Drug Policy in the Czech Republic.

BACKGROUND

The legal background of the current pharmaceutical pricing and reimbursement (P&R) setting in the Czech Republic is based on Act 48/1997. Since 2008, the P&R process has been coordinated by the State Institute for Drug Control, which is the main stakeholder in the decision-making process; marketing authorization holders and insurance funds (IFs) also participate.

OBJECTIVES

To present a general overview of the current Czech health care system and its P&R principles.

METHODS

The study used publicly available sources concerning health care, mainly acts related to public health care and public health care insurance, public notices related to P&R setting, and statistical data.

RESULTS

Regulation covers P&R. The official price represents the highest exfactory price, which cannot be exceeded. It is calculated as the mean of the three lowest prices in the European Union reference basket. Reimbursement is based on the lowest price per daily dose across the whole European Union. For reimbursement, products can be clustered into jumbo groups (mutually interchangeable), stated by law. In each group, reimbursement is set at the lowest price of any substance within the group. For highly innovative drugs a temporary reimbursement can be granted for a period of 3 years. During the administrative proceeding, efficacy, safety, cost-effectiveness, and budget impact are assessed. The cost-effectiveness principles are aligned with the guidelines of the National Institute for Health and Clinical Care Excellence, preferring cost-utility analyses. The willingness-to-pay threshold has been implicitly set at 3 times the gross domestic product per capita. Products exceeding this threshold are subject to further risk-sharing negotiations. Budget impact is becoming increasingly important mainly for IFs. The IFs have recently introduced their own methodology, which allows only products with a budget impact in the range of CZK16 to CZK48 million (CZK = Czech koruna; ∼€600,000 to €1.8 million) to enter the system. Products exceeding this budget impact have to negotiate risk-sharing schemes, mainly further discounts and/or budget caps.

CONCLUSIONS

The Czech pricing and reimbursement system is rather complex, taking into account clinical evidence, cost-effectiveness and budget impact. The strict regulations are a result of financial scarcity.