Pathways to get your medical device reimbursed in France

Pathways to get your medical device reimbursed in France

Webinar

Agenda

Introduction

1. Context around medical devices and health insurance policy in France

2. Understanding the reimbursement system for medical devices in France

• Different market access pathways (standard and derogatory)

• Key factors in pricing negotiations with medical device suppliers

3. Market Access case studies

• Medical device without CE marking yet

• Medical device with MDD (directive)

• Medical device with MDR (regulation)

4. Main challenges for the digital health acceleration strategy Q&A

Abbreviations and acronyms

Speakers

Hubert GALMICHE

Head of the Medical Device Assessment Department (SED)

French National Authority for Health (HAS)

Bernard CELLI

Vice-President in charge of Medical Devices

Economic Committee for Health Products (CEPS)

Vincent VERCAMER

Project Director in charge of Market Access of Digital Health Innovations

Delegation for Digital Health (DNS) - Ministry of Health

Thomas RIQUIER

MarketAccess Director

Digital Medical Hub

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Vincent VERCAMER

Project Director in charge Market Access of Digital Health Innovations

Delegation for Digital Health (DNS) - Ministry of Health

What is the context around medical devices and health insurance policy in France?

French health insurance landscape

● In France (67,9M people) health insurance is mandatory for everyone

● 99,9% of population in France is covered by general health insurance

In addition, 95% of French have a complementary health insurance, these voluntary health insurance are provided by :

● mutual organization

● & private insurances (417)

Reimbursement is regulated by the state

Example of reimbursement rates

General health insurance reimbursement rates :

● 70% for office visit

● 60% for medical devices

The remaining fees are covered by complementary health insurance or at 100% for patient with Long Term Disease (ALD ; 12.4M people)

About 3000 hospitals in France

MD market

France is the 2nd largest European MD market

5th world (~240B€), 2nd Europe (~100B€)

Revenue ~ 20 billion € :

● 12 B€ : Ambulatory

● 8 B€ : Hospital

Hubert GALMICHE

Haute Autorité de santé (French National Authority for Health) (HAS)

What are the different market access pathways (standard and derogatory) ?

HTA in France

MD assessment

Hubert Galmiche February 2024

Three core missions

Assess and appraise pharmaceuticals, devices and procedures for inclusion on the national list of reimbursed products and services

Recommend best practices for health care professionals and elaborate public health guidelines

Measure and improve the quality of care delivered in health and social care organizations

Advance quality in health and social care to serve both individual and collective interests

assessment

General rules for MD reimbursement

▪ CE marking is a requirement to be on EU market

▪ To be reimbursed, devices have to be assessed by HAS (if individual use)

▪ Before inclusion on the positive list of reimbursed products (LPPR or LATM)

▪ The reimbursement by the National Health Insurance is essential for the diffusion of a technology

▪ Clinical data should demonstrate the benefit for the patient

Distinction between technical performance and clinical benefit

Company should anticipate the requirements

for the CE marking

▪ and for the reimbursement by National Health Insurance

MD assessment

MDs: HAS assessment scope

Technologies without medical purpose ≠ MD

MD et DMD for individual use

MD for professional use

• Assessment based on initiative of manufacturers

• Individualised reimbursement of the device Assessment only through associated medical procedure

MD assessment

MD reimbursement in France -

Ambulatory care vs Hospital

Individual use

Funded by the LPP

Ambulatory care In hospital

DMD for remote monitoring

Associated to a procedure

Funded by the LATM

Included in procedure’s prices

MD assessment

Individual use

Associated to a procedure

Exception : Specific funding General rule

Included in hospital fees (DRG)

only for specific devices

Funded by the LPP

The 2 types of inscription for reimbursement

Generic lines

Set of products :

Common characteristics called "technical specifications".

Fulfill the same function and have the same indication

Reimbursed by health insurance funds at a single tariff.

Generic Lines re-assessment process is still in progress

⮚ Direct Access to the market, under specific conditions (once line is has been created after HAS assessment ) :

- Code declaration for LPPR

- IT conformity certification for DMD

Brand name

▪ If the device does not meet the criteria of existing generic lines

▪ If there is a ‘plus’ over an existing generic line

▪ If innovative or necessitates specific monitoring

=> Dossier to be submitted to HAS (CNEDiMTS ) : single technology assessment.

