Návrh na zaradenie pripočítateľnej položky - podanie lieku Paxlovid (nirmaterlvir/ritonavir)

Organisation: KLinika pneumológie, ftizeológie a funkčnej diagnostiky LF SZU a UN Bratislava

Created at: 26.03.2025

Processed at: 07.04.2026

Question

Nirmatrelvir/ritonavir is indicated for the treatment of adults with coronavirus 2019 (COVID-19) whose condition does not require supportive oxygen therapy and who are at increased risk of progression to severe COVID-19 disease.(1) Administration of nirmatrelvir/ritonavir is not currently included in either the list of covered medical procedures or the list of covered items. COVID-19 disease is caused by the SARS-CoV-2 RNA coronavirus, which is transmitted by infected droplets produced when coughing, sneezing, or talking, and carried up to 2 meters (2). Symptoms in each patient can vary in severity, ranging from an asymptomatic phase with no symptoms to a critical phase when respiratory failure, septic shock, or multiorgan failure is imminent (3). The patient's condition may change at any time in terms of the severity of the course. SARS-CoV-2 virus attacks a wide range of cells and tissues in the host body, but is most active in the upper and lower respiratory tract (4). The most affected organ is the lung because its alveolar cells have an angiotensin-converting enzyme 2 (ACE2) receptor on their surface, to which the viral 'spike' glycoprotein has a high affinity.(5) At present, we do not have accurate data on the prevalence of COVID-19 in Slovakia, as monitoring of the evolution of the number of cases has been considerably limited in comparison with the pandemic period. (6) At the same time, the regional public health authority publishes weekly statistics on the incidence of COVID-19, but these figures do not reflect all cases, as not every positive test for COVID-19 is currently reported. However, in recent years, we have observed seasonality of the disease, with it occurring mainly in the fall and winter seasons. (7) Effective primary prevention and early treatment options are key components for reducing transmission, progression of the disease to a severe state, reducing the burden on the health care system, and reducing the high mortality that has been attributed to COVID-19 (3, 8, 9). Despite the availability, safety, and efficacy of vaccination, many individuals could not and cannot undergo this prophylaxis for a variety of reasons. At the same time, even for vaccinated individuals, the risk of vaccine failure (breakthrough infection), decreased efficacy over time and new mutations of the virus, and cases of reinfection still necessitate the availability of effective treatment options for COVID-19 (10, 11, 12). Early administration of antiviral agents is also an important component of effective prevention of disease progression to severe disease.(10) Currently, two drugs are approved by the European Medicines Agency for the treatment of COVID-19 - nirmatrelvir/ritonavir (p.o.) and remdesvir (i.v.). The need for hospitalisation and possible artificial lung ventilation or ICU placement places a significant burden on the patient, but also on the healthcare system. Treatment that can be given orally to patients has the potential to significantly reduce the burden not only for patients but also for healthcare facilities. Nirmatrelvir/ritonavir is primarily intended for outpatient use as it is not intended for patients requiring oxygen supplementation and has an oral route of administration. (1) However, there is a small group of patients who are hospitalized for another reason and infection with COVID-19 occurs during hospitalization. This group of patients, along with those who are contraindicated for parenteral administration of remdesvir, are the patients who benefit from the option of administering the oral antiviral nirmatrelvir/ritonavir. References. Paxlovide Summary of Product Characteristics. Date of approval of the latest version: 14 February 2025. Available at: Paxlovid, INN-nirmatrelvir + ritonavir 2. CDC. Coronavirus Disease 2019 (COVID-19). 2025. Available at: https://www.cdc.gov/coronavirus/2019-ncov/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Ffaq.html. 3. NIH. COVID-19 Treatment Guidelines. 2025. Available at: Coronavirus Disease 2019 (COVID-19) Treatment Guidelines 4. Harrison AG, Lin T, Wang P. Mechanisms of SARS-CoV-2 Transmission and Pathogenesis. Trends Immunol. 2020 Dec;41(12):1100-15. PubMed PMID: 33132005. PMCID: PMC7556779. Epub 20201014. eng. 5. Verdecchia P, Cavallini C, Spanevello A, Angeli F. The pivotal link between ACE2 deficiency and SARS-CoV-2 infection. Eur J Intern Med. 2020 Jun;76:14-20. PubMed PMID: 32336612. PMCID: PMC7167588. Epub 20200420. eng. 6. Number of hospitalizations with COVID-19. 2025. Available at: | covid-19 Report 7. Office of Public Health.Slovak Republic. COVID-19 and beyond. Available at: COVID-19 and beyond 8. WHO. WHO Coronavirus (COVID-19) Dashboard - Situation by Region, Country, Territory & Area. 2023. Available at: https://covid19.who.int/table. 9. Phannajit J, Takkavatakarn K, Katavetin P, Asawavichienjinda T, Tungsanga K, Praditpornsilpa K, et al. Factors Associated with the Incidence and Mortality of Coronavirus Disease 2019 (COVID-19) after 126-million Cases: A Meta-analysis. J Epidemiol Glob Health. 2021 Sep;11(3):289-95. PubMed PMID: 34270185. PMCID: PMC8435869. Epub 20210614. eng. 10. Rahmah L, Abarikwu SO, Arero AG, Essouma M, Jibril AT, Fal A, et al. Oral antiviral treatments for COVID-19: opportunities and challenges. Pharmacological Reports. 2022 2022/12/01;74(6):1255-78. 11. Hacisuleyman E, Hale C, Saito Y, Blachere NE, Bergh M, Conlon EG, et al. Vaccine Breakthrough Infections with SARS-CoV-2 Variants. New England Journal of Medicine. 2021 2021/06/10;384(23):2212-8. 12. The Lancet Infectious D. Unmet need for COVID-19 therapies in community settings. The Lancet Infectious Diseases. 2021;21(11):1471.

