Decision support documents published by the Austrian Ludwig Boltzmann Institute

In August 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI-HTA) published four decision support documents. The assessed technologies are osteochondral allograft transplantation, allograft for anterior and posterior cruciate ligament reconstruction, human dermal allograft, and 177 Lutetium.

The Austrian Ministry of Health receives every year proposals for reimbursement of new medical interventions. LBI is responsible for the evaluation of the efficacy and safety of these interventions, suggested being included in the MEL (German for individual medical services) catalog. The interventions under evaluation by LBI-HTA are decided by the Ministry of Health. The assessments are based on systematic reviews for each intervention and a summary of the scientific evidence according to the GRADE scheme.

The first report is about osteochondral allograft transplantation for the knee (or other joints). A systematic review was conducted to investigate the safety and effectiveness of osteochondral allograft transplantation (OCA). Only prospective studies with at least two years of follow-up were considered for inclusion. The report concluded that the current evidence is not sufficient to prove that OCA for the knee and other joints, for the treatment of osteochondral defects, is more effective and equally safe than other surgical procedures. Based on available evidence, inclusion in the hospital benefit catalog is not recommended at this time.

The second technology assessed is allograft for anterior and posterior cruciate ligament reconstruction. A systematic search for relevant publications was carried out in 4 databases (Medline, Embase, the Cochrane Library, and the University of York Centre for Reviews and Dissemination). Overall, nine studies were eligible to be included in this assessment, eight randomized controlled trials, and one comparative cohort study. The authors of the study suggest that based on the evidence identified in this assessment, the inclusion in the catalog of benefits is currently not recommended and that a re-evaluation is necessary as soon as results of new RCTs are available.

Human dermal allograft for massive rotator cuff tears was also assessed. A systematic review was conducted to investigate the safety and effectiveness of human dermal allograft. Four biomedical databases (Medline, Embase, the Cochrane Library, the University of York Centre for Reviews and Dissemination) were searched from inception to 14 December 2018. After analyzing available evidence, the authors concluded that the evidence is insufficient to prove the technology is significantly more effective and safer than the comparator. Thus, it was recommended this technology be re-evaluated in 2021 when some of the ongoing trials have published results.

Last evaluation report focused on 177Lu-PSMA Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC). The aim of this systematic review was to investigate the use of 177Lu-PSMA in mCRPC patients when compared to best supportive care or second-line therapy or higher (hormonal therapy, chemotherapy, immunotherapy, radiopharmaceuticals, and steroids). The systematic literature search was carried out in four databases (Medline via Ovid, Embase, The Cochrane Library, CRD [DARE, NHS-EED, HTA]). After the evaluation of available evidence, the authors concluded that the inclusion in the catalog of benefits is currently not recommended. The current evidence is not sufficient to prove that the assessed technology 177Lu-PSMA is more effective and equally safe or equally effective, but safer than the comparators of best supportive care or the second line therapies: hormonal therapy, chemotherapy, immunotherapy, radiopharmaceuticals, or steroids. New study results will potentially influence the effect estimate considerably. The re-evaluation is recommended in 2021 after the completion of two ongoing RCTs.

See the all decision support documents in German and/or English here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.