Deadline for submission of proposals for early reimbursement of innovative in-vitro diagnostic tests in France

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 list includes IVD tests, for which definite value cannot be established yet and these tests cannot be included in NABM Nomenclature. For some of the tests, validation studies within PHRC or PRME frameworks can be running, which also precludes evaluation by National Authority for Health (HAS) for NABM Nomenclature. However, due to high potential value, these tests are temporary reimbursed via research budget by the Ministry of Health.

Application can be made via Innovarc online platform.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

Related news

22

Mar 2019

The Dutch Healthcare Authority (NZa) wants to contribute to stimulating the right care in the right place by making it possible to deploy e-health applications more broadly. In 2019 NZa will examine the possibilities for declaring e-health with the focus on district nursing and long-term care. Also, a large part of the e-health projects is in the pilot phase and the Dutch ‘Care for Innovation’ organization developed a step-by-step plan for a systematic approach for e-health introduction.

Read more

13

Mar 2019

The French National Authority for Health (HAS) regularly publishes new (32 in total) decisions about add-on reimbursement for medical devices. The decisions made in February 2019 concern various types of devices, including multiple orthopedic, cardiovascular and other devices.

Read more

11

Mar 2019

On February 5, 2019, the Federal Department of Home Affairs (FDHA) decided that in case of suspected infection or fever of unknown origin, positron emission tomography (TEP) will be considered mandatory services. Also, percutaneous electrical stimulation of the posterior tibial nerve (PTNS) was approved for incontinence indication. Furthermore, the reimbursement amounts relating to incontinence and ostomy materials will be reduced. List of Analyses was also updated.

Read more

05

Mar 2019

In mid-February 2019, the French High Authority for Health (HAS) has published the new guideline to clinical evaluation of connected medical devices in France.

Read more

21

Feb 2019

In early February 2019, the network of European HTA agencies, EUnetHTA, announced the final report of the project OTCA12 “C-reactive protein point-of-care testing (CRP POCT) to guide antibiotic prescribing in primary care settings for acute respiratory tract infections (RTIs)”.

Read more

20

Feb 2019

On January 31st, 2019, the French High Authority for Health (HAS) has published a new assessment of transcatheter aortic valve implantation (TAVI). The objective of this assessment was to clarify the level of requirements of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in terms of minimal clinical data to provide for the registration of a new TAVI on the LPPR, for the acceptance of a new indication for a TAVI already registered on the LPPR and for renewal of registration of a TAVI registered on the LPPR.

Read more

18

Feb 2019

Promising care must find its way to patients more quickly through inclusion in the basic health insurance. That is why the Dutch Ministry of Health, Welfare and Sport has adjusted the promising care with the new subsidy scheme. Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) carries out the scheme in collaboration with the Dutch Organization for Health Research and Development (Nederlandse organisatie voor gezondheidsonderzoek en zorginnovatie, ZonMw). The scheme will replace existing procedure with conditional reimbursement of medical technologies.

Read more

11

Feb 2019

In January 2019, the Institute for the Hospital Remuneration System (InEK) has published the of medical devices and procedures approved for innovation funding (NUB). Out of 709 applications for drugs and technologies, 180 (25%) received the positive status 1, and 69 of them were the requests for the medical technologies.

Read more

06

Feb 2019

The 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 January 2019. The decisions were made for eighteen medical devices.

Read more

05

Feb 2019

In December 2018, the National Institute for Health and Care Excellence (NICE) published one new diagnostic guidance (for tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer), two new interventional procedure guidance (for transcutaneous neuromuscular electrical stimulation for oropharyngeal dysphagia in adults and bronchial thermoplasty for severe asthma), and four MedTech innovation briefings.

Read more

30

Jan 2019

In late 2018, the French Ministry of Health announced that the telemedicine pilot project “ETAPES” will be maintained for four more years.

