In accordance with a Romanian government decision on 27 July, 21 active substances and combinations previously not reimbursed in Romania are being placed on the reimbursement list of the CNAS.
Implications | All of these active substances, apart from one, are proprietary (originator) products, with a number of oncology medicines among the new additions. |
Outlook | The addition of these new medicines to the reimbursement list is very positive for patients and the pharmaceutical industry, although in some cases it could take some time before they are actually available to patients, because of the administrative requirements of the Romanian system. |
Based on a government decision published on 27 July, 21 active pharmaceutical ingredients or combinations previously not reimbursed in Romania are being added to the reimbursement list of the National Health Insurance House (CNAS). The majority of these are innovative (originator) medicines, with the exception of only one. Out of the 21 medicines being added to the list, 17 are being added unconditionally – meaning they have obtained a sufficient number of points in a health technology assessment procedure carried out by the Romanian National Agency for Medicines and Medical Devices (ANMDM) to avoid being subject to a cost-volume contract. In the case of the remaining four, the producers will need to negotiate a cost-volume contract with the Romanian authorities in order to guarantee reimbursement. As explained by the CNAS in a press release, specialised committees of the Romanian Ministry of Health (MoH) will develop therapeutic protocols for the new additions to the reimbursement list, and they will only be reimbursed on the basis of these protocols. However, as mentioned in a government press release, some of the products will be made available to patients in the near future, without the requirement for protocols to be prepared.
Brand name | Active ingredient | Producer | Treatment area/indication | Unconditional/conditional |
|---|---|---|---|---|
Giotrif | Afatinib | Boehringer Ingelheim (Germany) | Non-small-cell lung cancer | Conditional |
Inlyta | Axitinib | Pfizer (United States) | Advanced renal cell carcinoma | Conditional |
Zaltrap | Aflibercept | Sanofi (France) | Metastatic colorectal cancer | Unconditional |
Vidaza | Azacitidine | Celgene (United States) | Myelodysplastic syndrome | Unconditional |
Bosiluf | bosutinib | Pfizer | Chronic myelomonocytic leukaemia | Unconditional |
Afinitor | everolimus | Novartis (Switzerland) | Advanced renal cell carcinoma | Unconditional |
Imbruvica | Ibrutinib | Janssen-Cilag (subsidiary of US major Johnson & Johnson) | Chronic myelomonocytic leukaemia | Unconditional |
Tyverb | Lapatinib | GlaxoSmithKline (GSK, United Kingdom) | Breast cancer | Conditional |
Lynparza | Olaparib | AstraZeneca (United Kingdom) | High-grade serous epithelial cancer of the ovary | Unconditional |
Vectibix | Panitumumab | Amgen (United States) | Metastatic colorectal cancer | Unconditional |
Votrient | Pazopanib | GSK | Advanced renal cell carcinoma | Unconditional |
Thalidomide Celgene | Thalidomide | Celgene | Untreated multiple myeloma | Unconditional |
Duaklir Genuair | Aclidinium bromide + formoterol fumarate | AstraZeneca | Chronic obstructive pulmonary disease | Unconditional |
Cimzia | Certolizumab pegol | UCB Pharma (Belgium) | Rheumatoid polyarthritis | Conditional |
Picato | Ingenol mebutate | Leo Pharma (Denmark | Actinic keratosis | Unconditional |
Lyxumia | Lixisenatide | Sanofi | Type 2 diabetes | Unconditional |
Galvus | Vildagliptin | Novartis | Type 2 diabetes | Unconditional |
Implicor | Metoprolol + ivabridine | Servier (France) | Angina pectoris | Unconditional |
Esbriet | Pirfenidone | Roche (Switzerland) | Idiopathic pulmonary fibrosis | Unconditional |
Aubagio | Teriflunomide | Sanofi | Multiple sclerosis | Unconditional |
Lipocomb* | Rosuvastatin + ezetimibe | Egis (Hungary) | Hypercholesterolemia | Unconditional |
*Not innovative Source: CNAS | ||||
Outlook and implications
From 2008 until 2014, there was no full update of the reimbursement list of the CNAS, and so the fact that from this time there have been several major updates, including many new innovative medicines, is very positive for the pharmaceutical industry. However, the administrative process of creating therapeutic protocols and getting to the stage of drugs actually being made available with reimbursement can take a long time.
This new update includes a good number of medicines that have been approved for marketing in the European Union in the past couple of years, meaning that Romanians will be able to have access to some of the most up-to-date and effective new therapies. At the same time, a number of the drugs included have been approved for a much longer time, and had been placed in the 'queue' for reimbursement in the country that accumulated from 2008.