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
Servicio de Dermatología, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain
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(A) January 2011. (B) March 2012. The inflammatory margins progressed centrifugally upwards to the medial aspect of the thigh. (C) September 2012. The margins reached the left hip and gluteus.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "J.M. Mir-Bonafé, J.C. Santos-Durán, A. Santos-Briz, E. Fernández-López" "autores" => array:4 [ 0 => array:2 [ "nombre" => "J.M." "apellidos" => "Mir-Bonafé" ] 1 => array:2 [ "nombre" => "J.C." "apellidos" => "Santos-Durán" ] 2 => array:2 [ "nombre" => "A." "apellidos" => "Santos-Briz" ] 3 => array:2 [ "nombre" => "E." 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Puig, A. López-Ferrer, E. Vilarrasa" "autores" => array:3 [ 0 => array:4 [ "nombre" => "L." "apellidos" => "Puig" "email" => array:1 [ 0 => "lpuig@santpau.cat" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "A." "apellidos" => "López-Ferrer" ] 2 => array:2 [ "nombre" => "E." "apellidos" => "Vilarrasa" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Servicio de Dermatología, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Análisis de coste-eficacia incremental de los tratamientos biológicos para la psoriasis en los momentos de valoración significativos para la práctica clínica" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 686 "Ancho" => 2920 "Tamanyo" => 132130 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Incremental cost effectiveness ratio for PASI 50 response at week 24.</p>" ] ] ] "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 (SPC) for each agent and that decisions should be made on a case-by-case basis and take into account economic considerations.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> Since the introduction of biologic agents, several authors have studied their cost-efficacy.<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2–4</span></a> However, none of these studies present an overall view of the results at clinically significant evaluation time points. The equation used for cost-effectiveness analysis, which can support therapeutic decisions, is the incremental cost effectiveness ratio (ICER): ICER = (C1–C2)/(E1–E2), 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.</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,<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> evaluating the most important variables at each time point. The outcomes and time points used were as follows: a 50% reduction in PASI score (PASI 50) at the time point the SPC recommends assessment of response in order to identify primary treatment failure, and PASI 50 and PASI 75 responses at week 24 (the end of the induction phase). The cost of each treatment was calculated on the basis of the pharmaceutical company's sale price as of January 2014 less the mandatory deduction under Spanish law (Real Decreto 08/2010) plus VAT.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> In the case of infliximab, the cost was calculated for a patient weighing 80 kg and included the additional expense of intravenous infusion at the updated price published by the SOIKOS-OBLIKUE program for 2014 (€254.68).<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> No other additional costs were included in the analysis. 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 (drug minus placebo). ICER 95% CI were calculated using the lower and upper 95% CI limits of the incremental efficacy values published in the meta-analysis.<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 (week 12 for etanercept, week 16 for adalimumab, week 22 for infliximab, and week 28 for ustekinumab) shows that the drug with the lowest ICER is adalimumab (€7076), followed by etanercept (€8818), ustekinumab 45 mg (€10 916), infliximab (€13 172), and ustekinumab 90 mg (€21 777) (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>.)</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, the treatment had not, in some cases, reached maximum efficacy. 