Re-evaluation of coronary stents in France

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Oct 2018

In May 2018, the French National Authority of Health, HAS, has published an update of the assessment of coronary stents.

The authors have published this paper in order to assess stents with the active release, stents coated with a non-pharmacologically active substance called "non-active stents," stents without coating metal ("bare stents") as well as those covered with a synthetic polytetrafluoroethylene membrane (“stents covered with PTFE”). The purpose of the re-evaluation is to update the indications for management and the prescription and use conditions of active, bare, non-active stents and stents covered with a synthetic membrane.

The authors have performed a systematic review of the literature found on Medline, Cochrane Library, other websites publishing guidelines or HTA reports, and on websites of competent medical societies. Only publications dating 2009-2016 were included in this review. Eventually, fifty-seven (57) publications that describe the safety and efficacy of coronary stents were incorporated.

Stents vs optimal medical treatment

The clinical situation concerned is that of disabling angina not responding to medical treatment. The data relate exclusively to active stents (2 superiority tests XIENCE, RESOLUTE, BIOMATRIX or NOBORI). The results show an 80% reduction in the risk of new hospitalization for revascularization with active stents without any difference regarding death or quality of life up to 2 years (approximately 13,000 patients in total). Current recommendations for the place of angioplasty versus medical treatment are not assessed.

Stents vs coronary bypass

The clinical situation concerned is stenoses involving more than 50% of coronary vessels and / or the left common trunk in order to treat the ischemic stroke. The data relate exclusively to active stents (3 trials of non-inferiority with a total of approximately 3,000 patients and 1 real-life study of 9,000 patients matched on propensity score evaluating XIENCE and BIOMATRIX ranges). The results show a risk of new hospitalization for revascularization 1.5 to 2.4 times higher with PCI compared to coronary bypass without concordant results between studies in terms of occurrence of IDM, death, stroke (approximately 1,000 patients in total). Current recommendations for the place of the coronary bypass is not assessed because available follow-up (3 years) is not sufficient to evaluate the benefit of angioplasty with active stent implantation.

Drug-eluting stents versus bare metal stents of equivalent generation

The clinical situation concerned is >50% stenosis, in case of stable disease or of the lesion(s) of an SCA with the aim of improving the vital prognosis. The data are only experimental and heterogeneous for population with low risk of bleeding comparing the XIENCE, PROMUS, RESOLUTE, NOBORI, BIOMATRIX, YUKON ranges to bare or non-active stents range TITAN or ENERGY (9 superiority trials in about 20,000 patients up to 6 years of follow-up) and to population at risk haemorrhagic comparing XIENCE and BIOFREEDOM ranges to bare stents (2 trials in approximately 3000 patients followed 1 year). Nevertheless, patients with complex lesional features are included in these studies (e.g. multi-node, bifurcation, STA-SCA, intrastent restenosis, total chronic occlusion, proximal IVA, or stenosis). The results are consistent between the analyzed populations with or without hemorrhagic risk. They are all in favour of active stents in terms of reducing the risk of new revascularization of the area already stented (between 50 and 70% at 1 year with maintenance after 1 year) and the occurrence of a new MI (between 20 and 50% at 1 year without support after 1 year). The risks of significant bleeding or stroke are poorly evaluated, and no difference between active and naked or non-active is observed at 1 year.

Stents covered with a synthetic membrane in the event of an accident related to angioplasty such as perforation or coronary rupture

The data are limited to case series of about 100 patients from single-center European and North American clinical trials (the number of reported implanted units ranging from 1 to 3 per patient). PTFE covered stents are part of the treatment options for the management of coronary artery perforations or ruptures, which are life-threatening complications in minutes.

See the full report in French here. See everything about the topic (notice documents, additional documents etc.) here.

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15

Oct 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published HTA of meniscal allograft transplantation for post-meniscectomy syndrome in Austria. It was concluded that there is not enough evidence demonstrating benefits in order to include MAT into the Austrian benefit catalogue.

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12

Oct 2018

In mid-September 2018, the Andalusian HTA agency, AETSA, published a report in which they assessed the safety and effectiveness of the cardiopoietic stem cells therapy of secondary heart failure to myocardial ischemia.

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10

Oct 2018

EUnetHTA is a network of HTA bodies within Europe that promote the development of health technology assessment in all European countries by working together. This article will present the plans for the projects that will be published in the near future.

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09

Oct 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published HTA of allogeneic mesenchymal stem cells for Crohn’s disease-associated complex perianal fistulas. Currently, inclusion into Austrian catalogue of benefits was not recommended with reevaluation in 2022.

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05

Oct 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published an evaluation of baroreceptor activation therapy for treatment-resistant hypertension. The authors concluded that there is no sufficient evidence to conclude on effectiveness or safety of BAT and thus inclusion of the procedure into the Austrian benefit catalogue is not recommended. There are currently three RCTs going on, and their results may bring new evidence.

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03

Oct 2018

On the 14th of August of 2018, the Norwegian Institute of Public Health (NIPH) has published a health technology assessment report in relation to autologous hematopoietic stem cell transplantation (AHSCT) comparing with standard treatment for patients with systemic sclerosis. The results have shown that the transplant‐related mortality after AHSCT is high, but risk of organ failure and death is lower after two years follow‐up and beyond compared to standard treatment, AHSCT provides a significant improvement of skin involvement and lung function measured by forced vital capacity compared to standard treatment with cyclophosphamide injections.

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01

Oct 2018

In mid-August 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI), has published an evaluation of efficacy and safety of carbon ion beam radiotherapy (CIRT) for twelve oncological indications.

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28

Sep 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published an assessment of left atrial appendage closure to prevent stroke to determine national coverage of the procedure. Considering this evidence, the authors do not recommend the inclusion in the hospital benefit catalogue, neither for percutaneous left atrial appendage occlusion nor for surgical closure using a special clip.

