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Wearable cardioverter-defibrillator (WCD) therapy for primary and secondary prevention of sudden cardiac arrest. Update 2022
The wearable cardioverter defibrillator (WCD) is intended to provide protection against sudden cardiac death in high-risk patients. In 2018, the first RCT was available (VEST/ Prevention of Early Sudden Death Trial), showing no reduction in sudden cardiac death when compared to medical therapy alone. Due to the fact that VEST was limited by poor compliance, it is still unclear whether anticipated patient-relevant benefits of using the WCD is supported by scientific evidence.
The project at hand aimed at synthesising the current available evidence regarding the use of the WCD: An update systematic review regarding the effectiveness and safety of the WCD was performed. The best available RCT evidence still consists of VEST solely. Low certainty evidence derived from one RCT (n=2,348) indicated that WCD therapy might not be associated with a clinical benefit in arrhythmic mortality in post-myocardial infarction (MI) patients with an ejection fraction of ?35%.
Six new observational studies were identified, yielding to 11 observational studies meeting our inclusion criteria (range of enrolled patients: 102-2,000). New observational studies indicate that compliance with WCD is well above 20 hours per day, with poor compliance being a major limitation of the only available randomised evidence for WCD use. Most of the evidence is, however, observational and consists of studies including mixed-populations in the analysis, leading to the inability to draw firm conclusions on indication-specific utility of the WCD.
In the absence of comparative effectiveness evidence, more RCT data are needed to justify continuing or expanding the use of WCD therapy in Austria.
Publication: Decision Support Document No. 103/2. Update 2022: https://eprints.aihta.at/1407/
Contact: Gregor Götz
Covid-19: HSS/ Horizon Scanning Living Document (v23 August/September2022)
The establishment of a HSS/ Horizon Scanning System for Covid19 interventions has the intentions of informing health policy makers at an early stage which interventions (vaccinations and drugs) are currently undergoing clinical trials and to monitor them over the next few months in order to support evidence-based purchasing if necessary. The products are monitored with regard to the status of the clinical studies up to approval and finally evaluated for their benefit and harm.
All work steps are conducted in close international (European) cooperation.
Publications:
- Policy Brief No. 002: http://eprints.aihta.at/1234/
Contact: Claudia Wild
Horizon Scanning in Oncology - Fact Sheets
We are pleased to introduce our four new HSO Fact Sheets.
Fact Sheet No. 105 (August 2022)
Relatlimab/nivolumab (Opdualag®) for the first line treatment of advanced melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression < 1%
Fact Sheet No. 106 (August 2022)
Fact Sheet No. 107 (August 2022)
Teclistamab (Tecvayli®) as monotherapy for the treatment of patients with relapsed and refractory multiple myeloma (MM) who have received at least three prior therapies
Fact Sheet No. 108 (August 2022)
Selpercatinib (Retsevmo®) as monotherapy for the treatment of adults and adolescents 12 years and older with advanced RET mutant medullary thyroid cancer (MTC)
Risk-based breast cancer screening in Austria: a systematic analysis of predictive models to assess individual breast cancer risk, their utility and applicability in a breast cancer screening program
Breast cancer screening programs aim to diagnose cancer earlier and reduce surgical therapies (e.g. mastectomy) or breast cancer deaths. However, screening (mammography) also carries risks, such as false-negative results or false-positive suspected breast cancer cases, which can result in unnecessary diagnostic procedures (biopsies) and therapies that are burdensome for patients. Risk-based screening considers multiple risk factors compared to traditional age-based breast cancer screening. Breast cancer should thus be detected equally well or earlier, and possible disadvantages of age-based screening should be reduced, for example, through risk-based screening recommendations – less frequent mammographies in women with a low risk of breast cancer. Against this background, the objective of this report was to investigate the risk prediction quality of identified risk prediction models and their effectiveness in a risk-based screening program. In addition, organisational requirements for implementing a risk-based screening program were summarised.
Publication: HTA Project Report No. 145: https://eprints.aihta.at/1402/
Contact: Ingrid Zechmeister-Koss
Horizon Scanning in Oncology - Fact Sheets
We are pleased to introduce our two new HSO Fact Sheets.
Fact Sheet No. 65 (July 2022)
Degarelix (Firmagon®) as a neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone-dependent prostate cancer
Fact Sheet No. 66 (July 2022)
Degarelix (Firmagon®) as a neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone-dependent prostate cancer
Horizon Scanning in Oncology - Fact Sheets
We are pleased to introduce our five new HSO Fact Sheets.
