{"id":129,"date":"2022-05-16T14:49:13","date_gmt":"2022-05-16T12:49:13","guid":{"rendered":"https:\/\/www.niho.sk\/?page_id=129"},"modified":"2025-01-03T14:03:11","modified_gmt":"2025-01-03T13:03:11","slug":"ako-funguje-system-na-slovensku","status":"publish","type":"page","link":"https:\/\/niho.sk\/en\/ako-funguje-system-na-slovensku\/","title":{"rendered":"How does the system of health technology reimbursement work in Slovakia?"},"content":{"rendered":"<div class=\"wp-block-group w-100 max-w-100  margin-0 is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-group defaultWidthGroup defaultPaddingGroup is-layout-flow wp-block-group-is-layout-flow\">\n<div class=\"wp-block-columns o-nas-container is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h1 class=\"wp-block-heading\">How does the system of health technology reimbursement work in Slovakia?<\/h1>\n\n\n\n<h3 class=\"wp-block-heading fw-400 padding-bottom-20\">Health technologies applying for reimbursement in the Slovak system have to undergo various assessment and approval processes. Different types of technologies go through different processes.<\/h3>\n\n\n\n<p><strong>Medicines<\/strong> undergo a\u202fmarketing authorisation process, which allows them to be placed on the European or Slovak market; this process is called registration. Furthermore, the manufacturers\/marketing authorisation holders may apply for full or partial reimbursement from the public health insurance; in Slovakia, this procedure is called categorization. <a><\/a><\/p>\n\n\n\n<p><strong>Medical\u202fdevices<\/strong><strong> (incl. medical aids, such as crutches and special medical supplies, such as implants) or dietetic foods<\/strong> also undergo the registration and\u202fcategorization process. The registration process is decentralized and the categorization process takes place less frequently while in this case the requirements are less extensive than for medicines.<\/p>\n\n\n\n<p><strong>Medical technologies also include other devices (such as MRI scanners), health care services, or medical procedures.<\/strong> These lists of these are created and approved at the Ministry of Health of the Slovak Republic in collaboration with experts. For example, standard medical procedures are formed by expert working groups and\u202fcontinuously evaluated by a multidisciplinary committee of the Ministry. Health care services are updated in the Health Care Services Catalogue according to requirements and inputs from professional associations; the update is guided by a regulation of the Government of the Slovak Republic and the Ministry coordinates this process. Furthermore, the Ministry assesses the purchase of larger devices for public health facilities on the grounds of the published methodology, taking into account its compliance with the broader investment strategy. <\/p>\n\n\n\n<p class=\"padding-bottom-20\">Several organizations play a role in the system of assessment and\u202fapproval of medicines, equipment and dietetic foods:<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"866\" height=\"1024\" src=\"https:\/\/niho.sk\/wp-content\/uploads\/2023\/11\/graf-v-5\u2013-EN.png\" alt=\"\" class=\"wp-image-831\" srcset=\"https:\/\/niho.sk\/wp-content\/uploads\/2023\/11\/graf-v-5\u2013-EN.png 1200w, https:\/\/niho.sk\/wp-content\/uploads\/2023\/11\/graf-v-5\u2013-EN-254x300.png 254w, https:\/\/niho.sk\/wp-content\/uploads\/2023\/11\/graf-v-5\u2013-EN-866x1024.png 866w, https:\/\/niho.sk\/wp-content\/uploads\/2023\/11\/graf-v-5\u2013-EN-768x908.png 768w, https:\/\/niho.sk\/wp-content\/uploads\/2023\/11\/graf-v-5\u2013-EN-10x12.png 10w\" sizes=\"auto, (max-width: 866px) 100vw, 866px\" \/><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>The marketing authorisation holder (e.g. a pharmaceutical company) <\/strong>owns the rights to sell the medicine, medical equipment (ME), specialized medical supplies (SMS) or dietetic food (DF) and submits an application for their\u202fcategorization. <\/li>\n\n\n\n<li><strong>The European Medicines Agency (EMA)\/ State Institute for Drug Control (SIDC) <\/strong>performs quality control, surveillance, registration and record keeping of medicinal products and\u202fmedical equipment. <\/li>\n\n\n\n<li><strong>The Ministry of Health of the Slovak Republic (MoH SR) <\/strong>receives the application from the marketing authorization holder and\u202fruns the categorization process. Upon approval of the health technology, the Ministry negotiates a Managed Entry Agreement with the Marketing authorization holder.<\/li>\n\n\n\n<li><strong>The Pharmacy and\u202fDrug Policy Department at the Ministry of Health (PDPD MH SR) <\/strong>issues statements and\u202fassessments on categorization applications of medicines, ME, SMS, DF for the Appraisal Committee. <\/li>\n\n\n\n<li>\u201e<strong>NIHO\u00a0<\/strong>issues comprehensive technology assessments based on applications for reimbursement of medicines, ME, SMS, and DF. Technologies with an expected net impact above approximately 1.5 million euros undergo a detailed assessment process. Technologies with a lower impact undergo an accelerated assessment process. The Appraisal Committee must justify any deviation from the NIHO recommendation<\/li>\n\n\n\n<li class=\"translation-block\">Based on the delivered evaluations and\u202fassessments, <strong>the Appraisal Committee of\u202fMH SR <\/strong>issues a recommendation to the Minister of Health.