Remdesivir received EMA’s nod for COVID-19 via compassionate use programmes – What next?
By Nairuti Patel, Associate Consultant, Global Pricing Innovations
Amidst the COVID-19 pandemic, EU countries (Estonia, Greece, Netherlands and Romania) requested an opinion from the Committee for Medicinal Products for Human Use (CHMP) regarding the conditions under which early access to remdesivir through compassionate use programmes (CUPs), could be given to COVID-19 patients.
Gilead’s remdesivir is an antiviral medication that was initially developed for the treatment of Ebola virus disease. It has also shown in vitro activity against SARS-CoV-2, the virus that causes COVID-19. However, there is only limited data on the use of the investigational medicine in patients with COVID-19.
EMA has recognised that the availability of this potentially effective antiviral agent would address a serious unmet medical need for the treatment of COVID-19 patients. After analysis of the submitted dossier, EMA’s CHMP recommended remdesivir ‘for the treatment of adults with COVID-19 who require invasive mechanical ventilation, when used as part of a compassionate use programme’.
Moreover, the CHMP has also acknowledged the need for a harmonised approach to compassionate use for patients not eligible for inclusion in clinical trials. As such, Gilead has been requested to make remdesivir available in a ‘fair and transparent way’ to EU countries who wish to participate in clinical trials or treat patients in compassionate use programmes.
If remdesivir continues to produce positive results in clinical studies, it will be interesting to see its pricing and market access implications, as the demand for low or no-cost medication to fight COVID-19 increases.
As remdesivir’s progresses in clinical trials, it raises a few key questions:
- At what price point will it be available for the treatment of COVID-19?
- Will access procedures in place become irrelevant due to the urgency and high demand associated with the pandemic?
- How will regulatory authorities respond to the crisis to ensure patient access if the medicine generates conclusive positive results, without compromising on drug safety protocols?
- How will the existing pricing of remdesivir be affected?
GPI can support your organisation in addressing key questions for P&MA implications through a combination of data-powered insights and forward thinking mindset.
EMA, 2020. EMA provides recommendations on
compassionate use of remdesivir for COVID-19. [Online]
Available at: https://www.ema.europa.eu/en/news/ema-provides-recommendations-compassionate-use-remdesivir-covid-19
[Accessed 21 04 2020].
Grein, J., Ohmagari, N., Shin, D., Diaz, G., Asperges, E., Castagna, A., Feldt, T., Green, G., Green, M.L., Lescure, F.X. and Nicastri, E., 2020. Compassionate Use of Remdesivir for Patients with Severe Covid-19. New England Journal of Medicine.
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