The Development of the Romanian Scorecard HTA System.

OBJECTIVES: To present the characteristics of the scorecard health technology assessment (HTA) implemented since 2014 and to show the results of this HTA process by the end of 2015.

METHODS: The health care context and the Romanian HTA legislation were studied while considering the reasons behind HTA introduction, the key stakeholders, and the HTA process as a whole. A critical appraisal was done covering public HTA reports and the decisions made by the Ministry of Health.

RESULTS: The scorecard HTA model is in place from 2014 and is based on six criteria: France HTA decision, UK HTA decision, Germany HTA decision, the number of European Union countries with reimbursement, the development of a local real-world data study, and a budget impact assessment. By December 2015, more than 200 HTA dossiers were evaluated and the scorecard HTA results were reflected in three processes of the drug reimbursement list update. Consequently, 25 new drugs, 11 fixed-dose combinations, 2 new indications, and 4 orphan drugs received unconditional inclusion, and 5 drugs received conditional inclusion via commercial arrangements. Moreover, the scorecard system was used for delisting drugs: 16 were delisted and another 21 were moved to a lower level of reimbursement (20%).

CONCLUSIONS: The implementation of the scorecard HTA started in 2014 using combined information from Romania and other countries. Although the scorecard HTA system makes no direct evaluation of the value of drugs, authorities consider it to be effective, being designed only to favor cost-saving drugs and to promote high discounts.