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26

Sep 2018

In the second half of July, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance for low-intensity pulsed ultrasound to promote healing of fresh fractures at low risk of non-healing, fresh fractures at high risk of non-healing, superior capsular augmentation for massive rotator cuff tears, transaxial interbody lumbosacral fusion for severe chronic low back pain and two new Medtech Innovation Briefings for remote ECG interpretation consultancy services for cardiovascular disease and mechanical thrombectomy devices for acute ischaemic stroke.

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24

Sep 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) released an assessment of the subcutaneous implantable cardioverter defibrillator to determine coverage of the service. Authors concluded that evidence is insufficient to make conclusions about the comparative effectiveness of subcutaneous and transvenous ICDs. However, a substantially lower risk for lead complications in patients treated with subcutaneous ICD.

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20

Sep 2018

Emilia Romagna Region published a preliminary information report on the LumiHeal™ KLOX system, a topical photo-converter system for the treatment of acute and chronic wounds.

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18

Sep 2018

On July 27th, 2018, the European network for HTA has published a rapid assessment of the continuous glucose monitoring (CGM real-time) and flash glucose monitoring (FGM) as personal, standalone systems in patients with diabetes mellitus treated with insulin.

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06

Sep 2018

Emilia Romagna Region published a rapid assessment report on the Medtronic’s Heli-FX™ EndoAnchor™ system. The authors concluded that published literature is of poor quality (mainly non-comparative studies) and mostly includes patients with abdominal aortic aneurysm. Data on the use of the device for thoracic aorta aneurysm repair are extremely limited.

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05

Sep 2018

In mid-July 2018, the Health Service of the Canary Islands, SESCS, has published a report in which they have assessed the safety, effectiveness and cost-effectiveness of the endoscopic ablation by radiofrequency in antral gastropathy and Actinic proctitis.

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31

Aug 2018

In the first half of July, the National Institute for Health and Care Excellence (NICE) published one new Diagnostics Guidance for biomarker tests to help diagnose preterm labour in women with intact membranesand one new medtech innovation briefing for airglove air warming system for venous access.

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30

Aug 2018

Three mini-method assessments regarding the magnetic non-radioactive detection system SentiMag Sienna + of sentinel lymph nodes in breast cancer, cough reflex testing and emergency targeted ultrasound implementation were initiated by Oslo University Hospital in June of 2018. All finalized mini-method assessments are published in the National Database for Mini-HTA.

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28

Aug 2018

In June of 2018, the Norwegian Institute of Public Health (NIPH) has published a single technology assessment regarding the MicraTM Transcatheter Pacing System (Micra TPS) - a leadless pacemaker produced by Medtronic to reduce the rate of complications following pacemaker implantations through design and novel technology. The objective of the assessment was to investigate the clinical efficacy, safety and cost effectiveness of Micra TPS in patients indicated for single chamber ventricular pacemaker implantation. The results have shown that the current evidence is not sufficient to prove that the Micra TPS gives less complications than standard pacemakers, also the use of Micra appeared not to be cost-effective.

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24

Aug 2018

In the second half of June, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance for laparoscopic ventral mesh rectopexy for internal rectal prolapse and MRI-guided focused ultrasound thalamotomy for treatment-resistant essential tremor, and two new medtech innovation briefings for negative pressure wound therapy for closed surgical incision wounds and ocular response analyzer to measure corneal hysteresis.

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14

Aug 2018

On 6th of July, 2018, the European network for health technology assessment, EUnetHTA, has opened the public consultation on ‘Horizon Scanning, Topic Identification, Selection and Prioritisation for European Cooperation on HTA – Draft recommendations.’

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10

Aug 2018

In April 2018, a national HTA program has been launched in order to re-evaluate benefits presently covered by the mandatory health insurance.

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06

Aug 2018

In April 2018, the French National Authority for Health (HAS) proposed an updated nomenclature in LPPR for foot orthosis and heel cup.

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03

Aug 2018

In late June 2018, the Andalusian Agency for Evaluation of Health Technologies, AETSA, has released a report on the efficacy and safety leadless pacemaker.

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02

Aug 2018

The French National Authority for Health (HAS) published new set of decisions about add-on reimbursement for medical devices in June. They concern orthopedic devices and endobronchial valve.

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31

Jul 2018

Minister of Health announced that it is planned to re-equip 609 vascular surgery centers. In parallel, about 30 departments will be upgraded to the level of the regional vascular centers, which will increase their capacity. Ministry plans that these efforts will help to double number of primary coronary interventions in acute coronary syndrome in Russia.

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27

Jul 2018

The French National Authority for Health (HAS) published new set of decisions about add-on reimbursement for medical devices in May. They concern pacemakers, orthopedic devices, radiofrequency ablation system, vagus nerve stimulator and some other devices.

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25

Jul 2018

At the beginning of June 2018, the Health Technology Evaluation Service of the Basque County, OSTEBA, has published an assessment of effectiveness, safety and indications of radiological bone suppression technology for the detection of lung cancer.

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23

Jul 2018

The French National Authority for Health (HAS) published new set of decisions about add-on reimbursement for medical devices in April. They concern orthopedic prostheses, neurostimulators and some other devices.

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18

Jul 2018

In the first half of June, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance for Intranasal phototherapy for allergic rhinitis and one new medtech innovation briefing for lung volume analysis in emphysema.

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11

Jul 2018

In the second half of May, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance for low-level laser therapy for preventing or treating oral mucositis caused by radiotherapy or chemotherapy and endoscopic bipolar radiofrequency ablation for treating biliary obstruction caused by cancer.

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09

Jul 2018

Two mini-method assessments regarding brachytherapy for esophageal cancer and targeted gene deep-sequencing panels were initiated by Oslo University Hospital in May of 2018. All finalized mini-method assessments are published in the National Database for Mini-HTA.

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06

Jul 2018

Norwegian Institute of Public Health (NIPH) conducted a full health technology assessment (HTA) of Peptide receptor radionuclide therapy (PRRT) using 177Luthetium (177Lu-PRRT) on the request from payers (“New methods” framework for introduction of innovations in Norway).

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29

Jun 2018

The Ludwig Boltzmann Institute (LBI-HTA), the Austrian HTA body, develops health technology assessments of medical technologies to support decision-making about coverage of these methods in Austrian public reimbursement system. MTRC summarized the list of reports to be published by LBI-HTA until the end of 2018.

