Cost-effectiveness analysis of active psoriatic arthritis treatment with ixekizumab in adult patients in Russian Federation health care system

Objective: to evaluate the economic impact of the use of various biologic disease-modifying antirheumatic drugs (bDMARDs) from the group of inhibitors of interleukins (iIL) 12/23 and iIL17 in adult patients with psoriatic arthritis (PsA) with insufficient response to therapy with TNFα inhibitors (TNFα inhibitors).

Patients and methods. A Microsoft Excel model has been developed, it allows to calculate the average cost of treatment of 1 patient with PsA who needs a second-line bDMARD from the iIL12/23 or iIL17 group. Only direct medical costs (drug costs) were considered. Cost minimization analysis and budget impact analysis were carried out.

Results and discussion. The results of a network meta-analysis demonstrate no statistically significant differences in efficacy and safety between ixekizumab (IXE) and secukinumab (SEC) and superiority SEC over ustekinumab when used in adult patients with active PsA with insufficient response to or intolerance of previous therapy with synthetic disease-modifying antirheumatic drugs or TNFα inhibitors. The analysis of cost minimization showed that the total cost of 1 patient managing for 1 year using IXE is 26% lower than treatment with SEC: on a 2 year horizon, the difference is 27%. Analysis of the impact on the budget revealed that on the horizon of 1 year the simulated distribution will lead to budget savings of 16,796,131 rubles, which will allow additional treatment of 17 patients with IXE, after 2 years the budget savings will amount to 39,289,373 rubles, which will allow to treat additionally 52 patients. The sensitivity analysis confirmed the robustness of the study results.

Conclusion. Thus, in adult patients with PsA requiring second-line bDMARDs, the use of IXE is more effective than the use of SEC and provides reduction in direct medical costs. The use of IXE will not have a significant impact on costs under the State Guarantee Program, but it can increase the availability of bDMARDs in patients with active PsA who have not responded to the previous therapy, without increasing the budget.

1. Korotaeva TV, Korsakova YuL, Loginova EYu, et al. Psoriatic arthritis. Clinical guidelines for diagnosis and treatment. Sovremennaya revmatologiya = Modern Rheumatology Journal. 2018;12(2):22–35. (In Russ.). doi: 10.14412/1996-7012-2018-2-22-35

2. Statistical collection «General morbidity of the adult population of Russia in 2017». https://www.rosminzdrav.ru/ministry/61/22/stranitsa-979/statisticheskie-i-informatsionnyematerialy/statisticheskiy-sbornik-2017-god

3. Statistical collection «Morbidity of the entire population of Russia in 2017». https://www.rosminzdrav.ru/ministry/61/22/stranitsa-979/statisticheskie-i-informatsionnyematerialy/statisticheskiy-sbornik-2017-god

4. Statistical collection «Morbidity of the adult population of Russia in 2017». https://www.rosminzdrav.ru/ministry/61/22/stranitsa-979/statisticheskie-i-informatsionnyematerialy/statisticheskiy-sbornik-2017-god

5. Lila AM, Nasonov EL, Korotaeva TV. Psoriatic arthritis: pathogenetic features and innovative methods of therapy. Nauchnoprakticheskaya revmatologiya. 2018;56(6): 685-91. (In Russ.).

6. State Register of Medicines. https://grls.rosminzdrav.ru/

7. Korotaeva TV. New possibilities of GIBP in the treatment of psoriatic arthritis: focus on ixekizumab. Opinion Leader. 2019;(9):60-6. (In Russ.).

