HTA MASTER FILE WITH CONTINUOUS MONITORING AND SYNTHESIS OF RELATED DATA - NEW APPROACH FOR INFORMATION MANAGEMENT

Author(s)

Pieniazek I1, Skóra K2, Augustyńska J3, Nikodem M4, Walczak J1
1Arcana Institute a Certara Company, Cracow, Poland, 2Arcana Institute a Certara Company, Krakow, Poland, 3Arcana Institute a Certara Company, CRACOW, Poland, 4Arcana Institute a Certara Company, Kraków, Poland

OBJECTIVES: Consider a global pharmaceutical company which developed a new drug and plan to get access to several markets. In different countries different data is needed to be gathered and synthesized for reimbursement submission. Moreover, one product might be prescribed for different indications and in each there might be specific subpopulations with separate evidence related just to them. Another aspect is that, over time, the clinical evidence may change. Besides, the classified information should be protected on different levels. Thus, the natural aim is to develop a tool that gathers all relevant product-related data in one place and navigates where to find properly formatted data appropriate for a particular user’s need, e.g. necessary to fulfil local requirements for reimbursement submission. METHODS: The concept of HTA Master File, a newly developed tool, is following. All the data (related to clinical evidence, costs, resource utilization, budget impact, local practise, epidemiology, legal aspects etc.) is granulated to smaller bricks, adequately formatted and tagged. For user-specified requirements the user gets access to all relevant and up-to-date pieces of information, but not more. Moreover, country-specific submission instruction and, if it is the case, list of missing items is provided. What is important, the documentation is formatted accordingly to EUnetHTA standards. RESULTS: The concept has been already implemented in 5 products (drugs for oncology, rare disease, type 2 diabetes and 2 products in nutrition in cancer patients). In first two cases it contained detailed submission instructions for 12 CEE countries, for the rest it was prepared for general use of the companies. CONCLUSIONS: The concept of HTA master file was found as very useful and really capturing all dimensions (population, indication, outcome, region, time). There is still space for improving automatization of continuous monitoring and data synthesis, which will be the direction for further development.

Conference/Value in Health Info

2018-11, ISPOR Europe 2018, Barcelona, Spain

Value in Health, Vol. 21, S3 (October 2018)

Code

PCP58

Topic

Methodological & Statistical Research

Topic Subcategory

Confounding, Selection Bias Correction, Causal Inference

Disease

Multiple Diseases

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×