Read more

15

Jan 2019

In December of 2018, the completed mini-method assessment for targeted deep sequencing panel for patients with varying types of hematological neoplasia was released by the Norwegian Institute of Public Health (NIPH). The method was determined as safe and efficient and was recommended to become a part of routine clinical practice.

Read more

11

Jan 2019

Federal Department of Home Affairs (FDHA) released changes in coverage of medical procedures, IVD tests and medical aids in Switzerland. They include extension of coverage for neonatal screening to severe congenital immunodeficiencies, extension of coverage under restrictions for TAVI, gene test for breast cancer, PET, PET / CT, local superficial hyperthermia during tumour treatment, external defibrillator and coverage for sub-urethral tapes for the treatment of stress urinary incontinence in women. Also, changes in the coverage for neonatal screening were introduced.

Read more

07

Jan 2019

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in December 2018 concern various types of devices (orthopedic, neurostimulators, drug-coated balloon and others). The decisions were brought for ten (10) medical devices.

Read more

20

Dec 2018

Danish Health Data Protection Agency (Sundhedsdatastyrelsen) calls for submission of the proposals for the change of DRG system for 2020 with the deadline of the 1st of February, 2019.

Read more

19

Dec 2018

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in November 2018 concern various types of devices. The decisions were brought for twenty-two (22) medical devices.

Read more

06

Dec 2018

In October of 2018, InEK has published the list of the devices, previously (in 2018) eligible for innovation funding via NUB, and which will be integrated into DRG payment system since 2019. Only two devices will be transferred into the DRG catalogue.

Read more

30

Nov 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In October, one new diagnostic code.

Read more

29

Nov 2018

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in October 2018 concern various types of devices.

Read more

15

Nov 2018

Adding the MammaPrint® to the standard risk assessment in patients with early-stage breast cancer has not demonstrated health gains compared to the current way of determining whether a patient needs chemotherapy. Dutch National Health Care Institute has concluded that the test is not eligible for reimbursement from the basic insurance package.

Read more

08

Nov 2018

On October 26, 2018, the French High Authority for Health (HAS) has announced that the composition of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) has been renewed.

Read more

05

Nov 2018

In the middle of October 2018, the Andalusian Agency for the Evaluation of Health Technologies, AETSA, has published a health technology report in which they have assessed the safety, efficacy and efficiency of FebriDx® test.

Read more

01

Nov 2018

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in the period July-September 2018 concern various types of devices. In total, 52 decisions were published.

Read more

30

Oct 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In July/August new codes for genetic tests, including 18S rRNA gene and sequencing and ELA2 Cyclic Neutropenia Genetic Screen were added to the CCSD Schedule.

Read more

29

Oct 2018

In mid-October 2018, the French Ministry of Solidarity and Health has published an article which describes the change of the financing of the health care system and proposes medium-term strategies for this gradual change. The report has been developed by the Directorate of research, studies, evaluation and statistics (DREES) of this ministry.

Read more

18

Oct 2018

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

Read more

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.

Read more

19

Sep 2018

In 2019 the regulation for “conditional reimbursement to the basic insurance” (Voorwaardelijke toelating tot het basispakket) will be replaced by the Subsidy Scheme for Promising Care. The goal is to make promising treatments, medical technologies, tools and medicines available for patients even faster. The Dutch Healthcare Institute is preparing for the implementation of the new subsidy scheme in the coming months.

Read more

10

Sep 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In July new codes for aminoglycoside induced deafness testing, Intra-Operative PTH profile, cytokine panels and lymphocyte immunophenotyping, streptococcus pneumoniae by PCR, OCT for cardiology, contract-enhanced ultrasound and faecal immunochemistry test were added to the CCSD Schedule.

Read more

23

Aug 2018

At the beginning of July of 2018, the Federal Joint Committee (G-BA) has commissioned to the Institute for Quality and Efficiency in Health Care (IQWiG) to provide an assessment of potential harm and benefits of biomarker-based tests for or against adjuvant chemotherapy in primary breast to understand its efficacy in comparison with the previous standard examinations in women who do not require chemotherapy due to a low/intermediate risk of relapse. The final report is expected to be released by G-BA at the end of 2018.

