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Cost Effectiveness of Darunavir/Ritonavir 600/100mg bid in Protease Inhibitor-Experienced, HIV-1-Infected Adults in Belgium, Italy, Sweden and the UK

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Abstract

Background: Two phase II trials (POWER 1 and 2) have demonstrated that darunavir co-administered with low-dose ritonavir (DRV/r) provides significant clinical benefit compared with control protease inhibitors (PIs) in highly treatment-experienced, HIV-1-infected adults, when co-administered with optimized background therapy (OBR).

Objective: To determine whether DRV/r is cost effective compared with control PIs, from the perspective of Belgian, Italian, Swedish and UK reimbursement authorities, when used in treatment-experienced patients similar to those included in the POWER 1 and 2 trials.

Methods: An existing Markov model containing health states defined by CD4 cell count ranges (>500, 351–500, 201–350, 101–200, 51–100 and 0–50 cells/mm3) and death was adapted for use in four European healthcare settings. Baseline demographics, CD4 cell count distribution and antiretroviral drug usage reflected those reported in the POWER 1 and 2 trials. Virological/immunological response rates and matching transition probabilities over the patients lifetime were based on results from the POWER trials and published data. After treatment failure, patients were assumed to switch to a tipranavir-containing regimen plus OBR. For each CD4 cell count range, utility values and HIV-related mortality rates were obtained from the published literature. National all-cause mortality data and published data on the increased risk of non HIV-related mortality in HIV-infected individuals were taken into account in the model. Data from observational studies conducted in each healthcare setting were used to determine resource-use patterns and costs associated with each CD4 cell count range. Unit costs were derived from official local sources; a lifetime horizon was taken and discount rates were selected based on local guidelines.

Results: In the base-case analysis, quality-adjusted life-year (QALY) gains of up to 1.397 in Belgium, over 1.171 in Italy, 1.142 in Sweden and 1.091 in the UK were predicted when DRV/r-based therapy was used instead of control PI-based treatment. The base-case analyses predicted an incremental costeffectiveness ratio (ICER) of h11 438/QALY in Belgium, h12 122/QALY in Italy, h10 942/QALY in Sweden and h16 438/QALY in the UK. Assuming an acceptability threshold of h30 000/QALY, DRV/r-based therapy remained cost effective over all parameter ranges tested in extensive one-way sensitivity analyses. Probabilistic sensitivity analysis revealed a 95% (Belgium), 97% (Italy), 92% (Sweden) or 78% (UK) probability of attaining an ICER below this threshold.

Conclusion: From four European payer perspectives, DRV/r-based antiretroviral therapy is predicted to be cost effective compared with currently available control PIs, when both are used with an OBR in treatment-experienced, HIV-1-infected adults who failed to respond to more than one PI-containing regimen.

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Acknowledgements

The authors wish to thank the investigators and the patients and their families for their participation and support during the POWER studies. Special thanks go to Josephine Mauskopf and Anita Brogan from the Research Triangle Institute (RTI), who developed the model structure and kindly provided technical support. The authors are also grateful to the investigators who participated in the Belgian cost-of-illness study (Robert Colebunders, Institute for Tropical Medicine, Antwerp, Belgium; Nathan Clumeck, Saint-Pierre University Hospital, Brussels, Belgium; Eric Van Wijngaerden, University Hospital Leuven, Belgium; Bernard Vandercam, Saint-Luc University Hospital, Brussels, Belgium; Michel Moutschen, Sart Tilman University Hospital, Liège, Belgium) and to the team led by Magnus Gisslén at the Department of Infectious Diseases within the Sahlgrenska Academy at Göteborg University, Gothenburg, Sweden, who participated in the Swedish cost-of-illness study. The authors also specially thank Tony Vangeneugden and Ben Van Baelen for analysing and providing the POWER trial data in line with the model structure and required inputs, and Eric Lefebvre, Martine De Pauw, Frederic Godderis, Piet De Doncker and the rest of the darunavir study team for their contributions. They would like to acknowledge Catherine McCarthy Bragg (medical writer, Gardiner-Caldwell Communications, Macclesfield, UK), for her assistance in editing the manuscript and collating author contributions. This project was financially supported by Johnson & Johnson Pharmaceutical Services, Janssen Cilag SpA (Italy), Janssen-Cilag NV (Belgium) and Janssen-Cilag AB (Sweden).

KM is an employee of IMS Health. IMS Health received an unrestricted grant from Johnson & Johnson for conducting this research. LA has received consultancy fees from Johnson & Johnson. ML is an employee of Janssen-Cilag AB, and owns stock options in Johnson & Johnson. GA is an employee of Janssen-Cilag SpA. VW is an employee of Janssen-Cilag NV. LH is an employee of Tibotec. ES is an employee of Johnson & Johnson Pharmaceutical Services, Beerse, Belgium, and owns stock options and shares in this company.

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Authors and Affiliations

  1. IMS Health, Health Economics Outcomes Research, Crayerstraat 6, 1000, Brussels, Belgium

    Karen Moeremans & Karin Caekelbergh

  2. Department of Public Health, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium

    Lieven Annemans

  3. Janssen-Cilag AB, Stockholm, Sweden

    Mickael Löthgren

  4. Janssen-Cilag S.P.A, Cologno Monzese, Italy

    Gabriele Allegri

  5. Janssen-Cilag NV, Berchem, Belgium

    Veronique Wyffels

  6. Tibotec, a division of Janssen-Cilag Ltd, Buckinghamshire, UK

    Lindsay Hemmet

  7. Johnson & Johnson Pharmaceutical Services LLC, Mechelen, Belgium

    Erik Smets

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  1. Karen Moeremans
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  2. Lieven Annemans
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  3. Mickael Löthgren
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  4. Gabriele Allegri
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  5. Veronique Wyffels
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  6. Lindsay Hemmet
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  7. Karin Caekelbergh
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  8. Erik Smets
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Correspondence to Karen Moeremans.

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Moeremans, K., Annemans, L., Löthgren, M. et al. Cost Effectiveness of Darunavir/Ritonavir 600/100mg bid in Protease Inhibitor-Experienced, HIV-1-Infected Adults in Belgium, Italy, Sweden and the UK. Pharmacoeconomics 28 (Suppl 1), 107–128 (2010). https://doi.org/10.2165/11587480-000000000-00000

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