Fact Sheet No. 100 (July 2022)
Melphalan flufenamide (Pepaxti®) with dexamethasone for the treatment of multiple myeloma (MM)
Fact Sheet No. 101 (July 2022)
Asciminib (Scemblix®) for the treatment of Philadelphia chromosome?positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase (CP)
Fact Sheet No. 102 (July 2022)
Trastuzumab deruxtecan (Enhertu®) as monotherapy for the treatment of unresectable or metastatic HER2 positive breast cancer
Fact Sheet No. 103 (July 2022)
Ibrutinib (Imbruvica®) in combination with venetoclax for the treatment of previously untreated chronic lymphocytic leukaemia (CLL)
Fact Sheet No 104 (July 2022)
Olaparib (Lynparza®) as monotherapy or in combination with endocrine therapy for the adjuvant treatment of patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer
Evaluation of individual medical procedures - Reports 2022
We are pleased to introduce our new reports.
Decision Support Documents 2022:
- DSD 130: Hepatic and portal vein embolisation prior to major hepatectomy: https://eprints.aihta.at/1390
- DSD 131: Microwave ablation for liver tumours: https://eprints.aihta.at/1391
- DSD 132: His-bundle-pacing for patients requiring a permanent pacemaker or cardiac resynchronisation: https://eprints.aihta.at/1392
- DSD 133: Chemosaturation with percutaneous hepatic perfusion for patients with liver cancer: https://eprints.aihta.at/1393
- DSD 134: Lower Esophageal Sphincter Devices for Laparoscopic Surgery in Patients with Gastroesophageal Reflux Disease (GERD): https://eprints.aihta.at/1394
+ 4 Updates:
- DSD 64: Percutaneous coronary interventions (PCI) for chronic total occlusion (CTO). Update 2022: https://eprints.aihta.at/1386
- DSD 100: Stimulation der oberen Atemwege bei mittelschwerer bis schwerer Schlafapnoe. Update 2022: https://eprints.aihta.at/1387
- DSD 109: Subcutaneous implantable cardioverter-defibrillator (S-ICD): 1. Update 2022: https://eprints.aihta.at/1388
- DSD 121: Percutaneous transvascular implantation of a coronary sinus reducing stent: Update 2022: https://eprints.aihta.at/1389
Covid-19: HSS/ Horizon Scanning Living Document (v22 June/July2022)
The establishment of a HSS/ Horizon Scanning System for Covid19 interventions has the intentions of informing health policy makers at an early stage which interventions (vaccinations and drugs) are currently undergoing clinical trials and to monitor them over the next few months in order to support evidence-based purchasing if necessary. The products are monitored with regard to the status of the clinical studies up to approval and finally evaluated for their benefit and harm.
All work steps are conducted in close international (European) cooperation.
Publications:
- Policy Brief No. 002: http://eprints.aihta.at/1234/
Contact: Claudia Wild
Horizon Scanning in Oncology - Fact Sheets
We are pleased to introduce our two new HSO Fact Sheets.
Fact Sheet No. 98 (June 2022)
Selinexor (Nexpovio®) in and dexamethasone for the treatment of multiple myeloma (MM)
Fact Sheet No. 99 (June 2022)
Pembrolizumab (Keytruda) as monotherapy for the adjuvant treatment of stage IIb IIc III melanoma
ATMPs and Gene Therapies in Development. Horizon Scanning – Update 2022
This report is an update of a previous Horizon Scanning report from 2020, which identified 32 ATMPs. Since August 2020, six of these new ATMPs have been approved by the EMA and five more will be decided by 2023. According to market analyses, 535 ATMPs will be investigated in phase 1 to 3 in 2022, with a further 1,451 in preclinical stages. Coagulation factor VIII (haemophilia A) remains the most common target for non-oncology indications and coagulation factor IX (haemophilia B) has risen to become the second most common indication.
To answer the questions, a systematic search of trial registries was conducted to identify gene therapies and ATMPs in development, followed by extraction of data on identified ongoing clinical trials (limited to phase 2/3 and 3), complemented by a search of the EMA database of medicines under assessment to identify those therapies that are close to approval. Published information on the products and the current development/regulatory status was then collected and subsequently converted into short "vignettes".
Publication: Policy Brief No. 006b: https://eprints.aihta.at/1383
Contact: Ozren Sehic
