Assessment of COVID-19 monoclonal antibodies is needed

The Beneluxa Initiative considers value assessments of medicines prior to reimbursement in their respective countries, to be essential in quantifying the potential added benefit of treatments relative to the price requested.  This concept was reaffirmed in a recent joint statement with the Nordic Pharmaceutical Forum.1 

The urgency of the pandemic had required some changes to normal medicine regulatory processes to tackle the global pressure on health systems; for the EMA this has resulted in the introduction of rolling reviews.  Rolling reviews involve a real time examination of evidence to establish if sufficient information is available to support a marketing authorization.  This allowed countries to prepare early on for joint procurement of e.g. vaccines at an exceptional time. 

More recently the EMA has begun rolling reviews on monoclonal antibodies to treat some patients with COVID-19 (September 2021)2. However the Beneluxa considers it appropriate at this stage of the pandemic that these therapies3  are assessed for value within established national processes, before decisions on reimbursement or procurement are made. Informed decision making in this matter includes exchange of available HTA information within Beneluxa.

 

https://amgros.dk/4889/
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/treatments-covid-19/covid-19-treatments-under-evaluation 
3 https://www.bmj.com/content/374/bmj.n2231

Last update: 01 October 2021