TRACKING DRUG UTILIZATION DATA TO ENABLE CONDITIONAL REIMBURSEMENT OF MEDICINES OR SPECIFIC INDICATIONS IN ROMANIA- ANALYSIS OF THE REQUIREMENT FOR AN EFFECTIVE IMPLEMENTATION
Author(s)
Chiriac ND1, Marcelli G2, Radu PC1
1Roche Romania Srl, Bucharest, Romania, 2Roche, Basel, Switzerland
Presentation Documents
Background Information: In 2014, Romania adopted a new legislation requiring Health_Technology_Assessment (HTA) as mandatory step in the drug reimbursement listing. The HTA System is a score-card, the drug/ a certain indication can be unconditional (80 – 145 points), or conditional approved (60-79 points). Conditional approved indications are reimbursed only if they are included in a cost-volume/cost-volume-result contract (CV/CVR) with the National Payer,- requiring the tracking of drug utilisation data on indication. This could lead to differentiated pricing, depending on the benefit the product provides in different indications (Multiple Indication Pricing-MIP). One single unit price could be not relevant for all indications (e.g in oncology), especially when the same drug has both unconditional and conditional reimbursement. Approach: Under MIP, drug utilisation would be tracked; the price of medicine per indication would be defined according to the benefit of the drug in that indication. Two approaches could be used: leverage existing national data collection by the National Payer, additionally collecting data like indication, treatment status, result, etc. by a separate module in the Hospital Information System or use e-health/electronic patient records. Implications: Required minimum data fields, data format and attributes must be defined. Data must be complete, consistent, available, allowing for validity checks. Marketing Authorization Holder (MAH) must receive reports containing information (anonymised and aggregated) on drug utilisation. To be defined: timing between data capturing and data availability, timing for paybacks, absorption of costs for data generation and capturing, error handling. Recommendations: Conduct pilot with a representative oncology clinic, set a methodology for collection, validation and use of data, generate reports, demonstrate the utility in managing CV/CVR. Scale up the project at national level through the National_Health_Insurance_House. Conclusion: Developing a system to identify drug utilisation on indication, could support implementing conditional reimbursement schemes by the Payer and increase patient access to drugs.
Conference/Value in Health Info
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PHP329
Topic
Health Policy & Regulatory
Disease
Oncology