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 (16 weeks between ustekinumab and etanercept, assessed at week 28 and 12, respectively), imputing the cost-efficacy of treatments at these very different time points does not result in an equitable analysis. The same reasoning can be applied to the analysis of the ICER for the time point at which the PASI 75 response is assessed to provide registry data for each drug.</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. By week 24, the induction phase has been completed in all the biologic agents and efficacy tends to have reached a plateau.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> Moreover, analysis at this time implies calculating the cost of treatment at the same point for all the drugs. The ICER results for a PASI 50 response at week 24 are as follows: ustekinumab 45 mg (€9703), followed by adalimumab (€10 384€), etanercept (€12 735€), infliximab (€13 536), and ustekinumab 90 mg (€19 674 ) (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>). As shown in <a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>, the 95% CIs of the ICERs for etanercept and infliximab overlap considerably, both one with another and with adalimumab. It is therefore not possible to establish any significant differences.</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 mg (€10 371), followed by adalimumab (€10 549 ), infliximab (€14 514 €), etanercept (€16 080 ), and ustekinumab 90 mg (€20 880 ) (<a class="elsevierStyleCrossRef" href="#fig0015">Fig. 3</a>). In this case, the 95% CIs for ustekinumab 45 mg and adalimumab almost overlap, and both are significantly favorable compared to infliximab, etanercept, and ustekinumab 90 mg.</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">To stratify the data on treatment with ustekinumab, we used the weight distribution of patients with psoriasis in the Spanish BIOBADADERM registry.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a>According to this data, 9.25% of these patients weigh over 100 kg. If we estimate that half of these patients are treated with ustekinumab 45 mg and half with ustekinumab 90 mg (in some regions this regimen is not reimbursed), the ICER values at week 24 for ustekinumab adjusted for weight distribution would be as follows: PASI 50, €10 189 and PASI 75 €10 994. When the ICER for PASI 50 at week 24 is evaluated, ustekinumab adjusted for weight distribution is still the most cost-effective treatment, while in the case of PASI 75 it is the second most cost-effective treatment, coming after adalimumab. In both cases, the 95% CI for ustekinumab adjusted for weight distribution overlaps that of adalimumab, meaning that the numerical differences would not be significant. In all cases, the calculations performed represent an extrapolation which, despite its limitations, approximates routine clinical practice.</p><p id="par0040" class="elsevierStylePara elsevierViewall">As psoriasis is a chronic disease, long-term results should be included in the analysis, including the additional cost of combining, escalating, or switching treatments in patients who do not achieve an optimal response or experience a loss of initial response over time, as well as the potential savings in patients in whom treatment intensity can be reduced or an intermittent regimen can be used.</p><p id="par0045" class="elsevierStylePara elsevierViewall">However, 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. The present analysis may be useful as regards treatment decisions, which must always be made on a case-by-case basis.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Puig L, López-Ferrer A, Vilarrasa E. Análisis de coste-eficacia incremental de los tratamientos biológicos para la psoriasis en los momentos de valoración significativos para la práctica clínica. Actas Dermosifiliogr. 2014;105:951–953.</p>" ] ] "multimedia" => array:3 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 883 "Ancho" => 3003 "Tamanyo" => 135676 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Incremental cost effectiveness ratio for PASI 50 response at the time primary treatment success assessment is recommended in the Summary of Product Characteristics (week 12 for etanercept, week 16 for adalimumab, week 22 for infliximab, and week 28 for ustekinumab).