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Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data

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Abstract

Objective

We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy.

Methods

A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulative costs saved to recover the Italian NHS investment in DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered.

Results

The disease stages of 2657 patients who consecutively underwent DAA therapy from January 2015 to December 2017 at 30 PITER clinical centres were standardized for 1000 patients. The investment in DAAs was considered to equal €25 million, €15 million, and €9 million in 2015, 2016, and 2017, respectively. For patients treated in 2015, the BPT was not achieved, because of the disease severity of the treated patients and high DAA prices. For 2016 and 2017, the estimated BPTs were 6.6 and 6.2 years, respectively. The total cost savings after 20 years were €50.13 and €55.50 million for 1000 patients treated in 2016 and 2017, respectively.

Conclusions

This study may be a useful tool for public decision makers to understand how HCV clinical and epidemiological profiles influence the economic burden of HCV.

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Acknowledgements

The PITER platform has been supported by “Research Project PITER2010” (RF-2010-2315839), awarded to SV. The authors wish to thank the PITER Collaborating group (available at www.progettopiter.it; see also the electronic supplementary material of this article). The model used in this study was provided to the journal’s peer reviewers for their reference when reviewing the manuscript. The members of PITER Collaborating group are: Principal Investigators and Coordinating Group: L. A. Kondili, S. Vella, M. G. Quaranta, S. Rosato, M. E. Tosti, L. E. Weimer, L. Ferrigno, F. D’Angelo, L. Falzano. PITER Investigators: A. Benedetti, L. Schiadà, M. Cucco, A. Giacometti, L. Brescini, S. Castelletti, D. Drenaggi, C. Mazzaro, G. Angarano, M. Milella, A. Di Leo, M. Rendina, A. Contaldo, A. Iannone, F. La Fortezza, M. Rizzi, G. Cologni, L. Bolondi, F. Benevento, I. Serio, P. Andreone, P. Caraceni, V. Guarneri, M. Margotti, G. Simonetti, G. Mazzella, G. Verucchi, V. Donati, P. Mian, G. Rimenti, A. Rossini, G.B. Contessi, F. Castelli, S. Zaltron, A. Spinetti, S. Odolini, G. Leandro, R. Cozzolongo, M. Zappimbulso, M. Russello, R. Benigno, C. Coco, C. Torti, C. Costa, G. Greco, M. Mazzitelli, V. Pisani, L. Cosco, F. Quintieri, M. De