IHS Global Insight Perspective | |
Significance | Slovenia's national health insurance organisation, the ZZZS, has updated the country's drug reimbursement list, adding a good number of new innovative treatments. |
Implications | Simultaneously to the addition of the new innovative drugs to the list, cost-containment measures are also high on the agenda. |
Outlook | The head of the ZZZS, Jurij Fürst, reveals that the Slovenian authorities have prepared new laws relating to the pricing of drugs, as well as other associated regulatory issues, indicating that there will be an intensification of the cost-containment agenda in the country's public pharmaceutical sphere in the foreseeable future. |
The Health Insurance Institute of Slovenia (ZZZS) has published its update to the country's drug reimbursement list for 2010, which includes a number of new innovative drugs. Among the additions to the list are several new-generation Type 2 diabetes drugs, namely two dipeptidyl peptidase-4 inhibitors Onglyza (saxagliptin), produced by Bristol-Myers Squibb (BMS; U.S.) and AstraZeneca (U.K.), and U.S. drug maker Merck & Co.'s Januvia (sitagliptin). The updated list also includes three innovative oncology treatments, two of which are specifically in the area of lung cancer: AstraZeneca's Iressa (gefitinib) and Swiss firm Roche's Tarceva (erlotinib). Most of the drugs on the list have some restrictions to their reimbursement, most often relating to their prescription by the appropriate specialist, at the appropriate healthcare facility in Slovenia. The full list can be accessed, in Slovenian, here.
Selected New Innovative Drugs Included in Update to Slovenian Drug Reimbursement List, December 2010 | |||
Drug Name | Producer | Indication/Drug Type | Reimbursement Rate/Restrictions to Reimbursement |
Onglyza (saxagliptin) | BMS/AstraZeneca | Type 2 Diabetes | 100% reimbursed. Prescription by specialist or by specialist's recommendation. |
Revolade (eltrombopag) | GlaxoSmithKline (GSK, U.K.) | Chronic immune (idiopathic) thrombocytopenic purpura (ITP) | 75% reimbursed. Prescription only by haematologists based at the haematology clinic of the University Medical Centre, Ljubljana. |
Multaq (dronedarone) | Sanofi-Aventis (France) | Atrial fibrillation | Intermediate List. To be prescribed once electrophysiological studies are completed, with the recommendation of a cardiologist. |
Truvada (tenofovir disoproxil fumarate) | Gilead Sciences (U.S.) | HIV/AIDS | 100% reimbursed. |
Iressa (gefitinib) | AstraZeneca | Non-small-cell lung cancer | 100% reimbursed. Limited to patients with epidermal growth factor receptor (EGFR) TK mutation. Only to be prescribed based on opinion of specialists at the Oncology Institute of Ljubljana or at the department for pulmonary diseases at Golnik |
Votrient (pazopanib) | GSK | Advanced renal cell carcinoma | 100% reimbursed. Prescription only based on the opinion of specialists at Ljubljana Oncology Institute. |
Simponi (golimumab) | Centocor Ortho Biotech (U.S.) | Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis. | 75% reimbursed. Prescription by rheumatologists only. |
Onbrez Breezhaler (indacaterol maleate) | Novartis (Switzerland) | Airflow obstruction in adults with chronic obstructive pulmonary disease | 75% reimbursed. |
Januvia (sitagliptin) | Merck & Co. (U.S.) | Type 2 diabetes | 100% reimbursed. Prescription only by specialist or specialist's recommendation. |
Janumet (sitagliptin/metformin) | Merck & Co. | Type 2 diabetes | Same as Januvia. |
Tarceva (erlotinib) | Roche | EGFR-positive lung cancer | Intermediate list. Restrictions the same as in the case of Iressa. |
Source: ZZZS | |||
New List to Save 9 Million Euro
In spite of the addition of a good number of new innovative drugs to the reimbursement list, the changes to list are predicted to save around 9 million euro (US$12.02 million) on an annual basis, according to Slovenian medical news provider Medicina Danes. The updated list also includes additions of new generics and changes to the maximum prices for particular active pharmaceutical ingredients in groups of interchangeable products.
Major Drug Law Change to Come, Problem of Overprescription to Elderly Patients Persists
In his introduction to the new drug reimbursement list, the head of the ZZZS, Jurij Fürst, reveals that the Slovenian Ministry of Health (MoH), together with other responsible bodies, has prepared a package of reforms concerning drug prices, the interchangeability of drugs, and their advertising. Fürst also emphasises the need for there to be action taken on the large number of elderly people in Slovenia who are taking an excessive number of prescription medicines at the same time. He emphasises the fact that although new treatments are prescribed for older people, these may not only treat, but also endanger them, on account of potential interactions with other prescription drugs the elderly person is taking. He states that there needs to be a concerted effort, in co-operation with patients, in order to analyse whether all the medicines they are taking are actually necessary for them.
Outlook and Implications
Slovenia has a relatively favourable policy towards the reimbursement of expensive, innovative medicines, compared with countries in the Central and Eastern Europe and South-Eastern Europe regions, as this new update to the Slovenian drug reimbursement list demonstrates. Indeed, in the Health Consumer Powerhouse report on healthcare systems in European countries, Slovenia's policy on pharmaceuticals was rated at a level comparable to a number of Western European countries.
Having already emphasised the importance of reducing the number of medicines used by elderly people in the update to the previous reimbursement list, the fact that it is being emphasised again reinforces the scale of the problem (see Slovenia: 1 December 2009: Slovenia's Updated Drug Reimbursement List Contains Several New Proprietary Drugs as ZZZS Highlights Huge Rise in Prescriptions to over 65s). As well as an issue of public health, it is a cost-containment issue; the Slovenian MoH earlier in the year announced its intention to launch a prescription-drug database in order to monitor the drugs prescribed to individuals and help it to alleviate this problem (see Slovenia: 29 September 2010: MoH Plans Launch of Prescription-Drug Database As Slovenes Use Increasing Number of Medicines Simultaneously).
Meanwhile, although the ZZZS's Fürst does not give any concrete details of the upcoming changes to the laws relating to pharmaceuticals in Slovenia, it is very likely that these will be the same as, or similar to, those mooted by the Slovenian MoH during the summer (see Slovenia: 29 June 2010: Slovenian MoH Puts Forward Series of Pharmaceutical Cost-Containment Measures). Therefore, it seems highly likely that the Slovenian authorities—while continuing to be relatively favourable in terms of reimbursement decisions for innovative producers—will become increasingly focused on cost containment, leading to a more challenging situation than previously for pharmaceutical companies operating in the country.