=> HTA report (CNEDiMTS appraisal)

⮚ Price negotiation by Economic Committee and Listing for LPPR

⮚ Fixed prices for remote monitoring MD

MD assessment

Market access pathway in France - MD

CE marking (medical device)

Innovation funding (optional)

2 pathways for early access authorisation

- PECT for “classic” MDs

- PECAN dedicated to digital MDs (telemonitoring & DTx DMDs) (optional)

Pricing negotiation

Patient access

HTA

MD assessment

Decision on registration

Request for RWD

Re-assessment (optional)

General assessment pathway

Request for reimbursement for the MD

Application for conformity certification if Digital MD

Opinion Decision

CNEDiMTS (MDs Assessment Committee)

Health Technology Assessment

Healthcare Products Economic Committee (CEPS) for LPPR

Price / Tariff Negotiation

Social Security Department For LATM

Minister

Listing Decision ⇨ LPPR ⇨ LATM

Product Launching

Vigilance Post-listing studies Reassessment

MD assessment

Exemption ways vs regular ways for reimbursement

DMD without therapeutic effect

Temporary funding (PECT)

Digital MD for individual use with therapeutic effect

Digital MD for remote monitoring

Early funding for Digital MD(PECAN)

Exemption way

Innovation package

List of remote medical monitoring activities (LATM) regular way

List of reimbursable products and services (LPPR)

General process MDs Assessment Committee

Take home messages

HAS assessment is linked to the funding pathway.

HAS assess MD for individual use.

For MD for professional use : Assessment only through associated medical procedure. There are dedicated assessment pathways for DMD. HAS makes a distinction between technical performance and clinical benefit.

Specific ways can be activated for innovative medical devices (PECT or PECAN).

MD assessment

What are the key factors in pricing negotiations with medical device suppliers?

Bernard CELLI Economic Committee for Health Products (CEPS)

CEPS - Economic Committee for Health Products

Tarification

Based on therapeutic value

Fair and reasonable prices

Economic impact of new health products

Attractivity

Ensuring Access to Healthcare

Balance between industrial innovation and economic sustainability

Regulation

Annual price decrease strategy

Cost-effectiveness

Overall economic value

Thomas RIQUIER Associate Partner, Market Access Director - Digital Medical Hub

What are the main challenges for the digital MD and other MD for market implementation?

Actions to support the implementation of new MD and Digital MD

Use cases in the French landscape / Maturity level

Tech. & Reg.

Clin./Mkt

with a CE mark

under MDR/IVDR

with a CE mark

under MDD

Hospital Ambulatory settings

Intended use

Associated w/ proc.

Others (RPM)

Individual use

without any CE mark

Structured Not yet…

Depending on the maturity of evidence

And specific regulations for France (IT, cyber, interop…)

Check the box!

❏ POC study

❏ Pivotal clinical investigation

❏ HEOR evaluation

❏ Prices & Reimbursement in other countries a/o

“situations” (use cases)

❏ Implementations in clinical routine (recommendations)

❏ Distribution channels

❏ Others:

❏ Carbon footprint

❏ Organisational impact

❏ UX/UI maturity for French HCP

❏ Level of commitment (staff/team): SLA & execution

If your solution (DMD or MD or IVD) is under clinical investigations or in need of a renewal Landscape of innovation fast-tracking opportunities

PECAN ≈ DiGA = Opportunity

NOTE. Compared to France, in the UK, no formal reimbursement process for medtech (device, DTx, digital health tech) but policy support mechanisms for national adoption with highly beneficial and innovative products

The benefits of a French-German axis strategy for digital MD

Opportunities in France

❏ Strong culture of innovation

❏ Very good clinical data

❏ Low prices for RCT and other clinical investigations

❏ Data integrity with (teaching) hospitals data warehouse

❏ Heal Data Hub

❏ National strategy for ehealth

Where are the barriers?

Time-to-market vs market access

What books say…

What market says…

How to deal with it?

Precision and commitment

Why the hospital route as a first strategy?