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28

Jun 2018

At the beginning of June 2018, the Andalusian agency for health technology evaluation, AETSA, has published a meta-analysis on digital tomosynthesis in breast cancer.

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21

Jun 2018

In late May 2018, the Health Technology Evaluation Service of the Basque County, OSTEBA, has published an assessment where they compared the clinical utility (safety, morbidity and effectiveness) of radiofrequency tonsil reduction with that of traditional tonsillectomy and other surgical options for enlarged tonsils.

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18

Jun 2018

On the 30th of May of 2018, Norwegian Institute of Public Health (NIPH) has published a report regarding effectiveness of shunt treatment for persons with idiopathic normal pressure hydrocephalus, which was earlier commissioned to NIPH by My treatment choices platform with the purpose to find and summarize key findings from systematic reviews about the effects of shunts in the treatment of idiopathic normal pressure hydrocephalus.

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11

Jun 2018

On 11th May, the Italian Ministry of Health announced from its website that five new Med Tech-related HTA documents are available for public consultation. See the details in the MTRC post.

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01

Jun 2018

European Med Tech and IVD Reimbursement Consulting Ltd. released a report, which identifies and provides an overview of the innovative payment schemes for medical devices and in-vitro diagnostic tests in European countries. The report was supported by the grant from the Med Tech Europe. Access the full version of the report at our web-site.

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31

May 2018

In the first half of May, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance for percutaneous balloon valvuloplasty for fetal critical aortic stenosis and three new medtech innovation briefings for patient position monitoring system for intracranial stereotactic radiosurgery, 3D/QFR imaging software to assess coronary fractional flow reserve non-invasively and point-of-care tests for diagnosing group A beta-haemolytic streptococcus (strep A) throat infection.

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18

May 2018

In the second half of April, the National Institute for Health and Care Excellence (NICE) published one diagnostic guidance on adjunctive colposcopy technologies for assessing suspected cervical abnormalities, four Interventional Procedure Guidance for robot-assisted kidney transplant, nerve transfer to partially restore upper limb function in tetraplegia, prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia and microinvasive subconjunctival insertion of a trans-scleral gelatin stent for primary open-angle glaucoma, and two new MedTech Innovation Briefings for sleep mask for diabetic retinopathy and diabetic macular oedema and disinfecting cap for needleless connectors.

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15

May 2018

On 26th April, the Italian national agency for regional healthcare, AGENAS, announced that five new HTA documents will be produced for medical technologies during the next months.

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25

Apr 2018

In the first half of April, the National Institute for Health and Care Excellence (NICE) published one new medtech innovation briefing for device that usesroutinely available datasets to help identify people who are at high risk of developing colorectal cancer.

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19

Apr 2018

Emilia Romagna Region published a preliminary information report on the Equistasi® device, a wearable proprioceptive stabilizer for rehabilitation of postural instability in Parkinson's disease, multiple sclerosis and athletes.

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17

Apr 2018

The Institute for Quality and Efficiency in Health Care (IQWiG) has selected four out of 31 themes for the future health technology assessments, which were proposed by the citizens at the web-site of ThemenCheck Medizin service and will presumably be published at the beginning of 2019. The next process of topics’ selection will start in August of 2018.

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12

Apr 2018

In the second half of March, the National Institute for Health and Care Excellence (NICE) published one new medical technologies guidance for a portable digital system for managing chest drains.

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02

Apr 2018

In January 2018, the Spanish Network of Technology and Services Evaluation Agencies of the National Health System (REDETS), together with the Basque regional government, has published a health technology assessment report on high intensity focused ultrasound in Tremor Essential, developed by the Basque Office for Health Technology Assessment.

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22

Mar 2018

In the first half of March, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedures Guidance (laparoscopic mesh pectopexy for apical prolapse of the uterus or vagina and mosaicplasty for symptomatic articular cartilage defects of the knee) and one new Technology appraisal guidance for autologous chondrocyte implantation using chondrosphere for treating symptomatic articular cartilage defects of the knee.

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21

Mar 2018

The Institute for Quality and Efficiency in Health Care (IQWiG) released the final report on the assessment of benefit for telemonitoring of cardiac implantable electronic devices compared to a standard treatment without telemonitoring in patients with ventricular tachyarrhythmias and / or heart failure. It was concluded that the benefits of the telemonitoring for patients with cardiac failure or heart rhythm disorders with a fast heart rate remain unclear.

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20

Mar 2018

In January 2018, the Galician HTA body, Avalia-T, released the technical review of The Vivistim® system, an implantable device for upper-limb rehabilitation after stroke. Evidence was found to be very limited to advice on the implementation of the technology.

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16

Mar 2018

On March 12th, 2018, Institute of Health Carlos III has published an evaluation report on therapeutic efficacy and safety of hyperbaric oxygen therapy for complex regional pain syndrome sympathetic reflex dystrophy.

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12

Mar 2018

In November 2017, the Andalusian Agency for Health Technology Assessment (AETSA) published an evaluation report (assessed within literature review) on the utility of exome sequencing for diagnosed dysmorphic syndromes.

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07

Mar 2018

In February, HAS published a set of decisions about add-on reimbursement of medical devices that were evaluated by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern cardiac pacemakers, devices for aortic root replacement, orthopedic devices (double mobility cups, porous high-density polyethylene implants) and other devices.

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05

Mar 2018

In the second half of February, the National Institute for Health and Care Excellence (NICE) published two new interventional procedures guidance (unilateral MRI-guided focused ultrasound thalamotomy for moderate to severe tremor in Parkinson’s disease and supraciliary microstent insertion with phacoemulsification for primary open-angle glaucoma) and one Medical technologies guidance for transanal irrigation system for managing bowel dysfunction.

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26

Feb 2018

In the first half of February, the National Institute for Health and Care Excellence (NICE) published two new Medtech innovation briefings for a compression bandage for venous leg ulcers and insertable cardiac monitor for detecting suspected asymptomatic atrial fibrillation after cryptogenic stroke, one new interventional procedures guidance (aortic valve reconstruction with a new valve made from chemically treated cow pericardium) and one Medical technologies guidance for Memokath-051 stent for ureteric obstruction.

