Posledné odporúčania EUnetHTA pre lieky, technológie a horizon scanning

ELENA MARUŠÁKOVÁ, M&C CONSULTING GROUPSSFE

Pri príprave prezentácie boli použité verejne dostupné správyiniciatívy EUnetHTA –https://eunethta.eu/rapid-reas/

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https://eunethta.eu/rapid-reas/

Hodnotenia technológií (okrem liekov)

V rámci prehľadu je dostupných 24 hodnotení rôznych technológií: Operačné prístupy

Zdravotnícke pomôcky

Diagnostické postupy

Diagnostické sety

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HTA pre iné technológie – správy publikované po 1.1.2018 (17 správ)

Point-of-care Tests (POCT): D-Dimer and Troponin

Screening for osteoporosis in the general population

Regional hyperthermia for high-risk soft tissue sarcoma treatment Lithium triborate (LBO) laser for photoselective vaporisation of the prostate (PVP) in the treatment of benign prostatic hyperplasia (BPH)

Bioresorbable Stents in cardiovascular indications (coronary artery disease)

Irreversible electroporation in liver and pancreatic cancer

Robot-assisted surgery in thoracic and visceral indications

C-reactive protein point-of-care testing (CRP POCT) to guide antibiotic prescribing in primary care settings for acute respiratory tract infections (RTIs)

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

Stool DNA testing for early detection of colorectal cancer High-intensity focused ultrasound (HIFU) ablation for the treatment of prostate cancer

Continuous glucose monitoring (CGM real-time) and flash glucose monitoring (FGM) as personal, standalone systems in patients with diabetes mellitus treated with insulin

Relative effectiveness assessment of Femtosecond laser-assisted cataract surgery (FLACS) compared to standard ultrasound phacoemulsification cataract surgery

Transcatheter aortic valve implantation (TAVI) in patients at intermediate surgical risk

Repetitive transcranial magnetic stimulation for treatment-resistant major depression

Added value of using gene-expression signature for adjuvant chemotherapy decisions in early breast cancer

Screening of fetal aneuploidies whereby non-invasive prenatal test (NIPT)

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Point of care testing

POCT- testy v bode starostlivosti (POCT), ide o diagnostické testy, ktoré sa vykonávajú v ambulancii alebo na pohotovosti, nie v centrálnych laboratóriách; na Slovensku napr. CRP u všeobecného lekára

EUnetHTA hodnotila POCT v dvoch projektoch: CRP na určenie potreby ATB liečby (OTCA12), v rýchlej diferenciácii ARI (u dospelých, u

detí nebol dostatok štúdií) Znižuje predpis ATB, avšak nie je dôkaz o znížení počtu návštev, alebo o skrátení počtu dní

potrebných na vyliečenie, zvyšuje spokojnosť pacienta.

Troponín a D-dimér v rýchlej diagnostike pri podozrení na akútny koronárny syndróm a venózny tromboembolizmus. Troponín ani D-dimér – nebol preukázaný efekt na zníženie morbidity alebo mortality ani v

pohotovosti ani v ambulancii

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Preventívne / skríningy Prítomnosť osteoporózy vo všeobecnej populácii

Dotazník hodnotenia klinického rizika (48 rôznych nástrojov) ± meranie BMD (DXA, CT, USG) – nebol zistený benefit skríningu u postmenopauzálnych žien, nebolo možné zistiť rozdiely medzi jednotlivými nástrojmi,

Trizómie 31, 18 a 13 neinvazívnym prenatálnym testovaním z krvi matky v 8 – 10 týždni tehotenstva 99,3% senzitivita a 99,9% špecificita (PCR amplifikácia cfDNA)

DNA testovanie na včasnú detekciu kolorektálneho karcinómu (Cologuard vs imunochemické testy stolice and ColoAlert vs gFOBT)

MammaPrint na zistenie génovej expresie pre rozhodnutie o adjuvantnej liečbe pri včasnom karcinóme prsníka hodnotí expresiu 70 génov súvisiacich s metastatickou kaskádou BC – pre rozhodnutie o

adjuvantnej liečbe áno, ako predikcia OS nie.

