The production of medical documentation

The documentation produced reflects the market access strategy developed upstream

The production of medical documentation

The documentation produced reflects the market access strategy developed upstream

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Our method for the production of medical documentation

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DEVELOPMENT OF A GUIDING THEME
Transposition of critical analysis conclusions

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COMPLETE OR PARTIAL PRODUCTION OF REIMBURSEMENT APPLICATION DOSSIERS

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REVIEW OF APPLICATIONS PRODUCED BY CUSTOMER

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SUPPORT FOR THE APPLICATION SUBMISSION PROCESS

Actions

Development of a guiding theme 

  • Transposition of critical analysis conclusions
  • Relationship between mechanism 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

  • 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 Acess 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.

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