Assessments REA (2016 – 2021)

Assessments REA (2016 – 2021)

 

PROJECT IDPATIENT INVOLVEMENTTITLEPUBLICATION OF FINAL ASSESSMENTAUTHORCO-AUTHORSDEDICATED REVIEWERSPUBLICATION OF PROJECT PLAN
PHARMACEUTICAL TECHNOLOGIES*
PTRCR20Bamlanivimab for the treatment of COVID-1931.05.2021AIHTASNHTASESCS, SUKLNA
PTRCR19

REGN-Cov2 for the treatment of COVID-19

Rapid Collaborative Review

 21.05.2021AIHTASNHTAGÖG, UCSC GemelliNA
PTRCR18 Dexamethasone for the treatment of COVID-19
Rapid Collaborative Review
19.11.2020AIHTASNHTARER, MoH UkraineNA
PTJA17Elivaldogene autotemcel (eli-cel) for treatment of Cerebral Adrenoleukodystrophy (CALD)

16.08.2021 (revised 03.09.2021)

ZINAOTMiT, GÖGSNHTA, MIZ26.05.2021
PTJA16Venetoclax 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)

NOMAJAZMPAEMPS, MoH Ukraine, NIPHNO, SMCA28.04.2021
PTRCR15 

Remdesivir for the treatment of COVID-19

First update

First update: 16.12.2020AIHTANAINFARMED, NCPE, RER, MoH UkraineNA
 Rapid Collaborative Review: PICO and Evidence gapsOriginal report: 29.09.2020INFARMEDNCPEAIHTA, RER, MoH UkraineNA
PTJA14Pretomanid 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
Publication was delayed by 5 weeks due to EPAR unavailability
HASMIZMoH Ukraine, SNHTAAEMPS, UU02.04.2020
PTJA13Satralizumab 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.

INFARMEDEUR, ZIN

AEMPS, JAZMP, HIS

Observer: VVKT

28.04.2021
PTJA12Glasdegib indicated for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML)30.07.2020HVBNCPEINFARMED, SNHTA, HAS06.05.2020
PTJA11Cefiderocol for the treatment of infections due to aerobic Gram-negative bacteria in adult patients with limited treatment options16.06.2020NOMAZINAEMPS, HAS, IQWIG03.03.2020 (revised 17.04.2020)
PTJA10Crizanlizumab for the prevention of vaso-occlusive crises in sickle cell disease patients aged 16 years and over25.11.2020 Publication delayed by 5 weeks due to EPAR unavailabilityZINAEMPSHAS, NICE, JAZMP28.07.2020
PTJA09Brolucizumab for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD)12.03.2020FIMEAAEMPS, AETSA

HAS, AOTMiT, HVB, RER

Observer: HTA Department/EC Ukraine

18.12.2019
PTJA08Siponimod for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity13.02.2020 (revised 03.03.2020)INFARMEDNCPEAIFA, ZIN, SESCS/FUNCANIS,
RER
20.11.2019
PTJA07Ustekinumab 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 therapies22.10.2019MIZTLV, AOTMiTUCSC Gemelli, NIPN, SNHTA, SESCS/FUNCANIS Observer: NCPHA29.07.2019
PTJA06Polatuzumab 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 transplant13.02.2020IQWIGHASFIMEA, SUKL, TLV, INFARMED
Observer: GBA
22.11.2019 (revised 12.02.2019)
PTJA05Enasidenib for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutationProduct withdrawn from market authorisationNOMAAEMPS, AETSAHAS, AIFA, SNHTA, HIS, DPA/MOH Malta11.02.2020
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