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Senzitivita Špecificita Senzitivita ŠpecificitaCologuard 92,3% 84,4% 46,4% 86,6%FIT-CHECK 73,8% 93,4% 27,7% 94,9%FOB Gold 96,7% 83,0% 51,1% 86,5%

ColoAlert 84,6% 87,0% 35,5% 88,4%gFOBT 68,0% 95,5% 22,3% 95,8%M2-PK 82,9% 58,7% 54,7% 60,1%

CRCCRC alebo pokročilý

adenóm

drugs

PROJECT IDPATIENT INVOLVEMENTTITLEPUBLICATION OF FINAL ASSESSMENTAUTHORCO-AUTHORSDEDICATED REVIEWERSPUBLICATION OF PROJECT PLAN

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)7/15/20HASMIZMoH Ukraine, SNHTA, AEMPS, UU4/2/20

PTJA12Glasdegib indicated for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML)7/30/20HVBNCPEINFARMED, SNHTA, HAS5/6/20

PTJA11Cefiderocol for the treatment of infections due to aerobic Gram-negative bacteria in adult patients with limited treatment options6/16/20NOMAZINAEMPS, HAS, IQWIG4/17/20

PTJA09Brolucizumab for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD)3/12/20FIMEAAEMPS, AETSAHAS, AOTMiT, HVB, RER Observer: HTA Department/EC Ukraine12/18/19

PTJA08Siponimod for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity2/13/20INFARMEDNCPEAIFA, ZIN, SESCS/FUNCANIS, RER11/20/19

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 therapies10/22/19MIZTLV, AOTMiTUCSC Gemelli, NIPN, SNHTA, SESCS/FUNCANIS Observer: NCPHA7/29/19

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 transplant2/13/20IQWIGHASFIMEA, SUKL, TLV, INFARMED Observer: GBA11/22/19

PTJA04Sotagliflozin for adult patients with Type 1 Diabetes Mellitus who have inadequate blood glucose control using insulin or insulin analogues Patient Input - Diabetes Type 16/7/19TLVZIN, NCPEAEMPS, SNHTA, NVD, INFARMED, AOTMiT Observer: HIS, EOF3/5/19

PTJA03Alecensa as monotherapy is indicated for the first-line treatment of adult patients with ALK+ advanced NSCLC1/23/18TLVHVB, MIZNICE, Regione Veneto, AETSA, NIPN Observer: MOH MALTA10/20/18

https://eunethta.eu/hashttps://eunethta.eu/fimeahttps://eunethta.eu/ptja08/https://eunethta.eu/infarmedhttps://eunethta.eu/ncpehttps://eunethta.eu/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-intoler/https://eunethta.eu/mizhttps://eunethta.eu/ptja06/https://eunethta.eu/iqwighttps://eunethta.eu/hashttps://eunethta.eu/nomahttps://eunethta.eu/mizhttps://eunethta.eu/ptja04-sotagliflozin-indicated-as-an-adjunct-to-insulin-therapy-to-improve-glycaemic-control-in-adults-with-type-1-diabetes-mellitus-with-a-body-mass-index-bmi-%E2%89%A5-27-kg/https://eunethta.eu/tlvhttps://eunethta.eu/wp4-ptja03-on-alectinib-alecensa-as-monotherapy-for-the-first-line-treatment-of-adult-patients-with-alk-positive-advanced-non-small-cell-lung-cancer-nsclc-is-now-available/https://eunethta.eu/tlvhttps://eunethta.eu/regorafenib-stivarga-indicated-as-monotherapy-for-the-treatment-of-adult-patients-with-hepatocellular-carcinoma-hcc-who-have-been-previously-treated-with-sorafenib/https://eunethta.eu/hashttps://eunethta.eu/infarmedhttps://eunethta.eu/final-assessment-report-on-midostaurin-rydapt-in-combination-with-standard-daunorubicin-and-cytarabine-induction-and-high-dose-cytarabine-consolidation-chemotherapy/https://eunethta.eu/fimeahttps://eunethta.eu/nomahttps://eunethta.eu/infarmedhttps://eunethta.eu/hvb/https://eunethta.eu/ncpehttps://eunethta.eu/nomahttps://eunethta.eu/zinhttps://eunethta.eu/zinhttps://eunethta.eu/aemps/

