Romania assesses new medicines with a points-based scorecard rather than a cost-effectiveness threshold. Enter the agency decisions, the reimbursement count across Europe and the annual therapy cost against the Romanian comparator. The result updates as you type.[1]
How the score works
For a new INN or indication (Table 4), the maximum is 100 points: 15 each for the HAS, NICE or SMC, and IQWiG/G-BA criteria, 25 for reimbursement in EU member states and the UK, and 30 for annual therapy cost. A score of 80 or more leads to unconditional inclusion; 60 to 79 to conditional inclusion through a cost-volume or cost-volume-result contract; below 60, the medicine is not included. Orphan medicines and ATMPs use Table 5, which awards 70 points for meeting the orphan or advanced therapy criterion and 10 for a supporting document.
Points to confirm with ANMDMR
- The 45-point route: The Order says these 45 points replace the HAS, NICE or SMC, and IQWiG/G-BA scores. It does not state expressly whether the reimbursement-count criterion still applies when this route is used, so the calculator shows both readings.[2]
- Older medicines: A medicine authorised before 2011 and reimbursed in both the UK and Germany receives 15 points automatically on the NICE and IQWiG/G-BA criterion. This case is not modelled here.
- Cost period: Costs are compared per patient per calendar year, over 3 years for induction plus consolidation, and over 5 years when one product has a limited duration and the other is chronic. The whole regimen is costed.
- Several regimens or lines: Unconditional inclusion requires the unconditional score in every regimen or line in the same indication and population.
For the full picture of HTA in Romania, including pricing and cost-volume contracts, see HTA and reimbursement in Romania.
References
- Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România (ANMDMR). Health technology assessment [Internet]. Bucharest: Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România (ANMDMR); [date unknown] [cited 2026 Oct]. Available from: https://www.anm.ro/en/portfolio/evaluare-tehnologii-medicale/
- Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România (ANMDMR). Order 861/2014, consolidated Romanian text including Order 1142/2025 (Annex 1, Tables 4 and 5; Annex 2) [Internet]. Bucharest: Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România (ANMDMR); [date unknown] [cited 2026 Oct]. Available from: https://www.anm.ro/_/ORDINE/Ordin%20861-2014.pdf
Rules reviewed October 2026. This calculator is indicative and independent of the agencies; check the latest official texts before submission.
