Applications for Reimbursement Status and Wholesale Price

The experts at Medfiles provide services in preparing applications for reimbursement status and wholesale price of pharmaceutical products and clinical nutritional preparations in the Nordic countries and the Baltics. Our services allow clients to focus on their core business and facilitate the market access of client companies’ products. Clients can choose an all-inclusive service package or specific services.

Services Related to Applications for Reimbursement Status and Wholesale Price

  • Planning Applications
    • Procedure to price confirmation / reference price system
    • Original product / biosimilar product / generic product / parallel imported product
    • Basic reimbursement status / special reimbursement status / restricted reimbursement status
    • New active substance / medicinal product / combination medicine
    • New strength / pharmaceutical form / package size / package form
    • Extension of reimbursement status
    • Renewed application
    • Application scheduling
  • Filling in Table Formats for Applications
    • Sales estimates
    • Trade names, wholesale prices and reimbursement status in the EEA states
    • Market forecast
  • Health Economic Evaluation
    • Localising a global health economic model
    • Constructing a health economic model (Markov state-transition model / decision tree model)
    • Reporting a health economic model in accordance with the instructions from national authorities
  • Preparing Application Memorandums
    • Proposal for a wholesale price and reimbursement status
    • Specification of the therapeutic value
    • Specification of the treatment costs
    • Comparison of treatment costs
    • Summary
  • Revising Application Documents
    • Drafting the application form
    • Drafting the table of contents and table of sources
    • Copies of the summary of product characteristics, decision on marketing authorization and payment receipt
    • Compiling and submitting the application documents
  • Communication
    • Follow-up of the application procedure
    • Communication with the client and local authorities
    • Responses to statements from local authorities
    • Drafting an additional specification
    • Interpreting the decision and translation work
    • Consulting and training

 

 

Health Economic Analyses, Tools and Applications

The experts at Medfiles provide services on health economic analyses and on illustrating evaluation results. Our services allow clients to focus on their core business, facilitate the market access of client companies’ products and support client companies in their decision-making. We offer practical solutions. Clients can choose an all-inclusive service package or specific services.

Services Related to Health Economic Analyses, Tools and Applications:

  • Constructing a Health Economic Tool or Application
    • An interactive mobile application / website / other tool to structure, visualise and illustrate data and health economic evaluation results
  • Planning Health Economic Evaluations
    • Choosing the evaluation method and planning the evaluation
    • Localising a global health economic model / constructing a health economic model
    • Health economic evaluation as part of the application for reimbursement status and wholesale price
  • Cost Accounting
    • Evaluating the number of patients
    • Evaluating the use of resources
    • Clarifying unit costs
    • Calculating total costs
  • Effect Assessment
    • Choosing indicators: financial / clinical / quality of life (QALY)
    • Effect assessment and valuing
  • Health Economic Modelling
    • Localising a global health economic model
    • Constructing a health economic model (Markov state-transition model / decision tree model / budget impact model)
  • Reporting Health Economic Evaluation Results
    • Cost-effectiveness analysis
    • Budget impact analysis
    • Sensitivity analyses
    • Reporting health economic evaluations
  • Communication
    • Communication with the client
    • Expert meetings and acquiring expert statements
    • Interpreting the evaluation results and translation work
    • Consulting and training