07.06.2019TLVZIN, NCPE

AEMPS, SNHTA, NVD, INFARMED, AOTMiT,

05.03.2019
PTJA03Alecensa as monotherapy is indicated for the first-line treatment of adult patients with ALK+ advanced NSCLC23.01.2018 (revised 23.02.2018)TLVHVB, MIZNICE, Regione Veneto, AETSA, NIPN
Observer: 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 treatment25.10.2017HASINFARMEDAAZ, SNHTA, FIMEA, LBI-HTA, NIPN, AETSA
Observer: EOFEKAPTY
21.07.2017
PTJA01Midostaurin for the indication of Acute Myeloid Leukaemia08.11.2017FIMEANOMATLV, ZIN, NICE, HAS, AEMPS
Information retrieval: IQWIG
Observer: SUKL, EOPYY, SESCS
28.06.2017
OTHER TECHNOLOGIES
OTCA28 Lung cancer screening in risk groups03.12.2020IAMEV / AIHTAIQWIG, AVALIA-TUMIT, RER, Observer: UTA30.06.2020
OTCA27 Comparative Effectiveness of surgical techniques and devices for the treatment of benign prostatic hyperplasia (BPH)30.04.2021RERAIHTASNHTA, VASPVT, Regione Del Veneto31.07.2020
OTCA26 Comparative effectiveness of surgical methods for treating people with morbid obesity03.08.2021NIPHNOHIQA, GÖGVASPVT, AQuAS, HAS11.08.2020 (revised 23.04.2021)
OTCA25Stereotactic Body Radiation Therapy (SBRT) for lung, prostate and hepatic cancer24.05.2021AQuASAOTMiTSNHTA, Regione Veneto, AETS-ISSCIII
Project Manager: AVALIA-T
01.07.2020 (revised 25.11.2020)
OTCA24 A pulse wave analysis device (Mobil-O-Graph) and ARC solver algorithm to identify cardiovascular frailty01.07.2020HVBUCSC/GemelliHIQA, AVALIA-T
Project Manager: MIZ
03.12.2019 (revised 26.03.2020)
OTCA23Biodegradable rectum spacers to reduce toxicity for prostate cancer28.07.2020NIPHNONSPHMPDBNICE, SNHTA, VASPVT18.11.2019 (revised 24.04.2020)
OTCA22 Point-of-care Tests (POCT): D-Dimer and Troponin12.12.2019LBI-HTANSPHMPDBSNHTA, HVB14.08.2019
OTCA21Hypoglossal nerve stimulation systems for treatment of obstructive sleep apnoea18.06.2020AETS-ISCIIINSPHMPDBNIPHB, SFOPH/SNHTA, SESCS21.01.2020 (revised 21.05.2020)
OTCA20 Prophylactic or therapeutic use of endoanchoring systems in endovascular aortic aneurysm repair (EVAR/TEVAR)18.11.2019 – 22.11.2019AETS-ISCIIIMoH SloveniaUSCS Gemelli, SNHTA28.01.2019
OTCA19Screening for osteoporosis in the general population20.09.2019IQWiGSNHTAAQuAS, NSPHMPDB, GOG19.12.2018
OTCA18 Regional hyperthermia for high-risk soft tissue sarcoma treatment31.10.2019NIPHNORERVASPVT, AETS-ISCIII, SNHTA14.05.2019
OTCA17 Lithium triborate (LBO) laser for photoselective vaporisation of the prostate (PVP) in the treatment of benign prostatic hyperplasia (BPH)22.11.2019AGENASRERSNHTA, AETSA18.10.2018
OTCA16 Bioresorbable Stents in cardiovascular indications (coronary artery disease)31.01.2019IAMEV/LBI-HTASNSMPSSESCS, HAS20.08.2018
OTCA15Irreversible electroporation in liver and pancreatic cancer05.07.2019AVALIA-TLBI-HTAVASPVT, NIPN, SNHTA23.10.2018
OTCA14 Robot-assisted surgery in thoracic and visceral indications06.05.2019LBI-HTARegione VenetoHIQA, DEFACTUM11.07.2018
OTCA13Vagal nerve blockade for obesityCancelled: expiration of CE approval for the technologyNIPHNOVASPVTSESCS/FUNCANIS, NIPHBCancelled: expiration of CE approval for the technology
OTCA12C-reactive protein point-of-care testing (CRP POCT) to guide antibiotic prescribing in primary care settings for acute respiratory tract infections (RTIs)29.01.2019HIQAHVBUCSC Gemelli, AETSA, AGENAS, HIS
Observer: 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 surgery19.04.2019DEFACTUMOSTEBAGÖG, KCE, MIZ, NIPN16.11.2018
OTJA10Stool DNA testing for early detection of colorectal cancer26.07.2019GÖGNIJZ, JAZMPNICE, AGENAS, DEFACTUM, OSTEBA
Observer: MoH Slovenia
25.07.2018
OTCA09 High-intensity focused ultrasound (HIFU) ablation for the treatment of prostate cancer12.04.2018LBI-HTAVASPVTSNHTAAETS-ISCIII, OSTEBA26.02.2018
OTJA08Continuous glucose monitoring (CGM real-time) and flash glucose monitoring (FGM) as personal, standalone systems in patients with diabetes mellitus treated with insulin27.07.2018MIZHVB, NIPHNOAQuAS, HIS, RER
Observer: ACSS-IP, AOTMiT
28.02.2018
OTCA07Relative effectiveness assessment of Femtosecond laser-assisted cataract surgery (FLACS) compared to standard ultrasound phacoemulsification cataract surgery26.10.2018RERGOGKCE, Osteba, SESCS/FUNCANIS and AQuAS
Observer: VASPVT
15.02.2018
OTCA06 Transcatheter aortic valve implantation (TAVI) in patients at intermediate surgical risk21.12.2018AGENASNIPHNOSNHTA, OCSC, HIQA, KCE, Regione Veneto08.11.2017 (revised 20.12.2017)
OTCA05 Repetitive transcranial magnetic stimulation for treatment-resistant major depression21.04.2017LBI-HTAOstebaKCE, FUNCANIS21.04.2017
OTCA04Added value of using gene-expression signature for adjuvant chemotherapy decisions in early breast cancer03.01.2018 (revised 06.02.2018)ZINKCELBI-HTA, HAS10.11.2017
OTCA03Screening of fetal aneuploidies whereby non-invasive prenatal test (NIPT)09.02.2018Avalia-tRERMIDT, SNHTA, NIPN, IQWIG Observer: EOPYY22.03.2017
OTCA02 Antibacterial-coated sutures versus non-antibacterial-coated sutures for the prevention of abdominal, superficial and deep, surgical site infection (SSI)27.04.2017MIZNSPHMPDBSUKL, NIPN/OGYEI, VASPVT, SNHTA, IQWIG06.10.2016
OTCA01Wearable cardioverter-defibrillator (WCD) therapy in primary and secondary prevention of sudden cardiac arrest in patients at risk20.12.2016LBI-HTAMIZAvalia-t, IQWiG09.09.2016

* EUnetHTA JA3 will not be accepting any further Letters of Intent with regard to new pharma Joint Assessments through the end of Joint Action 3 on 31st May, 2021.

= Patients have been involved in the assessment.

General abbreviations:

OT – Other Technologies

PT – Pharmaceutical Technologies

CA – Collaborative Assessment

JA – Joint Assessment

All EUnetHTA JA3 Assessment reports are published under the Creative Commons license CC-BY-NC.

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