Read more

16

Aug 2018

Hundreds of patients each year will benefit from fourteen new innovative treatments that will now be routinely available. These treatments include several devices and procedures: keraprosthesis for corneal blindness, left atrial appendage occlusion, selective dorsal rhizotomy and total pancreatectomy with islet transplantation for chronic pancreatitis.

Read more

07

Aug 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In June, new codes for genetic testing,including single gene tests and gene panel tests, next generation sequence and molecular profiling tests were added to the CCSD Schedule.

Read more

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.

Read more

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.

Read more

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.

Read more

26

Jul 2018

At the beginning of June 2018, the Federal Department of Home Affairs published an update of the Services Ordinance (Ordinanza sulle prestazioni, OPre). This update concerns many different fields, including the list of laboratory tests.

Read more

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.

Read more

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.

Read more

05

Jul 2018

In spring 2018, the Belgian Healthcare Knowledge Center, KCE, has published a rapid HTA report of MammaPrint® test for personalized management of adjuvant chemotherapy decisions in early breast cancer. The report complements evaluation of the clinical utility of the test from the EUNetHTA’s assessment with health economic evaluation in a Belgian context. Estimates show approximate mean chemotherapy-related costs in Belgium of €11 411 without considering sick leave costs and of €15 044 when the latter are included. KCE came to the conclusion that given the uncertainties surrounding the limited data on the clinical utility of MammaPrint®, no reliable incremental cost-effectiveness ratio could be calculated.

Read more

04

Jul 2018

MedTech Europe has published a paper with reflections on how to facilitate the dialogue between industry and funding and reimbursement decision makers, in order to create an innovation-friendly environment for healthcare in Europe. MTRC report on innovative payment schemes is cited in the paper.

Read more

26

Jun 2018

New recommendations for cervical cancer screening will focus on how we ensure that all women have the opportunity to participate in screening and on the use of HPV tests.

Read more

25

Jun 2018

MTRC has developed reimbursement overviews for 14 EU countries. Overviews cover stakeholders, money flow, payment model, DRG system, innovation funding, coverage with evidence development, the role of health technology assessment, funding frameworks and reimbursement pathways. Reports are delivered in PowerPoint. Video explanations are available as well.

Read more

25

Jun 2018

NHS England will fast track clinical trials and improve access for patients. As a result, patients will benefit from quicker access to clinical trials and the NHS will become a more attractive place to undertake research.

Read more

19

Jun 2018

On the 29th of May of 2018, the Institute for the Hospital Remuneration System (InEK) has published a joint document with G-DRG proposals for 2019. According to the decision made on the basis of § 17b KHG, the names of the applicants and procedure proposals for 2019 were provided.

Read more

13

Jun 2018

The list of the laboratory tests is based on the Services Order (Ordinanza sulle Prestazioni, OPre) of the September 29th, 1995; the latest update is in force since January 1st, 2018. The list contains the services whose costs are covered by the obligatory healthcare insurance (assicurazione obbligatoria delle cure medico-sanitarie, AOMS). With the latest update, there are 1931 tests on this list.
See the list of the January 2018 modifications in Italian here.
See the full list of current laboratory tests in Excel format (in French, German and Italian) here.
Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

Read more

08

Jun 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In April new codes for continuous glucose monitoring, vestibular and quantitative sensory testing were added to the CCSD Schedule.

Read more

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.

Read more

26

Apr 2018

In mid-April 2018, the Galician HTA body, Avalia-T, has published a rapid evaluation report on screening of fetal trisomies 21, 18 and 13 by non-invasive prenatal testing. The report was done within EUnetHTA framework.

Read more

13

Apr 2018

NHS England has announced the selected technology for the central funding to accelerate access within NHS. These technologies include HeartFlow, Plus Sutures, Endocuff Vision and SecurAcath. This is the second year selection of the technology for the fast track innovation payment scheme in England.

