Optimize the use of your existing data & materials on a product to build your HTA Master File for local submissions in CEE countries!
The HTA Master File is a useful resource when a company already has existing material and data on their product and wants to submit an application for reimbursement to local countries in the CEE, where requirements for HTA submissions vary. By organizing existing materials and data within the structure of the EUnetHTA Core Model, we provide instruction for use of existing information for local submission and point out any required information.
Key advantages for companies who use the HTA Master File:
- Saves time
- Useful for Market Access managers responsible for a region to know if there are gaps in a country
- Allows to plan timing of local submissions
- Helpful for local affiliates as all local requirements are provided with instructions
- Saves money
- Uses full potential of a company’s existing data and materials on a product to fulfill local submission requirements
- Identifies what is missing/needed to meet local requirements
- Focus is on optimal use of data to prevent unnecessary duplication of work
- Based on the framework of widely recognized EUnetHTA
EUnetHTA Core Model
Companies seeking reimbursement in EU countries for their drugs or medical devices must adhere to requirements for each country considered. However, a recently proposed regulation by the European Commission to the European Parliament and the Council aims to simplify this process with a joint clinical assessment for companies seeking reimbursement in EU member states. An important aspect of the joint clinical assessment is that it considers the achievements undertaken by EUnetHTA.
At Arcana Institute, the widely recognized EUnetHTA HTA Core Model forms the foundation of our HTA Master File tool. We create an HTA Master File by following the EUnetHTA HTA Core Model® version 3.0, producing a consortium of documents and information that optimizes the use of available data and materials on a product already gathered by our client. The aim of creating the HTA Master File is to transform a company’s varying data and materials on a product into a comprehensive tool used by local teams and affiliates for local submissions.
HTA Master File Deliverables
As part of our HTA Master File service, we provide clients with the following:
- User-friendly Manual
- Instruction for optimal use of documents found in the HTA Master File
- Includes table with summary of data provided in the HTA Master File to prepare your local dossier
- How to use Country Requirements & Gap Analysis in conjunction with data in Core Mock Dossier
- Local Country Requirements & GAP Analysis
- Guide for preparation of local reimbursement documentation according to local requirements
- GAP analysis of information collected in Core Mock Dossier in relation to local country requirements
- Core Mock Dossier
- Based on the layout of EUnetHTA Core Model
- Supplied with all necessary information and data taken from GVD, HE/HTA data and evidence required for a local submission
- Gathers all pieces of information about your product in one place
- Information on disease burden and clinical and economic value of product
Additional project extensions to the HTA Master File include development of modules for requested countries:
- Epidemiology and standard of care
- Gathering local data from each country of interest regarding epidemiology, burden of disease, current treatment standards and local clinical guidelines and recommendations
- Health Economics
- Two possible options: adapting an existing model to local data provided for a country/model return and recalculate, or adapting an existing model including gathering of local data
