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Nivolumab in malignant melanoma: contrasting the evidence from the pivotal trials with the real world evidence (RWE)
Nivolumab is an anti-PD1 checkpoint inhibitor used in patients with advanced malignant melanoma. The aim of this project was to evaluate the real world evidence from observational studies on Nivolumab for the treatment of malignant melanoma and to contrast the results with the evidence from pivotal RCTs. As a result of the comparison, there was good concordance between the outcomes of the included real-world studies and those of the pivotal RCTs across various lines of therapy, with slightly lower response rates.
Publication: HTA Project report No. 140: https://eprints.aihta.at/1341
Contact: Claudia Wild
Horizon Scanning in Oncology - Fact Sheets
We are pleased to introduce our five new HSO Fact Sheets.
Fact Sheet No. 60
Zanubrutinib (Brukinsa®) as monotherapy for the treatment of patients with waldenström’s macroglobulinaemia (WM)
Fact Sheet No. 62
Ripretinib (Qinlock®) for the treatment of patients with advanced gastrointestinal stromal tumour (GIST)
Fact Sheet No. 64
Pembrolizumab (Keytruda®) in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC)
Stool DNA testing for colorectal cancer (CRC) screening
Colorectal Carcinoma (CRC) is the third most frequent cancer type, with an incidence and prevalence of approximately 4,800 and 40,000 cases respectively each year in Austria. Multi-target stool DNA (MT-sDNA) testing is a novel non-invasive screening test that may be able to supplement or replace established stool tests by analysing (stool-based) tumour DNA. In this policy brief, the latest available evidence with regard to the clinical benefits and harms of MT-sDNA tests is summarized.
Publication: Policy Brief No. 011: https://eprints.aihta.at/1335
Contact: Gregor Goetz
Covid-19: HSS/ Horizon Scanning Living Document (v17 August/September 2021)
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
Health Services Research in Oncology: Patients with Non-Small Cell Lung Cancer (NSCLC) Treated with Anti-PD-1/PD-L1 Therapy in Real-World Practice
Real World Evidence (RWE) complements the data of randomised clinical trials, that are based on selected, homogeneous patient collectives and a limited study duration, with long-term data from clinical practice. As there has been no evaluation of immunotherapy in everyday care in Austria to date, a retrospective pilot study was conducted in six Austrian hospitals on the efficacy and safety of anti-PD-1/PDL1 monotherapy in patients with NSCLC using routine data.
Publication: HTA Project report No. 126: https://eprints.aihta.at/1227
Contact: claudia.wild@aihta.at; sabine.geiger-gritsch@tirol-kliniken.at
Non-interventional studies (NIS) in Austria, 2nd update of systematic analyses 2016 & 2017
Non-interventional studies (NIS) are observational studies that evaluate medicinal products and medical devices in routine care after market authorization in their approved indications. For some years now, there has been a critical discussion about their role, whether they are a valuable source of knowledge or a marketing instrument. In Austria, NIS are not subject to approval, but they are subject to notification. The NIS must be registered in a study database (register), in which some (but not all) information is also made publicly accessible. This systematic analysis addresses the questions of how many non-interventional studies are being conducted in Austria, who is responsible for them and what the knowledge interest of the registered NIS is.
Publication: Policy Brief Nr. 010: https://eprints.aihta.at/1333/
Contact: Ozren Sehic
Covid-19: HSS/ Horizon Scanning Living Document (v16 July 2021)
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 three new HSO Fact Sheets.
Fact Sheet No. 57 (July 2021)
Idecabtagene vicleucel (Abecma®) for the treatment of patients with relapsed and refractory multiple myeloma (MM)
Fact Sheet No. 58 (July 2021)
Tafasitamab (Minjuvi®; Monjuvi®) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Fact Sheet No. 59 (July 2021)
Adjuvant nivolumab (Opdivo®) as monotherapy for the treatment of patients with oesophageal (OC) or gastro-oesophageal junction cancer (GEJC)
(Good) practice organizational models using real-world evidence for public funding of high prized therapies
The growing market entry of high-cost medicines threatens the financial sustainability of healthcare systems. Limited data available on the benefit of therapies at the time of approval poses a challenge for payers. Outcome-based Managed-entry agreements (OBMEAs) present a reimbursement tool for payers to fund therapies and enable patient access - under conditions. The study aimed to design a generic organizational model for OBMEAs for highly-priced therapies, providing conditional funding while simultaneously generating publicly accessible data on the real-world evidence of treatment effects.
Publication: HTA Project report No. 138: https://eprints.aihta.at/1329
Contact: Claudia Wild
Evaluation of individual medical procedures - Reports 2021
We are pleased to introduce our new reports.
Decision Support Documents 2021:
- DSD 124: Percutaneous left ventricular assist devices: micro-axial flow pumps: https://eprints.aihta.at/1323
- DSD 125: Liposuction for surgical therapy of lipoedema: https://eprints.aihta.at/1324
- DSD 126: Triphasic biomaterial for augmentation of the osteoporotic femoral neck: https://eprints.aihta.at/1325
- DSD 127: Endoscopic plication therapy in patients with gastroesophageal reflux disease (GERD): https://eprints.aihta.at/1326
- DSD 128: Allogenic bone screw Shark Screw® in patients with hallux valgus or scaphoid fractures/pseudarthroses: https://eprints.aihta.at/1327
- DSD 129: Comparative effectiveness of surgical techniques and devices for the treatment of benign prostatic hyperplasia: https://eprints.aihta.at/1328
+1 Update:
- DSD 87/1: Implantation of Bulking Agents for Faecal Incontinence (1st Update): https://eprints.aihta.at/1322