The most relevant option to start your journey in France: taking purchasing operations as a key to select the best KPI

OPTION: → P4P & VBP

Tenders & Procurement framework → high specificity vs competitors, different criteria including prices but not only the price

Actions to support the implementation of new MD and Digital MD

Use cases in the French landscape: key principles before a full scalability in the French market

SHEP

KOL a/o Practitioners

/ Users involvement

Strategic fit & Product market fit

Competitors & Value

Product & environment

Integration & Deployment

Pricing & Reimbursement

Purchasing & Distribution

Legal & Compliance

ANSM ANS HAS MoH

GIE Sesame CNIL

(+GDPR)

Referencing (ARS, CPAM, tenders)

Communication & Awareness

MedEd

Protocol & Recomme ndations

Actions to support the implementation of new MD and Digital MD Use cases in the French landscape: Ambulatory setting

Problem: new wound therapy based on nurse prescription, CE marked, no need for medical procedure covered by national health insurance candidate for reimbursement in France, basic HEOR evidence (UK)

❏ Nurse do not prescribe directly

❏ LPP code does not exist: HAS procedure

❏ CE mark under MDR (class IIb)

❏ Direct purchasing by hospital: price?

❏ Protocol: recommendations?

❏ Evidence: weak in the French context, notably because patients’ journey is not defined properly

❏ Nurse prescribe directly

❏ Reimbursement code exist

❏ CE mark under MDD (class IIb)

❏ Direct purchasing by hospital: included in the patients’ journey

❏ Protocol: national

❏ Evidence: good, including HEOR for pricing purposes

Problem solving approach: Test&Deploy w/ leading hospital (learned society members inside)

Selection of KPI based on: clinical, organisational, budget, care management, HCP management (cooperation protocol), involving local authorities if necessary (budget purposes); i.e. nurses groups dedicated to wound management therapy, PROMs & PREMs data collection and interpretation

→ Scientific publication (open label test, quality/security purpose, other endpoints/criteria: budget)

→ Learned society involvement to create a new medical procedure and ad hoc reimbursement

Actions to support the implementation of new MD and Digital MD Use cases in the French landscape: Hospital setting

Problem: new AI based diagnostic tool for cardiovascular diagnostic integrated within Big Player devices for a better qualification of aneurysms (size, potential risks/complications, non contrasted possible)

❏ Radiologist or Surgeons

❏ Medical procedure excludes Surgeons

❏ CE mark under MDR (class IIb)

❏ DRG system: performance? Efficency?

❏ No VBP available: price?

❏ Protocol: recommendations on IA?”black box”?

❏ Evidence: weak on transposability

❏ Fully radiologist-based procedure

❏ no extra payment needed

❏ CE mark under MDR (class IIb)

❏ Direct purchasing by hospital: included in the VBP contract with Big Player

❏ Protocol: national

❏ Evidence: good, including HEOR for pricing purposes

Problem solving approach: Test&Deploy OR small RCT tackling feasability/scalability

KPI: security/feasibility, clinical, ROI (budget) OR Effectiveness study/HEOR evidence generation depending on final users willingness to do/learned society orientations (incl. Reg./ANS compliance, interop, identity + GDPR)

→ No Scientific publication + direct purchasing vs new medical procedure and ad hoc reimbursement (extra-DRG-like system)

Actions to support the implementation of new MD and Digital MD Use cases in the French landscape: ambulatory part of hospitalisation

Problem: new DTx solution based on a 3x functionalities (symptom-checker, PROMs, rehabilitation exercices selfadministered in neurological issues) is on the market in UK but does not have any reimbursement code available in the next couple of month

❏ GP are not trained

❏ LPP could exist: HAS procedure

❏ CE mark under MDR (class IIa)

❏ Direct purchasing by hospital: No, DTx

❏ Protocol: recommendations?

❏ Evidence: scarce, French context is close to UK context, strong (I-A) recommandation by EU.based med. soc.

❏ GP/Nurse well trained

❏ No reimbursement scheme in UK

❏ CE mark under MDR (class IIa)

❏ Direct purchasing by HMO-like GP groups

❏ Protocol: recommendations?

❏ Evidence: very good, no HEOR but quality and awareness are strongly demonstrated

Problem solving approach: PECAN/DTx + transposability study into French context (≈ 150 patients) in order to confirm the results → fully reimbursed DTx on LPPR

Question: is rehabilitation a matter of GP OR physiotherapists? - Answer: step-by-step evidence generation and cooperation protocol (scope: regional areas, ±3 years/ARS) based on reimbursement

Vincent VERCAMER

Delegation for Digital Health (DNS) - Ministry of Health

What are the main challenges for the digital health acceleration strategy ?