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20

Feb 2018

The method was under assessment by the Joint Federal Committee (G-BA) previously but the assessment was paused due to insufficient evidence in 2008. The final decision will concern the reimbursement of the method in the outpatient sector. The Institute for Quality and Efficiency in Health Care (IQWiG) is mandated to provide a health technology assessment (HTA) report to support G-BA’s decision.

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16

Feb 2018

KCE performed health technology assessment of 3D high-risk printed medical devices. It provides description of evidence concerning efficacy, safety and cost-effectiveness of the 3D printed medical devices as well as legal issues (requirements to enter to the market, liability, data protection, patient’s rights, traceability, reimbursement, intellectual property rights).

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09

Feb 2018

In order to decide upon the inclusion of medical benefits into the German statutory health insurance, the Joint Federal Committee (G-BA) can commission the Institute for Quality and Efficiency in Health Care (IQWiG) with the preparation of health technology assessments (HTA). At the turn of the year, IQWiG published its 220th evaluation dossier since its foundation in 2004. G-BA followed IQWiG’s recommendations in 70% of cases.

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08

Feb 2018

In the second half of January, the National Institute for Health and Care Excellence (NICE) published two new Medtech innovation briefings for an amniotic membrane allograft for treating chronic wounds and minimally invasive percutaneous nephrolitholapaxy medium to remove kidney stones, and one new Clinical Guideline for assessment and management of oesophago-gastric cancer in adults.

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07

Feb 2018

The Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) released seven decision support documents in 2017. In these, three technologies were recommended for inclusion into the national benefit catalogue. The rest was preliminarily not recommended for inclusion. HTA by LBI-HTA have indirect but strong connection to decision making about funding by the Ministry of Health.

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01

Feb 2018

Plasmapheresis procedure has not been supported for application in patients with Alzheimer’s by Spanish Health Technology Assessment Agency (AETS) due to insufficient evidence.

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31

Jan 2018

EUnetHTA analyzed HTA and reimbursement procedures in relation to pharmaceutical and non-pharmaceutical health technologies in EUnetHTA partner countries. About 59 HTA agencies and decision-makers provided country-specific information and outlined the process of HTA and reimbursement in 31 European countries.

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26

Jan 2018

The Andalusian Agency for Health Technology Assessment (AETSA) performed evaluation of transcranial Doppler ultrasonography in patients with acute ischemic stroke. Available evidence was considered as insufficient for formulation of final conclusion. However, AETSA prepared recommendations for evidence generation strategy for this procedure.

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24

Jan 2018

In December, HAS published a set of decisions about add-on reimbursement of medical devices that were evaluated by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern respiratory prostheses for total laryngectomy, mandibular advancement devices, some cardiovascular devices (transcutaneous bioprosthetic aortic heart valve, ventricular assist device, etc.) and other devices.

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23

Jan 2018

In the first half of January, the National Institute for Health and Care Excellence (NICE) published five new Medtech innovation briefings for in vitro diagnostic test for determining breast cancer subtypes, point-of-care creatinine tests before contrast-enhanced imaging, plasma EGFR mutation tests for adults with locally advanced or metastatic non-small-cell lung cancer, smartphone otoscope and sequencing panel for solid tumour cancers in children .

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02

Jan 2018

A 150-page reimbursement report covers angiography, intravascular ultrasound (IVUS), fractional flow reserve (FFR), cardiac computer tomography (CCT), optical coherence tomography (OCT) for angina and myocardial infarction in hospital settings. Stand-alone application of imaging / diagnostic methods and use in conjunction with percutaneous coronary intervention procedure was considered. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

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29

Dec 2017

The Basque Office for Health Technology Assessment (OSTEBA) published results of assessments of home telemonitoring on patients with heart failure. This intervention was considered as effective and cost-effectiveness technology. However, further research is needed to specify criteria for better application.

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19

Dec 2017

In the second half of November, the National Institute for Health and Care Excellence (NICE) published two new interventional procedures guidance (for hypoglossal nerve stimulation for moderate to severe obstructive sleep apnoea and processed nerve allografts to repair peripheral nerve discontinuities).

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18

Dec 2017

The meeting Improvement of Patient Quality of Life and Access to Innovation: Two Priorities in Medical Device Evaluations was organized by HAS on 24th of November to discuss evaluation principles of medical devices in France with manufacturers. In connection to the meeting new and updated policy documents were released.

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15

Dec 2017

The Belgian Health Care Knowledge Centre and the Netherlands Organisation for Health Research and Care innovation have signed an agreement to invest 6 million euros in the pilot project Belgium-Netherlands Funding of International Trials (BeNeFIT) for conduction of comparative, practice-oriented clinical studies which is relevant to patients, caregivers and policymakers in Belgium and the Netherlands.

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14

Dec 2017

In the second half of November, French HAS published new set of decisions for add-on reimbursement: four positive decisions for orthopedic medical devices, two negative decisions for coronary stents and two positive decisions for cochlear implant and kit for wheelchair.

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08

Dec 2017

Emilia Romagna Region announced the launch of two new series of documents, according to the new regional assessment framework for medical devices developed during 2017: rapid assessment reports and preliminary information reports.

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06

Dec 2017

The Institute for Quality and Efficiency in Health Care (IQWiG), in agreement with the relevant manufacturers' associations, has drafted a model contract to regulate the conditions under which information provided by manufacturers for the evaluation of medical devices is used by IQWiG and made available to third parties.

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05

Dec 2017

Emilia Romagna Region published a preliminary information report on the CytoSorb® device, an extracorporeal cytokine adsorber for the reduction of circulating cytokines in the blood stream.

