Pharmacoeconomic assessment of antipsychotic treatment in outpatients with schizophrenia

The aim: to provide a comprehensive pharmacoeconomic evaluation of the antipsychotic maintenance therapy in outpatients diagnosed with schizophrenia.

Materials and methods. The analysis was conducted in two mutually complementary stages: an epidemiological study on the management of outpatients with schizophrenia, and a  subsequent pharmacoeconomic modeling. Two medical technologies were evaluated and  compared: treatment with classical antipsychotics (CA) and treatment with atypical  antipsychotics (AA). Based on a retrospective study of patients’ medical records, we selected the  parameters to be used in the clinical and economic analysis of these treatments. Direct and indirect costs were taken into account to perform the cost-effectiveness analysis,  incremental analysis, and «budget impact» analysis.

Results. We determined the costs of managing of outpatients with schizophrenia in relation to the health budget and in relation to the social burdens; the appropriateness and effectiveness of  the present costs was analyzed for different time intervals – 6, 12 and 24 months. As shown, the treatment strategies involving AA were more budget-consumptive than the CA treatments. If the  treatments were switched to the reproduced AA (up to 100% replacement of reference  medications), the costs would remain to be higher than those for the CA. The «costeffectiveness » analysis related to «the proportion of stable patients» for the horizons of 6  and 12 months indicated that the reproduced AA would be more economically effective than the  CA. However, when the observation period is increased to 24 months, this economic advantage of AA disappears, and the CA drugs have a lower CER instead. For the «number of  hospitalization-free days per year», the use of AA was more cost-effective only versus the 100% use of reproduced AA at the simulated horizon of 12 months. When estimated for the use of 100% reference AA or the combined reference + reproduced AA, the treatment with CA  remained more economically effective, regardless of the simulated period.

Conclusion. The pharmacoeconomic simulation of the antipsychotic therapy in outpatients with schizophrenia suggests the ways of treatment optimization. Among them, using AA for the  treatment of at least 15.6% of patients (those who are employed); keeping the ≥60% use of CA  to ensure the optimal resource-saving effect of the treatment; using reproduced AA at the level  of ≥70% (instead of the reference AA similar in efficacy and safety) to keep the treatment economically justified.

1. Krasnov V. N., Gurovich I. Ya. Clinical guidelines: models for the diagnosis and treatment of mental and behavioural disorders [Klinicheskoe rukovodstvo: Modeli diagnostiki i lecheniya psikhicheskikh i povedencheskikh rasstroistv (in Russian)]. Moscow. 1999; 224 s.

2. Mosolov S. N., Kalinin V. V., Eremin A. V. Comparative effectiveness and tolerance of a new generation of antipsychotics in the treatment of exacerbations of schizophrenia. New achievements in the treatment of mental illness [Sravnitel’naya effektivnost’ i perenosimost’ novogo pokoleniya antipsikhoticheskikh sredstv pri lechenii obostrenii shizofrenii. Novye dostizheniya v terapii psikhicheskikh zabolevanii (in Russian)]. Moscow. 2002; 82-94.

3. Krasnov V. N., Gurovich I. Ya., Mosolov S. N., Shmukler A. B. Psychiatric care for schizophrenia patients. Clinical guideline [Psikhiatricheskaya pomoshch’ bol’nym shizofreniei. Klinicheskoe rukovodstvo (in Russian)]. Moscow. 2007; 260 s.

4. Gurovich I. Ya., Lyubov E. B. Pharmacoepidemiology and pharmacoeconomics in psychiatry [Farmakoepidemiologiya i farmakoekonomika v psikhiatrii (in Russian)]. Moscow. 2003; 264 s.

5. Gurovich I. Ya., Lyubov E. B., Kozyrev V. N. et al. Sotsial’naya i klinicheskaya psikhiatriya (in Russian). 2002; 12 (3): 46-55.

6. Rise D. P. Economic burden of mental disorders in the USA. Econom.Neurosc. 1999; I: 40-44.

7. Yastrebov V. S., Solokhina T. A., Shevchenko L. S., Mitikhin V. G., Tvorogova N. A., Khar’kova T. L. Sotsial’naya i klinicheskaya psikhitariya (in Russian). 2009; 19 (4): 21-28.

8. Lyubov E. B. Sotsial’naya i klinicheskaya psikhitariya (in Russian). 2012; 2 (2): 100-108.

9. Oliva-Moreno J., Lypez-Bastida J. et al. The costs of schizophrenia in Spain. Eur. J. Health Econ. 2006; 7: 182-188.

10. Jacobson L., Jonasson M., Lindblom Y. et al. The societal cost of schizophrenia in Sweden. 15 annual meeting of the International Society for Pharmacoeconomic and Outcomes Research (ISPOR). Washington. May 15-19, 2010.

11. Salize H. J. et al. Cost of treatment of schizophrenia in six European countries. Schizophr. Res. 2009; 111: 70-77.

12. Janicak P. G. The CATIE study and its implications antipsychotic drug use. Essent Psychopharmacol. 2006; 7: 53-63.

13. Kahn R. S. et al. Effectiveness of antipsychotic drugs in firstepisode schizophrenia an schizophreniform disorder: an open randomized clinical trial. Lancet. 2008; 371-1085-97.

