1. Pharmaceutical Pricing & Reimbursement Information ÖBIG Warsaw 29 October 20071 List of reimbursable pharmaceuticals PPRI Project Christine Leopold Gesundheit Österreich GmbH PPRI Conference Warsaw, 29 October 2007

2. Pharmaceutical Pricing & Reimbursement Information ÖBIG Warsaw 29 October 20072  Product-specific  most common (e.g. AT, EL, IT, SK, SI)  Example Austria  main criterion is the product  assessment of the product by pharmacological evaluation, medical-therapeutic evaluation, health-economic evaluation  Disease-specific  Baltic states, sub-scheme in some countries (BG, CZ, FR, IE)  Example Latvia  Main criterion is the underlying disease which shall be treated  „List of reimbursable diseases“  Same pharmaceuticals may be reimbursed at different reimbursement rates for the treatment of different diseases Type of reimbursement - eligibility criteria

3. Pharmaceutical Pricing & Reimbursement Information ÖBIG Warsaw 29 October 20073  Patient-group-specific  CY, IE, MT; TR  Example Malta and Cyprus  Specific population groups are eligible for reimbursement e.g. children, elderly person, handicapped persons or low income population.  Non-eligible persons have to buy health services and pharmaceuticals out-of-pocket  Consumption-based  DK and SE  Example DK  Level of reimbursement depends on the expenses for pharmaceuticals of a patient within a certain period of time (e.g. a year)  Patient pays the full cost of his/her reimbursable medication up to a threshold of about € 64.- per a 12 month period. After passing this threshold, the reimbursement rate rises gradually Type of reimbursement - eligibility criteria

4. Pharmaceutical Pricing & Reimbursement Information ÖBIG Warsaw 29 October 20074 Pricing procedures  External price referencing  Internal price referencing  Cost-plus  Others (e.g. indirect price control) See PPRI Glossary, http://ppri.oebig.at Pricing of reimbursable pharmaceuticals – pricing procedures

5. Pharmaceutical Pricing & Reimbursement Information ÖBIG Warsaw 29 October 20075  External price referencing (international price comparisons )  Used in nearly all Member States  For at least a range of pharmaceuticals Focus on a few countries (exceptions: AT, BE), mostly MS/neighbouring countries  Framework  Relevance  Methodological issues Pricing procedures Methodology to determine a price

6. Pharmaceutical Pricing & Reimbursement Information ÖBIG Warsaw 29 October 20076  Internal price referencing  often in connection with reimbursement  Cost-plus  For locally-produced pharmaceuticals (CZ, CY, EL, SK, exceptionally - UK)  Others  Indirect price control - PPRS (UK)  Agreed prices - Price competition (SK) Pricing procedures Methodology to determine a price

7. Pharmaceutical Pricing & Reimbursement Information ÖBIG Warsaw 29 October 20077  Define which pharmaceuticals are considered as reimbursable  Positive lists  in all EU Member States (exemption EL)  Negative lists  seldom used (FI - not implemented; ES and UK)  Updating of reimbursement lists  Annually  Quarterly  Every three months  As soon as a new pharmaceutical enters the market Reimbursement lists

8. Pharmaceutical Pricing & Reimbursement Information ÖBIG Warsaw 29 October 20078 Share of reimbursable pharmaceuticals 2005 Cost-Containment in Europe Source: PPRI 2007

9. Pharmaceutical Pricing & Reimbursement Information ÖBIG Warsaw 29 October 20079  All pharmaceuticals on the positive list(s) are 100% reimbursed  only in AT, IT, IE, MT, NL, UK  Percentage reimbursement rates  according to severity of disease for which the pharmaceutical is used  Further co-payments (e.g. prescription fees)  Reference price systems What does reimbursable mean?

10. Pharmaceutical Pricing & Reimbursement Information ÖBIG Warsaw 29 October 200710  Positive list includes 5.744 pharmaceuticals (1.8.2006) ->100% reimbursement for all pharmaceuticals on the list Reimbursement in Austria Yellow Box Drugs not qualifying for automatic reimbursement. Inclusion based on certain criteria (disease group..) AND after prior approval from the chief medical officer reimbursable. Green Box Drugs qualifying for automatic reimbursement. Inclusion of a drug in this box may be based on certain criteria relating to drug usage, such as disease group, age of patient and mode of application. “light yellow“ Box Drug on prevailing conditions reimbursable BUT Ex-post control by the chief medical officer List of not reimbursable drugs -> possibility of individual reimbursement after approval by the chief medical officer Red Box As soon as an application is filed, the corresponding drug is included in this box Maximum: 24 (respectively 36) months after prior approval from the chief medical officer reimbursable Code of Reimbursement (Positive List)

11. Pharmaceutical Pricing & Reimbursement Information ÖBIG Warsaw 29 October 200711  Criteria  Product-specific criteria ( Pharmacological evaluation, medical-therapeutic evaluation, health-economic evaluation)  Pricing procedure  External price refercening: EU average price  Updating of the list twice per year (1 January and 1 July)  Individual reimbursement  In case were no treatment alternative is available  Ex-ante or ex-post approval is necessary  On average 45.000 prescriptions per month Reimbursement in Austria