other technologies

PROJECT IDPATIENT INVOLVEMENTTITLEPUBLICATION OF FINAL ASSESSMENTAUTHORCO-AUTHORSDEDICATED REVIEWERSPUBLICATION OF PROJECT PLAN

OTCA22Point-of-care Tests (POCT): D-Dimer and Troponin12/12/19LBI-HTANSPHMPDBSNHTA, HVB8/14/19

OTCA19Screening for osteoporosis in the general population9/20/19IQWiGSNHTAAQuAS, NSPHMPDB, GOG12/19/18

OTCA18Regional hyperthermia for high-risk soft tissue sarcoma treatment10/31/19NIPHNORERVASPVT, AETS-ISCIII, SNHTA5/14/19

OTCA17Lithium triborate (LBO) laser for photoselective vaporisation of the prostate (PVP) in the treatment of benign prostatic hyperplasia (BPH)11/22/19AGENASRERSNHTA, AETSA10/18/18

OTCA16Bioresorbable Stents in cardiovascular indications (coronary artery disease)1/31/19IAMEV/LBI-HTASNSMPSSESCS, HAS8/20/18

OTCA15Irreversible electroporation in liver and pancreatic cancer7/5/19AVALIA-TLBI-HTAVASPVT, NIPN, SNHTA10/23/18

OTCA14Robot-assisted surgery in thoracic and visceral indications5/6/19LBI-HTARegione VenetoHIQA, DEFACTUM7/11/18

OTCA12C-reactive protein point-of-care testing (CRP POCT) to guide antibiotic prescribing in primary care settings for acute respiratory tract infections (RTIs)1/29/19HIQAHVBUCSC Gemelli, AETSA, AGENAS, HIS Observer: AOTMiT4/19/18

OTCA11Custom-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 surgery4/19/19DEFACTUMOSTEBAGÖG, KCE, MIZ, NIPN11/16/18

OTJA10Stool DNA testing for early detection of colorectal cancer7/26/19GÖGNIJZ, JAZMPNICE, AGENAS, DEFACTUM, OSTEBA Observer: MoH Slovenia7/25/18

OTCA09High-intensity focused ultrasound (HIFU) ablation for the treatment of prostate cancer4/12/18LBI-HTAVASPVTSNHTA, AETS-ISCIII, OSTEBA2/26/18

OTJA08Continuous glucose monitoring (CGM real-time) and flash glucose monitoring (FGM) as personal, standalone systems in patients with diabetes mellitus treated with insulin7/27/18MIZHVB, NIPHNOAQuAS, HIS, RER Observer: ACSS-IP, AOTMiT2/28/18

OTCA07Relative effectiveness assessment of Femtosecond laser-assisted cataract surgery (FLACS) compared to standard ultrasound phacoemulsification cataract surgery10/26/18RERGOGKCE, Osteba, SESCS/FUNCANIS and AQuAS Observer: VASPVT2/15/18

OTCA06Transcatheter aortic valve implantation (TAVI) in patients at intermediate surgical risk12/21/18AGENASNIPHNOSNHTA, OCSC, HIQA, KCE, Regione Veneto11/8/17

OTCA05Repetitive transcranial magnetic stimulation for treatment-resistant major depression4/21/17LBI-HTAOstebaKCE, FUNCANIS4/21/17