Delegation for Digital Health (DNS)

Part of the French Ministry of Health, DNS manages digital health transformation projects

Regulation & Compliance

Hela

Co-responsible for Digital Health

Technical Board

Europe & International relations

SPIS

Skills, Innovation and Research

Public Service for Health Information

"Ségur Numérique"

Mon Espace Santé

Ghariani and David Sainati

A strategy to support all levels of a digital health project cycle

Foster the conditions for the large-scale deployment of successful digital health projects

Sustain the implementation of experimentations in real-life conditions and first industrial steps

Support the development of structural projects to strengthen strategic territorial advantages

Prepare the future generation of key digital health technologies and facilitate rapid transfer mechanisms of research results

Develop stakeholder training, stakeholder trust and professional attractiveness of the sector

Actions to support the life cycle of digital health projects

Exemple of a digital medical device (DMD) reimbursement

Actions

Research, development, innovation

Regulatory diagnostic service for MD

Call for proposals for evaluation support

Clinical evaluation harmonisation

third party digital healthcare solutions

PEPR

Prematuration/ maturation calls

I-Nov call for projects

Health data warehouses

« AMI » call for proposals

Research

Commercialization

CE marking

Clinical investigation

Regulatory support

Technical documentation

Quality Management System

Financial support

Experimentation

Co-design

Maturation

Innovation

Health Data Warehouses

Education

Regulatory support

Clinical or medico-economic research protocols

European collaboration

Harmonisation of clinical evidence methods

Experimentation

Uses

Experimentation

Evaluation

Health professionals, engineers, computer scientists, in-houselawyers, regulatory affairs associates

Experimentation Post Marketing Clinical Follow-up

PECAN, an innovative approach to derogatory reimbursement of digital medical devices (DMDs)

• New one-year transitional and temporary reimbursement access scheme

• Launched in April 2023

• First listed solution in October 2023

• Innovative DMDs for individual use

• for therapeutic purposes (DTx)

• Remote Monitoring (TLS)

• With initial elements to assess the potential benefits of the solution

• Running studies with results available before the end of PECAN

Overview Scope Why?

• Rapid access to digital health innovations for patients

• Operational deployment in parallel of procedures to get a standard definitive reimbursement

How?

• Parallel evaluation process by HTA Agency (HAS) & Digital health agency (ANS)

• Authorisation decision by the Minister of Health

• process duration: less than 6 months from application to first patient

The requirements of the repository are derived from the doctrine of digital healthcare and the various ANS benchmarks.

Documents available on the Digital Health Agency portal for industrials:

https://industriels.esante.gouv.fr/produits-et-services/dispositifs-medicaux-avec-des-fonctions-numeriques

https://www.hassante.fr/jcms/p_3213810/en/pathway-ofmedical-devices-in-france

Additional online resource

Last CEPS activity report

https://sante.gouv.fr/IMG/pdf/ra_ceps _2022.pdf

Abbreviations and acronyms

HAS= Haute Autorité de santé (French National Authority for Health)

LPPR= Liste des produits et prestations remboursables (List of products and services qualifying for reimbursement

MD=Medical Device

DMD=Digital Medical Device

DRG= Diagnosis-related group

CNEDiMTS=Commission nationale d’évaluation

des dispositifs médicaux et technologies de santé (Medical Device and HealthTechnology Evaluation Committee)

CEPS=Comité économique des produits de santé (French Healthcare Products Pricing Committee)

PECT= mécanisme de prise en charge transitoire (transitional reimbursement mechanism)

PECAN=prise en charge anticipée numérique (Early Access to Reimbursement for Digital Medical Devices.

MDR : medical device regulation (2017/745)

IVDR : in vitro device regulation (2017/746)

MDD : medical device directive (93/42 CE)

Clin/Mkt : Cinical/Market

RPM : remote patient monitoring

POC : proof of concept

HEOR: health economics and outcome research

UX/UI : interface user experience (usability)

HCP: healthcare professional

SLA: service level agreement

Abbreviations and acronyms

RCT: randomized controlled trials

RWD/RWE: real world date real world evidence

BD/L: bus dev and licensing

SHEP/KOL: stakeholder engagement plan/key opinion leaders

P4P/VBP: payment for performance/value based procurement

Meded: medical education

PROMs/PREMs: patient reported outcome/experience

DRG: disease related groups

GP: general practitioners

HMO: health management organisation

Q&A

• Chaymaa.chalf@fcdo.gov.uk

• Julie.lebouleux@fcdo.gov.uk