REGULATORY & REIMBURSEMENT DECISIONS DATABASE FOR INNOVATIVE DRUGS TO IMPROVE CONSISTENCY OF DECISION-MAKING
Author(s)
Augustynska J, Skora K, Walczak J, Tomassy J
Arcana Institute Ltd, Krakow, Poland
Presentation Documents
OBJECTIVES: To create a reimbursement applications database for innovative drugs. Particularly, the further goal is to promote case-based analogical precedent-conscious reasoning and evidence-based decision making in Poland. METHODS: Information was gathered from documents published by the Agency for Health Technology Assessment and Tariff System (AHTAPol) and the Ministry of Health (MoH) between January 2012 and June 2017. Information from statements of AHTAPol’s Transparency Council (STC), recommendations of AHTAPol’s President (RPA) and MoH’s reimbursement decisions (MoHD) was extracted. RESULTS: The prepared database includes 470 reimbursement applications corresponding to 334 brand names and 288 unique substances. Applications were submitted by 100 companies. The database consists of 60 categories and includes the following: applicant name, product description, indication, market authorisation type, detailed process timelines, requested reimbursement mode, STC, RPA, MoHD, discrepancy between requested conditions and MoHD, information from BIA and ICER value if applicable, and key findings from available clinical analyses. CONCLUSIONS: Health care systems based on public money should treat all applicants equally if the conditions for the decision are similar and should provide equal access to benefits for patients with similar needs. The database gathers information on all precedent decisions of marketing authorization and public payer practices of similar products or similar indications. This approach opens up the possibility for improvement of transparency and decision-making practices not only in Poland, but in each country.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PRM61
Topic
Real World Data & Information Systems
Topic Subcategory
Reproducibility & Replicability
Disease
Multiple Diseases