title: [The evaluation of cost-effectiveness and cost-utility of valganciclovir for the prophylaxis of cytomegalovirus disease to 200 days after kidney transplantation].
abstract: Standard procedure for cytomegalovirus disease (CMV) prophylaxis in kidney transplant patients was the administration of valganciclovir for up to 110 days after organ transplant. This prophylaxis has been extended up to 200 days in Poland since 2011. The decision was based on the results of clinical trials which showed significant clinical benefit in case of prolonged administration of the drug. The aim of the analysis was to provide the economic evaluation of extending the CMV prophylaxis with co-financed from public funds Valcyte (valganciclovirum; 60 tab. a 450 mg; Roche Polska Sp. z o.o.) from 110 to 200 days, in the high risk patients group after kidney transplant (seronegative recipient and infected donor, D+/R-). The analysis was performed from the Polish healthcare payer's perspective.
  
  
  METHODS
  All methods used in the following study were consistent with the Requirements of the Polish HTA Agency (AHTAPOL). The cost-effectiveness and the cost-utility analysis were performed on the basis of a randomised study which was identified as a result of the systematic search of the medical databases, comparing 200 days valgancyclovir administration with 100 days drug use as a prophylaxis of CMV disease in the patients group mentioned above. The Markov model was developed, simulating the disease evolution over time considering a high risk patient after kidney transplant treated with valgancicloviras the CMV disease prophylaxis. The disease period was divided into health states that are the most probable for this condition and the transitions probabilities between them were identified and assigned. Based on the clinical trial results, registry database of health conditions usability and experts' opinion, all health states (i.e. death, kidney transplant, CMV disease) were attributed with utilities and costs. The direct costs, important from the Polish healthcare payer's perspective, were included in the analysis. Extension of the proposed model in the series of one month time cycles made it possible to assess long-term (assumed time horizon was median patient's life expectancy--23,5 years) costs and clinical effects of the compared technologies.
  
  
  RESULTS
  The Incremental Cost-Effectiveness Ratio (ICER) was 39 669 008 PLN and The Incremental Cost-Utility Ratio (ICUR) was 48 008 PLN in the specified time horizon. The result is well below the accepted threshold of profitability in Poland (assuming tripled GDP per capita cost-utility threshold, i.e. 99 543 PLN), which means that the therapy is cost-effective.
  
  
  CONCLUSIONS
  The results of the analysis confirmed that the 200 days use of valganciclovirin the prevention of CMV disease compared to standard 110 days therapy is economically justified from the Polish healthcare payer's perspective.
authors.affiliation: Uniwersytet Jagielloński w Krakowie, Zakład Gospodarki Lekiem, Instytut Zdrowia Publicznego, Wydział Nauk o Zdrowiu. pawel.kawalec@uj.edu.pl
authors.forename: Paweł
authors.initials: P
authors.lastname: Kawalec
authors.forename: Przemysław
authors.initials: P
authors.lastname: Holko
authors.forename: Monika
authors.initials: M
authors.lastname: Szkultecka-Debek
authors.forename: Anna
authors.initials: A
authors.lastname: Paszulewicz
authors.forename: Maria
authors.initials: M
authors.lastname: Boratyńska
authors.forename: Maciej
authors.initials: M
authors.lastname: Głyda
authors.forename: Ewa
authors.initials: E
authors.lastname: Ignacak
authors.forename: Justyna
authors.initials: J
authors.lastname: Maks
authors.forename: Monika
authors.initials: M
authors.lastname: Russel-Szymczyk
authors.forename: Aneta
authors.initials: A
authors.lastname: Kaweczyńska-Lasoń
mesh_terms: D000998:Antiviral Agents / Q000191:economics* / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D003586:Cytomegalovirus Infections / Q000191:economics / Q000209:etiology / Q000517:prevention & control*; D015774:Ganciclovir / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D006801:Humans; D016030:Kidney Transplantation / Q000009:adverse effects*; D008390:Markov Chains; D015233:Models, Statistical; D011044:Poland; D019057:Quality-Adjusted Life Years; D000077562:Valganciclovir; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D000077562:Valganciclovir; D015774:Ganciclovir