Over the past decade, the world has seen increased competition in the drug market and the medical device industry. Therefore, today it is not enough to provide all the data on a new product’s safety and efficacy to bring it to the market. The competent development and compilation of a value dossier are of great importance, demonstrating to potential consumers the clinical and economic value of the developed drug or technology.
What is a value dossier
Global Value Dossier (GVD) is a document that combines data on current treatments available to the public and the value of a new product developed by a manufacturer. Typically, a company provides this document to affiliated sales and marketing organizations a couple of months before the product is released on the national market.
The GVD contains data that proves the value of the new product compared to existing analogues:
- all data on the clinical trials conducted;
- safety information;
- economic and commercial data.
Such a document is used:
- For the presentation of the product to the officials that decide on the market clearance of the product;
- for the presentation of the product to potential customers;
- during reimbursement negotiations with the authorities;
- to prepare an application for an OMT.
GVD is an effective tool that helps in product promotion. Therefore, creating a GVD is often trusted by healthcare consulting companies.
Common omissions in GVD drafting
Developing a GVD is a fairly complex task that usually involves multiple professionals in different disciplines:
- medical professionals;
- clinical research specialists;
A well-written GVD should be:
- clear and concise;
- take into account local application templates;
- take into account the requirements and recommendations of the international medical community and the national Ministry of Health.
It is also worth noting the most common omissions in the development of GVDs:
- Lack of reliable justification of all parameters confirming the product’s value.
- Lack of or incomplete information on clinical trials and analysis, lack of references to relevant studies.
- Insufficient demonstration of the humanistic burden of disease, the impact on the patient’s life of existing treatment protocols, and the new product’s benefits.
- Lack of assessment of the cost-effectiveness of the new product and its comparison with existing standards.
- Local government offices that make decisions about drug admission, reimbursement and funding have their own requirements for information and evidence of reliability, which should also be considered when compiling the GVD template.
Digital Value Dossier Solutions
Today, many companies offer drug and medical device manufacturers to develop GVD templates as digital applications. Such a solution has several advantages:
- visibility and structured information, making it easier to communicate with customers and consumers;
- instant update after each change is made to the product itself;
- consideration of global and local requirements for documentation, the possibility of local adaptation;
- automatic completion of international and local documents based on the data entered.
The GVD digital solution is developed individually for each customer, taking into account the company and its product and the tasks to be solved by the dossier.