Drug Shortages During The COVID-19 Pandemic: Is There A Role For Accelerated Approval And Uptake Of Biosimilars To Play?
Moderator: Dalia M Dawoud, -, National Institute for Health and Care Excellence (NICE), London, LON, UK;
Speakers: Noluthando Gloria Nematswerani, -, Centre for Clinical Excellence, Midrand, GP, South Africa; Oksana Pyzik, -, School of Pharmacy, University College London, London, UK; Asmaa Fouad Ismail, -, Egyptian Drug Authority, Cairo, Egypt; Marthinus Stander, MBChB, MBA, TCD Outcomes Research Centurion, Pretoria, South Africa and Managing Director, Value In Research, Dubai, South Africa
Purpose: To discuss the COVID-19 pandemic’s impact on the supply of and demand for biologics in low- and middle-income countries (LMICs), the resultant shortages and the role that accelerating access to biosimilars can play. Description: International emergencies, such as the COVID-19 pandemic, come with unprecedented challenges that test healthcare systems’ preparedness and ability to function under and adapt to extreme conditions. One challenge that we witnessed is the shortage of many medicines as a result of either repurposing these medicines for use as potential treatments for COVID-19 or the measures put in place to combat the spread of the pandemic such as closures of manufacturing sites, export bans and border closures. Some governments have responded by stockpiling medications, which caused widespread condemnations across the world and concerns around the rise of black markets, and sub-standard and falsified medicines, as a result. The problem has been profound for biologics that have no alternative biosimilar approved for use, particularly those currently being tested as potential COVID-19 treatments (e.g. IL-1/6 inhibitors such as tocilizumab) but also those used for other conditions. Innovative approaches and policy decisions to accelerate the approval, manufacture and uptake of biosimilars could address some of these shortages and ensure patient access to effective treatments is not disrupted. Polling questions to assess the scale of the problem in the countries represented in the audience, seek audience views regarding the potential impact of accelerating biosimilars’ approval and use on patients’ access to medications and the barriers and facilitators to achieving this potential will be used. Dr Nematswerani will present the LMIC payer perspective on the topic, Dr Pyzik will provide a non-governmental organisation perspective, Dr Fouad will provide the regulator perspective and Dr Stander will provide a research consultancy perspective. Dr Dawoud will present the HTA perspective and moderate the forum.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy