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Nachrichten, Termine, Experten
Nachrichten, Termine, Experten
The Austrian Institute for Health Technology Assessment (AIHTA) checks on a monthly basis what evidence there is on the effectiveness and safety of possible Covid-19 drugs. A total of 35 drugs have been closely monitored since April 2020, but there is still no real high-flyer yet.
Austria's politicians have learned from the "Tamiflu" case. As a reminder: In 2009, during the swine flu pandemic, large quantities of the largely ineffective flu drug "Tamiflu" were hastily purchased. Such a mistake has not been made again some eleven years later: "In Austria, politicians recognised very early on that the Covid-19 pandemic would occupy us in the longer term and commissioned the Austrian Institute for Health Technology Assessment (AIHTA) to conduct a 'horizon scanning' of Covid 19 drugs," says Claudia Wild, head of AIHTA. Since April 2020, the institute has been continuously evaluating which Covid-19 therapeutics are in clinical trials and what evidence there is on the efficacy and safety of the drugs. This is to ensure that the procurement of Covid-19 medicines is evidence-based.
So far, 35 potential candidates have been observed more closely. A real beacon of hope is not to be found among them, as the analyses of the AIHTA show. Besides monitoring of candidates, the AIHTA has carried out early evaluations within the framework of the European cooperation EUnetHTA on four drugs that are either already approved throughout the EU or are in the process of being approved: REGN-COV2, Bamlanivimab, Remdesivir and Dexamenthasone.
Ways to proactively counter hypes and misconceptions
Interest in REGN-COV2, also known as the "Trump- drug", and Bamlanivimab was particularly high after German Health Minister Jens Spahn announced at the end of January 2021 that he would purchase a 400 million euro contingent of the two drugs, which are not yet approved in Europe. In the USA, the therapeutics already received emergency approval from the FDA in November 2020. "The preliminary results from the still ongoing clinical trials indicate that the antibody drugs can reduce the viral load of non-hospitalised patients, but an evidence-based recommendation is currently not possible," concludes Claudia Wild. "The logistics of administration make it more difficult: the drug has to be administered via an infusion and thus requires at least a hospital outpatient clinic, even though the patients are only mildly ill and should actually stay at home," the expert adds. The antibody cocktail is explicitly not intended for patients who are already seriously ill.
The preliminary results on remdesivir are similarly sobering. The data currently available show that the drug may delay deterioration somewhat, but treatment with remdesivir is unlikely to prevent deaths from COVID-19. The best results were observed for dexamethasone, an "old" and long-known corticosteroid. It significantly reduced mortality in patients who needed oxygen therapy. Dexamethasone, on the other hand, did not show any benefits in COVID-19 patients who were not artificially ventilated.
Horizon scanning" is also intended to identify supposed drug "high-flyers" that often arise from media hypes. For example, the asthma drug budesonide was prematurely celebrated as a cure in the pandemic in the reporting of numerous media. However, the AIHTA analysis showed that the current data situation is not sufficient to reliably prove a positive effect in the case of COVID-19 disease.
Three new covid-19 drugs by October 2021
The EU Commission has agreed in its new Health Emergency Preparedness and Response Authority (HERA) that it will compile a portfolio of ten potential COVID-19 therapeutics and identify the five most promising among them by June 2021. AIHTA will then – again in collaboration with EUnetHTA partners across Europe – conduct an early assessment of the five selected medicines. "This process is intended to ensure that only those medicines that actually have a benefit are purchased throughout the EU," explains Claudia Wild. HERA's declared goal is to have three new therapeutics for the treatment of COVID-19 approved by October 2021.
Priv. Doz. Dr. phil. Claudia Wild
phone: +43 / 1 / 236 81 19-12
e-Mail: claudia.wild@aihta.at
Covid-19 HSS/ Horizon Scanning, Living Document V15 2021.
https://eprints.aihta.at/1234/128/Policy_Brief_002_Update_06.2021.pdf
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