The HTA Master File is a kind of HTA core model dedicated for defined products.
The primary purpose of the HTA Master File is to gather all of the information that is necessary to compose an HTA report into one comprehensive document, forming the basis for creating a dossier that responds to local market access needs (e.g. for the countries of Central and Eastern Europe). The HTA Master File is prepared in a modular version, making it possible for users to select only the sections and level of details that are necessary and valuable. All sections contain a comprehensive summary and key messages, which makes the document useful even in the absence of formal documentation requirements for reimbursement.
The HTA Master File follows the EUnetHTA HTA dossier template due to its wide recognition. The most crucial elements of the EUnetHTA are included in our HTA Master File, defined by the following domains:
- Health problem description, presentation of epi data, unmet need data & clinical practise guidelines
- Description and characteristics of intervention
- Clinical effectiveness of intervention (efficacy and safety)
- Costs and economic effectiveness of intervention
- Ethical and social aspects
- Legal and organizational aspects
Each section of the HTA Master File contains the following elements:
- Instructions for navigating specific sections
- Summary and key messages
- Description of methodology: formulating questions to relevant issues within a section & presenting methods for response (e.g. approach used to perform MTC, assumptions of economic model)
- Results cards (e.g. results of MTC & economic analysis)
The HTA Master File may also include an additional section instructing users how to create their own local reimbursement dossier. Such instructions indicate which sections of the HTA Master File are relevant for preparation of a particular local dossier and presents which data, especially local, are necessary and need to be completed by users.
In order to develop such instruction, it is necessary to gather information for formal reimbursement application requirements for the country of interest. In the HTA Master File, all requirements for each particular country are outlined, which may include:
- Need of preparing and scope of P&R dossier/s;
- Other required or non-essential supportive evidence (for example: EPAR, SPC, ITC, meta-analyses, systematic reviews, etc.);
- Choosing the comparator (how is the choice made and what are the benchmarks);
- Requirements on how to initiate the process of obtaining public funding.
It is important to note that INAR experts are also able to characterise the price reimbursement system of each selected country (with particular emphasis on responsible authorities, pathways for decision-making and relevant stakeholders) and answer the following questions:
- Is there an application for public funding?
- Is there an official template for the application?
- Who is entitled to submit the application?
- Who is the addressee of the application?
- Who is the public funding decision maker?
- Who makes official recommendations?
- Are analytic data required with the application?
- When to submit the application?
- Is there a formal deadline to make P&R decision?
- What is the practical time to make P&R decision?
- Formal administration costs to submit the application?
- Costs to prepare the application by solution provider (including dossier, if applicable)?
The HTA Master File may be used to prepare three main types of reimbursement documentation:
- Extensive version – all sections are included
- Rapid version – fast assessment limited to select sections
- Other – contains only minor information (e.g. summary, key messages, description of main clinical trial, etc.), useful in cases where countries have no formal requirements specified