BUDGET IMPACT ANALYSIS OF PERAMPANEL FOR ADJUNCTIVE TREATMENT IN EPILEPSY PATIENTS 12 YEARS OF AGE AND OLDER FOR PARTIAL ONSET SEIZURES WITH OR WITHOUT SECONDARY GENERALIZATION AND PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN THE RUSSIAN FEDERATION
https://doi.org/10.17749/2070-4909.2016.9.2.028-037
Abstract
Objectives. To assess the incremental budget impact (BI) of using of utilizing perampanel to treat partial-onset seizures (POS) and primary generalized tonic-clonic seizures (PGTCS) in patients who are 12 years of age and older in Russia.
Methods. The budget impact was estimated by comparing two different scenarios: Cost of POS & PGTCS without Perampanel and Cost of POS & PGTCS with Perampanel (Perampanel Adoption). In the latter scenario, market share of perampanel was assumed to increase every year for up to five years. The model was developed from a payer perspective with a time horizon of five years. Direct costs included drugs and medical resources (hospitalization, emergency care costs, visits to physician). BI was calculated as the difference in costs between Perampanel Adoption scenario and the cost without Perampanel.
Results. In Russia, approximately 125,499 patients who are at least 12 years old are treated for refractory POS & PGTCS each year. The market share of perampanel in the perampanel adoption scenario from year 1 to year 5 was 0.1%, 0.5%, 1.0%, 2.0% and 3.0%, respectively. During the same period, the adoption of perampanel is projected to increase drug costs (in millions) by RUB15.2 (1.2%), RUB76.1 (6.2%), RUB152.4 (12.3%), RUB305.4 (24.7%), and RUB459.0 (37.0%), respectively. A significant portion of the 5-year cumulative increase in drug costs (RUB 1,008 million) will be offset by a decrease in non-drug medical resources (-RUB152.7 million). The cumulative budget impact from perampanel adoption for the first five years is projected to be RUB855 million (0.7%), with an additional 231 patients gaining seizure freedom over a period of 5 years from the adoption of perampanel.
Conclusion. Perampanel should be considered as an alternative alongside current antiepileptic drugs in patients with symptoms refractory to prior antiepileptic treatments.
About the Authors
V. R. Mkrtchyan
Scientific and Practical Center for Neuropsychiatry, Moscow Health Department;
Russian Medical Academy of Postgraduate Education Ministry of Health of Russia, Moscow
Russian Federation
Russian Federation
MD, Head of the Department of Neuropsychiatric Disorders Associate with Neurological Disorders and Old Age, Moscow Research and Clinical Center for Neuropsychiatry, Donskaya street, 43, Moscow, 115419;
ul. Barrikadnaya, 2/1, bldg. 1, Moscow, Russia, 125993.
A. M. Sergeev
Russian Presidential Academy of National Economy and Public Administration, Moscow
Russian Federation
Russian Federation
post-graduate student,
Vernadky prospect, 82, bldg.1, Moscow, 119571
K. I. Pochigaeva
Scientific and Practical Center for Neuropsychiatry, Moscow Health Department
Russian Federation
Russian Federation
MD, Research assistant, Department of Neuropsychiatric Disorders Associate with Neurological Disorders and Old Age, Moscow Research and Clinical Center for Neuropsychiatry,
ul. Donskaya, 43, Moscow, 115419
I. A. Shpak
Scientific and Practical Center for Neuropsychiatry, Moscow Health Department
Russian Federation
Russian Federation
Research assistant, Department of Neuropsychiatric Disorders Associate with Neurological Disorders and Old Age, Moscow Research and Clinical Center for Neuropsychiatry,
ul. Donskaya, 43, Moscow, 115419
References
1. Abaimov D. A., Sariev A. K., Noskova T. Yu., Shvedkov V. V., Shiryaeva M. V., Styrova E. Yu., Prokhorov D. I., Seifulla R. D. Epilepsiya i paroksizmal'nye sostoyaniya / Epilepsy and paroxysmal conditions. 2013; 2: 31-41.
2. Avakyan G. N., Belousova E. D., Ermakov A. Yu., Avakyan G. G. Epilepsiya i paroksizmal'nye sostoyaniya / Epilepsy and paroxysmal conditions. 2013; 3: 41-48.