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01

Dec 2017

Emilia Romagna Region published a rapid assessment report on the cardiac cryoablation catheter (also known as cryoballoon) for atrial fibrillation (AF). The authors concluded that, compared to radiofrequency ablation, cryoablation is not linked to higher effectiveness but presents shorter procedural time.Emilia Romagna Region published a rapid assessment report on the cardiac cryoablation catheter (also known as cryoballoon) for atrial fibrillation (AF). The authors concluded that, compared to radiofrequency ablation, cryoablation is not linked to higher effectiveness but presents shorter procedural time.

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27

Nov 2017

EUnetHTA has published project plan of rapid assessment of TAVI procedure in patients with intermediate risk. Current plan describes the design and methodology of the assessment, list of involved reviewers, stakeholders and timelines of the project. The final report will be prepared till the end of January 2018.

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24

Nov 2017

In the first half of November, HAS published a set of decisions about add-on reimbursement of medical devices that were evaluated by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern orthopedic devices (double-mobility cup, meniscal repair system), electrodes for radiofrequency ablation, portable oxygen concentrator, drug–coated balloons and other devices.

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23

Nov 2017

In the first half of November, the National Institute for Health and Care Excellence (NICE) published two new interventional procedures guidance (for total distal radioulnar joint replacement in symptomatic joint instability or arthritis and extracranial to intracranial bypass in intracranial atherosclerosis), one new diagnostics guidance for tests to identify people at high risk of ovarian cancer and four new Medtech innovation briefings.

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09

Nov 2017

The Basque Office for Health Technology Assessment (OSTEBA) published results of assessments of different techniques for biopsy of prostate. In accordance to this report, biopsy with image fusion (MRI and ultrasound) can be considered as a first diagnostic option for prostate biopsy.

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07

Nov 2017

In the second half of October, the National Institute for Health and Care Excellence (NICE) published two new clinical guidelines (for cataracts in adults and cystic fibrosis), and published two new Medtech innovation briefings for radiation dose monitoring software for medical imaging with ionising radiation and Promonitor for monitoring response to biologics in rheumatoid arthritis.

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06

Nov 2017

The Belgian Health Care Knowledge Center (KCE) performed assessment of use of static automated external defibrillators (AED) by bystanders for out of hospital cardiac arrest. The aim was to inform government, whether current practice of placing AED for public use should be supported or not. No strict recommendations were given due to insufficient evidence for this device in use by bystanders.

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03

Nov 2017

In October, HAS published a set of decisions about add-on reimbursement of medical devices that were assessed by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern orthopedic devices (foot prosthesis, bone graft substitute), TAVI using Sapien valve, liquid embolic system, remote monitoring system, wound dressing and home oxygen system.

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26

Oct 2017

In the first half of October, the National Institute for Health and Care Excellence published one new Technology appraisal guidance (for autologous chondrocyte implantation for treating symptomatic articular cartilage defects of the knee) and four new Medtech innovation briefings for PleuraFlow Active Clearance Technology for maintaining chest tube patency, Mepilex Border dressings for preventing pressure ulcers, Thora-3Di for assessing asthma in children and Memokath-028, 044 and 045 stents for urethral obstruction.

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24

Oct 2017

In June of 2017, the Ordering Forum RHF commissioned rapid method assessment for the Prosigna test. Only when the Norwegian Institute of Public Health receives documentation from the suppliers they carry out a quick method assessment. On 16th of the October, suppliers were requested to submit data to the Norwegian Institute of Public Health (NIPH) regarding clinical efficacy, safety and economics of Prosigna test.

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23

Oct 2017

On 13th of October of 2017, the Ministry of Health of Poland commissioned Agency of Health Technology Assessment and Tariff Systems (AOTMiT) to assess the benefit of angioplasty of arteries of lower extremities (femoral and popliteal) with drug-eluting balloons.

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18

Oct 2017

In the second two weeks of September, the National Institute for Health and Care Excellence published 2 new and 3 updated clinical, four new Interventional Procedures Guidance (for intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure caused by high spinal cord injuries and motor neurone disease, ab externo canaloplasty for primary open-angle glaucoma, high-intensity focused ultrasound for symptomatic breast fibroadenoma), and 3 Medtech innovation briefings (Farco-fill Protect, Caris Molecular Intelligence for guiding cancer treatment and Aptiva for painful diabetic neuropathy).

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17

Oct 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in September 2017. They include knee and hip prostheses, therapeutic shoes, coronary stents, heart valves, peripheral stents, and balloons.

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12

Oct 2017

Irreversible electroporation (IRE) is a new minimally invasive method for the ablation of tumors. Currently, this method is not used in Norway. The conclusion of mini-HTA stated that IRE should be included as part of the routine clinical practice in the hospital.

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10

Oct 2017

At the beginning of August 2017, the French National Authority for Health (HAS) published a health technology assessment of systems for remote monitoring for implantable cardioverter defibrillators (ICD). The aim of this assessment was an update and clarification of arrangements for the provision of implantable cardioverter defibrillator systems (ICDS) to improve the quality of care for patients with ICD and to promote the deployment of effective solutions in the country.

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09

Oct 2017

Agreement on the national HTA programme for medical devices has been reached between the central and regional authorities during the last Assembly. The main player in this context will be the Cabina di Regia per l’HTA. The steering committee will produce policy recommendations about the use of the assessed technologies and monitor implementation by procurement organizations. Read about the scope of the framework in our blog post.

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28

Sep 2017

MTRC has analyzed timing of decision-making (negotiation about price, final ministerial decision and publication of the decision) after recommendation by CNEDiMTS about expected benefit (AS) and added clinical value (ASA) for invasive non-implantable medical devices reimbursed via LPPR list, title V. Since establishment of the title V program, 5 technologies were added to the List (stent retrievers for stroke; peripheral drug-coated balloons). Time from the recommendation by CNEDiMTS until the start of reimbursement varied from 7 to 13 months (9.4 months on average).

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25

Sep 2017

Ministry of Health will close applications for proposals for inclusion of novel innovative tests into the List of Acts Outside Nomenclature in 2018 (Référentiel des actes Innovants Hors Nomenclatures, RIHN) 3rd of October 2017. RIHN provides early reimbursement for innovative tests, for which value is not yet validated to allow enlisting in the NABM Nomenclature.

