The Romanian healthcare system has been struggling to use a more transparent approach in evaluating health care technologies for more than 10 years. No systemic and satisfactory approach to evaluate health technologies was implemented until the present. The objective of the presentation is to describe the characteristics of the HTA system used by the Romanian healthcare authority as well as the consequences of the drug assessments by using the actual Romanian health technology assessment (HTA) evaluation framework, from the initiation in May 2014 to the end of year 2017.

The drug reimbursement context and the healthcare legislation regarding HTA evaluation were studied. A critical appraisal of the scorecard was conducted, taking into consideration general principles of the health technology assessment. A descriptive analysis covering the assessment drug reports issued by the National Agency for Drug and Medical Devices (NADMD) issued between May 2014 and December 2017 was presented, together with the decision made by the Ministry of Health and the Romanian government.

During the analyzed period of time, more than 10 updates of the reimbursement list were implemented by the Ministry of Health. By November 2017, more than 180 drugs (new INN, new indications or fix dose combinations) were included in the reimbursement system with conditional or unconditional reimbursement; more than 230 reports were assessed by the NADMD. While the new drugs reimbursed between May 2014 and November 2017, in the most part demonstrated cost savings, a lot of new innovative drugs proposed to be evaluated were rejected since the drugs had no comparators on the Romanian market and their costs were considered to have a negative impact on the healthcare budget.

The rapid HTA assessment has many strengths, by using a proper scorecard. Limitations and weakness of the actual scorecard were identified, mainly regarding the lack of a basic budget impact analysis which must include at least the direct healthcare cost, as well as the imported results of different healthcare environments that are not matching the Romanian context. Opportunities to implement a more rapid and accurate HTA evaluation are identified since the scorecard could be updated in order to address the HTA general principles.