New Oncological Drugs: Analysis of Survival Gain

Martone, Nicoletta; Lucioni, Carlo; Mazzi, S.; Fadda, Valeria

doi:10.5301/grhta.2014.12359

Cited by 4 publications

(3 citation statements)

References 51 publications

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“…After inspection of the abstract or the full text of these articles, a total of eight studies [Martone et al . 2014a, 2014b; Schnipper et al . 2015; Ebara et al .…”

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“…Our first extraction of eligible papers from PubMed selected a total of 258 citations. After inspection of the abstract or the full text of these articles, a total of eight studies [Martone et al 2014a[Martone et al , 2014bSchnipper et al 2015;Ebara et al 2013;Shiroiwa et al 2011;Tsuchiya et al 2011;Mouri et al 2013;Österlund et al 2014] were found to satisfy the inclusion criteria; these articles referred to the following four countries: Italy, US, Japan and Scandinavia. Figure 1 (panels a through d) illustrates the results of our analyses.…”

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Pricing of innovative drugs: correlation between incremental cost and survival gain in four countries

Mengato

Messori

2016

Ther Adv Med Oncol

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In pharmacoeconomics, ICER (incremental costeffectiveness ratio) is a recognized parameter that quantifies the cost-effectiveness for the comparison between an innovative drug and the standard of care [McCabe et al. 2008]. An extensive literature has been published on how ICERs should be interpreted and how their values ultimately translate into pricing decisions (e.g. value-based pricing). Given that ICER algebraically is the ratio of incremental cost and incremental benefit (i.e. survival gain), we designed a study to assess the correlation between these two parameters in different developed countries. A strong correlation would indicate that drug prices are strictly related to the benefit, while a poor correlation would indicate that prices are unrelated to benefits. To our knowledge, while hundreds of papers have been focused on theoretical and practical implications of ICERs, only a few studies have assessed the above mentioned correlation, and no study at all has performed an international comparison. The present analysis was restricted to anticancer agents and was aimed at carrying out this specific international comparison.We first performed a literature search in PubMed (www.pubmed.org) and Google Scholar (www. scholar.google.it) covering the period from 1 January 2010 to the present time (the last query was on 17 February 2016). The keywords employed to select eligible papers were the following: survival AND gain AND cost AND (oncology OR 'anticancer drug'). The time interval from 1 January 2010 to present time was selected also to obtain the overall survival (OS) data of those drugs for which this information was unavailable from included studies. Eligible papers were included in our analyses if they met the following criteria for each innovative drug: reporting of clinical indication, standard of care, incremental OS and incremental cost. Papers were included even though the latter two parameters were not directly presented, but enough information was given to recalculate them. To include as many papers as possible, our search was extended to all citations reported in the references of included articles. We separately examined whether the inclusion criteria were met by individual studies. Differences in this assessment were resolved by consensus. Standard correlation analyses were carried out to generate our results.Our first extraction of eligible papers from PubMed selected a total of 258 citations. After inspection of the abstract or the full text of these articles, a total of eight studies [Martone et al. 2014a[Martone et al. , 2014bSchnipper et al. 2015;Ebara et al. 2013;Shiroiwa et al. 2011;Tsuchiya et al. 2011;Mouri et al. 2013;Österlund et al. 2014] were found to satisfy the inclusion criteria; these articles referred to the following four countries: Italy, US, Japan and Scandinavia. Figure 1 (panels a through d) illustrates the results of our analyses. The values of correlation coefficient showed a substantial association between incremental cost and incremental OS for Scandinavia (r = 0.767...

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“…After inspection of the abstract or the full text of these articles, a total of eight studies [Martone et al . 2014a, 2014b; Schnipper et al . 2015; Ebara et al .…”

mentioning

confidence: 99%

mentioning

confidence: 99%

Pricing of innovative drugs: correlation between incremental cost and survival gain in four countries

Mengato

Messori

2016

Ther Adv Med Oncol

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“…Non escludiamo di avere male interpretato qualche passaggio dell'articolo di Ballatori e colleghi, ma a nostro avviso sarebbe invece interessante incorporare nel calcolo una soglia. Su questo punto, inoltre, potrebbe essere interessante un confronto con la precedente letteratura (8)(9)(10)(11)(12).…”

Section: Il Beneficio Dei Farmaci Oncologici: Commento All'articolo Dunclassified

Il Beneficio dei Farmaci Oncologici: Commento All'Articolo di Ballatori e Colleghi