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21

Sep 2017

Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) released results of a re-evaluation of percutaneous volume reduction of the intervertebral disk with a focus on chemolucleolysis. Based on current evidence, chemonucleolysis was recommended for inclusion into health benefit catalogue in Austria while percutaneous nucleotomy and percutaneous laser disc decompression were currently not recommended.

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18

Sep 2017

Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) released results of re-evaluation of leadless pacemakers for right ventricular pacing. Due to lack of comparative evidence vs conventional pacemakers, leadless pacemakers were not recommended for inclusion into health benefit catalogue in Austria.

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08

Sep 2017

All significant innovations in Norway should undergo either national or hospital-based health technology assessment within “New Methods” framework. Guiding criteria for prioritization of topics for assessments were recently formulated by the administration of the program.

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07

Sep 2017

In 2016, Joint Federal Committee (G-BA) commissioned Institute for Quality and Efficiency in Health Care (IQWIG) for benefit assessment of telemonitoring systems in patients with implantable cardioverter defibrillators (ICD). In July 2017, IQWIG published a preliminary report. Due to lack of evidence, no benefit statement was made.

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06

Sep 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in August 2017. They include different types of stents and stent-grafts for multiple indications (coronary, peripheral vascular), mechanical thrombectomy devices for stroke, medical devices applied for treatment of ulcer of venous origin, remote monitoring for Implantable Cardioverter Defibrillator Systems (ICDS).

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05

Sep 2017

Ludwig Boltzmann Institute HTA evaluated EST for GERD and found the current evidence insufficient to recommend its inclusion into health benefit catalogue. Reevaluation is recommended in 2022 when more evidence becomes available.

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04

Sep 2017

There is an ongoing process to change the structure of add-on reimbursement for peripheral vascular stents in France. In July 2017 CNEDiMTS issued additional clarifications about proposed reimbursement requirements for stents and stent-grafts. Read about proposed changes in our post.

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01

Sep 2017

In the second two weeks of August, the National Institute for Health and Care Excellence published three new Interventional Procedures Guidance for liposuction for chronic lymphoedema, radiofrequency treatment for haemorrhoids, biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer.

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30

Aug 2017

There is an ongoing process to establish add-on reimbursement for FFR guidewires. Earlier in 2017 two guidewires (Verrata & Verrata More, Philips Volcano; Pressurewire (Certus - Aeris – X), Abbott) received a positive assessment by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) with moderate improvement vs. standard of care. In June 2017, COMET device also received a positive recommendation from CNEDiMTS (no improvement vs. already recommended devices) only on the basis of data about technical equivalency. This is unusual for brand-specific applications and may be an interesting precedent for further applications.

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28

Aug 2017

In the first two weeks of August, the National Institute for Health and Care Excellence published three new Medtech Innovation Briefings for Biopatch for venous or arterial catheter sites, Urethrotech UCD for difficult or failed catheterization and VEST external stent for coronary artery bypass grafts.

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17

Aug 2017

In 2017, PAE was evaluated by the Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) to define whether evidence for this minimally invasive procedure can be sufficient for inclusion into benefit catalogue. Within this research work, evidence in relation to efficacy and safety of PAE was assessed in comparison to transurethral resection of the prostate (TURP) and open prostatectomy. Based on the results of literature review, LBI-HTA did not recommend PAE for inclusion into benefit catalogue in Austria. LBI-HTA recommended re-evaluating PAE procedure in the 2021 year when new potential evidence is available.

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16

Aug 2017

In the second two weeks of July, the National Institute for Health and Care Excellence published one new (FebriDx for C-reactive protein and Myxovirus resistance protein A testing in primary care) and 3 updated Medtech Innovation Briefings, new Diagnostics Guidance for quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care and three new Interventional Procedures Guidance for laparoscopic insertion of a magnetic titanium ring for gastro-oesophageal reflux disease, transcatheter aortic valve implantation for aortic stenosis and hysteroscopic sterilisation by insertion of intrafallopian implants.

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15

Aug 2017

European Network for health technology assessment (EUnetHTA) is initiating a project on assessment of screening of fetal aneuploidies (trisomy 13, 18 and 21) using non-invasive prenatal test (NIPT) in collaboration with Galician Agency for Health Technology Assessment (AVALIA-T) and Italian HTA agency Regione Emilia-Romagna. Completion of the project is planned to be on 30th of January, 2018 and aimed to evaluate effectiveness and safety of prenatal screening with NIPT, and also to assess organizational, ethical, legal issues and patient outcomes associated with this procedure.

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14

Aug 2017

In the first half of 2017, Galician Agency for Health Technology Assessment (AVALIA-T) published 4 HTAs for medical technologies and procedures including Impella ventricular assist device in cardiogenic shock, microwave ablation for tumors of the liver, microsurgery in limb lymphedema and intravitreal injections. Read high-level conclusions from these assessments.

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10

Aug 2017

The National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) reviewed indications for number of devices on the LPPR list and made recommendations about structure of the section in the LPPR list.

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08

Aug 2017

The Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) has published report with results of systematic literature review of application extracorporeal cytokine adsorption therapy (ECAT) for treatment and prevention of sepsis or systemic inflammatory response syndrome (SIRS). Considered evidence was assessed as insufficient to prove that ECAT is effective and safe procedure in patients with sepsis, septic shock and SIRS. Therefore, ECAT is currently not recommended for inclusion into the benefit catalogue.

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07

Aug 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of 10 medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). They include microprocessor controlled knee prosthesis, transcatheter pulmonary valve, deep brain stimulation device, kit for self-monitoring of blood glucose and others.

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28

Jul 2017

The Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) has published results of systematic literature review of evidence in relation to efficacy and safety of radiofrequency ablation for patients with metastatic spinal lesions. In conclusion, LBI-HTA recommended radiofrequency ablation of spinal metastatic lesions for inclusion in benefit catalogue with restrictions.

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27

Jul 2017

As of today, 11 Italian regions have specific regulations for health technology assessment. Medical devices are among the most commonly assessed types of technologies. Read English summary of the comprehensive report on HTA in Italy, developed by Agenas and SIHTA.

