How Romanian reimbursement works
Market access for a prescription medicine in Romania runs through three bodies. The Ministry of Health approves the maximum price. The National Agency for Medicines and Medical Devices of Romania (ANMDMR) carries out the health technology assessment and issues a decision on inclusion in, or exclusion from, the list of reimbursed medicines. The National Health Insurance House (CNAS) funds reimbursed medicines and, with the Ministry, is party to the cost-volume contracts that underpin conditional inclusion.[1]
The marketing authorisation holder submits an HTA dossier to ANMDMR for a new international non-proprietary name (INN), a new indication or a fixed-dose combination. The comparator is confirmed with the Ministry of Health's specialist commissions. ANMDMR must communicate its decision within 90 working days of receiving the complete documentation, with a further 90 days where the product has no approved price. Decisions can be appealed to an appeals commission, and then in the administrative courts.
A positive decision does not by itself give access. The INN must be added to the list annexed to Government Decision (HG) 720/2008, which the Ministry updates by further Government Decisions. The list is organised in sublists: A (reimbursed at 90% of the reference price), B (50%) and C (100%, with C1 for disease groups, C2 for national health programmes and C3 for children, students and pregnant and postpartum women). Prescribing then follows the relevant therapeutic protocol.
- HAS rating: 15
- NICE or SMC: 15
- IQWiG/G-BA: 15
- EU countries and UK reimbursing: 25
- Cost vs comparator: 30
A EUnetHTA assessment for the indication can earn 45 points in place of the three agency criteria. Orphan medicines and ATMPs use a separate table.
Evidence requirements: the scorecard
Romania does not ask for a local cost-effectiveness model, and there is no cost-per-QALY threshold. Instead, Ministry of Health Order 861/2014, amended several times since (most recently by Order 1142/2025), sets a points-based scorecard. For a new INN or indication, the maximum is 100 points:
| Criterion | Maximum points |
|---|---|
| HAS (France) rating of therapeutic benefit | 15 |
| NICE or SMC recommendation, unrestricted or restricted | 15 |
| IQWiG/G-BA additional benefit, with or without restriction | 15 |
| Number of EU member states (and the UK) that reimburse the medicine, 14 or more for full points | 25 |
| Annual therapy cost per patient compared with the Romanian comparator, savings above 5% for full points | 30 |
Specified documents, including a EUnetHTA assessment for the indication, can earn 45 points in place of the three agency criteria. Orphan medicines and ATMPs are scored on a separate table that awards 70 points for meeting the orphan or advanced therapy criterion, with further points for supporting documentation. Further tables cover rare diseases with no therapeutic alternative, generics and biosimilars, and national public health programmes.
The cost criterion is calculated at the maximum retail price including VAT, per patient per calendar year, at the recommended dose. Small changes in dosing, treatment duration or comparator choice can move a product between bands.
| HAS rating of therapeutic benefit | 15 points |
| NICE or SMC recommendation | 15 points |
| IQWiG/G-BA additional benefit | 15 points |
| Reimbursed in 14 or more countries (EU member states and the UK) | 25 points |
| Annual therapy cost against the Romanian comparator (0 points assumed in this example) | 0 points |
| Total | 70 points |
With 70 points, the medicine qualifies for conditional inclusion through a cost-volume or cost-volume-result contract. A saving of more than 5% against the comparator would add 30 points (100 in total), enough for unconditional inclusion unless the comparator is itself under a cost-volume contract.
Figures are invented for illustration and assume the agency decisions qualify for full points. Points for each criterion depend on the exact conditions in Order 861/2014, as amended.
Estimate your own ANMDMR score with our free scorecard calculator.
Open the romania HTA scorecard calculatorConditional inclusion and cost-volume contracts
A product scoring 60 to 79 points can only be included conditionally, through a cost-volume or cost-volume-result contract. A product whose comparator is itself under a cost-volume contract also receives a conditional decision, even if its score would allow unconditional inclusion. Below 60 points, the INN is not included.