OTCA04Added value of using gene-expression signature for adjuvant chemotherapy decisions in early breast cancer1/3/18ZINKCELBI-HTA, HAS11/10/17

OTCA03Screening of fetal aneuploidies whereby non-invasive prenatal test (NIPT)2/9/18Avalia-tRERMIDT, SNHTA, NIPN, IQWIG Observer: EOPYY3/22/17

Point-of-care Tests (POCT): D-Dimer and Troponin Screening for osteoporosis in the general population Regional hyperthermia for high-risk soft tissue sarcoma treatment Lithium triborate (LBO) laser for photoselective vaporisation of the prostate (PVP) in the treatment of benign prostatic hyperplasia (BPH) Bioresorbable Stents in cardiovascular indications (coronary artery disease) Irreversible electroporation in liver and pancreatic cancer Robot-assisted surgery in thoracic and visceral indications C-reactive protein point-of-care testing (CRP POCT) to guide antibiotic prescribing in primary care settings for acute respiratory tract infections (RTIs) 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 Stool DNA testing for early detection of colorectal cancer High-intensity focused ultrasound (HIFU) ablation for the treatment of prostate cancer Continuous glucose monitoring (CGM real-time) and flash glucose monitoring (FGM) as personal, standalone systems in patients with diabetes mellitus treated with insulin Relative effectiveness assessment of Femtosecond laser-assisted cataract surgery (FLACS) compared to standard ultrasound phacoemulsification cataract surgery Transcatheter aortic valve implantation (TAVI) in patients at intermediate surgical risk Repetitive transcranial magnetic stimulation for treatment-resistant major depression Added value of using gene-expression signature for adjuvant chemotherapy decisions in early breast cancer Screening of fetal aneuploidies whereby non-invasive prenatal test (NIPT)

