The Romanian government has adopted a proposal by the Ministry of Health concerning the inclusion of a number of novel innovative medicines and new indications in the country's reimbursement list.
IHS Life Sciences perspective | |
Implications | There are a number of new innovative oncology medicines, as well as two pulmonary hypertension treatments, among those included in Romania's reimbursement list. The inclusion of these new drugs and indications is being presented as a continuation of the process of adding new innovative medicines to the reimbursement list that began with the addition of around 40 last year. |
Outlook | Considering that the new medicines and indications are likely to be either reimbursed under the auspices of national health programmes (which have restrictive inclusion criteria) or subject to cost-volume or cost-volume-outcome contracts, there is unlikely to be a major increase in reimbursement expenditure by the Romanian authorities and, consequently, the producers whose drugs are included would also not be likely to benefit from such a rise in earnings. |
The Romanian government has approved the Ministry of Health's (MoH) proposal to amend and supplement government decision 720/2008 on the list of international non-proprietary names reimbursed fully or partly within the health insurance system and under the auspices of national health programmes, according to a press release published by the MoH on 21 October. The decision includes the addition of new innovative drugs to the reimbursement list, and new indications for innovative drugs already on the list.
Therefore, with the adoption of the appropriate regulatory act, new molecules and new indications for existing innovative (patented) molecules are to be introduced to the reimbursement list, the MoH states. The medicines mentioned in its press release are shown in the table below. In the case of the cancer medicines, it is not specified for which indications they are precisely being included in the reimbursement list; it is only stated that they will be available under the national health programme for oncology. Therefore, the main indications for which these medicines are to be used are provided.
New innovative medicines/indications introduced to the Romanian reimbursement list | ||
Drug name | Producer | Main indication(s) |
Votrient (pazopanib) | GlaxoSmithKline (GSK, UK) | Advanced renal carcinoma, soft tissue sarcoma |
Xalkori (crizotinib) | Pfizer (US) | ALK-positive non-small-cell lung cancer |
Adcetris (brentuximab vedotin) | Takeda (Japan) and Seattle Genetics (US) | Hodgkin lymphoma, systemic anaplastic large-cell lymphoma |
Tafinlar (dabrafenib) | GSK | BRAF V600-positive advanced melanoma |
Zytiga (abiraterone acetate) | Johnson & Johnson (J&J, US) | Metastatic, castration-resistant prostate cancer |
Opsumit (macitentan) | Actelion (Switzerland) | Pulmonary hypertension |
Adempas (riociguat) | Bayer (Germany) | Pulmonary hypertension |
Exviera (dasabuvir) | AbbVie (US) | Hepatitis C |
Viekirax (ombitasvir + paritaprevir + ritonavir) | AbbVie | Hepatitis C |
Sirturo (bedaquiline) | J&J | Multi-drug-resistant tuberculosis |
Humira (adalimumab) | AbbVie | Juvenile idiopathic arthritis |
RoActemra (tocilizumab) | Roche (Switzerland) | Juvenile idiopathic arthritis |
Source: Romanian MoH | ||
Outlook and implications
The MoH has presented this new government decision as a part of the continued addition of new innovative medicines to the reimbursement list, which began with the inclusion of 40 new medicines last year. This had followed a period from 2008 when no full update of the reimbursement list had taken place, after the previous update resulted in an uncontrolled increase in reimbursement expenditure that led to the introduction of the clawback system for reimbursed pharmaceuticals.
This time around, the Romanian authorities have insured themselves against overspending related to new innovative medicines entering the reimbursement list with the creation of the system of cost-volume and cost-volume-outcome contracts with producers of these treatments. Similar to the clawback system, the cost-volume and cost-volume-outcome contracts also involve producers making regular payments into the Romanian health insurance system, as well as covering assorted costs connected with diagnostic tests and monitoring.
The health technology assessment (HTA) reports published by the Romanian National Agency for Medicines and Medical Devices (ANMDM) concerning the medicines added to the reimbursement list under this new government decision (the ANMDM's HTA reports can be accessed here, in Romanian) show that many of these treatments have been awarded the minimum 80 points required to be exempt from the cost-volume contract system and be included unconditionally in the reimbursement list. However, that does not mean "unlimited" reimbursement, because the criteria for inclusion in national health programmes are necessarily restrictive. Among the drugs and indications awarded fewer than 80 points, and therefore subject to cost-volume or cost-volume-outcome contracts, were Votrient in soft tissue sarcoma, Tafinlar, and Xalkori.