What Principles Should Govern The Use Of Managed Entry Agreements

In the five countries with available data on the number of different MEA instruments, by type (Slovenia, Hungary, Latvia, Estonia and Romania), the most frequently implemented pharmaceutical rebates (n -495, 73%), followed by depreciation (n -92, 14%), price volume agreements (n – 37.5%), free boxes (n – 25. 4%), group agreements and others (n – 19, 3%) and payment terms (n -10 per cent), and 1 per cent (Fig. 2a). Although Estonian, Hungary, Latvia and Romania are able to implement agreements on health outcomes, most of the agreements implemented were financial in nature (n -668, 99% funding, No. 10, >1% agreement on health outcomes). Although the other countries did not provide data on the actual number of meA instruments, respondents stated that most agreements in Bulgaria, Croatia, the Czech Republic, Poland and Bosnia and Herzegovina (including the Federation of Bosnia and Herzegovina and the Republic of Srpska) were known as financial agreements. No country has provided available data on the type of ME implemented to report the implementation of coverage with evidence. In the Czech Republic, a large number of innovative and high-value medicines have a special status as “highly innovative medicines” (vysoce inovativn) leeived perpravek (VILP) and are, as such, subject to investigation. They can be refunded for up to 3 years, although exceptional cases of temporary reimbursement beyond 3 years are also known.

Manufacturers are required to implement monitoring systems, provide cost-benefit analyses, limit budgetary impact and pay for treatment of existing patients after the temporary reimbursement is completed. In March 2017, there were 19 VILPs (corresponding to six business names) with temporary refunds and 22 (13 business names) that received a permanent refund. About nine VILPs (five business names) are currently without coverage. The conditions for obtaining VILP status are prescribed by law and are set by the regulator and not by a contract between manufacturers and payers and, as such, do not comply with the MEA definition used in this study. However, in recent years, payers have insisted on the inclusion of clauses on future MEAS for new VILP-based drugs. Other high-priced drugs without VILP status may also be subject to MEAs in the Czech Republic, but information on their existence is limited and details are confidential. Implementation of MEAs in Central and Eastern Europe from February 2017. In blue countries, MEAs are implemented. The years refer to the year in which the first MEA was introduced in a given country. In some countries, for example. B in Serbia, the law was introduced long before the signing (2014) of the first MEA (2016).

The orange-coloured countries did not implement the meAs as of February 2017, and the grey countries were not part of the study or we had no information about it. AL Albania, BG Bulgaria, BH Bosnia and Herzegovina, CZ Czech Republic, EE Estonia, LT Lithuania, LV Latvia, HR Croatia, HU Hungary, KV Kosovo, PL Poland, RO Romania, RS Serbia, SLOVENIA, SK Slovakia, MEAs manages entry agreement agreement Garattini L, Curto A, van de Vooren K. Are The Italian risk-sharing agreements on drugs interesting? Eur J Health Econ. 2015;16(1):1-3. Although the terms “high cost” or “high prices” are widely used in the literature and political debate, there is no standardized definition of drugs considered to be such. Here too, these drugs are implicitly considered new (i.e. patented) drugs, in particular new biologic drugs and targeted therapies for the treatment of cancer, diseases of the immune system (for example. B rheumatoid arthritis), infectious diseases (hepatitis C) and rare diseases.