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Cost-effectiveness of trastuzumab in metastatic breast cancer: Mainly a matter of price in the EU?

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  • Garattini, Livio
  • van de Vooren, Katelijne
  • Curto, Alessandro

Abstract

Trastuzumab (TR), a monoclonal antibody approved by EMA in 2000 and one of the first examples of “targeted therapy”, is indicated to treat human epidermal growth factor receptor 2 (HER2) positive breast cancer. TR, whose patent will expire in 2015 in Europe, has been judged positively for reimbursement by most public authorities in the EU. Here we critically review the existing evidence on TR in metastatic breast cancer (MBC), in line with the multidisciplinary health technology assessment (HTA) approach, to assess whether the existing evidence supports TR positive reimbursement decisions taken in MBC by EU health authorities. We did a literature search for the main HTA topics (efficacy, quality of life and ethics) on the PubMed international database (2000–2013). Then, we did a specific literature search to select the full economic evaluations (FEEs) conducted in EU countries focused on TR as first-line innovative therapy in MBC. We retrieved scant evidence in the literature to support TR reimbursement in MBC. We found only two clinical trials and their results were unclear because of the large proportion of patients who crossed over. Moreover, the quality of methods was poor in all four European FEEs selected. This example of HTA exercise on a mature monoclonal antibody in a specific indication casts doubts on how often the reimbursement decisions taken by EU health authorities in emotional pathologies like cancer are rational. These decisions should at least be reconsidered periodically on the basis of the latest evidence.

Suggested Citation

  • Garattini, Livio & van de Vooren, Katelijne & Curto, Alessandro, 2015. "Cost-effectiveness of trastuzumab in metastatic breast cancer: Mainly a matter of price in the EU?," Health Policy, Elsevier, vol. 119(2), pages 212-216.
    • Handle: RePEc:eee:hepoli:v:119:y:2015:i:2:p:212-216
    DOI: 10.1016/j.healthpol.2014.12.002
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    References listed on IDEAS

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    1. Garattini, Livio & van de Vooren, Katelijne & Curto, Alessandro, 2012. "Regional HTA in Italy: Promising or confusing?," Health Policy, Elsevier, vol. 108(2), pages 203-206.
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    3. Bonny Parkinson & Sallie-Anne Pearson & Rosalie Viney, 2014. "Economic evaluations of trastuzumab in HER2-positive metastatic breast cancer: a systematic review and critique," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 15(1), pages 93-112, January.
    4. María-Isabel Farfan-Portet & Sophie Gerkens & Isabelle Lepage-Nefkens & Irmgard Vinck & Frank Hulstaert, 2014. "Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures?," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 15(3), pages 223-228, April.
    5. Leopold, C. & Vogler, S. & Habl, C. & Mantel-Teeuwisse, A.K. & Espin, J., 2013. "Personalised medicine as a challenge for public pricing and reimbursement authorities – A survey among 27 European countries on the example of trastuzumab," Health Policy, Elsevier, vol. 113(3), pages 313-322.
    6. Curto, Sandro & Ghislandi, Simone & van de Vooren, Katelijne & Duranti, Silvy & Garattini, Livio, 2014. "Regional tenders on biosimilars in Italy: An empirical analysis of awarded prices," Health Policy, Elsevier, vol. 116(2), pages 182-187.
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    1. Livio Garattini & Alessandro Curto & Katelijne Vooren, 2015. "Western European markets for biosimilar and generic drugs: worth differentiating," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 16(7), pages 683-687, September.

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