Siena, F. Giancotti, J. Vecchiet, K. Falasca, A. Mastroianni, L. Chidichimo, G. Apuzzo, F. G. Foschi, A. C. Dall’Aglio, M. Libanore, D. Segala, L. Sighinolfi, D. Bartolozzi, E. Salomoni, P. Blanc, F. Baragli, B. Del Pin, E. Mariabelli, F. Mazzotta, A. Poggi, A. L. Zignego, M. Monti, F. Madia, A. Xheka, E. M. Cela, T. A. Santantonio, S. Bruno, C. Viscoli, A. I. Alessandrini, C. Curti, A. Di Biagio, L. A. Nicolini, E. Balletto, C. Mastroianni, K. Blerta, D. Prati, L. Raffaele, M. Andreoletti, G. Perboni, P. Costa, L. Manzini, G. Raimondo, R. Filomia, A. Lazzarin, G. Morsica, S. Salpietro, M. Puoti, C. Baiguera, S. Vassalli, M. G. Rumi, S. Labanca, M. Zuin, A. Giorgini, D. Orellana, A. D’Arminio Monforte, A. Debona, S. Solaro, S. Fargion, L. Valenti, G. Periti, S. Pelusi, M. Galli, E. Calvi, L. Milazzo, A. Peri, P. Lampertico, M. Borghi, R. D’Ambrosio, E. Degasperi, M. Vinci, E. Villa, V. Bernabucci, L. Bristot, F. Pereira, L. Chessa, M. C. Pasetto, M. Loi, A. Gori, I. Beretta, V. Pastore, A. Soria, M. Strazzabosco, A. Ciaccio, M. Gemma, G. Borgia, A. Foggia, E. Zappulo, I. Gentile, A. R. Buonomo, N. Abrescia, A. Maddaloni, N. Caporaso, F. Morisco, S. Camera, L. Donnarumma, C. Coppola, D. C. Amoruso, L. Staiano, M. R. Saturnino, N. Coppola, S. Martini, C. Monari, A. Federico, M. Dallio, C. Loguercio, G. B. Gaeta, G. Brancaccio, G. Nardone, C. Sgamato, G. D’Adamo, A. Alberti, M. Gonzo, S. Piovesan, L. Chemello, A. Buggio, L. Cavalletto, F. Barbaro, E. Castelli, A. Floreani, N. Cazzagon, I. Franceschet, F. P. Russo, A. Zanetto, E. Franceschet, S. Madonia, M. Cannizzaro, G. Montalto, A. Licata, A. R. Capitano, A. Craxì, S. Petta, V. Calvaruso, F. Rini, C. Ferrari, E. Negri, A. Orlandini, M. Pesci, R. Bruno, A. Lombardi, V. Zuccaro, R. Gulminetti, A. Asti, M. Villaraggia, M. Mondelli, S. Ludovisi, F. Baldelli, F. Di Candilo, G. Parruti, P. Di Stefano, F. Sozio, M. C. Gizzi, M. R. Brunetto, P. Colombatto, B. Coco, L. Surace, G. Foti, S. Pellicano, G. Fornaciari, S. Schianchi, P. Vignoli, M. Massari, R. Corsini, E. Garlassi, G. Ballardini, M. Andreoni, C. Cerva, M. Angelico, A. Gasbarrini, M. Siciliano, M. De Siena, L. Nosotti, G. Taliani, E. Biliotti, M. Santori, M. Spaziante, F. Tamburini, V. Vullo, G. D’Ettorre, E. N. Cavallari, T. S. Gebremeskel, P. Pavone, R. Cauda, A. Cingolani, S. Lamonica, G. D’Offizi, R. Lionetti, U. Visco Comandini, A. Grieco, F. D’Aversa, A. Picardi, A. De Vincentis, G. Galati, P. Gallo, C. Dell’Unto, A. Aghemo, A. Gatti Comini, M. Persico, M. Masarone, M. Anselmo, P. De Leo, M. Marturano, E. Brunelli, F. Ridolfi, A. M. Schimizzi, M. Ayoubi Khajekini, L. Framarin, G. Di Perri, G. Cariti, L. Boglione, C. Cardellino, L. Marinaro, G. M. Saracco, A. Ciancio, P. Toniutto, G. Alterini, F. Capra, D. Ieluzzi.

