PRS25 Transparency Helped a Small Pharmaceutical Company to Have the Price of Their Drug with Few Million Euro Annual Revenue in Poland Practically Increased by 168% by the Minister of Health - a Case Study of Publicly Available Documents from Administrative Proceedings on Novo-Helisen Depot

Abstract

A small (6.5 million EUR reimbursement cost in Poland in 2018) pharmaceutical company was under pressure by German HQ to increase the official price of Novo-Helisen Depot (NHD) by est. 2 times to catch up with other European countries prices. The drug is indicated for dust mites allergen immunotherapy with no reimbursed equivalents in Poland. This study aims to present the case of how unconventional transparency-based approach helped to achieve a seemingly impossibly large price increase which could potentially result in 8 million EUR budget impact. We analysed documents made public either directly by the company or by the Foundation for Transparency and Predictability of Administrative Decisions. Having submitted on 2019-05-15 the applications (1) to increase NHD initial set price by 128%, (2) to increase NHD one-vial maintenance set price by 228%, (3) to reimburse NHD two-vials maintenance set with a price per vial 228% higher than the reimbursed product price, the company published unredacted argumentation to MoH at https://allergopharmanexter.pl/application/files/5715/5860/5403/Pismo_do_MZ.pdf. They also sponsored the press conference “Does the Minister of Health in Poland Have the Absolute Power in the Reimbursement Proceedings?” on 2019-09-12 during which the Foundation’s president and first author of this study highlighted MoH failures to proceed lawfully based on administrative documents shared by the company (available at https://www.dlaprzejrzystosci.pl/pytanie-z-konferencji-czy-minister-zdrowia-jest-wladca-absolutnym-refundacji-w-polsce-ciagle-aktualne/). Just a month later on 2019-10-14 the Minister of Health took a positive decision to reimburse the two-vials maintenance set with ex-factory price per vial 168% higher than the most recent official reimbursed price (490.00PLN vs 183.10PLN), without a content-related justification although the company provided it. In countries like Poland where positive reimbursement decisions on drugs and their prices lack content-related justification smaller companies may use openness and transparency to communicate the rational justification of their applications and to obtain fair decisions which otherwise apparently would not be achieved.