Transparency and Professionalism of Drug Reimbursement Policy

Abstract

Slovakia spent a total of €1.1 billion of public funds in 2015 on medicines (reimbursed to health insurance companies). This is more than the annual budgets for the Ministries of Defence and Culture combined.

The categorisation of medicines is a key part of the decision-making process on drug expenditure. The health care system decides whether medicines are subject to full or partial public health compensation.

Given the high level of spending, TI Slovakia has been working to increase the transparency of the categorisation process. It believes that the process should be subject to transparency standards that allow for the ´biggest-possible public scrutiny. In particular, scrutiny around the approval of innovative, uncategorised medicines, medical devices and dietetic foods.

Annually, the Ministry of Health receives around one hundred requests from pharmaceutical companies and other manufacturers to categorise a new drug, decisions that are being made by expert working groups on pharmaeconomics.

TI Slovakia has studied this process with a view to making recommendations designed to improve transparency and accountability.

Methodology

The analysis included a total of 265 categorisation processes. The sample selection was primarily structured by time: The selected processes were all initiated between 1 January 2013 and 31 December 2015. The second criterion was the type of procedure: The sample include procedures for the (conditional) addition of new drugs or pharmaceutical products to the categorisation list and official price determination processes. Final decisions on all selected processes had to be given by 01/08/2016. They represented the majority (94%) of new drug inclusion processes.

Findings

1. Declarations of conflicts of interest of advisory group members are missing.
2. The decisions are insufficiently justified and do not allow for control or public debate.
3. Advisory group membership is free, although the group has the decision-making authority over millions of public means per year, which increases the vulnerability to bad or corrupt decisions.
4. Data on estimates from pharmaceutical companies and other manufacturers is not very reliable, which may undermine the quality of the decision-making on funding priorities.

Recommendations

1. Professionalise the categorisation process by including paid experts in the advisory group and make its membership more selective, i.e., based on merit / expertise and have membership criteria.
2. Introduce mandatory public declarations of conflicts of interest for the evaluators of drug applications.
3. Publish more detailed protocols on the discussions for and against the inclusion of medicines.
4. Control the consumption of newly categorised medicines and the financial impact on the public health insurance as opposed to categorisation assumptions.
5. Publish categorisation procedures in a more user-friendly form.