COMPREHENSIVE EXPERTISE

OUR EXPERTISE

picto titre
le mot du president

CHAIRMAN'S MESSAGE

" In the space of just a few years, our company has established its credentials as a major player in the fields of Market Access and reimbursement in the medical device sector in France and French-speaking Europe. 

Meditech Access’s growth, underpinned by a comprehensive service offer, reflects the expertise and professionalism we deliver every day. Alongside this expertise, enthusiasm, rigour and availability are the driving forces behind our consultants as they seek to build a long-term relationship of trust with you. Such is the philosophy at Meditech Access. 

I’ll leave you to discover the expertise we can offer to support you through your development. "

Michel VERHASSELT

picto fusee

MARKET ACCESS STRATEGY

picto market

PUBLIC
AFFAIRS

picto microscope

PRODUCTION OF
MEDICAL DOCUMENTATION

picto lecture

TRAINING

picto cell

DUE DILIGENCE AND
BUSINESS DEVELOPMENT

picto strategie

Market access strategy

MediTech Access supports you in the definition and implementation of the
best market access strategy for your health technologies in Europe

image strategie

ACTIONS

Step 1. Definition of the state of the art

  • Systematic review of the literature, with identification of recommendations and clinical evidence either available or in the process of being gathered;
  • Definition of therapeutic strategy on the basis of current recommendations;
  • Competitive analysis, including identification of competitors and existing reimbursement conditions. 



Step 2. Critical analysis

  • Assessment of the level of evidence and degree of integration in medical practice;
  • Identification of the indication claimed for reimbursement with comparison with the CE marking indication;
  • Estimation of the associated target population;
  • Identification of potential cover problems specific to the category of device considered;
  • Identification & description of recommended market access routes, nationally, regionally and locally, both short term and long term. 

The conclusions of the critical analysis are compared with the convictions of the Healthcare authorities, KOLs and medical societies



RESULTS

Detailed feasibility study, containing

  • The definition of the state of the art, established in step 1;
  • The strategic recommendations resulting from step 2;
  • Action plans for strategy implementation, with indication of implementation time-frames. 
picto affaires publiques

Public affairs

Our strategic vision, experience, relations and capacity to coordinate
all players are assets for the success of your project

organigramme affaires publiques

ACTIONS

Strategic advice:

  • Global strategic vision of all players, funding solutions and evolution of regulatory constraints
  • Identification of pitfalls specific to the customer project
  • Development of market access solutions: either existing or testing new processes in partnership with authorities
  • Coordination of the involvement of all players and influencers regarding market access for medical devices

Support:
  • Post-HAS submission follow-up (particularly during any hearing phase)
  • Price negotiations with the CEPS (French Economic committee for healthcare products)
  • Long-term support: in “in-house” functions within the medical device company

Expert network:
  • Solid KOL network, developed through the mutual pooling of expertise
  • "Expert to expert" relationship between KOLs and MediTech Access (joint work concerning study protocol and or hospital market access)

RESULTS

Three projects that do MediTech Access proud:

  • FFR measurement: creation of a specific procedure following a rapid evaluation process, increase in GHS (DRG-based standard fee) and trialling of the new title V status for implantable medical devices.
  • TAVI (Transcatheter Aortic Valve Implantation): obtaining of alternative funding then inclusion on the LPPR (list of reimbursable products and services)
  • The Cordiva project: Roll-out of a telemedicine programme across France

An example: The FFR (myocardial fractional flow reserve measurement) project

  • Coordination of players and influencers: industrial, Medical society, CNAM (French Health Insurance Fund), French Ministry of Health, DSS (French Social Security Directorate), DGOS (French General Directorate of Healthcare Provision), ATIH (French Technical Agency for Information on Hospital Care), etc.
  • Three levels of results:
              - First specific procedure creation following a rapid evaluation process: FFR measurement
              - Obtaining of increase in GHS fee after discussion with the DGOS and the ATIH
              - Trialling by the authorities of evaluation for listing under the new title V
  • Success thanks to three of our major strengths: Our strategic vision, our relations and our capacity to produce scientific documentation


organigramme affaires publiques
picto redaction medicale

The production of medical documentation

The documentation produced reflects the market access strategy developed upstream

organigramme affaires publiques

ACTIONS  

  • Development of a guiding theme: transposition of critical analysis conclusions
    • Relationship between mechanism of action of the device, patient typology and treatment strategy
    • Promotion of the clinical and economic benefit as a function of the level of evidence in the indication claimed
  • Complete or partial production of reimbursement application dossiers
  • Review of applications produced by customer
  • Support for the application submission process
    • Letter writing, structuring of application dossiers and appendices
    • Reprographics (outsourced to expert service provider)
    • Submission to authorities and customer where appropriate
  • Drafting of responses to additional questions from the authorities and documentation for hearing phases
  • Production of documentation for price negotiations with the competent authorities

RESULTS
France

  • Nationally:
    • Application for inclusion on the LPPR or the intra-GHS list: therapeutic interest notice and tabulated summaries of clinical trials to be sent to the CNEDIMTS (French national commission for the evaluation of medical devices and health technologies), as well as the economic notice to be sent to the CEPS
    • Application for cover of costs via the Forfait Innovation (French national innovation funding) mechanism
  • Regionally: Hospital reference listing application

Other European countries
  • Reimbursement applications
  • Price structure development application dossiers

Application dossiers reviewed by MediTech Access in the event of submission of a pre-written application dossier

Letters providing responses to additional questions and documentation for hearing phase and price negotiation.

picto due diligence et business development

Due diligence and business development

Explanation and clarification of the decision and risk management in order to
help various players in their innovation funding decision-making

image diligence

ACTIONS
Experience sharing and advice aimed at private investors/investment funds, the medical device industry
Product positioning (competitive and environmental analyses, market access anticipation)


RESULTS
Report and telephone interviews

picto formation

Training

Passing on our experience to raise awareness among operational
teams and students of market access challenges 

organigramme affaires publiques
schema formation
picto fleche

HAUT