</p>" ] ] 1 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Figure 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 686 "Ancho" => 2920 "Tamanyo" => 132130 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Incremental cost effectiveness ratio for PASI 50 response at week 24.</p>" ] ] 2 => array:7 [ "identificador" => "fig0015" "etiqueta" => "Figure 3" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr3.jpeg" "Alto" => 769 "Ancho" => 3003 "Tamanyo" => 133109 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Incremental cost effectiveness ratio for PASI 75 response at week 24.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:8 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Directrices españolas basadas en la evidencia para el tratamiento de la psoriasis con agentes biológicos, 2013. 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 5 | 11 | 16 |
| 2024 October | 66 | 44 | 110 |
| 2024 September | 66 | 63 | 129 |
| 2024 August | 100 | 71 | 171 |
| 2024 July | 58 | 38 | 96 |
| 2024 June | 67 | 33 | 100 |
| 2024 May | 64 | 38 | 102 |
| 2024 April | 67 | 28 | 95 |
| 2024 March | 64 | 37 | 101 |
| 2024 February | 52 | 34 | 86 |
| 2024 January | 34 | 36 | 70 |
| 2023 December | 36 | 17 | 53 |
| 2023 November | 43 | 24 | 67 |
| 2023 October | 42 | 11 | 53 |
| 2023 September | 33 | 21 | 54 |
| 2023 August | 37 | 11 | 48 |
| 2023 July | 43 | 30 | 73 |
| 2023 June | 41 | 21 | 62 |
| 2023 May | 79 | 19 | 98 |
| 2023 April | 66 | 19 | 85 |
| 2023 March | 61 | 19 | 80 |
| 2023 February | 47 | 20 | 67 |
| 2023 January | 50 | 16 | 66 |
| 2022 December | 62 | 52 | 114 |
| 2022 November | 27 | 18 | 45 |
| 2022 October | 21 | 17 | 38 |
| 2022 September | 20 | 24 | 44 |
| 2022 August | 30 | 41 | 71 |
| 2022 July | 31 | 35 | 66 |
| 2022 June | 23 | 18 | 41 |
| 2022 May | 56 | 36 | 92 |
| 2022 April | 63 | 28 | 91 |
| 2022 March | 45 | 42 | 87 |
| 2022 February | 33 | 22 | 55 |
| 2022 January | 37 | 28 | 65 |
| 2021 December | 33 | 35 | 68 |
| 2021 November | 44 | 35 | 79 |
| 2021 October | 55 | 43 | 98 |
| 2021 September | 38 | 38 | 76 |
| 2021 August | 26 | 28 | 54 |
| 2021 July | 66 | 26 | 92 |
| 2021 June | 36 | 18 | 54 |
| 2021 May | 49 | 27 | 76 |
| 2021 April | 99 | 58 | 157 |
| 2021 March | 67 | 15 | 82 |
| 2021 February | 51 | 24 | 75 |
| 2021 January | 26 | 16 | 42 |
| 2020 December | 28 | 14 | 42 |
| 2020 November | 19 | 13 | 32 |
| 2020 October | 21 | 7 | 28 |
| 2020 September | 18 | 10 | 28 |
| 2020 August | 23 | 13 | 36 |
| 2020 July | 29 | 13 | 42 |
| 2020 June | 16 | 14 | 30 |
| 2020 May | 17 | 14 | 31 |
| 2020 April | 21 | 19 | 40 |
| 2020 March | 19 | 12 | 31 |
| 2020 February | 3 | 5 | 8 |
| 2020 January | 4 | 6 | 10 |
| 2019 December | 8 | 1 | 9 |
| 2019 November | 4 | 0 | 4 |
| 2019 September | 4 | 3 | 7 |
| 2019 August | 4 | 7 | 11 |
| 2019 July | 4 | 5 | 9 |
| 2019 June | 6 | 10 | 16 |
| 2019 May | 4 | 40 | 44 |
| 2019 April | 2 | 11 | 13 |
| 2019 March | 4 | 8 | 12 |
| 2019 February | 0 | 4 | 4 |
| 2019 January | 5 | 0 | 5 |
| 2018 December | 0 | 6 | 6 |
| 2018 November | 9 | 0 | 9 |
| 2018 October | 59 | 0 | 59 |
| 2018 September | 6 | 0 | 6 |
| 2018 May | 0 | 2 | 2 |
| 2018 March | 1 | 1 | 2 |
| 2018 February | 30 | 3 | 33 |
| 2018 January | 21 | 3 | 24 |
| 2017 December | 26 | 8 | 34 |
| 2017 November | 21 | 2 | 23 |
| 2017 October | 18 | 5 | 23 |
| 2017 September | 15 | 5 | 20 |
| 2017 August | 21 | 11 | 32 |
| 2017 July | 19 | 3 | 22 |
| 2017 June | 20 | 10 | 30 |
| 2017 May | 21 | 6 | 27 |
| 2017 April | 20 | 12 | 32 |
| 2017 March | 16 | 12 | 28 |
| 2017 February | 17 | 5 | 22 |
| 2017 January | 15 | 8 | 23 |
| 2016 December | 20 | 10 | 30 |
| 2016 November | 33 | 8 | 41 |
| 2016 October | 26 | 12 | 38 |
| 2016 September | 0 | 7 | 7 |
| 2016 August | 0 | 1 | 1 |
| 2016 July | 8 | 1 | 9 |
| 2016 June | 18 | 2 | 20 |
| 2016 May | 12 | 1 | 13 |
| 2016 April | 12 | 6 | 18 |
| 2016 March | 6 | 4 | 10 |
| 2016 February | 4 | 2 | 6 |
| 2016 January | 10 | 4 | 14 |
| 2015 December | 10 | 2 | 12 |
| 2015 November | 15 | 1 | 16 |
| 2015 October | 11 | 8 | 19 |
| 2015 September | 7 | 4 | 11 |
| 2015 August | 11 | 3 | 14 |
| 2015 July | 20 | 3 | 23 |
| 2015 June | 15 | 1 | 16 |
| 2015 May | 12 | 5 | 17 |
| 2015 April | 6 | 1 | 7 |
| 2015 March | 17 | 4 | 21 |
| 2015 February | 18 | 6 | 24 |
| 2015 January | 3 | 5 | 8 |
| 2014 December | 4 | 0 | 4 |
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