[The evaluation of cost-effectiveness and cost-utility of valganciclovir for the
prophylaxis of cytomegalovirus disease to 200 days after kidney transplantation]. [Article in Polish]
Author(s): Kawalec P(1), Holko P, Szkultecka-Debek M, Paszulewicz A, Boratyńska M, Głyda M,
Ignacak E, Maks J, Russel-Szymczyk M, Kaweczyńska-Lasoń A.
Affiliation(s): Author information:
(1)Uniwersytet Jagielloński w Krakowie, Zakład Gospodarki Lekiem, Instytut Zdrowia
Publicznego, Wydział Nauk o Zdrowiu. pawel.kawalec@uj.edu.pl
Publication date & source: 2013, Pol Merkur Lekarski. , 34(204):332-8
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.MATERIAL AND 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.
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