14. Davis J. M. et al. A meta-analysis of efficacy of secondgeneration antipsychotics. Arch. Gen. Psychiatry. 2003; 60: 733-759.

15. Newton A. S. Antipsychotics in adult with schizophrenia: comparative effectiveness of fist-generation versus second-generation medications a systematic review and meta-analysis. Ann. Int. Med. 2012; 157: 498-511.

16. On approval of the industry standard “Clinical and economic research. General provisions”: order No. 163 of the Ministry of Health of the Russian Federation dated 27.05.2011 [Ob utverzhdenii otraslevogo standarta «Kliniko-ekonomicheskie issledovaniya. Obshchie polozheniya»: prikaz №163 Ministerstva Zdravookhraneniya Rossiiskoi Federatsii ot 27.05.2011 (in Russian)].

17. Avksent’eva M. A., Gerasimov B. V., Sura M. V. Clinical and economic analysis (evaluation, selection of medical technologies and quality management of medical care). Ed. by P. A. Vorobyov [Klinikoekonomicheskii analiz (otsenka, vybor meditsinskikh tekhnologii i upravleniya kachestvom meditsinskoi pomoshchi). Pod red. P. A. Vorob’eva (in Russian)]. Moscow. 2004; 404 s.

18. Belousov Yu. B. Planning and conducting clinical trials of drugs [Planirovanie i provedenie klinicheskikh issledovanii lekarstvennykh sredstv (in Russian)]. Moscow. 2000; 579 s.

19. The main concepts in the evaluation of medical technologies: Handbook. Under. edited by A. S. Kolbin, Zyryanov S. K., Belousov D. Yu. [Osnovnye ponyatiya v otsenke meditsinskikh tekhnologii: metodicheskoe posobie. Pod. red. A. S. Kolbina, S. K. Zyryanova, D. Yu. Belousova (in Russian)]. Moscow. 2013; 42 s.

20. Walley T., Haycox A., Boland A. Pharmacoeconomics. Elsevier Health Sciences. 2004. 216 s.

21. Josephine A. Mauskopf. et al. Principles of Good Practice for Budget Impact Analysis: Report of the ISPOR Task Force on Good Research Practices – Budget Impact Analysis. Value in Health. 2007; 10 (5); 336-347.

22. State register of medicines. URL: http://grls.rosminzdrav.ru/Default.aspx. Accessed: 30.08.2017 g.

23. The order of the Ministry of health of the Russian Federation of December 24, 2012 N 1400N “about the approval of the standard of specialized medical care at schizophrenia, the acute (subacute) phase with the protracted course and prevalence of social and rehabilitation problems” [Prikaz Ministerstva zdravookhraneniya RF ot 24 dekabrya 2012 g. N 1421n «Ob utverzhdenii standarta spetsializirovannoi meditsinskoi pomoshchi pri shizofrenii, podostroi faze v usloviyakh dnevnogo statsionara» (in Russian)].

24. The order of the Ministry of health of the Russian Federation of December 24, 2012 N 1400N “About the approval of the standard of specialized medical care at schizophrenia, the acute (subacute) phase with the protracted course and prevalence of social and rehabilitation problems» [Prikaz Minzdrava RF ot 24 dekabrya 2012 g. N 1400n «Ob utverzhdenii standarta spetsializirovannoi meditsinskoi pomoshchi pri shizofrenii, ostroi (podostroi) faze s zatyazhnym techeniem i preobladaniem sotsial’no-reabilitatsionnykh problem» (in Russian)].

25. The order of the Government of the Russian Federation of 19.12.2016 N 1403 “about the Program of the state guarantees of free rendering medical care to citizens for 2017 and on planning period 2018 and 2019” [Postanovlenie Pravitel’stva RF ot 19.12.2016 N 1403 «O Programme gosudarstvennykh garantii besplatnogo okazaniya grazhdanam meditsinskoi pomoshchi na 2017 god i na planovyi period 2018 i 2019 godov» (in Russian)].

26. Official site of Territorial Fund OMS of St.-Petersburg. URL: http://www.spboms.ru/. Accessed: 10.09.2017 g.

27. Russian pharmaceutical portal “PHARM-index”. URL: https://www.pharmindex.ru/. Accessed: 31.08.2017 g.

28. The Federal law of 29.12.2006 N 255-FZ (edition of 03.12.2011) “about obligatory social insurance in case of temporary disability and in connection with motherhood” [Federal’nyi zakon ot 29.12.2006 N 255-FZ (red. ot 03.12.2011) «Ob obyazatel’nom sotsial’nom strakhovanii na sluchai vremennoi netrudosposobnosti i v svyazi s materinstvom» (in Russian)].

29. Territorial authority of the Federal state statistics service of St. Petersburg and Leningrad region, official website. URL: http://petrostat.gks.ru/. Accessed: 10.01.2017 g.