The second part of the interview with Michel Verhasselt about the reimbursement of medical devices in France

21

Sep 2019

We have released the second part of the interview on the Market Access Insider channel on Youtube. Michel Verhasselt is the Founder and CEO of Meditech Access SAS.

The interview covered key stakeholders, procedure coding, principles of functioning of DRG system and add-on reimbursement for medical devices via LPPR List. Reimbursement pathways for devices, evidence requirements, pricing considerations, innovation funding (PHRC, PRME, forfeit innovation, Article 51, ETAPES program) were also discussed. 

Watch the interview here.

 

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Oct 2018

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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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25

Apr 2018

In April 2018, Oleg Borisenko with support from the MTRC launched an international stipend and mentoring program. The objective of the program is to support medical students in developing countries with achieving maximum results in a medical profession. For the first round of the program (six months until Oct 2018), three students were selected. The program includes a stipend, bi-weekly meetings on different subjects (goal setting, evidence-based medicine, clinical epidemiology, medical experiment, marketing, publication standards and others) and a personal mentoring of Oleg Borisenko.

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19

Apr 2018

The CEO of MTRC co-authored the article "Cost–utility analysis of bariatric surgery", published in the leading European surgical journal, British Journal of Surgery. Analysis indicated that currently used surgical methods in England were found to be cost saving over the lifetime of individuals treated in England.

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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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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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17

Jan 2018

Article “Cost-effectiveness analysis of bariatric surgery for morbid obesity in Belgium” published in the “Journal of Medical Economics” provides insights about economic outcomes of bariatric surgery in Belgium using Markov modeling. Over the 10-year horizon, bariatric surgery led to a cost increment of €3,788 and 1.4 additional QALY (€2,809/QALY) compared with optimal medical management. Over lifetime horizon, surgery led to 1.1 life years and 5.0 QALY gains and €9,332/patient average cost savings.

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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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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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04

Dec 2017

CEO of the MTRC, Dr. Oleg Borisenko will attend the "MedTech Access Leaders Forum" 5-7 of December in Berlin. Please, write to info@mtrconsult.com if you would be interested to arrange a meeting to discuss your market access needs in Europe. 

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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

We have developed a one-day training in market access for IVD companies, covering essential areas of reimbursement, funding, health technology assessment, the role of clinical and economic evidence, stakeholder engagement. The seminar is based on the in-house expertise and extensive interview program with laboratory experts. During the course, both general aspects of market access and specific pathways for IVD tests in 12 European countries are reviewed. CEO Oleg Borisenko performs seminar on the client’s facility.

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07

Nov 2017

The article "Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study" published in the Journal of Hepatology provides valuable insights into efficacy, safety and cost outcomes of the innovative method for managing refractory ascites.

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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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31

Oct 2017

The article "Patient Characteristics, Procedural and Safety Outcomes of Bariatric Surgery in England: a Retrospective Cohort Study—2006–2012" published in Obesity Surgery reviews the UK experience with bariatric surgery.

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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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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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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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20

Sep 2017

CEO of the MTRC, Dr. Oleg Borisenko will be present at the 2nd Annual Medical Devices Sales and Marketing Conference, 28-29 of September in Cologne, Germany. Please, contact us at info@mtrconsult.com if you would like to arrange a meeting to discuss your needs with reimbursement and market access in Europe.

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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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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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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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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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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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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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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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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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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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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

MTRC has developed a comprehensive introductory course in European market access. Course has duration between few hours and one day and takes place on your site. Topics include payment mechanisms, reimbursement pathways, role of HTA, economic argumentation and others. The cost is 5,000 euros irrespective of number of participants and duration of the course.

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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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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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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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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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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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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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