Read more

30

Mar 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In February new codes for genetic tests and immunological tests for infections were added to the CCSD Schedule.

Read more

19

Mar 2018

In January 2018, the Institute for the Hospital Remuneration System (InEK) has published the List of the requests for innovation funding (NUB). Out of 705 requests for drugs and technologies, 171 (24%) received the positive status 1, and 72 of them were the requests for the medical technologies.

Read more

09

Mar 2018

According to the recommendation of the National Board of Health and Welfare (Socialstyrelsen), hospitals and clinics should not offer screening for prostate cancer with PSA tests with or without other supplementary tests before tissue sampling. The recommendation is based on that the benefit of screening for prostate cancer with PSA tests does not outweigh the negative effects on a population level.

Read more

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.

Read more

28

Feb 2018

This report calls for new approaches to scalling tried and tested health care innovations. It highlights the need to create the right conditions to spread this successfully across the NHS.

Read more

15

Feb 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In January new codes for Anti C1Q antibodies, soluble CD25, umbilical Cord Ph Level and several genetic tests were added to the CCSD Schedule.

Read more

02

Feb 2018

Ninety-two new codes have been implemented, including protein fractions and reproductive medicine tests.

Read more

25

Jan 2018

The German Institute of Medical Documentation and Information (DIMDI) opened the annual application process for procedure codes (OPS) in the inpatient sector. Applications can be submitted by medical societies and other associations within the German healthcare system Deadline for applications is February 28th 2018 and the new codes will be incorporated in the OPS version effective from 2019.

Read more

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.

Read more

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 .

Read more

19

Jan 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In November new codes for allergy diagnostics, diagnostic profiles for certain diseases and detection of antibodies against Chlamydia were added to the CCSD Schedule.

Read more

25

Dec 2017

The Institute for the Hospital Remuneration System (InEK) has opened the proposal procedure for integrating the medical and scientific expertise in the further development of the G-DRG system for the year 2019. Proposals, e.g. add-on payments, DRG re-grouping and changes in coding guidelines or cost calculation can be submitted until March 31st, 2018.

Read more

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.

Read more

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.

Read more

29

Nov 2017

Shockwave Medical, the manufacturer of the Coronary Lithoplasty® System for the treatment of calcified coronary artery stenosis, requested a consultation by the Joint Federal Committee (G-BA) to find out whether their device requires an early benefit assessment according to §137h of the Social Code Book V (SGB V). The G-BA decided that the technology is highly invasive and innovative and therefore will need to undergo benefit assessment to be granted innovation funding.

Read more

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.

Read more

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.

Read more

15

Nov 2017

A manufacturer (PQ Bypass) requested a consultation by the Joint Federal Committee (G-BA) about the eligibility of their medical device for an early benefit assessment according to §137h of the Social Code Book V (SGB V). The technology (PQ Bypass Stent Graft System) is a fully-percutaneous femoral-popliteal bypass procedure for peripheral arterial disease. The G-BA argued that the method is not based on the use of a high-risk medical device and therefore does not have to undergo a §137h assessment.

Read more

13

Nov 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New codes were added for nitrogen washout test for lung capacity and fractional flow reserve CT measurement.

Read more

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.

Read more

31

Oct 2017

Following the request of a patient organization, the Joint Federal Committee (G-BA) evaluated the newborn screening for tyrosinemia type I by tandem mass spectrometry and decided to include the method into the relevant guideline. Before the method can be applied and reimbursed in the statutory health insurance (SHI) in Germany, the Genetic Diagnostics Act requires approval by the Genetic Diagnostics Commission (GEKO).

Read more

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.

Read more

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.

Read more

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.

Read more

02

Oct 2017

On 25th of September, the Norwegian Decision Forum of “New Methods” had a meeting to review several medical technologies and IVD tests. Decisions were made in relation to the introduction of 2 new newborn screening tests, prehospital emergency thoracotomy, aortic valve replacement using sutureless stent Perceval, and digital breast tomosynthesis.