https://eunethta.eu/aihtahttps://eunethta.eu/ucsc-gemellihttps://eunethta.eu/otca23-final-project-plan-and-related-documents-now-available/https://eunethta.eu/niphno-formerly-nokchttps://eunethta.eu/nsphmpdbhttps://eunethta.eu/otca22-final-assessment-report-and-related-documents-now-available/https://eunethta.eu/aihta/https://eunethta.eu/nsphmpdbhttps://eunethta.eu/otca21-final-project-plan-and-related-documents-now-available/https://eunethta.eu/aets-isciiihttps://eunethta.eu/nsphmpdbhttps://eunethta.eu/rerhttps://eunethta.eu/octa20-final-assessment-report-is-now-available-2/https://eunethta.eu/aets-isciiihttps://eunethta.eu/moh-sloveniahttps://eunethta.eu/otca19-screening-for-osteoporosis-in-the-general-population-final-assessment-and-related-documentation-is-now-available/https://eunethta.eu/iqwighttps://eunethta.eu/snhtahttps://eunethta.eu/otca18-final-assessment-report-is-now-available/https://eunethta.eu/niphno-formerly-nokc/https://eunethta.eu/rerhttps://eunethta.eu/otca17-final-assessment-report-and-related-documents-now-available/https://eunethta.eu/aihtahttps://eunethta.eu/agenashttps://eunethta.eu/rerhttps://eunethta.eu/otca16-bioresorbable-stents-for-the-treatment-of-cardiovascular-indications-coronary-artery-disease-final-assessment-now-available/https://eunethta.eu/lbi/https://eunethta.eu/nsphmpdb/https://eunethta.eu/otca15/https://eunethta.eu/avalia-thttps://eunethta.eu/aihta/https://eunethta.eu/otca14-robot-assisted-surgery-for-thoracic-and-visceral-surgery-final-assessment-now-available/https://eunethta.eu/aihta/https://eunethta.eu/niphno-formerly-nokchttps://eunethta.eu/veneto-crufhttps://eunethta.eu/niphno-formerly-nokchttps://eunethta.eu/vaspvthttps://eunethta.eu/the-collaborative-assessment-otca12-on-c-reactive-protein-point-of-care-testing-crp-poct-to-guide-antibiotic-prescribing-in-primary-care-settings-for-acute-respiratory-tract-infections-r/https://eunethta.eu/hiqahttps://eunethta.eu/hvbhttps://eunethta.eu/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-o/https://eunethta.eu/defactum-formerly-cfk/https://eunethta.eu/osteba/https://eunethta.eu/otja10-final-assessment-report-and-related-documents-are-now-available/https://eunethta.eu/hiqahttps://eunethta.eu/gog/https://eunethta.eu/otca09-high-intensity-focused-ultrasound-hifu-ablation-for-the-treatment-of-prostate-cancer-is-now-available/https://eunethta.eu/aihta/https://eunethta.eu/vaspvt/https://eunethta.eu/the-joint-assessment-on-continuous-glucose-monitoring-cgm-real-time-and-flash-glucose-monitoring-fgm-as-personal-standalone-systems-in-patients-with-diabetes-mellitus-treated-with-insuli/https://eunethta.eu/mizhttps://eunethta.eu/the-collaborative-assessment-otca07-on-femtosecond-laser-assisted-cataract-surgery-flacs-for-the-treatment-of-age-related-cataract-is-now-available/https://eunethta.eu/rerhttps://eunethta.eu/the-collaborative-assessment-otca06-on-transcatheter-aortic-valve-implantation-tavi-in-patients-at-intermediate-surgical-risk-is-now-available/https://eunethta.eu/agenashttps://eunethta.eu/aquas/https://eunethta.eu/niphno-formerly-nokchttps://eunethta.eu/the-ca-of-ja3-wp4-on-repetitive-transcranial-magnetic-stimulation-for-treatment-resistant-major-depression-is-now-available/https://eunethta.eu/aihta/https://eunethta.eu/ostebahttps://eunethta.eu/final-assessment-report-on-mammaprint-added-value-of-using-the-gene-expression-signature-test-mammaprint-for-adjuvant-chemotherapy-decision-making-in-early-breast-cancer/https://eunethta.eu/zinhttps://eunethta.eu/kcehttps://eunethta.eu/wp4-otca03-screening-fetal-trisomies-21-18-13-non-invasive-prenatal-testing-now-available/https://eunethta.eu/avalia-thttps://eunethta.eu/rerhttps://eunethta.eu/aotmithttps://eunethta.eu/the-ca-of-ja3-wp4-on-antibacterial-coated-sutures-versus-non-antibacterial-coated-sutures-for-the-prevention-of-abdominal-superficial-and-deep-incisional-surgical-site-infection-ssi-is-now-ava/https://eunethta.eu/mizhttps://eunethta.eu/nsphmpdbhttps://eunethta.eu/1st-collaborative-assessment-wearable-cardioverter-defibrillator-wcd-therapy-in-primary-and-secondary-prevention-of-sudden-cardiac-arrest-in-patients-at-risk/https://eunethta.eu/aihtahttps://eunethta.eu/mizhttps://eunethta.eu/otca24-final-project-plan-and-related-documentation-now-available/https://eunethta.eu/hvb/

Sheet3

uSenzitivita:

uCologuard na CRC - 92,3% vs 73,8% (OC FIT-CHECK) vs 96,7% (OC – FOB Gold); na CRC alebo pokročilý adenóm – 46,4% vs 27,7% (OC FIT-CHECK) vs 51,1% (OC – FOB Gold);

uColoAlert na CRC – 84,6% vs 68% (OC gFOBT) vs 82,9% (OC – M2-PK); na CRC alebo pokročilý adenóm – 35,5% vs 22,3% (OC gFOBT) vs 54,7% (OC – M2-PK);

uŠpecificita

uCologuard na CRC – 84,4% vs 93,4% (OC FIT-CHECK) vs 83,0% (OC – FOB Gold); na CRC alebo pokročilý adenóm – 86,6% vs 94,9% (OC FIT-CHECK) vs 86,5% (OC – FOB Gold);

uColoAlert na CRC – 87,0% vs 95,5% (OC gFOBT) vs 58,7% (OC – M2-PK); na CRC alebo pokročilý adenóm – 88,4% vs 95,8% (OC gFOBT) vs 60,1% (OC – M2-PK);

