Entitlement of patient for correct treatment
Each and every individual having permanent residence in Slovakia has mandatory health insurance in some of the health insurance companies. There are currently three health insurance companies active in Slovakia (Všeobecná zdravotná poisťovňa, poisťovňa Dôvera, Union zdravotná poisťovňa). Each person is from the health insurance entitled to healthcare leading to the prolongation of life and improvement of its quality (Art. 40 of the Constitution of the Slovak Republic in relation to the Act No. 576/2004 Coll. on Healthcare and Act No. 580/2004 Coll. on Health Insurance). The right to such treatment is contained also in the legal relationship between the patient and the healthcare provider, who shall pursuant to the provisions of Section 4(3) of the Act No. 576/2004 Coll. on Healthcare provide the healthcare correctly, meaning that the healthcare provider shall provide timely and effective treatment with the aim to heal the respective person or to improve the condition of such person taking into account current knowledge of the medical science.
Medicine registration means the authorisation to market the medicine and registering it in the list of registered medicines. All mass-produced medicinal products are subject to registration, i.e. only medicines registered in Slovakia can be prescribed or sold. Decisions about medicine registration are issued by the State Institute for Drug Control (ŠÚKL) or European Commission on the grounds of expert assessment of the European Medicines Agency (EMA) if it concerns the so-called European registration, when the medicine is approved by the decision of EC in the whole European Union at once. The ŠÚKL maintains a list of all medicines registered in the Slovak Republic. This list is available also on the website www.sukl.sk. Details concerning the registration of medicines are governed by the Act No. 362/2011 Coll. on Medicines and Medical Aids.
Categorisation of medicines
Registration of a medicine in the Slovak Republic does not mean that it is also paid from the health insurance. The scope of payment for medicines from the health insurance is governed by the Act No. 363/2011 Coll. on Scope and Terms of Payment for Medicines, Medical Aids and Dietetics based on Public Health Insurance. Medicines provided during in-patient treatment are fully paid from the health insurance, but medicines provided within out-patient treatment are paid only if they are included in the so-called list of categorised medicines (List of medicinal products and medicines fully or partially paid from the public health insurance) and medicines prepared individually in the pharmacy.
Categorisation of medicines is a process of determining the amount of payment from the public health insurance. The categorisation determines whether the medicine or a part thereof will be paid on the grounds of health insurance. Part of the price for medicine, which is not paid from the health insurance, is paid by the patient in form of so-called supplement. The categorisation committee, composed of representatives of the Slovak Medical Association, health insurance companies and Ministry of Health of the Slovak Republic, makes categorisation decisions. The categorisation takes place every month, which means that changes in the amount of supplement or conditions for prescribing a medicine can occur as often as 12 times a year. The key factor for including a medicine into the list of categorised medicines are additional costs spent from the public health insurance per unit of health condition improvement using the assessed medicine as effect of the more effective treatment variant (quality-adjusted life-year - QALY).
A medicine can be in the list of categorised medicines
a) included, if QALY is lower or equal to 24 times of average monthly salary in Slovak Republic in the year which precedes by two years the year in which the formula is applied
b) conditionally included, if QALY equals 24-35 times of average monthly salary OR if the medicine is intended for treatment of a disease the prevalence of which is lower in the Slovak Republic than 1:100 000.
A medicine cannot be included in the list of categorised medicines if its QALY exceeds 35 times of average monthly salary; this DOES NOT APPLY if the medicine is intended for treatment of a disease the prevalence of which is lower in the Slovak Republic than 1:100 000. Multiple myeloma does not belong to the group of diseases with prevalence lower than 1:100 000.
Medicines included in the list of categorised medicines are paid for if they are prescribed and used in line with prescription restrictions and indication restrictions and if the health insurance company granted consent with the payment for the medicine in cases where such consent is required. The prescription restriction means that the medicine can be prescribed only by the determined specialist physician or general practitioner on specialist’s recommendation. A medicine having in the list of categorised medicines the prescription restriction HEM/ONK can be prescribed only by a haematologist or oncologist. The indication restriction means that the medicine can be prescribed only upon indications and under conditions as specified in the medicine categorisation decision. Indication restrictions can include also specification of workplaces of which physicians can prescribe the medicine or approve such prescription if it was prescribed by a specialist from another workplace. The condition of previous consent of the health insurance company is applied if the medicine is included in the list of categorised medicines with such condition. Said restrictions limit the application of medicine in the medical practice. Prescription and indication restrictions are determined especially for financially demanding medicines; many categorised medicines can be prescribed and administered without any prescription or indication restrictions or previous consent of the health insurance company.
Categories of medicines
The list of categorised medicines contains medicines of several categories according to the method of prescription, distribution and payment – A, I, S, V and AS. Medicines of category A are administered during the provision of out-patient treatment in the office of the physician. These are medicines with so-called special payment method, meaning that the health insurance company pays for their administration directly to the healthcare provider. The health insurance company will not pay for such medicines if they were given to the patient in the pharmacy. Medicines given on the grounds of medical prescription are divided to medicines of category I, which are fully paid by the insurance company; medicines of category S, paid with deductible (supplement) of the patient; vaccines for mandatory vaccination (category V).
A medicine not included in the list of categorised medicines can be paid from the health insurance only on the grounds of consent granted by the health insurance company, only in justified cases, especially if the provision of medicine is the only suitable option with regard to the health condition of the insured. Application for consent is submitted to the health insurance company by the healthcare provider (not the patient). There is no legal entitlement or claim to have the consent granted. Our law does not contain any mechanism by which the decision of the insurance company about refusal can be contested.
Sufficient amount of medicine
The holder of registration for medicine (pharmaceutical company) included in the list of categorised medicines shall assure that the medicine is available on the market in sufficient amount during the whole time the medicine remains in the list of categorised medicines. A stock of medicine sufficient to cover estimated monthly consumption of medicine in the Slovak Republic is deemed to be sufficient amount. In case the medicine is not available on the market in sufficient amount during the period of 60 consecutive days, the Ministry can decide to exclude the medicine from the list of categorised medicines. That means that patients in the Slovak Republic are entitled to availability of all medicines included in the categorisation list and paid through the public health insurance. If the pharmacy does not have the medicine, the pharmacy shall acquire such medicine for the patient within 48 hours.
Aj malým príspevkom nám pomáhate prinášať pacientom zrozumiteľné a aktuálne informácie a presadzovať práva pacientov na kvalitnú zdravotnú starostlivosť.