3. Belousov D. Yu., Afanas'eva E. V., Efremova E. A. Kachestvennaya klinicheskaya praktika. 2014; 1: 24-39.
4. Avakyan G. N. Epilepsiya i paroksizmal'nye sostoyaniya / Epilepsy and paroxysmal conditions. 2013; 2: 52-53.
5. Avakyan G. G., Bogomazova M. A., Zhuravleva I. I., Ismailov A. M., Komel'kova E. G., Lesinker L. N., Logvinov Yu. I., Otcheskaya O. V., Petrov S. V., Rubleva Yu. V., Solomatin Yu. V., Teplysheva A. M., Udovichenko T. N., Khromykh E. A., Shikhkerimov R. K., Shomakhova M. M. Epilepsiya i paroksizmal'nye sostoyaniya / Epilepsy and paroxysmal conditions.2014; 4: 23-28.
6. Badalyan O. L., Bogomazova M. A., Zhuravleva I. I., Ismailov A. M., Artemova I. Yu., Komel'kova E. G., Lesinker L. N., Logvinov Yu. I., Otcheskaya O. V., Petrov S. V., Solomatin Yu. V., Teplysheva A. M., Udovichenko T. N., Khromykh E. A., Chukanova A. S., Lebedeva A. V., Burd S. G., Boiko A. N. Epilepsiya i paroksizmal'nye sostoyaniya / Epilepsy and paroxysmal conditions. 2012; 4: 40-48.
7. Belousova E. D. Epilepsiya i paroksizmal'nye sostoyaniya / Epilepsy and paroxysmal conditions. 2014; 1: 27-33.
8. Belousov D. Yu., Afanas'eva E. V., Efremova E. A. Kachestvennaya klinicheskaya praktika. 2014; 1: 24-39.
9. Burd S. G. Epilepsiya i paroksizmal'nye sostoyaniya / Epilepsy and paroxysmal conditions. 2012; 1: 34-39.
10. Vlasov P. N. Epilepsiya i paroksizmal'nye sostoyaniya / Epilepsy and paroxysmal conditions. 2015; 4: 40-49.
11. Voronina T. A. , Nerobkova L. N., Avakyan G. N., Khromykh E. A., Gaidukov I. O, Avakyan G. G. Epilepsiya i paroksizmal'nye sostoyaniya / Epilepsy and paroxysmal conditions. 2013; 4: 29-31.
12. Dzhalalov S. Ch., Dzhalalova D. Kh., Khoch D. S. Meditsinskie Tekhnologii. Otsenka i Vybor. 2014; 4: 19-28.
13. Dzhalalov S. Ch., Dzhalalova D. Kh., Khoch D. S. Meditsinskie Tekhnologii. Otsenka i Vybor. 2014; 3: 10-17.
14. Kovaleva I. Yu. Epilepsiya i paroksizmal'nye sostoyaniya / Epilepsy and paroxysmal conditions. 2015; 4: 50-57.
15. Maksimova L. V. Meditsinskie Tekhnologii. Otsenka i Vybor. 2012; 3: 68-74.
16. Mil'chakova L. E. Epilepsy in the Russian Federation: Epidemiological, Pharmacoepidemiological, social and clinical aspects. Dr. diss. [Epilepsiya v Rossiiskoi Federatsii: epidemiologicheskie, farmakoepidemiologicheskie, sotsial'nye i klinicheskie aspekty. Diss. …dokt. med. nauk (in Russian)]. Moscow. 2008.
17. Resolution of experts on the rational use of anticonvulsants in clinical practice. Epilepsiya i paroksizmal'nye sostoyaniya / Epilepsy and paroxysmal conditions. 2015; 4: 72-75.
18. Rudakova I. G. Epilepsiya i paroksizmal'nye sostoyaniya / Epilepsy and paroxysmal conditions. 2014; 1: 64-69.
19. Rudakova I. G. Epilepsiya i paroksizmal'nye sostoyaniya / Epilepsy and paroxysmal conditions. 2014; 4: 62-66.
20. The standard of primary health care with partial epilepsy in remission. Annex to the Order of the Ministry of Health of the Russian Federation of December 20, 2012 № 1107n. [Standart pervichnoi mediko-sanitarnoi pomoshchi pri partsial'noi epilepsii v faze remissii. Prilozhenie k prikazu Ministerstva zdravookhraneniya Rossiiskoi Federatsii ot 20 dekabrya 2012 g. № 1107n. (in Russian)].
