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Added therapeutic benefit and drug licensing

One aspect of the ongoing debate about drug pricing is the added therapeutic benefit of new drugs compared with existing — and potentially cheaper — therapies. Here, we discuss the merits and pitfalls of proposals that are being discussed with regard to the role of regulatory agencies in establishing added therapeutic benefit.
By
  1. Hans-Georg Eichler

    1. European Medicines Agency (EMA), Amsterdam, Netherlands.

  2. Harald Enzmann

    1. European Medicines Agency (EMA), Amsterdam, Netherlands; Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.

  3. Guido Rasi

    1. European Medicines Agency (EMA), Amsterdam, Netherlands; University of Rome Tor Vergata, Rome, Italy.

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Some new drugs are game-changers but others show no or only modest benefits over existing treatment options, even though their benefit–risk profile is positive. Nevertheless, nearly all new drugs come with a price tag higher than already available therapies, leading health-care payers and other stakeholders to emphasize that ‘innovation’ is not synonymous with ‘added therapeutic benefit’ and to increasingly resist paying breakthrough prices for absent or small added benefit.

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Nature Reviews Drug Discovery 18, 651-652 (2019)

doi: https://doi.org/10.1038/d41573-019-00068-x

Disclaimer

The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the agencies or organizations with which the authors are affiliated.

References

  1. Van Bambeke, F. et al. Quinolones in 2005: an update. Clin. Microbiol. Infect. 11, 256–280 (2005).

    Article  PubMed  Google Scholar 

  2. Blind, E. et al. Rosiglitazone: a European regulatory perspective. Diabetologia 54, 213–218 (2011).

    Article  PubMed  Google Scholar 

  3. Smolen, J. S. et al. Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis: 2-year efficacy and safety results from the randomised EXXELERATE study. Lancet 388, 2763–2774 (2016).

    Article  PubMed  Google Scholar 

  4. Postmus, D. et al. Individual trade-offs between possible benefits and risks of cancer treatments: results from a stated preference study with patients with multiple myeloma. Oncologist 23, 44–51 (2017).

    Article  PubMed  Google Scholar 

  5. Tafuri, G. et al. How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory‐HTA parallel scientific advice. Br. J. Clin. Pharmacol. 82, 965–973 (2016).

    Article  PubMed  Google Scholar 

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Competing Interests

The authors declare no competing interests.

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