Under a cost-volume contract, the company provides an agreed number of units at no charge, or supplies the medicine at an agreed price, for a defined patient group and period. A cost-volume-result contract links that commitment to a defined therapeutic target. The conditional decision is valid only while the contract is in force. The Ministry of Health's explanatory note to the HG 720/2008 update applying from 1 April 2026 describes contracts valid for 12 months from the month of first prescription, so renewal is a recurring part of the access plan.
Romania also applies a clawback contribution to reimbursed medicines. A peer-reviewed analysis by Radu and colleagues (2025) describes a fixed rate for unconditionally reimbursed medicines and a sliding grid for those under cost-volume contracts, so net price modelling has to reflect the reimbursement route.[2]
Price approval and external reference pricing
Maximum prices are set under Ministry of Health Order 368/2017, as amended. For the national catalogue of maximum prices (CANAMED), the proposed producer price must be at or below the lowest price of the same medicine in 12 reference countries: Austria, Belgium, Bulgaria, the Czech Republic, Germany, Greece, Hungary, Italy, Lithuania, Poland, Slovakia and Spain. The Minister may revise the basket each year, and prices are recalculated annually.[3]
Because the HTA clock extends when no price is approved, and because Romanian prices are referenced by other countries, the price dossier and the HTA dossier should be planned together. Our international pricing work looks at how a Romanian price sits within a wider launch sequence.
How EU JCA interacts with Romania
The EU-wide phase-in dates are set out in our HTA requirements comparison. Article 13 requires member states to give due consideration to the published JCA report and not to request at national level information already submitted at Union level. Pricing and reimbursement remain national competences.[4]
The Romanian scorecard already credits a EUnetHTA assessment. The consolidated text of Order 861/2014 published by ANMDMR, which includes the 2025 amendment, does not yet name JCA reports as a scored document, so how JCA evidence will be recognised is a point for companies to follow closely. In practice, the JCA dossier, its PICOs and its comparisons should be built so that they can be reused in the Romanian file. See our EU JCA dossier services.[5]
What we deliver
- Scorecard simulation: projected points under each criterion, with the evidence and price assumptions behind them
- HTA dossier preparation for ANMDMR, for new INNs, new indications and fixed-dose combinations
- Comparator analysis and annual therapy cost calculations at Romanian maximum prices
- Budget impact analysis for the reimbursed population
- Analysis of cost-volume and cost-volume-result scenarios, including net price under clawback
- Reference price mapping across the 12-country basket
- Reuse of JCA evidence, including indirect treatment comparisons, in the national file
- Technical input to ANMDMR queries and appeals commission submissions, alongside your legal advisers
What to get right
- Plan the scorecard early: Points depend on decisions taken elsewhere: the timing of HAS, NICE or SMC and G-BA outcomes, and the number of countries reimbursing, all shape the result.
- Confirm the comparator early: The cost criterion, and in some cases the decision type, depend on the comparator confirmed by the specialist commission.
- Align price and HTA: Having an approved price in place keeps the assessment on its standard timeline.
- Model conditional inclusion over several years: A cost-volume contract is renewed, so the commercial terms are best modelled across its likely life.
- Submit a complete dossier: The 90-working-day clock runs from a complete dossier, so completeness protects the timeline.
Why Evidaxia
Evidaxia is led by a clinician and health economist with more than a decade in healthcare and experience as an HTA Technical Lead and Analyst at NICE. Our EU-level work, including EU JCA dossiers, PICO scoping, indirect comparisons and global model adaptation, is built to feed national processes, and we bring that EU experience to the ANMDMR scorecard and the commercial agreements that follow. See also market access consultancy.
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/
- Radu C, Serban DE, Chiriac ND. Delayed access to innovative medicines in Romania: a comprehensive analysis of the reimbursement processes (2015-2024). Front Public Health. 2025;13:1592419. doi:10.3389/fpubh.2025.1592419 Available from: https://www.frontiersin.org/articles/10.3389/fpubh.2025.1592419/full
- Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România (ANMDMR). Order 368/2017 on medicine prices (consolidated) [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%20368-2017.pdf
- Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU. Official Journal of the European Union. 2021 Dec 22;L458:1-32. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32021R2282
- Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România (ANMDMR). Order 861/2014, consolidated Romanian text including Order 1142/2025 [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
Sources reviewed October 2026. Methods and procedures change; check the latest agency guidance before submission.