8. Government Order № 3073-r of November 23, 2020 «On approval of the list of vital and essential drugs for medical use for 2021, the list of drugs for medical use, including drugs for medical use, prescribed by decision medical commissions of medical organizations, a list of drugs intended to provide people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, as well as the minimum range of drugs required for the provision of medical care». http://static.government.ru/media/files/XSa8p7I5b5HKbAYd2xmfvVzBsosxagSe.pdf

9. Decree of the Government of the Russian Federation №1610 of December 7, 2019 «On the Program of State guarantees of free provision of medical care to citizens for 2020 and for the planning period of 2021 and 2022». https://tyumen.ldc.ru/userfiles/public/postanovlenie-1610.pdfhttps://tyumen.ldc.ru/userfiles/public/postanovlenie-1610.pdf

10. Korotaeva TV, Korsakova YuL, Loginova EYu, et al. Optimizing the diagnosis, a monitoring and treatment system for psoriatic arthritis in real practice: general principles for organizing an All-Russian register of patients with psoriatic arthritis. Nauchno-Prakticheskaya Revmatologiya. 2019;57(4):407-14 (In Russ.). doi: 10.14412/1995-4484-2019-407-414

11. State Register of Medicines. Instructions for the medical use of the drug Tals. https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=c819bbb6-be51-4ff5-9344-050d1084f6a1&t=

12. National Institute for Health and Care Excellence. Ixekizumab for treating active psoriatic arthritis after inadequate response to DMARDs. [TA537]. https://www.nice.org.uk/guidance/ta537

13. Minutes of the Meeting of the profile commission of the Expert Council of the Ministry of Health of the Russian Federation on the specialty «Rheumatology» №23 dated September 28, 2019 Nauchno-prakticheskaya revmatologiya. 2019;57(5):604-7. (In Russ.).

14. Methodical recommendations for conducting a comparative clinical and economic assessment of a medicinal product, approved by order of the Federal State Budgetary Institution «Center for examination and quality control of medical care» of the Ministry of Health of Russia dated December 29, 2018 №242-od. https://rosmedex.ru/hta/recom/

15. Methodological recommendations for assessing the impact on the budget within the framework of the implementation of the program of state guarantees of free provision of medical care to citizens, approved by order of the Federal State Budgetary Institution «Center for examination and quality control of medical care» of the Ministry of Health of Russia dated December 29, 2018 №242-od. https://rosmedex.ru/hta/recom/

16. Wu D, Yue J, Tam LS. Efficacy and safety of biologics targeting interleukin-6,-12/23 and-17 pathways for peripheral psoriatic arthritis: a network meta-analysis. Rheumatology (Oxford). 2018 Mar 1;57(3):563-71. doi: 10.1093/rheumatology/kex452.

17. Rebrova Oyu, Fedyaeva VK. Questionnaire for assessing the reliability of network metaanalysis (including indirect and mixed comparisons). Meditsinskie tekhnologii. Otsenka i vybor. 2016;(2):48-54. (In Russ.).

18. Jansen JP, Trikalinos T, Cappelleri JC, et al. Indirect treatment comparison/network meta-analysis study questionnaire to assess relevance and credibility to inform health care decision-making: an ISPOR-AMCP-NPC Good Practice Task Force report. Value Health. 2014 Mar;17(2):157-73. doi: 10.1016/j.jval.2014.01.004.

19. Data limits wholesale premiums and limits retail markups to the prices for vital and essential pharmaceuticals established in constituent entities of the Russian Federation (data of February 10, 2020). https://fas.gov.ru/documents/686367

20. Estimation of the resident population as of January 1, 2020 and on average for 2019. Federal State Statistics Service. http://www.gks.ru/free_doc/new_site/population/demo/Popul2020.xls

21. Instructions for use of the medicinal product for medical use of Cosentics (secukinumab). https://grls.rosminzdrav.ru/GRLS.aspx

22. Instructions for the use of the drug for medical use Stelara (ustekinumab). https://grls.rosminzdrav.ru/GRLS.aspx

23. Walpole SC, Prieto-Merino D, Edwards P, et al. The weight of nations: an estimation of adult human biomass. BMC Public Health. 2012 Jun 18;12:439. doi: 10.1186/1471-2458-12-439.

24. Lila AM, Dreval' RO, Shipitsyn VV. Assessment of organization of medical care and drug provision for patients with rheumatic diseases, and the socioeconomic burden of these diseases in the Russian Federation. Sovremennaya revmatologiya = Modern Rheumatology Journal. 2018;12(3):112–9. (In Russ.) doi: 10.14412/1996-7012-2018-3-112-119