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Authors and Affiliations

  1. CEIS-Economic Evaluation and HTA (EEHTA), Faculty of Economics, University of Rome “Tor Vergata”, Via Columbia 2, 00133, Rome, Italy

    Andrea Marcellusi, Raffaella Viti & Francesco Saverio Mennini

  2. Institute for Leadership and Management in Health, Kingston University London, London, UK

    Andrea Marcellusi & Francesco Saverio Mennini

  3. Istituto Superiore di Sanità, Rome, Italy

    Loreta A. Kondili, Stefano Rosato & Stefano Vella

Authors
  1. Andrea Marcellusi
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  2. Raffaella Viti
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  3. Loreta A. Kondili
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  4. Stefano Rosato
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  5. Stefano Vella
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  6. Francesco Saverio Mennini
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Consortia

PITER Collaborating group available at www.progettopiter.it

  • L. A. Kondili
  • , S. Vella
  • , M. G. Quaranta
  • , S. Rosato
  • , M. E. Tosti
  • , L. E. Weimer
  • , L. Ferrigno
  • , F. D’Angelo
  • , L. Falzano
  • , A. Benedetti
  • , L. Schiadà
  • , M. Cucco
  • , A. Giacometti
  • , L. Brescini
  • , S. Castelletti
  • , D. Drenaggi
  • , C. Mazzaro
  • , G. Angarano
  • , M. Milella
  • , A. Di Leo
  • , M. Rendina
  • , A. Contaldo
  • , A. Iannone
  • , F. La Fortezza
  • , M. Rizzi
  • , G. Cologni
  • , L. Bolondi
  • , F. Benevento
  • , I. Serio
  • , P. Andreone
  • , P. Caraceni
  • , V. Guarneri
  • , M. Margotti
  • , G. Simonetti
  • , G. Mazzella
  • , G. Verucchi
  • , V. Donati
  • , P. Mian
  • , G. Rimenti
  • , A. Rossini
  • , G. B. Contessi
  • , F. Castelli
  • , S. Zaltron
  • , A. Spinetti
  • , S. Odolini
  • , G. Leandro
  • , R. Cozzolongo
  • , M. Zappimbulso
  • , M. Russello
  • , R. Benigno
  • , C. Coco
  • , C. Torti
  • , C. Costa
  • , G. Greco
  • , M. Mazzitelli
  • , V. Pisani
  • , L. Cosco
  • , F. Quintieri
  • , M. De Siena
  • , F. Giancotti
  • , J. Vecchiet
  • , K. Falasca
  • , A. Mastroianni
  • , G. Apuzzo
  • , L. Chidichimo
  • , F. G. Foschi
  • , A. C. Dall’Aglio
  • , M. Libanore
  • , D. Segala
  • , L. Sighinolfi
  • , D. Bartolozzi
  • , E. Salomoni
  • , P. Blanc
  • , F. Baragli
  • , B. Del Pin
  • , E. Mariabelli
  • , F. Mazzotta
  • , A. Poggi
  • , A. L. Zignego
  • , M. Monti
  • , F. Madia
  • , A. Xheka
  • , E. M. Cela
  • , T. A. Santantonio
  • , S. R. Bruno
  • , C. Viscoli
  • , A. I. Alessandrini
  • , C. Curti
  • , A. Di Biagio
  • , L. A. Nicolini
  • , E. Balletto
  • , C. Mastroianni
  • , K. Blerta
  • , D. Prati
  • , L. Raffaele
  • , M. Andreoletti
  • , G. Perboni
  • , P. Costa
  • , L. Manzini
  • , G. Raimondo
  • , R. Filomia
  • , A. Lazzarin
  • , G. Morsica
  • , S. Salpietro
  • , M. Puoti
  • , C. Baiguera
  • , S. Vassalli
  • , M. G. Rumi
  • , S. Labanca
  • , M. Zuin
  • , A. Giorgini
  • , D. Orellana
  • , A. D’Arminio Monforte
  • , A. Debona
  • , S. Solaro
  • , S. Fargion
  • , L. Valenti
  • , G. Periti
  • , S. Pelusi
  • , M. Galli
  • , E. Calvi
  • , L. Milazzo
  • , A. Peri
  • , P. Lampertico
  • , M. Borghi
  • , R. D’Ambrosio
  • , E. Degasperi
  • , M. Vinci
  • , E. Villa
  • , V. Bernabucci
  • , L. Bristot
  • , F. Pereira
  • , L. Chessa
  • , M. C. Pasetto
  • , M. Loi
  • , A. Gori
  • , I. Beretta
  • , V. Pastore
  • , A. Soria
  • , M. Strazzabosco
  • , A. Ciaccio
  • , M. Gemma
  • , G. Borgia
  • , A. Foggia
  • , E. Zappulo
  • , I. Gentile
  • , A. R. Buonomo
  • , N. Abrescia
  • , A. Maddaloni
  • , N. Caporaso
  • , F. Morisco
  • , S. Camera
  • , L. Donnarumma
  • , C. Coppola
  • , D. C. Amoruso
  • , L. Staiano
