PHARMACEUTICAL TECHNOLOGIES* PTRCR20 Bamlanivimab for the treatment of COVID-19 31.05.2021 AIHTA SNHTA SESCS , SUKL NA PTRCR19 REGN-Cov2 for the treatment of COVID-19
Rapid Collaborative Review
21.05.2021 AIHTA SNHTA GÖG , UCSC Gemelli NA PTRCR18 Dexamethasone for the treatment of COVID-19 19.11.2020 AIHTA SNHTA RER , MoH UkraineNA PTJA17 Elivaldogene autotemcel (eli-cel) for treatment of Cerebral Adrenoleukodystrophy (CALD) 16.08.2021 (revised 03.09.2021)
ZIN AOTMiT , GÖG SNHTA , MIZ 26.05.2021 PTJA16 Venetoclax with a hypomethylating agent for the treatment of adult patients with newly-diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy 08.07.2021 (revised 03.09.2021)
NOMA JAZMP AEMPS , MoH Ukraine, NIPHNO, SMCA 28.04.2021 PTRCR15 Remdesivir for the treatment of COVID-19
First update
First update: 16.12.2020 AIHTA NA INFARMED , NCPE , RER , MoH UkraineNA Rapid Collaborative Review: PICO and Evidence gaps Original report: 29.09.2020 INFARMED NCPE AIHTA , RER , MoH UkraineNA PTJA14 Pretomanid as part of a combination regimen with bedaquiline and linezolid, in adults for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB) 19.08.2020 HAS MIZ MoH Ukraine, SNHTA , AEMPS , UU 02.04.2020 PTJA13 Satralizumab is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive Assessment discontinued due to unexpected changes to the timelines of the EU regulatory procedure.
Following CHMP opinion, EUnetHTA’s PICO is published in the project plan.
INFARMED EUR , ZIN AEMPS , JAZMP, HIS
Observer: VVKT
28.04.2021 PTJA12 Glasdegib indicated for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) 30.07.2020 HVB NCPE INFARMED , SNHTA , HAS 06.05.2020 PTJA11 Cefiderocol for the treatment of infections due to aerobic Gram-negative bacteria in adult patients with limited treatment options 16.06.2020 NOMA ZIN AEMPS , HAS , IQWIG 03.03.2020 (revised 17.04.2020) PTJA10 Crizanlizumab for the prevention of vaso-occlusive crises in sickle cell disease patients aged 16 years and over 25.11.2020 Publication delayed by 5 weeks due to EPAR unavailability ZIN AEMPS HAS , NICE , JAZMP 28.07.2020 PTJA09 Brolucizumab for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD) 12.03.2020 FIMEA AEMPS , AETSA HAS , AOTMiT , HVB , RER
Observer: HTA Department/EC Ukraine
18.12.2019 PTJA08 Siponimod for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity 13.02.2020 (revised 03.03.2020) INFARMED NCPE AIFA , ZIN , SESCS /FUNCANIS ,RER 20.11.2019 PTJA07 Ustekinumab for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic, or have medical contraindications to such therapies 22.10.2019 MIZ TLV , AOTMiT UCSC Gemelli , NIPN , SNHTA , SESCS /FUNCANIS Observer: NCPHA 29.07.2019 PTJA06 Polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant 13.02.2020 IQWIG HAS FIMEA , SUKL , TLV , INFARMED GBA 22.11.2019 (revised 12.02.2019) PTJA05 Enasidenib for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation Product withdrawn from market authorisation NOMA AEMPS , AETSA HAS , AIFA , SNHTA , HIS , DPA/MOH Malta 11.02.2020 PTJA04 Sotagliflozin for adult patients with Type 1 Diabetes Mellitus who have inadequate blood glucose control using insulin or insulin analogues
Patient Input – Diabetes Type 1
07.06.2019 TLV ZIN , NCPE AEMPS , SNHTA , NVD , INFARMED , AOTMiT ,
05.03.2019 PTJA03 Alecensa as monotherapy is indicated for the first-line treatment of adult patients with ALK+ advanced NSCLC 23.01.2018 (revised 23.02.2018) TLV HVB , MIZ NICE , Regione Veneto , AETSA , NIPN MOH MALTA 20.10.2018 PTJA02 Regorafenib (Stivarga©) indicated as monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib treatment 25.10.2017 HAS INFARMED AAZ , SNHTA , FIMEA , LBI-HTA , NIPN , AETSA EOF , EKAPTY 21.07.2017 PTJA01 Midostaurin for the indication of Acute Myeloid Leukaemia 08.11.2017 FIMEA NOMA TLV , ZIN , NICE , HAS , AEMPS IQWIG SUKL , EOPYY , SESCS 28.06.2017 OTHER TECHNOLOGIES OTCA28 Lung cancer screening in risk groups 03.12.2020 IAMEV / AIHTA IQWIG , AVALIA-T UMIT , RER , Observer: UTA 30.06.2020 OTCA27 Comparative Effectiveness of surgical techniques and devices for the treatment of benign prostatic hyperplasia (BPH) 30.04.2021 RER AIHTA SNHTA , VASPVT , Regione Del Veneto 31.07.2020 OTCA26 Comparative effectiveness of surgical methods for treating people with morbid obesity 03.08.2021 NIPHNO HIQA , GÖG VASPVT , AQuAS , HAS 11.08.2020 (revised 23.04.2021) OTCA25 Stereotactic Body Radiation Therapy (SBRT) for lung, prostate and hepatic cancer 24.05.2021 (revised 20.01.2022)
