Reducing carbon footprint of inhalers: analysis of climate and clinical implications of different scenarios in five European countries
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  • Published on:
    Response to Dr Wilkinson and Professor Woodcock
    • Daniele Pernigotti, CEO Aequilibria Srl-SB, Venezia, Italy
    • Other Contributors:
      • Carol Stonham, Respiratory nurse
      • Sara Panigone, Global Marketing
      • Federica Sandri, Global Marketing
      • Rossella Ferri, Corporate Health Safety and Environment
      • Yasemin Unal, Global Medical Affairs
      • Nicolas Roche, Respiratory physician and clinical researcher

    We are grateful to Dr Wilkinson and Professor Woodcock for their comments on our paper.

    A key topic raised is related to the assumptions on the timelines to transition to low-Global Warming Potential (GWP) propellants. As of today, several Companies have committed to substantial investments in metered dose inhalers (MDIs) with novel propellants (1-4), indicating developments are progressing fast to target market introduction over the next few years, with 2025 as suggested initial date, and roll-out across portfolios and geographies. Previous transition from CFC to HFC-containing MDIs represents a precedent experience that can be leveraged to ensure a faster process, also dictated by pressure imposed by evolving regulations of HFC use. The new lower global warming potential propellant used for the inhaler transition in this analysis, HFA-152a, has been under development by Koura for an extended period for use in MDIs for the treatment of respiratory disorders such as asthma and COPD (5). In 2020, Koura reported that the US FDA had approved clinical trials with HFA-152a (6) and that the medical-grade propellant has been subject to an extensive suite of inhalation safety testing (including a chronic two-year pre-clinical study). It is understood that this extensive program will be used to support the future commercial use of medical-grade HFA-152a, with the essential Drug Master File expected to be finalized in 2022 (7). We agree that, in addition, the necessary clinic...

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    Conflict of Interest:
    DP was contracted by Chiesi Farmaceutici for the analysis. SP, FS, RF and YU are employees of Chiesi Farmaceutici.
  • Published on:
    Missed opportunities to improve disease control and unrealistic expectations about novel propellants.
    • Alexander JK Wilkinson, Respiratory Consultant East and North Hertfordshire NHS Trust
    • Other Contributors:
      • Ashley A Woodock, Respiratory Consultant

    We are strongly supportive of efforts to reduce the carbon footprint of inhalers. We believe this should be achieved by providing easily understood information to patients and health care workers to be able to make informed decisions about their inhaled treatments. Near term changes prioritising controller medication with the very large range of available Dry powder inhalers (DPIs) could reduce the carbon footprint by 90%, bringing the UK in line with the rest of Europe.

    The paper is essentially written by Chiesi pharmaceuticals. We are concerned about potential bias in the paper arising from this conflict of interest. Chiesi are to be applauded for having committed substantial R&D to the development of metered dose inhalers (MDIs) containing a novel lower GWP propellant HFC-152a to replace high GWP 134a. They are one of only two companies who have announced a transition using HFC-152a for their large range of MDIs.(1,2) However, the paper contains a number of inaccuracies, and is over-optimistic on the timing and pace of transition.

    The timelines for achieving a transition to HFC 152a pMDIs are unrealistic; the transition to HFA152a is likely to take far longer than described in the paper. So far, no safety or efficacy data is available for any inhaler containing HFC-152. No detail on requirements for HFC 152a inhalers has been published by the regulatory agencies, although it seems almost certain that long-term human safety data will be required.(3)...

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    Conflict of Interest:
    Ashley Woodcock works voluntarily as Co-chair of the Montreal Protocol Technology and Economic Assessment Panel, and Member of the Medical and Chemical Technical Options Committee. He has received compensation for consulting activities from GlaxoSmithKline, Novartis, and Sandoz UK; compensation for speaker activities from Novartis, GlaxoSmithKline, and Teva.

    Alexander Wilkinson has made unpaid contributions to studies on the carbon footprint of inhaled treatments and asthma care which were sponsored by AstraZeneca and GlaxoSmithKline