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26

Jul 2017

In the first two weeks of July, National Institute for Health and Care Excellence published four Medtech Innovation Briefings (Nasal Alar SpO2 sensor for monitoring oxygen saturation by pulse oximetry, Arctic Sun 5000 for therapeutic hypothermia after cardiac arrest, L-Dex U400 for lymphoedema after breast cancer treatment, FreeStyle Libre for glucose monitoring), new clinical guideline for Parkinson’s disease in adults, and updated diagnostic guidance for a new generation cardiac CT scanners.

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24

Jul 2017

HAS is the key decision-making body in relation to evaluation of sufficiency of clinical evidence to establish add-on reimbursement for medical devices, development of new procedure (CCAM) and clinical biology (NABM) codes in France. Annual report provides valuable insights into evaluation landscape for medical device and IVD tests. MTRC has extracted key facts related to assessment of medical technologies from the report.

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20

Jul 2017

New version 5.0 of the guidance “Allgemeine Methoden” provides basis for the scientific work of the Institute and its external experts. Multiple changes were made to existing sections, several new sections were added as well. Guidance provides brief overview of assessments performed in connection to benefit assessment for high class risk medical technologies, submitted for the innovation funding (NUB) for the first time.

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19

Jul 2017

Researchers evaluated care process, access, administrative efficiency, equity and health care outcomes in 11 countries on the basis of published health care statistics for 72 indicators. The best overall performers among European countries were the UK (ranked 1st), the Netherlands (3rd), Norway (4th), Sweden and Switzerland (6th). Germany (8th) and France (10th) were low in the ranking.

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11

Jul 2017

Recently, CNEDiMTS at HAS issued positive recommendation for inclusion of HeartMate 3 ventricular assist device into add-on reimbursement catalogue (LPPR title III). No added value was established vs earlier version of device (HeartMate II), despite better safety profile demonstrated in the randomized controlled trial.

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06

Jul 2017

An assessment was initiated earlier this year. The Institute will evaluate compliance of dynamic fusion in lumbar spondylosis with the state of science and practice.

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03

Jul 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of 8 medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). They include coronary stents, portable oxygen concentrators, Urolift device, spinal ganglion stimulator and insulin pumps.

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29

Jun 2017

In last two weeks of June, National Institute for Health and Care Excellence published one Medtech Innovation Briefing (RIDASCREEN tests for monitoring infliximab in inflammatory bowel disease), four new interventional procedures guidance for vaginal vault prolapse and uterine prolapse and one new diagnostics guidance for multiple frequency bioimpedance devices to guide fluid management in people with chronic kidney disease having dialysis.

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27

Jun 2017

KCE is working now on development of research program for 2018 and proposals for research topics can be submitted by filling in an online form until 6 September, 2017. Proposal can also be submitted by the industry.

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27

Jun 2017

Assessments were directed by national HTA body AGENAS. They cover renal denervation for hypertension, next generation sequencing in oncology, robotic surgery, sling operation for urinary incontinence and vertebral disc replacement.

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23

Jun 2017

An assessment was initiated earlier this year on the request from Dutch Hypertension Society and umbrella organization of 9 health insurance companies Zorgverzekeraars Nederland. The Institute will evaluate compliance of baroreflex activation therapy (BAT) for treatment of resistant hypertension with the state of science and practice.

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21

Jun 2017

The deadline for acceptance of applications for conditional reimbursement in 2019 by the Care Institute Netherlands (Zorginstituut Nederland) is 29th of June 2017. Conditional reimbursement for the period of up to 4 years can be available for promising technologies, which did not meet criteria for “state of science and practice” in the assessments of Zorginstituut Nederland.

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21

Jun 2017

In first two weeks of June National Institute for Health and Care Excellence published two Medtech Innovation Briefings (Neo Pedicle Screw System for spinal fusion surgery and device for securing cerebrospinal fluid drainage catheters) and updated two clinical guidelines for head injury and spondyloarthritis in adults.

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20

Jun 2017

In May 2017, CNEDiMTS at the National Authority for Health (HAS) issued positive assessment of Urolift for add-on reimbursement via LPPR list. Added value was found to be minor in comparison with transurethral resection of prostate (TURP). This assessment provides better results compared to the earlier one in January 2017. Add-on reimbursement might be established within about one year period.

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08

Jun 2017

Administrators of the “New Method” program, which is focused on managed introduction of innovations into Norwegian system, have initiated technology assessments of 10 technologies and now have requested manufacturers to make submission of clinical and economic evidence.

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06

Jun 2017

HAS published updated program that defines priority areas of work for 2017, including evidence review as part of developing new procedure codes for robotic surgery, endoscopic procedures, and technology assessments of remote monitoring, dialysis, coronary stents and others.

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05

Jun 2017

In second two weeks of May, National Institute for Health and Care Excellence has published two Medtech Innovation Briefings (collagen paste for anal fistulae and portable pulse‑echo ultrasound device to assist diagnosis of osteoporosis) one Interventional Procedure Guidance for endoscopic full thickness removal of non-lifting colonic polyps.

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31

May 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of 9 medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in May and April. Among others decision included MRI compatible and recharge free spinal cord stimulation devices, resorbable plates for osteosynthesis.

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30

May 2017

The Institute for Quality and Efficiency in Health Care (IQWIG) published final report of evaluation of extracorporeal shock wave therapy in patients with heel. Results demonstrated benefit of the extracorporeal treatment in comparison with placebo, ultrasound and iontophoresis.

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29

May 2017

An updated form for notification of medical technology to Italian national health technology assessment program has been released in May. Any stakeholder, including industry, can make notification, which will be reviewed and prioritize every six months.

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26

May 2017

Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) is working on three health technology assessment projects, related to medical technologies and in-vitro diagnostics, including diagnostics of prostate cancer, diagnostics of endometriosis and surgery for arm fractures in elderly.

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24

May 2017

In 2016, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to perform evaluation of controlled active motion (CAM) in patients with rupture of the anterior cruciate ligament. The final report of assessment was published on May of 2017. No definite conclusion can be made in relation to comparative efficacy and safety of studied technologies due to lack of evidence.

