ROMANIAN QUICK-HTA DEVELOPMENT IN 2013

Author(s)

Radu C, Cernea R
Roche Romania, Bucharest, Romania

OBJECTIVES The objectives are to present the characteristics of the quick-HTA started in June 2013 and to show the results of the first quick-HTA process in Romania. METHODS The health-care context and the Romanian legislation covering HTA were studied by considering: the reasons behind HTA introduction, the key stakeholders and the HTA process. A critical appraisal was done covering public HTA reports and the decisions taken by the Ministry of Health (MofH). RESULTS The introduction of quick-HTA began mid-June 2013 when MofH released the legislation and the HTA Unit started receiving dossiers for new drugs/indications. The HTA model was based on a “score-card” system with 6 criteria: HAS (France) opinion, NICE/SMC/AWMSG (UK) opinion, the number of EU countries with reimbursement, relative efficacy, relative safety and relative patient-reported-outcomes (PRO), but no role of budget impact. From June to December 2013, 167 HTA dossiers were evaluated by the HTA Unit with an acceptance rate of about 80%. Most of the drugs accepted for reimbursement were oncological (23%); other main therapeutic areas were diabetes with 16 drugs/indications receiving positive evaluations, rheumatology (14), oncohaematology (8) and neurology (7). The HTA included also biosimilars, all 4 of them receiving positive decisions.Unfortunately, early 2014, the new Government abrogated this HTA legislation and the already-published HTA reports, claiming that the process didn’t mentioned the criteria for de-listing reimbursed drugs nor the budget impact, within HTA reports. Moreover, the HTA process was moved into the responsibility of the National Agency for Drugs. CONCLUSIONS The implementation of the quick-HTA in Romania took a good start, using a mixture of information, from benefits and cost-effectiveness in other countries, to relative effectiveness, safety and PRO. However, the lack of consideration for the local context and the political disagreements led to a temporary suspension of this quick-HTA process in Romania.

Conference/Value in Health Info

2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands

Value in Health, Vol. 17, No. 7 (November 2014)

Code

PHP241

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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