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CAR-T Celltherapies, ATMPs and Gene Therapies in Development, Horizon Scanning
It is predicted that by 2022 there will be about 16 "Advanced Therapies Medicinal Products" (ATMPs) on the market, about 2-4 new therapies per year. There are currently 11 ATMPs approved. According to the annual report of the "Alliance of Regenerative Medicine (ARM)", by the end of 2019 more than 1,000 clinical trials worldwide are investigating regenerative/ advanced therapies for various diseases, 94 of which are in phase 3, 591 in phase 2, 60% in oncological indications alone. Among the best known already approved are the CAR-T cell therapies (2 approved in Europe, 1 in the approval process) and gene therapies for spinal muscular atrophy (also 2 approved in Europe, 1 in the approval process). Two Horizon Scanning reports – a cooperation project of AIHTA and Tirol Kliniken - dealt with a look into the near future of further gene therapies.
The European Medicines Agency (EMA) classifies ATMPs into three main types: Gene therapeutics and somatic cell therapeutic drugs and tissue engineering products. The two reports should address the questions for which indications CAR-T cell therapies and other ATMPs/gene therapies are in development and by when a marketing authorization is expected. To answer the questions, a systematic search of study registries was performed to identify gene therapies in development and ATMPs, followed by the extraction of data on the identified ongoing clinical trials, complemented by a search of the EMA database of drugs under evaluation to identify those therapies that are expected to be approved soon. Finally, published information on the products, their indication and patient population was collected. The search identified 32 ATMPs in 8 broad indication areas and 13 CAR-T cell therapies in haematological malignancies at an advanced stage of development.
Publications:
- Car-T Cell Therapies, Policy Brief No. 6a: http://eprints.aihta.at/1268/
- ATMPs and Gene Therapies, Policy Brief No. 6b: http://eprints.aihta.at/1269/
Contact: Claudia Wild
Horizon Scanning in Oncology - Fact Sheets
We are pleased to introduce our four new HSO Fact Sheets.
Fact Sheet No. 14 (ad April 2020)
Carmustine (Carmustine Obvius®) as conditioning treatment before transplantation in patients with Hodgkin’s lymphoma (HL) and non-Hodgkin’s lymphomas (NHL)
Fact Sheet No. 15 (Juli 2020)
Acalabrutinib (Calquence®) for the treatment of chronic lymphocytic leukaemia (CLL)
Fact Sheet No. 16 (Juli 2020)
Avapritinib (Ayvakyt®) for the treatment of gastrointestinal stromal tumours (GIST)
Fact Sheet No. 17 (Juli 2020)
Belantamab mafodotin (Blenrep®) as monotherapy for the treatment of relapsed or refractory multiple myeloma (MM)
Fact Sheet No. 18 (Juli 2020)
Durvalumab (Imfinzi®) in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC)
Fact Sheet No. 19 (Juli 2020)
Ibrutinib (Imbruvica®) as a single agent or in combination with rituximab or obinutuzumab for the treatment of previously untreated chronic lymphocytic leukaemia (CLL)
Covid-19: HSS/ Horizon Scanning Living Document (v05 August 2020)
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.
Publication: Policy Brief No. 002: http://eprints.aihta.at/1234/
Contact: Claudia Wild
Evaluation of individual medical procedures - Reports 2020
We are pleased to introduce our new reports.
Decision Support Documents 2020:
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DSD 119: Implantation of a wireless pulmonary artery pressure sensor in patients with advanced heart failure’
http://eprints.aihta.at/1254 -
DSD 120: Intrauterine ultrasound-guided transcervical radiofrequency ablation
http://eprints.aihta.at/1255 -
DSD 121: Percutaneous Transvascular Implantation of a Coronary Sinus Reducing Stent
http://eprints.aihta.at/1256 -
DSD 122: Radiofrequency-Induced Intravesical Chemohyperthermia for Non-Muscle-Invasive Bladder Cancer
http://eprints.aihta.at/1257 DSD 123: Vaskuläre photodynamische Therapie mit Padeliporfin (Tookad® Lösung)
http://eprints.aihta.at/1258 -
DSD 123: Vaskuläre photodynamische Therapie mit Padeliporfin (Tookad® Lösung)
http://eprints.aihta.at/1258
+2 Updates:
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DSD 97/2. Update 2020: Leadless pacemaker for right ventricle pacing (Update 2020)
http://eprints.aihta.at/1252 -
DSD106/Update 2020: Extracorporeal cytokine haemadsorption therapy in patients with sepsis or SIRS.
http://eprints.aihta.at/1253
Covid-19: HSS/ Horizon Scanning Living Document (v04 July 2020), Report & Appendix
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.