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19

May 2017

In 2014, Federal Joint Committee (G-BA) commissioned Institute for Quality and Efficiency in Health Care (IQWiG) to conduct health technology assessment of different approaches for lung volume reduction in patients with severe pulmonary emphysema. And now IQWiG has published the final report. The main conclusion is that it was not possible to draw any conclusion about relative effectiveness of bronchoscopic and surgical methods due to lack of the data.

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18

May 2017

The report issued within the framework of Joint Action 3 confirmed superiority of triclosan-coated sutures in reducing the risk of total incisional surgical site infections over non-antibacterial coated sutures. No conclusions were made in relation to the chlorhexidine-coated sutures due to lack of evidence.

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17

May 2017

At the meeting of 18th of April National Commission for Evaluation of Medical Devices and Health Technologies made decisions about add-on reimbursement of 17 medical devices. Ten decisions have been released to date for orthopedic, osteointegrated processing, cardiac and intravascular devices.

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16

May 2017

Cédric Carbonneil from the Ministry of Health published a letter in Value in Health in response to the article "New French Coverage with Evidence Development for Innovative Medical Devices: Improvements and Unresolved Issues" published in January 2016. Dr Carbonneil offers an interesting insights into background, rationale and direction of development of this important coverage with evidence development program for medical devices, in-vitro diagnostics and medical procedures in France.

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16

May 2017

European Commission launched an evaluation of necessity to prolong support to cooperation between health technology assessment agencies beyond 2020, when the current EUnetHTA Joint Action 3 comes to an end) in September 2016. As part of the assessment, it launched an online public consultation in October 2016, which ended in January 2017. The objective of the consultation was to collect views of different stakeholders on the future of collaboration in the HTA field.

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15

May 2017

In first two weeks of May NICE has published one Diagnostic Guidance, two Medtech Innovation Briefings, one Interventional Procedure Guidance, and has updated three Clinical Guidelines.

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10

May 2017

This post presents an extract from our reimbursement analysis for angioplasty of arteries of lower extremities with stenting using bare metal and drug-eluting stents for peripheral arterial disease in England, France and Germany. Procedure is reimbursed via combination of diagnosis-related group (DRG) and add-on reimbursement in England and France and solely via DRG in Germany.

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09

May 2017

National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) positively appraised Verrata and Verrate Plus guidewires for add-on reimbursement via LPPR title V. Level of added clinical value was considered moderate (ASA III) in comparison with management strategy, based solely on angiography data. This decision complements decision early this year in relation to St. Jude Medical’s (now Abbott) PressureWire FFR wires.

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09

May 2017

Ludwig Boltzmann Institute - HTA conducted a budget impact analysis on request from the Federal Ministry of Health and Women (BMGF) for testing of TSH as screening for hypothyroidism, urine culture as screening for asymptomatic bacteriuria and ultrasound screening for foetal anomalies.

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08

May 2017

Ministerial decree to enlist Medtronic's IN.PACT Admiral for the LPPR title V for add-on reimbursement was published on 6th of May 2017 in the Official Journal of French Republic. This is not only the first peripheral DCB on the List, but one of the first invasive non-implantable devices to get add-on reimbursement in France.

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08

May 2017

French National Authority for Health (HAS) has initiated an assessment of organizational impact of mechanical thrombectomy on the system of stroke management in France with objective to find the most adequate way of further introduction of the method into French health care system.

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05

May 2017

A new decree changed reimbursement approach for critical care in France. Before, it was reimbursed via daily supplements on top of base DRG tariff. New model introduces a mixed payment system with daily supplements and additional annual flat-rate fee, which depends on the size of the intensive care unit and activity in the previous year.

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04

May 2017

Check out reimbursement summary for the most established transcatheter mitral valve repair procedure in England, France and Germany. Reimbursement is established in Germany and France (for one indication). It is in process to be established in England and in France (for other indications).

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04

May 2017

Currently there are 10 ongoing mini-health technology assessments of medical technologies in Norway. After completion of evaluation, decision will be made about funding of these technologies at hospital level.

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03

May 2017

National Institute for Health and Care Excellence (NICE) in the UK issued one Interventional Procedure Guidance, one Med Tech Innovation Briefing and updated two of Clinical Guidelines in April 2017.

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02

May 2017

The Forum of Norwegian payers made decision about introduction of three medical technologies: mechanical thrombectomy for stroke, baroreflex activation therapy for resistant hypertension and non-invasive prenatal testing for detection of trisomy 13, 18 and 21.

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01

May 2017

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.

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28

Apr 2017

Three mini-HTAs were published since beginning of 2017: procalcitonin for diagnostic of bacterial infections, Per Oral Endoscopic Myotomy (POEM) for achalasia, and use of the Prosigna test (PAM50 ROR) for decisions on adjuvant treatment in breast cancer. These assessments can support introduction of methods at local hospital level in Norway.

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27

Apr 2017

Assessment using HTA Core Model framework revealed that technology is safe, but evidence of efficacy is limited.

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24

Apr 2017

National Institute for Health and Care Excellence (NICE) in the UK issued two Interventional Procedure Guidance, one Medical Technology Guidance, five Med Tech Innovation Briefings and updated number of Clinical Guidelines in March 2017.

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19

Apr 2017

The French National Authority for Health (HAS) has released report about evaluation of cardiac defibrillation probes and proposed updated nomenclature.

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17

Apr 2017

Belgian Health Care Knowledge Center issued information about ongoing and planned health technology assessments of medical technologies and IVD tests. They include external cardiac defibrillators, bariatric surgery, OncoType for breast cancer, peripheral drug eluting balloons and others.

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06

Apr 2017

A paper comes in response to the European Commission's impact assessment on ways to strengthen the use of and cooperation on Health Technology Assessments (HTAs) at European level. Med Tech Europe proposes five key principles for such a cooperation.

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04

Apr 2017

NICE in the UK has released a consultation document in relation to the TAVI procedure (Interventional Procedure Guidance). Publication of the final guidance, which will replace the guidance from the 2012, is expected in July 2017.

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