<\/li>\n\n\n\n<li>In the <strong>appeal<\/strong> process, any of the\u202fparties may appeal against the 1st degree decision made by the Ministry. The submission will be examined by the <strong>Appraisal Board<\/strong>, which will issue a recommendation to the minister. The minister issues a decision or returns the submission for reconsideration back to the Committee.<\/li>\n\n\n\n<li><strong>The Minister of Health <\/strong>decides (on behalf of the Ministry) on the basis of the recommendation of the Appraisal Committee. <\/li>\n\n\n\n<li><strong>Health insurance companies <\/strong>cover technologies in the amount approved in the categorization process (or cover them under an exceptional reimbursement regime upon consideration of an individual patient\u2019s application)<\/li>\n<\/ul>\n\n\n\n<p class=\"padding-top-20\">For a better explanation, a more detailed example on medicines is provided, since their assessment constitutes a significant amount of work of NIHO:<\/p>\n\n\n\n<h2 class=\"wp-block-heading padding-top-20\">What does it mean when a medicine is registered?<\/h2>\n\n\n\n<p>This means that the EMA, or in\u202fsome cases the SIDC in Slovakia, has recognized it as suitable for use in\u202fEurope or Slovakia. To do so, the medicine must meet quality, efficacy, and safety requirements and\u202fdemonstrate that it has an effect compared to placebo or standard technology.<\/p>\n\n\n\n<p>This does not mean that it  automatically reimbursed by health insurance companies. However, a\u202fphysician may prescribe it and the patient may pay the\u202ffull amount (if it is not categorized) or it might be a\u202ftype of a\u202fmedicine that is used and\u202fpurchased by hospitals. The price of the medicine does not play any role in the registration.<\/p>\n\n\n\n<h2 class=\"wp-block-heading padding-top-20\">What does it mean when a medicine is categorized?<\/h2>\n\n\n\n<p>This means that a medicine is fully or partially reimbursed by health insurance companies. In order for a medicine to become categorized, it must undergo a categorization process that is covered and\u202fmanaged by the Ministry of Health of the Slovak Republic pursuant to Act No. 363\/2011 Coll. If the medicine is only partially reimbursed, the patient pays the rest of the price in the form of a\u202fco-payment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading padding-top-20\">How does the reimbursement process of a medicine look like?<\/h2>\n\n\n\n<p>(a detailed description of the process is given in\u202fAct No. 363\/2011 Coll.)<\/p>\n\n\n\n<ol style=\"list-style-type:1\" class=\"wp-block-list\">\n<li>The marketing authorization holder (a pharmaceutical company) submits a categorization application on the <a rel=\"noreferrer noopener\" href=\"https:\/\/kategorizacia.mzsr.sk\/Lieky\/Common\/Requests\" target=\"_blank\">medicines reimbursement website.<\/a>.<\/li>\n\n\n\n<li>NIHO do 130 dn\u00ed (nezahr\u0148aj\u00fac preru\u0161enie konania) vypracuje hodnotenie a&nbsp;odpor\u00fa\u010danie pre <a href=\"https:\/\/www.health.gov.sk\/?kategorizacne-komisie\" target=\"_blank\" rel=\"noreferrer noopener\">the Appraisal Committee<\/a>. <\/li>\n\n\n\n<li>During this period, NIHO communicates with the professional public and patients, as well as with the marketing authorization holder, about\u202fany ambiguities or shortcomings in the\u202f application. NIHO reviews the application and prepares an assessment of the medicine.<\/li>\n\n\n\n<li>NIHO issues its assessment, which is then provided to the Appraisal Committee. NIHO may recommend the technology to be categorised, not categorised or not categorised until the marketing authorisation holder modifies the application (e.g. lowers the cost of the medicine). The marketing authorisation holder may then modify the application.<\/li>\n\n\n\n<li>The Appraisal Committee (consisting of representatives of the professional public, the Ministry of Health, health insurance companies) meets, appraises the materials provided and\u202fissues a recommendation to the Minister. If the Committee departs from the recommendation of NIHO, it issues a publicly available justification.<\/li>\n\n\n\n<li>The Ministry issues a decision. The marketing authorization holder or any other party involved may appeal against it. The appeal is later examined by the Appraisal Board and a recommendation is issued to the Minister. He issues the final decision. The Ministry then enters into negotations of the managed entry agreement.