How does the system of health technology reimbursement work in Slovakia?
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.
Medicines undergo a marketing 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.
Medical devices (incl. medical aids, such as crutches and special medical supplies, such as implants) or dietetic foods pomôcky, špeciálny zdravotnícky materiál alebo dietetické potraviny also undergo the registration and categorization 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.
Medical technologies also include other devices (such as MRI scanners), health care services, or medical procedures. 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 continuously 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.
Several organizations play a role in the system of assessment and approval of medicines, equipment and dietetic foods:
- The marketing authorisation holder (e.g. a pharmaceutical company) owns the rights to sell the medicine, medical equipment (ME), specialized medical supplies (SMS) or dietetic food (DF) and submits an application for their categorization.
- The European Medicines Agency (EMA)/ State Institute for Drug Control (SIDC) performs quality control, surveillance, registration and record keeping of medicinal products and medical equipment.
- The Ministry of Health of the Slovak Republic (MoH SR) prijíma žiadosť od držiteľa registrácie a zastrešuje proces kategorizácie. Na základe hodnotenia uzatvára s držiteľom registrácie zmluvu o podmienkach úhrady lieku.
- The Pharmacy and Drug Policy Department at the Ministry of Health (PDPD MH SR) issues statements and assessments on categorization applications of medicines, ME, SMS, DF for the Appraisal Committee.
- „NIHO vydáva komplexné hodnotenia technológií na základe žiadostí o kategorizáciu u liekov, ZdP, DP s čístým dopadom na rozpočet nad cca 1,5 mil. eur. NIHO spolu so SFLP si každý mesiac pomenuje ktoré technológie majú očakávaný čistý dopad nad cca 1,5 mil. eur. Pri akýchkoľvek pochybnostiach spradá hodnotenie pod NIHO. Komisia musí odôvodniť odklonenie sa od odporúčania NIHO.
- Based on the delivered evaluations and assessments, the Appraisal Committee of MH SR issues a recommendation to the Minister of Health.
- V procese appeal sa niektorý z účastníkov konania môže odvolať voči prvostupňovému rozhodnutiu, odvolanie posúdi Appraisal Board, which will issue a recommendation to the minister. The minister issues a decision or returns the submission for reconsideration back to the Committee.
- The Minister of Health decides (on behalf of the Ministry) on the basis of the recommendation of the Appraisal Committee.
- Health insurance companies cover technologies in the amount approved in the categorization process (or cover them under an exceptional reimbursement regime upon consideration of an individual patient’s application)
For a better explanation, a more detailed example on medicines is provided, since their assessment constitutes a significant amount of work of NIHO:
What does it mean when a medicine is registered?
This means that the EMA, or in some cases the SIDC in Slovakia, has recognized it as suitable for use in Europe or Slovakia. To do so, the medicine must meet quality, efficacy, and safety requirements and demonstrate that it has an effect compared to placebo or standard technology.
This does not mean that it automatically reimbursed by health insurance companies. However, a physician may prescribe it and the patient may pay the full amount (if it is not categorized) or it might be a type of a medicine that is used and purchased by hospitals. The price of the medicine does not play any role in the registration.
What does it mean when a medicine is categorized?
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 managed 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 co-payment.
How does the reimbursement process of a medicine look like?
(a detailed description of the process is given in Act No. 363/2011 Coll.)
- The marketing authorization holder (a pharmaceutical company) submits a categorization application on the medicines reimbursement website..
- PDPD and NIHO (within 130 days excluding interruption to the process) prepare assessments and recommendations for the Appraisal Committee. NIHO focuses on applications of medicines with an annual budget impact above about 1.5 million euros (depending on the development of the average wage in the economy), PDPD assesses all the other applications.
- During this period, NIHO communicates with the professional public and patients, as well as with the marketing authorization holder, about any ambiguities or shortcomings in the application. NIHO reviews the application and prepares an assessment of the medicine.
- PDPD and NIHO issue their assessments. Later they are sent to the Appraisal Committee. NIHO may recommend that the technology should be categorized, not categorized or not categorized until the marketing authorization holder modifies the application (e.g. the required reimbursement for the medicine or indication limitation). The marketing authorization holder may subsequently modify the application.
- The Appraisal Committee (consisting of representatives of the professional public, the Ministry of Health, health insurance companies) meets, appraises the materials provided and issues a recommendation to the Minister. If the Committee departs from the recommendation of NIHO, it issues a publicly available justification.
- 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.
- 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).
- The reimbursemented medicine is then included in the List of reimbursemented medicines and is 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 medicine, including the price, the reimbursement, or the amount of the patient's co-payment. The list is updated monthly.