Publication: Policy Brief No. 002: http://eprints.aihta.at/1234/
Contact: Claudia Wild
Update PET/PET-CT evidence for need based planning in the area of oncology
Since the 1990s, the imaging technique Positron Emission Tomography (PET) has been widely used. In recent years, hardly any other technology has been examined as frequently as PET diagnostics by Health Technology Assessment Institutions. The aim of the present update was to identify oncological indications for which the use of PET/PET-CT is recommended or explicitly not recommended by relevant societies and in evidence-based guidelines. A total of 37 evidence-based guidelines were identified regarding the use of PET for oncological indications. In the case of four oncological indications, a positive recommendation regarding the use of PET could be identified. In contrast, for eight indications a restricted use was recommended. No evidence in favour of PET examinations was identified for six indications, and for seven indication there was no, too little or inconclusive (controversial) evidence available. Just in a scarcity of instances an overall recommendations for the application of PET as a primary or standard diagnostic procedure was issued in the update 2020. In general, the present summarised evidence of guidelines can support appropriate health care service provision in Austrian hospitals.
Publication: AIHTA Policy Brief No.: 003: http://eprints.aihta.at/1249/
Contact: Nicole Grössmann
Horizon Scanning in Oncology - Fact Sheets
We are pleased to introduce our four new HSO Fact Sheets.
Fact Sheet No. 11 (Mai 2020)
Maintenance olaparib (Lynparza®) for the treatment of patients with germline BRCA-mutated metastatic pancreatic cancer
Fact Sheet No. 12 (Mai 2020)
Alpelisib (Piqray®) plus fulvestrant for PIK3CA-mutated, hormone receptor–positive advanced breast cancer
Fact Sheet No. 13 (Mai 2020)
Entrectinib (Rozlytrek®) for the treatment of patients whose solid tumours have a NTRK gene fusion, or patients with ROS1-positive advanced NSCLC
Covid-19: HSS/ Horizon Scanning Living Document (v03 June 2020)
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.
Publication: Policy Brief No. 002: http://eprints.aihta.at/1234/
Contact: Claudia Wild
Proton and carbon ion therapy – an update on indications
Worldwide, 82 particle therapy facilities are currently in clinical operation; further 37 centers are under construction or in planning. This means that the number of centres worldwide has more than doubled since 2013. In Europe alone, 27 centres are currently operational (2013: 14). With such a large number of treatment centers, it should be assumed that the underlying clinical evidence on patient benefit is convincing. The update of the LBI-HTA report 2013 has the task to give an overview of secured indications as well as indications that are only recommended under clinical research. Only a hand search for HTA reviews and systematic reviews was conducted. The identified reviews articulate in unison that the available - mostly retrospective - studies are of low quality and insufficient to make conclusive statements on the added value of proton or carbon ion therapy. Only a few indications are recommended for proton or carbon ion therapy (chordomas and chondrosarcomas, uveamelanoma, pediatric tumors in the base of the skull, brain and head and neck tumors) to avoid secondary tumors. Further indications, with curative intention and non-metastatic, are only recommended under conditions of prospective clinical studies.
Publication: AIHTA Policy Brief No.: 004: http://eprints.aihta.at/1245/
Contact: Claudia Wild
Horizon Scanning in Oncology - Fact Sheets
We are pleased to introduce our four new HSO Fact Sheets.
Fact Sheet No. 7 (April 2020)
Encorafenib (Braftovi®) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation
Fact Sheet No. 8 (April 2020)
Cabazitaxel Accord for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel containing regimen
Fact Sheet Nr. 9 (April 2020)
Daratumumab (Darzalex®) in a new pharmaceutical form associated with a new strength and a new route of administration for the treatment of multiple myeloma
Fact Sheet No. 10 (April 2020)
Glasdegib (Daurismo®) with low-dose cytarabine (LDAC) in patients with newly diagnosed acute myeloid leukaemia (AML)