Read more

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).

Read more

27

Sep 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New diagnostic codes cover different indications and analytical methods.

Read more

19

Sep 2017

NHS Improvement together with providers of pathology (laboratory) services in England determined ways to integrate laboratory services to increase efficiency and reduce cost. The final proposal includes integration of pathology services of 105 English hospitals into 29 pathology networks, which would save NHS up to £200m annually.

Read more

13

Sep 2017

The deadline for submission of proposals for DRG change for year 2019 to the Danish National Board of Health (Sundhedsdatastyrelsen) is November 1, 2017. Different stakeholders can submit a proposal. However, hospitals and individual physicians are the most relevant applicants. Application form for DRG change in Denmark is much simplier compared to other countries.

Read more

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).

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

11

Aug 2017

In the Netherlands, there is a possibility to test novel ways of delivering health care services (e.g. mobile diagnostic modules, online counselling, telemonitoring, screening/diagnostic for some complex conditions in primary care etc.) by establishing short (3 years) experiments between health provider and insurance company. After completion of experiment, analysis shall be performed about effect of the intervention. If it works, a new model can be population as novel type of care service in broader settings. See full list of ongoing small-scale experiment projects, extracted by MTRC.

Read more

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.

Read more

09

Aug 2017

Changes will be made in eleven chapters of Nomenclature. In relation to medical technologies and in-vitro diagnostics, the most important changes include changes in conditions for Stomatology, Radiotherapy and Nuclear Medicine codes, introduction of new codes for IVD tests, including diagnostics of tuberculosis and screening for EGFR mutation.

Read more

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.

Read more

03

Aug 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. Several codes were added to both procedural and diagnostic Schedules, including procedures for treatment of knee and hip osteoarthritis, robotic procedure, insertion of wireless pacemaker.

Read more

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.

Read more

24

Jul 2017

Hofmann and Gilbert published article exploring potential value of four novel diagnostic tests for clinicians: immunosignature for cancer and infections, breath test for lung cancer, patch vital sign monitoring and biomarkers for Alzheimer’s disease.

Read more

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.

Read more

17

Jul 2017

The NIP test is a non-invasive prenatal test aimed at detecting Down's syndrome in fetus. This test is a screening performed using mother's blood sample from the 12th week of pregnancy. From 1 July 2017, non-invasive prenatal test will be reimbursed for all pregnant women.

Read more

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.

Read more

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.

Read more

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.

Read more

26

Jun 2017

NHS Innovation Accelerator has initiated process of collection of applications for English innovation funding scheme. Selected devices and technologies will receive add-on reimbursement from NHS England for the period of 3 years. Applications will be accepted until 26th of July 2017.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

16

May 2017

Changes will be made in nine chapters of Nomenclature. In relation to medical technologies and in-vitro diagnostics, the most important changes include changes in conditions for two ophthalmology and endoscopy codes, new conditions for reimbursement of photodynamic therapy in dermatology, introduction of two new codes for IVDs, and creating of requirements for reimbursement of number of IVD tests in pregnancy.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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).

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

28

Apr 2017

Suggestions for change of DRG system will be accepted by Dutch Healthcare Authority (NZa) by 1st of June 2017. If accepted, changes will be implemented in 2019.

Read more

26

Apr 2017

German Federal Joint Committee (G-BA) has released information about results of benefit assessment (in connection to the §137h SGB V) for two methods: catheter-based lung denervation system for COPD and high-intensity focused ultrasound.

Read more

21

Apr 2017

SwissDRG has released the application form for suggestions for DRG change in 2017. Applications will be collected between 29th of May and 10th of July 2017. Approved changes will be implemented in 2019.

Read more

19

Apr 2017

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

Read more

18

Apr 2017

Danish Health Data Protection Agency (Sundhedsdatastyrelsen) calls for submission of the proposals for the change of DRG system with the deadline of the 1st of November 2017. Changes will be considered for implementation from 1st of January 2019.

Read more