<\/li>\n\n\n\n<li>When a new medicine is introduced, the whole process from the submission until the decision should take 180 days (excluding interruption of the process). For medicines that are already reimbursemented in our country but apply for a change (for example an extension of the indication for a larger patient population), this period is 270 days (excluding interruption of the process).<\/li>\n\n\n\n<li>The reimbursemented medicine is then included in the <a rel=\"noreferrer noopener\" href=\"https:\/\/www.health.gov.sk\/?zoznam-kategorizovanych-liekov\" target=\"_blank\">List of reimbursemented medicines<\/a> and\u202fis reimbursed by health insurance companies. Reimbursement is often limited only to selected diseases and lines of treatment. The list of categorized medicines contains information about the\u202fmedicine, including the price, the reimbursement, or the amount of the patient's co-payment. The list is updated monthly.<\/li>\n<\/ol>\n<\/div>\n\n\n\n<div class=\"wp-block-column o-nas-sidebar is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<div class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\"><nav class=\"is-vertical wp-block-navigation is-layout-flex wp-container-core-navigation-is-layout-fe9cc265 wp-block-navigation-is-layout-flex\" aria-label=\"Navigation\"><ul class=\"wp-block-navigation__container  is-vertical wp-block-navigation\"><li class=\"wp-block-navigation-item has-child wp-block-navigation-submenu\"><a class=\"wp-block-navigation-item__content\" href=\"https:\/\/niho.sk\/en\/niho\/\"><span class=\"wp-block-navigation-item__label\">NIHO<\/span><\/a><ul class=\"wp-block-navigation__submenu-container wp-block-navigation-submenu\"><li class=\"wp-block-navigation-item wp-block-navigation-link\"><a class=\"wp-block-navigation-item__content\"  href=\"https:\/\/niho.sk\/en\/niho\/legislativny-ramec\/\"><span class=\"wp-block-navigation-item__label\">The legislative framework<\/span><\/a><\/li><li class=\"wp-block-navigation-item wp-block-navigation-link\"><a class=\"wp-block-navigation-item__content\"  href=\"https:\/\/niho.sk\/en\/niho-institut\/tim\/\"><span class=\"wp-block-navigation-item__label\">Team<\/span><\/a><\/li><li class=\"wp-block-navigation-item wp-block-navigation-link\"><a class=\"wp-block-navigation-item__content\"  href=\"https:\/\/niho.sk\/en\/niho-institut\/organy-institutu\/\"><span class=\"wp-block-navigation-item__label\">Bodies of the Institute<\/span><\/a><\/li><\/ul><\/li><li class=\"wp-block-navigation-item wp-block-navigation-link\"><a class=\"wp-block-navigation-item__content\"  href=\"https:\/\/niho.sk\/en\/co-je-hta\/\"><span class=\"wp-block-navigation-item__label\">What is HTA<\/span><\/a><\/li><li class=\"wp-block-navigation-item has-child wp-block-navigation-submenu\"><a class=\"wp-block-navigation-item__content\"><span class=\"wp-block-navigation-item__label\">Task of NIHO<\/span><\/a><ul class=\"wp-block-navigation__submenu-container wp-block-navigation-submenu\"><li class=\"wp-block-navigation-item wp-block-navigation-link\"><a class=\"wp-block-navigation-item__content\"  href=\"https:\/\/niho.sk\/en\/ako-funguje-system-na-slovensku\/\"><span class=\"wp-block-navigation-item__label\">How does the system of health technology reimbursement work in Slovakia?<\/span><\/a><\/li><li class=\"wp-block-navigation-item wp-block-navigation-link\"><a class=\"wp-block-navigation-item__content\"  href=\"https:\/\/niho.sk\/en\/ulohy-niho\/hlavna-uloha-a-dalsie-ulohy-niho\/\"><span class=\"wp-block-navigation-item__label\">The main task and future tasks of NIHO<\/span><\/a><\/li><\/ul><\/li><li class=\"wp-block-navigation-item wp-block-navigation-link\"><a class=\"wp-block-navigation-item__content\"  href=\"https:\/\/niho.sk\/en\/pracovna-metoda\/\"><span class=\"wp-block-navigation-item__label\">Methods<\/span><\/a><\/li><li class=\"wp-block-navigation-item wp-block-navigation-link\"><a class=\"wp-block-navigation-item__content\"  href=\"https:\/\/niho.sk\/en\/partnerske-organizacie\/\"><span class=\"wp-block-navigation-item__label\">Partner organizations<\/span><\/a><\/li><\/ul><\/nav><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Ako funguje syst\u00e9m na Slovensku? Zdravotn\u00e9 technol\u00f3gie, ktor\u00e9 sa uch\u00e1dzaj\u00fa o&nbsp;vstup do slovensk\u00e9ho syst\u00e9mu, musia prejs\u0165 r\u00f4znymi procesmi posudzovania a schva\u013eovania. Pre r\u00f4zne typy technol\u00f3gi\u00ed existuj\u00fa r\u00f4zne procesy. Lieky prech\u00e1dzaj\u00fa procesom registr\u00e1cie, \u010d\u00edm z\u00edskaj\u00fa povolenie predaja na eur\u00f3pskom \u010di slovenskom trhu. Ich v\u00fdrobcovia m\u00f4\u017eu \u010falej po\u017eiada\u0165 v&nbsp;jednotliv\u00fdch krajin\u00e1ch o&nbsp;kategoriz\u00e1ciu, aby mohli by\u0165 tieto lieky plne [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-129","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/pages\/129","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/comments?post=129"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/pages\/129\/revisions"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=129"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}