Authors' objectives:

The aim of this report is to clarify the safety risks for age-related macular degeneration (AMD) patients treated with Avastin and to estimate the liability risks for the providing physicians and institutions.

Authors' results and conclusions: The analysis of the studies regarding the safety of intravitreous AMD therapy by Bevacizumab does not provide any valid evidence either for or against the use of Avastin. The performed trials are methodologically inadequate and insufficient to draw firm conclusions. Specifically, the evaluation of treated and untreated patients, information on diagnoses and AMD stages, incomplete reporting on side-effects, and varying number of patients in the follow-ups limit the validity of the existing evidence. However, based on preliminary data, administration of Bevacizumab (Avastin) is appraised as promising, since the monitored side-effects are of moderate clinical relevance only. Nevertheless, only a comprehensive randomized comparative clinical trial of Bevacizumab and Ranibizumab could produce final valid results.

Authors' recommendations: Though evidence for intravitreous Bevacizumab is missing, experts believe that Bevacizumab offers a low-price alternative to Ranibizumab. Until solid evidence becomes available, health policy makers should focus on the aspects related to the allocation of resources such as access and fairness. Due to limited financial resources and in view of the unusual consensus between payers and ophthalmologists in different countries, it is likely that a cost-effectiveness analysis would decide for Bevacizumab because of the enormous price difference, even if differences in effectiveness and side-effects were evident. An important question to consider is how good Ranibizumab has to be to justify a price that is 30 times higher than a possible alternative treatment.

Project Status: Completed

URL for project: http://eprints.hta.lbg.ac.at/718/

Year Published: 2007

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Austria

Organisation Name: Ludwig Boltzmann Institute for Health Technology Assessment

Contact Address: Ludwig Boltzmann Institute for fuer Health Technology Assessment (LBI-HTA), Garnisongasse 7/rechte Stiege Mezzanin (Top 20), 1090 Vienna, Austria. Tel: +43 1 236 8119 - 0 Fax: +43 1 236 8119 - 99

Contact Name: tarquin.mittermayr@aihta.at

Contact Email: office@aihta.at

Copyright: Ludwig Boltzmann Institut fuer Health Technology Assessment (LBIHTA)