AQuAS AOTMiT SNHTA , Regione Veneto , AETS-ISSCIII AVALIA-T 12.06.2020 (revised 25.11.2020)
OTCA24 A pulse wave analysis device (Mobil-O-Graph) and ARC solver algorithm to identify cardiovascular frailty 01.07.2020 HVB UCSC/Gemelli HIQA , AVALIA-T MIZ 03.12.2019 (revised 26.03.2020) OTCA23 Biodegradable rectum spacers to reduce toxicity for prostate cancer 28.07.2020 NIPHNO NSPHMPDB NICE , SNHTA , VASPVT 18.11.2019 (revised 24.04.2020) OTCA22 Point-of-care Tests (POCT): D-Dimer and Troponin 12.12.2019 LBI-HTA NSPHMPDB SNHTA , HVB 14.08.2019 OTCA21 Hypoglossal nerve stimulation systems for treatment of obstructive sleep apnoea 18.06.2020 AETS-ISCIII NSPHMPDB NIPHB , SFOPH/SNHTA , SESCS 21.01.2020 (revised 21.05.2020) OTCA20 Prophylactic or therapeutic use of endoanchoring systems in endovascular aortic aneurysm repair (EVAR/TEVAR) 18.11.2019 – 22.11.2019 AETS-ISCIII MoH Slovenia USCS Gemelli , SNHTA 28.01.2019 OTCA19 Screening for osteoporosis in the general population 20.09.2019 IQWiG SNHTA AQuAS , NSPHMPDB , GOG 19.12.2018 OTCA18 Regional hyperthermia for high-risk soft tissue sarcoma treatment 31.10.2019 NIPHNO RER VASPVT , AETS-ISCIII , SNHTA 14.05.2019 OTCA17 Lithium triborate (LBO) laser for photoselective vaporisation of the prostate (PVP) in the treatment of benign prostatic hyperplasia (BPH) 22.11.2019 AGENAS RER SNHTA , AETSA 18.10.2018 OTCA16 Bioresorbable Stents in cardiovascular indications (coronary artery disease) 31.01.2019 IAMEV/LBI-HTA SNSMPS SESCS , HAS 20.08.2018 OTCA15 Irreversible electroporation in liver and pancreatic cancer 05.07.2019 AVALIA-T LBI-HTA VASPVT , NIPN , SNHTA 23.10.2018 OTCA14 Robot-assisted surgery in thoracic and visceral indications 06.05.2019 LBI-HTA Regione Veneto HIQA , DEFACTUM 11.07.2018 OTCA13 Vagal nerve blockade for obesity Cancelled: expiration of CE approval for the technology NIPHNO VASPVT SESCS /FUNCANIS , NIPHB Cancelled: expiration of CE approval for the technology OTCA12 C-reactive protein point-of-care testing (CRP POCT) to guide antibiotic prescribing in primary care settings for acute respiratory tract infections (RTIs) 29.01.2019 HIQA HVB UCSC Gemelli , AETSA , AGENAS , HIS AOTMiT 19.04.2018 OTCA11 Custom-made or customisable 3D printed implants and cutting guides versus non-3D printed standard implants and cutting guides for improving outcome in patients undergoing knee, maxillofacial, or cranial surgery 19.04.2019 DEFACTUM OSTEBA GÖG , KCE , MIZ , NIPN 16.11.2018 OTJA10 Stool DNA testing for early detection of colorectal cancer 26.07.2019 GÖG NIJZ , JAZMP NICE , AGENAS , DEFACTUM , OSTEBA MoH Slovenia 25.07.2018 OTCA09 High-intensity focused ultrasound (HIFU) ablation for the treatment of prostate cancer 12.04.2018 LBI-HTA VASPVT SNHTA , AETS-ISCIII , OSTEBA 26.02.2018 OTJA08 Continuous glucose monitoring (CGM real-time) and flash glucose monitoring (FGM) as personal, standalone systems in patients with diabetes mellitus treated with insulin 27.07.2018 MIZ HVB , NIPHNO AQuAS , HIS , RER ACSS-IP , AOTMiT 28.02.2018 OTCA07 Relative effectiveness assessment of Femtosecond laser-assisted cataract surgery (FLACS) compared to standard ultrasound phacoemulsification cataract surgery 26.10.2018 RER GOG KCE , Osteba , SESCS/FUNCANIS and AQuAS VASPVT 15.02.2018 OTCA06 Transcatheter aortic valve implantation (TAVI) in patients at intermediate surgical risk 21.12.2018 AGENAS NIPHNO SNHTA , OCSC , HIQA , KCE , Regione Veneto 08.11.2017 (revised 20.12.2017) OTCA05 Repetitive transcranial magnetic stimulation for treatment-resistant major depression 21.04.2017 LBI-HTA Osteba KCE , FUNCANIS 21.04.2017 OTCA04 Added value of using gene-expression signature for adjuvant chemotherapy decisions in early breast cancer 03.01.2018 (revised 06.02.2018) ZIN KCE LBI-HTA , HAS 10.11.2017 OTCA03 Screening of fetal aneuploidies whereby non-invasive prenatal test (NIPT) 09.02.2018 Avalia-t RER MIDT, SNHTA , NIPN , IQWIG Observer: EOPYY 22.03.2017 OTCA02 Antibacterial-coated sutures versus non-antibacterial-coated sutures for the prevention of abdominal, superficial and deep, surgical site infection (SSI) 27.04.2017 MIZ NSPHMPDB SUKL , NIPN /OGYEI , VASPVT , SNHTA , IQWIG 06.10.2016 OTCA01 Wearable cardioverter-defibrillator (WCD) therapy in primary and secondary prevention of sudden cardiac arrest in patients at risk 20.12.2016 LBI-HTA MIZ Avalia-t , IQWiG 09.09.2016 
= Patients have been involved in the assessment.
All EUnetHTA JA3 Assessment reports are published under the Creative Commons license CC-BY-NC.
