Representative of French Ministry of Health has commented on the article describing challenges of innovating funding program (“Forfait Innovation”)

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 original article "New French Coverage with Evidence Development for Innovative Medical Devices: Improvements and Unresolved Issues" here

Read response from Cédric Carbonneil here.  

Read more about Innovation Funding scheme at the web-site of National Authority for Health (HAS) in French here.

Subscribe to our biweekly newsletter 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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