Messori

Trippoli

2015

Global & Regional Health Technology Assessment

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Il beneficio dei farmaci oncologici: commento all'articolo di Ballatori e colleghiDear Editor, Abbiamo letto con interesse l'articolo di Ballatori e colleghi (1). Si tratta di un contributo di attualità che, oltre ad arricchire la rivista, solleva una serie di ulteriori importanti questioni da approfondire (soprattutto nella prospettiva dei futuri percorsi italiani). Procediamo per punti:Primo punto. Permane la tradizionale dualità di impostazioni [Overall Survival (OS) vs Progression Free Survival (PFS)] nella scelta del parametro che quantifica il beneficio incrementale. Come noto, questo parametro di "quantificazione" è definito, nel caso si scelga l'OS, come prolungamento della sopravvivenza sino a fine vita (unità di misura = tempo) oppure, nel caso si scelga il PFS, oltre che come prolungamento della sopravvivenza fino alla progressione, anche come miglioramento (assoluto o relativo che sia) della percentuale di pazienti event-free riferita a un dato tempo del follow-up (unità di misura = percentuale di pazienti event-free). In questa dualità di impostazioni merita, a nostro avviso, ricordare che il "primo modo" (miglioramento della OS) è molto più vantaggioso del secondo (miglioramento della PFS), soprattutto perché i benchmark economici già in uso da tanti anni (2-10) fanno riferimento al guadagno di sopravvivenza complessiva (es. costo per anno di vita guadagnato) e non alla progressione (a prescindere che quest'ultima sia espressa come tempo guadagnato oppure come percentuale eventfree migliorata). Il "primo modo" va inoltre privilegiato perché tende a essere patologia-indipendente.Secondo punto. Il metodo di Ballatori e colleghi, qualora misuri il beneficio in termini di OS, può essere applicato anche incorporando una soglia di riferimento, cioè un valore che esprima la willingness to pay (WTP) (misurata come costo per anno di vita guadagnato). Lo stesso non si può dire, quantomeno al momento attuale, qualora si misuri il beneficio in termini di PFS, per mancanza di soglie di accettabilità per la PFS. Forse è per tale motivo che gli esempi descritti nell'articolo sono tutti impostati per eseguire il calcolo senza confrontare il risultato con una soglia, facendo cioè diretto riferimento al prezzo del nuovo farmaco auto-determinato dall'industria magari assieme ad AIFA (sappiamo che, in Italia, tali prezzi non riflettono una specifica soglia di WTP). Non escludiamo di avere male interpretato qualche passaggio dell'articolo di Ballatori e colleghi, ma a nostro avviso sarebbe invece interessante incorporare nel calcolo una soglia. Su questo punto, inoltre, potrebbe essere interessante un confronto con la precedente letteratura (8-12).Terzo punto. L'approccio basato sulla densità di probabilità, come descritto da Ballatori e colleghi, è attraente e appare concettualmente superiore rispetto al tradizionale approccio basato su metodi grafici di stima della mediana di OS o PFS. Bisogna però tenere conto che l'approccio tradizionale è sostenuto da tanta letteratura storica [ad esempio, vedasi (2-10, 13)], che...

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Cost-effectiveness analysis of caplacizumab in the new standard of care for immune Thrombotic Thrombocytopenic Purpura in Italy

Minno

Ravasio²

2021

Grhta

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Objectives: To evaluate the cost-effectiveness analysis (CEA) of caplacizumab in combination with plasmapheresis (PEX) and immunosuppression compared to PEX and immunosuppression in the treatment of acute episodes of iTTP. Methods: A Markov model was used to conduct the CEA from the perspective of the hospital, over a lifetime horizon. Clinical data derived from HERCULES trial and a systematic literature review. Economic input included direct costs only. Utility and disutility values were obtained from literature. Data on healthcare resources and costs were retrieved from HERCULES trial, literature, TTP guidelines and Italian tariffs. A sensitivity analysis was conducted. The cost-effectiveness probability was tested for several options of discount levels considering a suggested willingness to pay (WTP) threshold of € 60,000 in Italy. Results: The use of caplacizumab in combination with PEX and immunosuppression is associated with a positive difference in survival of 3.27 life years (24.53 vs 21.26) and in quality of life of 3.06 QALY (22.01 vs 18.96) when compared to PEX and immunosuppression. Caplacizumab leads to an ICER per life years of € 41,653 and an ICER per QALY of € 44,572. For the suggested WTP threshold, the probability of caplacizumab being cost-effective is 82.4% (no discount), 92.8% (15% discount), 95.3% (20% discount), 96.9% (25% discount) and 98.2% (30% discount). Conclusions: Caplacizumab in addition to PEX and immunosuppression is cost-effective, allowing the hospital to achieve greater efficiency in managing the burden of a life-threatening disease such as iTTP.

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New Oncological Drugs: Analysis of Survival Gain

Cited by 4 publications

References 51 publications

Pricing of innovative drugs: correlation between incremental cost and survival gain in four countries

Pricing of innovative drugs: correlation between incremental cost and survival gain in four countries

Il Beneficio dei Farmaci Oncologici: Commento All'Articolo di Ballatori e Colleghi

Cost-effectiveness analysis of caplacizumab in the new standard of care for immune Thrombotic Thrombocytopenic Purpura in Italy

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