Clinical and economic evaluation of the effectiveness of the use of Riociguat for the treatment of patients with inoperable, recurrent or persistent chronic thromboembolic pulmonary hypertension under the conditions of the Republic of Kazakhstan

Abstract

Riociguat is included in international guidelines and local clinical protocols for the treatment of pulmonary hypertension (PH) and chronic thromboembolic pulmonary hypertension (CTEPH), where it is the first choice drug for the treatment of patients with inoperable, persistent and recurrent forms of CTEPH. Therefore, it is necessary to include this drug in the GVoFMC (The Guaranteed Volume of Free Medical Care) reimbursement lists and the CSHI (Compulsory Social Health Insurance) system, which will alleviate access to medication for patients suffering from PH and CTEPH. Purpose of the study. Determination of the cost effectiveness parameters of using riociguat in comparison with bosentan and combined therapy of bosentan/sildenafil in medication therapy of CTEPH. Material and methods. A Markov model of CTEPH dynamics in patients with riociguat prescription was developed in comparison with application of bosentan and sildenafil. Modeling step was 16 weeks, modeling horizon – 10 years. Direct medical costs per patient were taken into account in the model, including the cost of drug therapy, costs of outpatient visits due to CTEPH, hospitalization costs due to clinical deterioration of CTEPH, emergency calls. Results and discussion. The results of “cost-effectiveness” Markov pharmacoeconomic modeling showed that riociguat application reveals a dominant position in comparison with the practice of using bosentan with addition of sildenafil for specific therapy at deterioration of patient's condition up to III-IV functional class (FC). Riociguat is characterized by the best values of “cost effectiveness” coefficients according to efficiency criterion of FC increase and the “value of 6-min walk distance test”. The results of analysis of the impact on budget showed that inclusion of riociguat in GVoFMC/CSHI will lead to budget savings of 154 million tenge in the first year, 294 million tenge in the second year and 415 million tenge in the third year compared to the existing clinical practice without riociguat use. Conclusions. On the basis of conducted complex pharmacoeconomic analysis, the application of riociguat in patients with inoperable or persistent/ recurrent form of CTEPH is a more preferable strategy in comparison with the strategy of application of bosentan with addition of sildenafil and will allow to reduce budget expenses within the framework of GVoFMC and CSHI system. Keywords: pulmonary hypertension, chronic thromboembolic pulmonary hypertension, riociguat.