CRCCRC alebo pokročilý adenóm

SenzitivitaŠpecificitaSenzitivitaŠpecificita

Cologuard92.3%84.4%46.4%86.6%

FIT-CHECK73.8%93.4%27.7%94.9%

FOB Gold96.7%83.0%51.1%86.5%

ColoAlert84.6%87.0%35.5%88.4%

gFOBT68.0%95.5%22.3%95.8%

M2-PK82.9%58.7%54.7%60.1%

HTA liekov - alektinib7

Projekt Alektinib ako monoterapia v prvej línii ALK+ NSCLC,

Komparátor krizotinib; ceritinib

Hodnotené výsledky OF; PFS

Záver vs krizotinib OS nehodnotiteľné; PFS s HR 0,47; vs ceritinib OS bez štatisticky významného

rozdielu; PFS s HR 0,41

HTA liekov - Sotagliflozín8

Projekt Sotagliflozín ako doplnok k inzulínovej terapii na zlepšenie kontroly glykémie u dospelých

s diabetes mellitus 1. typu s indexom telesnej hmotnosti (BMI) ≥ 27 kg / m2, u ktorých sa napriek optimálnej inzulínovej terapii nepodarilo dosiahnuť dostatočnú kontrolu glykémie,

Komparátor empagliftozín; dapagliftozín

Hodnotené výsledky podiel pacientov s HbA1c

HTA liekov - Polatuzumab9

Projekt Polatuzumab vedotín v kombinácii s bendamustínom a rituximabom na liečbu

relapsovaného / refraktérneho difúzneho veľkého B-bunkového lymfómu (DLBCL), ktorí nie sú vhodní na transplantáciu krvotvorných kmeňových buniek,

Komparátor PICO 1a: GemOx; ICE (ifosfamide-carboplatin-etoposide), alebo DHAP (cytozíne

arabinoside-cisplatin-dexamethasone) +/- rituximab; rituximab+bendamustín; PICO 1b: axicabtagene ciloleucel; tisagenlecleucel; pixantrón; Rituximab + bendamustine combination; Best supportive care (BSC)

Hodnotené výsledky mortalita; HRQol; AE; symptómy; PFS, CR, počet pacientov s protilátkami polatuzumabu

Záver PICO 1a: pre skupinu po zlyhaní 1.línie neboli výsledky využiteľné na porovnanie s

komparátormi; PICO 1b: pre skupinu po zlyhaní 2 a viac línií neboli výsledky využiteľné na porovnanie s komparátormi

HTA liekov - Ustekinumab10

Projekt Ustekinumab na liečbu dospelých pacientov so stredne až silne aktívnou ulceratívnou kolitídou

(uc), u ktorých bola neprimeraná reakcia, stratená odpoveď na intoleranciu konvenčnej terapie alebo biologickej liečby, alebo ktorí boli na tieto terapie kontraindikovaní,

Komparátor placebo; adalimumab; infliximab; golimumab; vedlizumab a tofacitinib;

Hodnotené výsledky klinická odpoveď; klinická remisia; hojenie sliznice

Záver Zlyhanie na klasickej liečbe: vs placebo, golimumab a adalimumab - štatisticky významné

zlepšenie; vs infliximab a tofacitinib - nie je možné posúdiť; vs vedolizumab - bez štatistickejvýznamnosti; Zlyhanie na biologickej liečbe: vs placebo - klinicky i štatisticky významnézlepšenie; vs golimumab, adalimumab, infliximab, vedolizumab a tofacitinib - klinickyefektívnejší, ale nie sú údaje k hojeniu sliznice; z pohľadu bezpečnosti sú potrebné ďalšieúdaje.

