasis is a chronic disease&#44; long-term results should be included in the analysis&#44; including the additional cost of combining&#44; escalating&#44; or switching treatments in patients who do not achieve an optimal response or experience a loss of initial response over time&#44; 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Case and Research Letters
Incremental Cost-Effectiveness Ratio Analysis of Biologic Treatments for Psoriasis at Clinically Significant Evaluation Time Points
Análisis de coste-eficacia incremental de los tratamientos biológicos para la psoriasis en los momentos de valoración significativos para la práctica clínica
L. Puig
Autor para correspondencia
lpuig@santpau.cat

Corresponding author.
, A. López-Ferrer, E. Vilarrasa
Servicio de Dermatología, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain
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    "titulo" => "Incremental Cost-Effectiveness Ratio Analysis of Biologic Treatments for Psoriasis at Clinically Significant Evaluation Time Points"
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0010" class="elsevierStylePara elsevierViewall">The Spanish guidelines for the treatment of psoriasis recommend that drug choice should be guided by the criteria established in the Summary of Product Characteristics &#40;SPC&#41; for each agent and that decisions should be made on a case-by-case basis and take into account economic considerations&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> Since the introduction of biologic agents&#44; several authors have studied their cost-efficacy&#46;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#8211;4</span></a> However&#44; none of these studies present an overall view of the results at clinically significant evaluation time points&#46; The equation used for cost-effectiveness analysis&#44; which can support therapeutic decisions&#44; is the incremental cost effectiveness ratio &#40;ICER&#41;&#58; ICER&#160;&#61;&#160;&#40;C1&#8211;C2&#41;&#47;&#40;E1&#8211;E2&#41;&#44; where C1 and E1 are the cost and effect in the treatment group and C2 and E2 are the cost and effect in the control group&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">The present analysis is intended to provide useful information to guide clinical practice based on the results of a recent meta-analysis&#44;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> evaluating the most important variables at each time point&#46; The outcomes and time points used were as follows&#58; a 50&#37; reduction in PASI score &#40;PASI 50&#41; at the time point the SPC recommends assessment of response in order to identify primary treatment failure&#44; and PASI 50 and PASI&#160;75 responses at week 24 &#40;the end of the induction phase&#41;&#46; The cost of each treatment was calculated on the basis of the pharmaceutical company&#39;s sale price as of January 2014 less the mandatory deduction under Spanish law &#40;Real Decreto 08&#47;2010&#41; plus VAT&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> In the case of infliximab&#44; the cost was calculated for a patient weighing 80&#160;kg and included the additional expense of intravenous infusion at the updated price published by the SOIKOS-OBLIKUE program for 2014 &#40;&#8364;254&#46;68&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> No other additional costs were included in the analysis&#46; The ICER was calculated by dividing the cost of treatment up to the time point when response should be assessed by the mean incremental efficacy &#40;drug minus placebo&#41;&#46; ICER 95&#37; CI were calculated using the lower and upper 95&#37; CI limits of the incremental efficacy values published in the meta-analysis&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Analysis of incremental cost-effectiveness for PASI 50 at the time point recommended in the SPC for treatment response assessment to identify nonresponders &#40;week 12 for etanercept&#44; week 16 for adalimumab&#44; week 22 for infliximab&#44; and week 28 for ustekinumab&#41; shows that the drug with the lowest ICER is adalimumab &#40;&#8364;7076&#41;&#44; followed by etanercept &#40;&#8364;8818&#41;&#44; ustekinumab 45&#160;mg &#40;&#8364;10&#160;916&#41;&#44; infliximab &#40;&#8364;13&#160;172&#41;&#44; and ustekinumab 90&#160;mg &#40;&#8364;21&#160;777&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#46;&#41;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0020" class="elsevierStylePara elsevierViewall">While the analysis was carried out at the time point recommended in the SPC for the assessment of primary response&#44; the treatment had not&#44; in some cases&#44; reached maximum efficacy&#46; Owing to this difference in time to maximum response and the large differences in the number of weeks specified before treatment response