News

Since 2006, natalizumab is used for the treatment of relapsing-remitting multiple sclerosis. Assessing seven studies, which met the inclusion criteria, the present project report investigated the clinical efficacy and safety of natalizumab compared to alternative immunomodulating drugs for a treatment period of at least 36 months.

Transcatheter aortic valve implantation (TAVI, also called percutaneous aortic valve replacement) is the insertion of a bioprosthesis into the aortic valve using a catheter. Since the introduction of TAVI in 2007 for patients at high surgical risk, TAVI is being used more and more frequently. The EUnetHTA report with a German summary analyzes the results from 2 RCTs on patients with moderate operative risk.

Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary artery disease. In Europe, there are about 350 000 out of hospital SCAs per year. Mostly, ventricular tachycardia and ventricular fibrillation are the underlying aetiology of SCA. The wearable cardioverter defibrillator (WCD) – a novel defibrillation therapy – claims to prevent sudden cardiac deaths that may result from SCA. To date, it is unclear whether the plausible and promising theoretical benefits can be translated into clinically relevant benefits.

Therefore, the project at hand aimed at synthesising the current available evidence regarding the use of the WCD: A systematic review regarding the effectiveness and safety of the WCD was hereby performed.
In total, 11 studies were identified: 1 RCT was eligible for the evidence synthesis of the effectiveness of the WCD and further 10 observational studies were additionally included for the evaluation of safety of the device. The scientific evidence from 1 RCT indicates the WCD in combination with guideline-directed medical therapy (GDMT) is not proven to be more effective than GDMT alone based on the endpoint arrhythmic mortality. The studies included in the evaluation of safety of the device suggest that the WCD could be a relatively safe device.

To date, the comparative effectiveness of the WCD could not be established – it is unclear if and especially for whom the plausible theoretical advantages of using the WCD can be translated into clinically relevant benefits. Further research is needed in this context.

On the one hand, reimbursement decisions on medicines in Austria are divided into outpatient and inpatient sector, on the other hand, decisions are made regionally in the inpatient sector (on a federal state level). Both can result in an unequal availability in particular of high-priced drugs. In favour of equal access to medical services, often there are deliberative decision-making processes that seek to make public (health policy) decisions fairly, transparently, and evidence-based. The present HTA report provides a basis for discussion of an Austria-wide standardised and transparent reimbursement process for high-priced hospital drugs taking into account deliberative processes.