HTA liekov - Siponimod11

Projekt Siponimod na liečbu dospelých pacientov so sekundárnou progresívnou roztrúsenou sklerózou (SPMS) s

aktívnym ochorením, ktoré sa prejavuje relapsami alebo zobrazovacími prvkami zápalovej aktivity, (zapojila sa pacientska skupina zo Slovenska)

Komparátor Interferón-β-1a alebo -β-1b + BSC Ocrelizumab + BSC Natalizumab + BSC Fingolimod + BSC Kladribín + BSC Rituximab + BSC

Hodnotené výsledky progresia invalidity; MS symptómy, klinický relaps, mortalita, HRQol, MRI zápalová aktivita; AE, SAE, AU

vedúce k ukončeniu liečby, úmrtie súvisiace s liečbou;

Záver údaje buď boli nedostupné, alebo klinický prínos nebol štatisticky významný; hodnotenie bolo možné len

voči placebu.

HTA liekov - Brolucizumab12

Projekt Brolucizumab na liečbu dospelých s neovaskulárnou (mokrou) vekom podmienenou makulárnou degeneráciou

(AMD)

Komparátor priame vs aflibercept, nepriame vs ranibizumab alebo bevacizumab

Hodnotené výsledky Účinnosť: Najlepšia korigovaná zraková ostrosť (ošetrené oko)

Anatomické parametre aktivity ochorenia:

•Hrúbka centrálneho poľa

• Choroidálna neovaskularizačná oblasť

• Subretinálna tekutina

• Intraretinálna tekutina / cysta

• Subretinálna pigmentová epitelová tekutina

• Neurosenzorická hrúbka sietnice

Qol súvisiaca so zrakom, HRQol

Záver non inferiorita vs aflibercept; mierne lepší výsledok vs ranibizumab, alebo bez významnejších rozdielov vs

ranibizumab alebo bevacizumab

Horizon scanning v EU

Horizon scanning and topic identification, selection and prioritisation (TISP)

Spoločný horizon scanning pre celú EU Vykonávať by mal jeden alebo viacero štátov Spolupracovať bude s EMA a HTA Podklad pre ďalšie následné aktivity Potreba identifikácie lieku 3 – 6 mesiacov pred vstupom do zoznamu

registrovaných liekov Priradenie priority má vyplynúť zo spolupráce s HTA na EU úrovni V poslednej verzii nariadenia Európskeho parlamentu a Rady o hodnotení

zdravotníckych technológií a zmene smernice 2011/24/EÚ bol HS doplnený ako tretí pilier

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Návrh procesu pre HS14

Prioritizácia v EU dnes

Pri liekoch má 15 krajín EU kritériá výberu témy alebo priority. V prípade ostatných technológií je to 15 krajín EU.

Kritériá výberu tém sú podobné pre farmaceutické a iné technológie a najčastejšie sú založené na: ekonomický dopad

potenciálne prínosy pre zdravie

závažnosť alebo zaťaženie chorobou

veľkosť populácie

dôležitosť pre zdravotnú politiku a / alebo zdravotnú starostlivosť

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Ďakujem za pozornosťelena.marusakova

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Slovensko

Posledné odporúčania EUnetHTA pre lieky, technológie �a horizon scanning�Hodnotenia technológií (okrem liekov)HTA pre iné technológie – správy publikované po 1.1.2018 (17 správ)Point of care testingPreventívne / skríningyHTA liekov - alektinibHTA liekov - SotagliflozínHTA liekov - PolatuzumabHTA liekov - UstekinumabHTA liekov - SiponimodHTA liekov - BrolucizumabHorizon scanning v EUNávrh procesu pre HSPrioritizácia v EU dnesĎakujem za pozornosť