assessment for each drug &#40;16 weeks between ustekinumab and etanercept&#44; assessed at week 28 and 12&#44; respectively&#41;&#44; imputing the cost-efficacy of treatments at these very different time points does not result in an equitable analysis&#46; The same reasoning can be applied to the analysis of the ICER for the time point at which the PASI&#160;75 response is assessed to provide registry data for each drug&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">The assessment of PASI response at week 24 is a very useful variable in clinical practice because the decision concerning the success or failure of treatment can be made at that time&#46; By week 24&#44; the induction phase has been completed in all the biologic agents and efficacy tends to have reached a plateau&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> Moreover&#44; analysis at this time implies calculating the cost of treatment at the same point for all the drugs&#46; The ICER results for a PASI&#160;50 response at week 24 are as follows&#58; ustekinumab 45&#160;mg &#40;&#8364;9703&#41;&#44; followed by adalimumab &#40;&#8364;10&#160;384&#8364;&#41;&#44; etanercept &#40;&#8364;12&#160;735&#8364;&#41;&#44; infliximab &#40;&#8364;13&#160;536&#41;&#44; and ustekinumab 90&#160;mg &#40;&#8364;19&#160;674&#160;&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46; As shown in <a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#44; the 95&#37; CIs of the ICERs for etanercept and infliximab overlap considerably&#44; both one with another and with adalimumab&#46; It is therefore not possible to establish any significant differences&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">The results for a PASI 75 response at week 24 show that the treatment with the lowest ICER is ustekinumab 45&#160;mg &#40;&#8364;10&#160;371&#41;&#44; followed by adalimumab &#40;&#8364;10&#160;549&#160;&#41;&#44; infliximab &#40;&#8364;14&#160;514&#160;&#8364;&#41;&#44; etanercept &#40;&#8364;16&#160;080&#160;&#41;&#44; and ustekinumab 90&#160;mg &#40;&#8364;20&#160;880&#160;&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a>&#41;&#46; In this case&#44; the 95&#37; CIs for ustekinumab 45&#160;mg and adalimumab almost overlap&#44; and both are significantly favorable compared to infliximab&#44; etanercept&#44; and ustekinumab 90&#160;mg&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">To stratify the data on treatment with ustekinumab&#44; we used the weight distribution of patients with psoriasis in the Spanish BIOBADADERM registry&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a>According to this data&#44; 9&#46;25&#37; of these patients weigh over 100&#160;kg&#46; If we estimate that half of these patients are treated with ustekinumab 45&#160;mg and half with ustekinumab 90&#160;mg &#40;in some regions this regimen is not reimbursed&#41;&#44; the ICER values at week 24 for ustekinumab adjusted for weight distribution would be as follows&#58; PASI&#160;50&#44; &#8364;10&#160;189 and PASI&#160;75 &#8364;10&#160;994&#46; When the ICER for PASI&#160;50 at week 24 is evaluated&#44; ustekinumab adjusted for weight distribution is still the most cost-effective treatment&#44; while in the case of PASI&#160;75 it is the second most cost-effective treatment&#44; coming after adalimumab&#46; In both cases&#44; the 95&#37; CI for ustekinumab adjusted for weight distribution overlaps that of adalimumab&#44; meaning that the numerical differences would not be significant&#46; In all cases&#44; the calculations performed represent an extrapolation which&#44; despite its limitations&#44; approximates routine clinical practice&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">As psoriasis is a chronic disease&#44; long-term results should be included in the analysis&#44; including the additional cost of combining&#44; escalating&#44; or switching treatments in patients who do not achieve an optimal response or experience a loss of initial response over time&#44; as well as the potential savings in patients in whom treatment intensity can be reduced or an intermittent regimen can be used&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">However&#44; the cost of the induction phase before a population-based plateau of treatment response is achieved represents an important component of the total cost of treatment in the first year&#46; The present analysis may be useful as regards treatment decisions&#44; which must always be made on a case-by-case basis&#46;</p></span>"
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  "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1578219014002844?idApp=UINPBA000044"
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Información del artículo
ISSN: 15782190
Idioma original: Inglés
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