1. Drug Policy Experience of Visegrad Group countries, Warszava Oct 29-30, 2007 Price Volume Agreements in the Czech Republic Tomas Sechser Daniela Rrahmaniova Ministry of Health Czech Republic

2. Agenda a)Definitions b)Statutary control c)Price negotiations d)Pricing procedures CR PPR 29.10.2007 tosc@volny.cz

3. Price volume agreement  Like a framewok agreement, a volume control tool  The price of a pharmaceutical is agreed between public authorities and a manufacturer on the basis of a forecast volume of sales.  If the actual sales volume exceeds the the forecast, the price of the pharmaceutical is usually reviewed downwards. CR PPR 29.10.2007 tosc@volny.cz [PPRI Glossary]

4. Pricing policy  Regulations or procedures used by regulator (government authority) to set or limit the amount paid by purchachers or the amount received by sellers (e.g. statutary control, price negotiations) CR PPR 29.10.2007 tosc@volny.cz [PPRI Glossary]

5. Pricing policy in the Czech Republic  Statutary control  Price negotiations  Price Volume Agreement CR PPR 29.10.2007 tosc@volny.cz [ Amendment of Public Health insurance Act 2007 ]

6. Statutary pricing  For all pharmaceuticals CR PPR 29.10.2007 tosc@volny.cz [Amendment of Public Health insurance Act 2007 ]

7. Price negotiations a)When the Insurance Fund agrees with manufacturer on a concrete price, which should be lower than maximum price b)The agreement should be valid for the whole pharmaceutical market in CR c)In case of very expensive treatment, the agreement covers both the price and the number of the treated patients in specialized centres d)The agreement is valid for 6 months, if number of patients in need is higher than expected, the exceeding costs are covered by the manufacturer CR PPR 29.10.2007 tosc@volny.cz [Amendment of Public Health insurance Act 2007 ]

8. Pricing procedures  External price referencing (i.e. cross reference pricing)  ESP, PG, GR,ITA, FIN, SLO (other EU countries)  Internal price referencing CR PPR 29.10.2007 tosc@volny.cz [Amendment of Public Health insurance Act 2007 ]

9.  group of medical products essentially therapeutically interchangeable with a similar efficacy and safety and with a similar clinical use CR PPR 29.10.2007 tosc@volny.cz [ Amendment of Public health insurance Act 2007 ] Reference group § 39c