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

Authors

  • Andrey V AVDEYEV Medical Center Hospital of the President’s Affairs Administration of the Republic of Kazakhstan
  • Murat A MUKAROV National Research Cardiac Surgery Center
  • Sabira К ZHAUGASHEVA Karaganda Medical University
  • Lubov I  PIVEN Karaganda Medical University
  • Tatyana V KIM Karaganda Medical University

DOI:

https://doi.org/10.31082/1728-452X-2020-213-214-3-4-8-16

Keywords:

pulmonary hypertension, chronic thromboembolic pulmonary hypertension, riociguat

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.

References

Chazova IE, Martynyuk TV, Valieva ZS, et al. Clinical recommendations for the diagnosis and treatment of pulmonary hypertension // Eurasian Association of Cardiology. – Moscow. 2019. 98 p. Available from: http://cardio-eur.asia/media/files/clinical_recommendations/Klinicheskiye_rekomendatsii_Yevraziyskoy_assotsiatsii_kardiologov_po_diagnostike_i_lecheniyu_legochnoy_gipertenzii_2019. pdf

Bekbosynova MS, Mukarov MA, Mukatova IYu, Makalkina LG. Klinicheskii protokol diagnostiki i lecheniia «Legochnaia gipertenziia» // Odobren Obieedinennoi komissiei po kachestvu meditsinskikh uslug MZ RK, protokol № 66 ot 16.05.2019 g. – 43 s. [Clinical protocol for diagnosis and treatment “Pulmonary Hypertension” // Approved by the Joint Commission for the Quality of Medical Services of the Ministry of Health of the Republic of Kazakhstan, protocol No. 66 dated 05/16/2019. – 43 p.]

Galie N, Humbert M, Vachiery JL, et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). Eur Heart J. 2016;37(1):67-119. doi: 10.1093/eurheartj/ehv317

Simonneau G, Gatzoulis MA, Adatia I, et al. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2013;62(25):D34-D41. doi: 10.1016/j.jacc.2013.10.029

Lang IM, Dorfmüller P, Vonk Noordegraaf A. The pathobiology of chronic thromboembolic pulmonary hypertension. Ann Am Thorac Soc. 2016;13(3):S215-S221. doi: 10.1513/AnnalsATS.201509-620AS

Mathai SC, Ghofrani HA, Mayer E, Pepke-Zaba J, Nikkho S, Simonneau G. Quality of life in patients with chronic thromboembolic pulmonary hypertension. Eur Respir J. 2016;48(2):526-537. doi: 10.1183/13993003.01626-2015

Pepke-Zaba J, Delcroix M, Lang I, et al. Chronic thromboembolic pulmonary hypertension (CTEPH): results from an international prospective registry. Circulation. 2011;124(18):1973-1981. doi: 10.1161/CIRCULATIONAHA.110.015008

Kim NH, Delcroix M, Jenkins DP, et al. Chronic thromboembolic pulmonary hypertension. J Am Coll Cardiol. 2013;62(25):D92-D99. doi: 10.1016/j.jacc.2013.10.024

Lang IM, Simonneau G, Pepke-Zaba JW, et al. Factors associated with diagnosis and operability of chronic thromboembolic pulmonary hypertension: a case-control study. Thromb Haemost. 2013;110(1):83-91. doi: 10.1160/TH13-02-0097

Gall H, Hoeper MM, Richter MJ, Cacheris W, Hinzmann B, Mayer E. An epidemiological analysis of the burden of chronic thromboembolic pulmonary hypertension in the USA, Europe and Japan. Eur Respir Rev. 2017;26 (143):Pii 160121. doi: 10.1183/16000617.0121-2016

Fernandes T, Auger W, Fedullo P. Epidemiology and risk factors for chronic thromboembolic pulmonary hypertension. Thromb Res. 2018;164:145-149. doi: 10.1016/j.thromres.2018.01.012

Ghofrani HA, D'Armini AM, Grimminger F, et al. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013;369(4):319-329. doi: 10.1056/NEJMoa1209657

Simonneau G, D'Armini AM, Ghofrani HA, et. al. Predictors of long-term outcomes in patients treated with riociguat for chronic thromboembolic pulmonary hypertension: data from the CHEST-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016;4(5):372-380. doi: 10.1016/S2213-2600(16)30022-4

Olschewski H, Behr J, Bremer H, et. al. Pulmonary hypertension due to lung diseases: Updated recommendations from the Cologne Consensus Conference 2018. Int J Cardiol. 2018;272S:63-68. doi: 10.1016/j.ijcard.2018.08.043

Barberà JA, Román A, Gómez-Sánchez MÁ, et al. Guidelines on the Diagnosis and Treatment of Pulmonary Hypertension: Summary of Recommendations. Arch Bronconeumol. 2018;54(4):205-215. doi: 10.1016/j.arbres.2017.11.014

Zhonghua Xin Xue Guan Bing Za Zhi, working Group on Pulmonary Vascular Diseases of Chinese Society of Cardiology of Chinese Medical Association. Chinese guidelines for the diagnosis and treatment of pulmonary hypertension. Chinese Journal of Cardiology. 2018;46(12):933-964. doi: 10.3760/cma.j.issn.0253-3758.2018.12.006

Abzaliev KB, Mukarov MA, Smagulov NK, Kalieva ShS. Klinicheskii protokol diagnostiki i lecheniia «Khronicheskaia posttromboembolicheskaia legochnaia gipertenziia» // Odobren obieedinennoi komissiei po kachestvu meditsinskikh uslug MZ SR RK, protokol № 6 ot 28.06.2016 g. – 44 str. [Clinical protocol for the diagnosis and treatment “Chronic post-thromboembolic pulmonary hypertension” // Approved by the Joint Commission on the Quality of Medical Services of the Ministry of Health and Social Development of the Republic of Kazakhstan, protocol No. 6 dated 06/28/2016. 44 p.]

Wilkens H, Konstantinides S, Lang IM, et al. Chronic thromboembolic pulmonary hypertension (CTEPH): Updated Recommendations from the Cologne Consensus Conference 2018. Int J Cardiol. 2018;272S:69-78. doi: 10.1016/j.ijcard.2018.08.079

Jaïs X, D'Armini AM, Jansa P, et al. Effects in inoperable Forms of chronic Thromboembolic pulmonary hypertension Study Group. Bosentan for treatment of inoperable chronic thromboembolic pulmonary hypertension: BENEFIT (Bosentan Effects in inoperable Forms of chronic Thromboembolic pulmonary hypertension), a randomized, placebo-controlled tria. J Am Coll Cardiol. 2008;52 (25):2127-2134. doi: 10.1016/j.jacc.2008.08.059

Suntharalingam J, Treacy CM, Doughty NJ, et al. Long-term use of sildenafil in inoperable chronic thromboembolic pulmonary hypertension. Chest. 2008;134(2):229-236. doi: 10.1378/chest.07-2681

Published

2020-04-07

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