IHS Global Insight Perspective | |
Significance | A new updated drug reimbursement list for 2011 has been brought into force by the Romanian National Health Insurance House; meanwhile, an independent Romanian organisation is going to complain to the European Parliament about the very low level of funding planned for public healthcare in 2011. |
Implications | This is the first update to the drug reimbursement list since the introduction of a change to the methodology for setting the reference price for the purposes of calculating drug reimbursement, and this new methodology will certainly have an effect on how and to what extent the drugs on the list are reimbursed. |
Outlook | It remains to be seen to what extent the obstacles in the way of access to innovative, high-cost drugs will affect the level of consumption of these in Romania during 2011, but with their reimbursement subject to intensive monitoring, and with such limited public funding for healthcare available, it seems highly likely that the picture will be overwhelmingly negative. Meanwhile, favourable regulations and the ongoing funding squeeze are sure to boost further the volume of generics prescribed in the country this year. |
The Romanian National Health Insurance House (CNAS) has published its new list of partially and fully reimbursed drugs for 2011, which is valid from the beginning of the year, reports Romanian pharmaceutical news provider Pagina Farmacistilor. At the same time, the Romanian Ministry of Health (MoH) has outlined its priorities for 2011, as it is confirmed that public healthcare expenditure will reach no higher than 3% of GDP this year.
Reimbursement List Update Comes Into Force
The CNAS has published its full updated reimbursement list for 2011, which includes five separate sub-lists. The list can be accessed in Romanian here, although drug names are given in a recognisable form. Sub-list A, which features mostly generic drugs that are considered essential and cost effective, and are 90% reimbursed, contains a total of 1,588 products. Sub-list B, which features drugs that are considered less essential, and are thus reimbursed at the level of 50%, contains a total of 882 drugs.
Sub-lists C1, C2, and C3 feature medicines that are fully reimbursed. In sub-list C1, drugs are included that are used in the treatment of certain diseases in an outpatient context, and for which reimbursement is provided on the basis of treatment protocols regarding the monitoring of prescription and consumption, carried out by joint committees. These include certain cancers such as leukaemia and lymphomas, epilepsy, multiple sclerosis, psychological disorders, and Parkinson's disease. Among the drugs included in list C1 are:
- Aranesp (darbepoetin alpha; Genzyme, U.S.), indicated for the treatment of chronic renal failure
- Azilect (rasagiline mesylate; Lundbeck, Denmark), indicated in the treatment of the symptoms of Parkinson's disease
- Lyrica (pregabalin; Pfizer, U.S.), used mainly in the treatment of epilepsy
- ZypAdhera (olanzapine prolonged-release suspension for injection; Eli Lilly, U.S.), used in the treatment of schizophrenia
In the case of all but section G1 of sub-list C1, which includes drugs for chronic heart failure, all drugs on this sub-list can only be prescribed by specialist doctors.
In sub-list C2, drugs are included that are reimbursed as part of national health programmes, and in the case of sub-lists C2 and C1, prescriptions are retained by the pharmacy. Sub-list C3 includes all drugs that are not included in the other sub-lists and are suitable for use in the treatment of children up to the age of 18, for young adults between the ages of 18 and 26, pregnant women, and women with infants.
Chronic Underfunding of Public Healthcare Continues, European Parliament to Be Notified
The Alliance for Health in Romania is going to notify the European Parliament of what it perceives to be a violation of the rights of Romanian citizens to receive proper medical care, in the context of the Romanian government's allocation of only 3% of GDP to public healthcare, reports Romanian pharmaceutical news source Pharma Business. This follows the adopting of the budget act for 2011, in which the aforementioned level of public funds is allocated to healthcare. The Alliance for Health in Romania states its belief that the budget was passed without proper consideration of the basic health needs of Romanians, and emphasises that fact that the low level of public funding means that an increasing burden is being placed on citizens to buy medicines and pay for treatments themselves.
Romanian MoH Outlines Priorities for 2011
Meanwhile, the Romanian MoH has outlined its priorities for 2011, as reported by Pharma Business. The source reports that production of national health cards is due to start in January, and that it will be mandatory for Romanians wishing to obtain access to public healthcare to present a health card. It is also planned that investments will be made in the oncology and intensive care areas, with 190 million lei (US$57.49 million) due to be spent on new equipment for oncology wards and intensive-care facilities. The investment in oncology inpatient care is part of a new programme being implemented by the Romanian MoH that is aimed at reducing the incidence of cancer in the country.
Outlook and Implications
The publication and entering into force of the new updated reimbursement list in Romania follows important changes to the system for establishing reference prices for the purposes of reimbursement in 2010, which favoured an increase in the volume of generics prescribed in the country (see Romania: 7 July 2010: New Method of Reference-Price Calculation to Be Introduced in Romania Despite Opposition). This will have a continuing effect on the Romanian market in 2011, and it is also open to question what impact the drastic reduction of wholesaler and pharmacy margins on medicines in sub-list C2 will have on access to these drugs during the year (see Romania: 3 December 2010: Margins Set to Be Reduced Drastically on Reimbursed Chronic-Disease Drugs in Romania, Shortages Expected). It seems certain that generics will benefit from the changes, while it remains to be seen to what extent obstacles in access to more expensive drugs will affect the eventual consumption of these drugs this year (see Romania: 30 December 2010: New Regulations Boost Romanian Generics Market; Pharma Market Set for Lower Growth in 2011).
Meanwhile, the exceptionally low level of funding for public healthcare in Romania—just about the lowest in the entire European Union—continues to cause consternation in the country, and will also be of concern to pharmaceutical companies and others involved in supplying the healthcare sector in the country, which has traditionally spent very little on healthcare from public funds. However, in the context of an ageing population and increased incidence of chronic diseases, this very limited expenditure appears all the more unjustifiable.