  • , M. R. Saturnino
  • , N. Coppola
  • , S. Martini
  • , C. Monari
  • , A. Federico
  • , M. Dallio
  • , C. Loguercio
  • , G. B. Gaeta
  • , G. Brancaccio
  • , G. Nardone
  • , C. Sgamato
  • , G. D’Adamo
  • , A. Alberti
  • , M. Gonzo
  • , S. Piovesan
  • , L. Chemello
  • , A. Buggio
  • , L. Cavalletto
  • , F. Barbaro
  • , E. Castelli
  • , A. Floreani
  • , N. Cazzagon
  • , I. Franceschet
  • , F. P. Russo
  • , A. Zanetto
  • , E. Franceschet
  • , S. Madonia
  • , M. Cannizzaro
  • , G. Montalto
  • , A. Licata
  • , A. R. Capitano
  • , A. Craxì
  • , S. Petta
  • , V. Calvaruso
  • , F. Rini
  • , C. Ferrari
  • , E. Negri
  • , A. Orlandini
  • , M. Pesci
  • , R. Bruno
  • , A. Lombardi
  • , V. Zuccaro
  • , R. Gulminetti
  • , A. Asti
  • , M. Villaraggia
  • , M. Mondelli
  • , S. Ludovisi
  • , F. Baldelli
  • , F. Di Candilo
  • , G. Parruti
  • , P. Di Stefano
  • , F. Sozio
  • , M. C. Gizzi
  • , M. R. Brunetto
  • , P. Colombatto
  • , B. Coco
  • , L. Surace
  • , G. Foti
  • , S. Pellicano
  • , G. Fornaciari
  • , S. Schianchi
  • , P. Vignoli
  • , M. Massari
  • , R. Corsini
  • , E. Garlassi
  • , G. Ballardini
  • , M. Andreoni
  • , C. Cerva
  • , M. Angelico
  • , A. Gasbarrini
  • , M. Siciliano
  • , M. De Siena
  • , L. Nosotti
  • , G. Taliani
  • , E. Biliotti
  • , M. Santori
  • , M. Spaziante
  • , F. Tamburini
  • , V. Vullo
  • , G. D’Ettorre
  • , E. N. Cavallari
  • , T. S. Gebremeskel
  • , P. Pavone
  • , R. Cauda
  • , A. Cingolani
  • , S. Lamonica
  • , G. D’Offizi
  • , R. Lionetti
  • , U. Visco Comandini
  • , A. Grieco
  • , F. D’Aversa
  • , A. Picardi
  • , A. De Vincentis
  • , G. Galati
  • , P. Gallo
  • , C. Dell’Unto
  • , A. Aghemo
  • , A. Gatti Comini
  • , M. Persico
  • , M. Masarone
  • , M. Anselmo
  • , P. De Leo
  • , M. Marturano
  • , E. Brunelli
  • , F. Ridolfi
  • , A. M. Schimizzi
  • , M. Ayoubi Khajekini
  • , L. Framarin
  • , G. Di Perri
  • , G. Cariti
  • , L. Boglione
  • , C. Cardellino
  • , L. Marinaro
  • , G. M. Saracco
  • , A. Ciancio
  • , P. Toniutto
  • , G. Alterini
  • , F. Capra
  •  & D. Ieluzzi

Contributions

AM, FSM, RV, and LAK, designed the study, conducted the analysis and finalized the draft of the manuscript. FSM and SV provided guidance on the methodology, reviewed the results and critically assessed the manuscript. All the authors provided data and/or reviewed the results of the final draft of the manuscript. All authors approved the final version of the manuscript. LAK had full access to all the data used in the study and had final responsibility for the decision to submit for publication.

Corresponding author

Correspondence to Andrea Marcellusi.

Ethics declarations

The PITER cohort study protocol was approved by the Ethics Committee of Istituto Superiore di Sanità (Italian National Institute of Public Health) and by the local ethics committees of each clinical centre. Patient data were evaluated via an anonymous analysis, adopting codes generated by the electronic case-report form. Informed consent was obtained from each patient participating in this study.

Conflicts of interest

AM, RV, LAK, SR, FSM and SV have no competing interests to declare regarding the content of this article.

Additional information

The members of PITER collaboration study group are listed in acknowledgements.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (DOCX 128 kb)

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Marcellusi, A., Viti, R., Kondili, L.A. et al. Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data. PharmacoEconomics 37, 255–266 (2019). https://doi.org/10.1007/s40273-018-0733-3

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  • DOI: https://doi.org/10.1007/s40273-018-0733-3

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