We propose the inclusion of oral administration of nirmatrelvir+ritonavir in the List of Creditable Items - due to: - the indication of Paxlovid (nirmatrelvir+ritonavir) for the treatment of coronavirus 2019 (COVID-19) disease, whose condition does not require supportive oxygen therapy, and who are at increased risk of progression to severe COVID-19 disease in adult patients, - the limited number of patients treated, - the financial complexity of the medicine (reimbursement per hospital case does not cover the cost of provision and purchase of the medicine), - full reimbursement of the medicine in the Categorised List of Medicines, - equal access to other medicines indicated for the treatment of COVID-19 and already included in the Schedule of Creditable Items [remdezivir (Veclaura)]. We propose to include the administration of Paxlovid (nirmatrelvir+ritonavir) in the List of Creditable Items in the same breakdown as the administration of the drug in the List of Medical Procedures: administration of nirmatrelvir+ritonavir, oral in the indication limitation: 300 mg + 100 mg Administration of nirmatrelvir+ritonavir, oral in the indication limitation: 600 mg + 200 mg Administration of nirmatrelvir+ritonavir, oral in the indication limitation: 900 mg + 300 mg Administration of nirmatrelvir+ritonavir, oral in the indication limitation: 1200 mg + 400 mg Administration of nirmatrelvir+ritonavir, oral in indication limitation: 1500 mg + 500 mg Administration of nirmatrelvir+ritonavir, oral in indication limitation: 1800 mg + 600 mg Administration of nirmatrelvir+ritonavir, oral in indication limitation: 2100 mg + 700 mg Administration of nirmatrelvir+ritonavir, oral in the indication limitation: 2400 mg + 800 mg Administration of nirmatrelvir+ritonavir, oral in the indication limitation: 2700 mg + 900 mg Administration of nirmatrelvir+ritonavir, oral in the indication limitation: 3000 mg + 1000 mg

Answer

That request has been reassessed in accordance with Chapter 8 of the Methodology for Updating Attributable Items for SK-DRG 2026, available here: https://www.cksdrg.sk/sk/dokumenty/568/Metodika%20aktualizácie%20pripočítateľných%20položiek%20pre%20SK-DRG%202026.pdf

Due to the failure to meet the criteria, the Medical Analysis Working Group proceeded to a vote, which is recorded in the minutes available here: https://www.cksdrg.sk/sk/dokumenty/571/Zápisy%20z%20rokovaní%20medicínsko-analytickej%20pracovnej%20skupiny%20s%20hlasovaniami.pdf , whereby the Working Group rejected the proposed PP as it is a medicine that can also be administered in an outpatient form and at the time of the evaluation of the submission - summer 2025 - had not gone through the legal process of categorisation of the medicine, so it does not meet the criteria of the methodology as outlined above.