21. The standard of primary health care with partial epilepsy (Phase diagnosis and selection of therapy). Annex to the Order of the Ministry of Health of the Russian Federation of December 24, 2012 № 1404n. [Standart pervichnoi mediko-sanitarnoi pomoshchi pri partsial'noi epilepsii (faza diagnostiki i podbora terapii). Prilozhenie k prikazu Ministerstva zdravookhraneniya Rossiiskoi Federatsii ot 24 dekabrya 2012 g. № 1404n. (in Russian)].
22. The standard of primary health care in generalized epilepsy in remission. Annex to the Russian Ministry of Health order of December 24, 2012 № 1440n. [Standart pervichnoi mediko-sanitarnoi pomoshchi pri generalizovannoi epilepsii v faze remissii. Prilozhenie k prikazu Minzdrava Rossii ot 24 dekabrya 2012 g. № 1440n. (in Russian)].
23. The standard of primary health care in generalized epilepsy (the phase of diagnosis and selection of therapy). Annex to the Russian Ministry of Health order of December 24, 2012 № 1439n. [Standart pervichnoi mediko-sanitarnoi pomoshchi pri generalizovannoi epilepsii (faza diagnostiki i podbora terapii). Prilozhenie k prikazu Minzdrava Rossii ot 24 dekabrya 2012 g. № 1439n. (in Russian)].
24. The tariff agreement for the payment of medical assistance for the territorial program of compulsory health insurance the city of Moscow for 2016 on December 25, 2015. URL: http://www.mgfoms.ru/medicinskie-organizacii/tarifi. Accessed: 20.02.2016.
25. The population of the Russian Federation by sex and age as of January 1, 2015. Federal State Statistics Service. URL: http://www.gks.ru/wps/wcm/connect/rosstat_main/rosstat/ru/statistics/publications/catalog/doc_1140095700094. Accessed: 24.02.2016.
26. European Medicines Agency. Fycompa: EPAR — Product Information. 7 March 2016. URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002434/human_med_001572.jsp&mid=WC0b01ac058001d124 Accessed: 07.03.2016.
27. French J. A., Krauss G. L., Biton V., Squillacote D., Yang H., Laurenza A., Kumar D., Rogawski M. A. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology. 2012 Aug 7; 79 (6): 589-96.
28. French J. A., Krauss G. L., Steinhoff B. J., Squillacote D., Yang H., Kumar D., Laurenza A. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: results of randomized global phase III study 305. Epilepsia. 2013; 54 (1): 117-25.
29. French J. A., Krauss G. L., Wechsler R. T., Wang X., DiVentura B., Brandt C., Trinka E., O'Brien T. J., Laurenza A., Patten A., Bibbiani F. Perampanel for tonic-clonic seizures in idiopathic generalized epilepsy. A randomized trial. Neurology. 2015; 85: 1-8.
30. Guekht A., Hauser W. A., Milchakova L., Churillin Y., Shpak A., Gusev E. The epidemiology of epilepsy in the Russian. Epilepsy Research. 2010; 92: 209-218.
31. Gupta S., Kwan P., Faught E., Tsong W., Forsythe A., Ryvlin P. Understanding the burden of idiopathic generalized epilepsy in the United States, Europe, and Brazil: An analysis from the National Health and Wellness Survey. Epilepsy & Behavior. 2016; 55: 146-156.
32. IMS Health, obtained from databases, «Retail Audit of Drugs and dietary supplements in the Russian Federation», 2013–2015 years.
33. Krauss G. L., Serratosa J. M., Villanueva V., Endziniene M., Hong Z., French J., Yang H., Squillacote D., Edwards H. B., Zhu J., Laurenza A. Randomized phase III study 306: adjunctive perampanel for refractory partial-onset seizures. Neurology. 2012 May 1; 78 (18): 1408-15.
34. NICE UK. The Epilepsies: clinical practice guideline July 2010, Appendix P: Cost-effectiveness Analysis.
35. U. S. Food and Drug Administration. U. S. Department of Health & Human Services. Drugs@FDA. Label and Approval History. June 2015. URL: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202834s005lbl.pdf. Accessed: 26.02.2016.
36. WHO Collaborating Center for Drug Statistics Methodology. URL: http://www.whocc.no/atc_ddd_index/. Accessed: 26.02.2016.
37. World Bank. URL: http://data.worldbank.org/indicator/SP.POP. TOTL, 2014. URL: http://data.worldbank.org/indicator/SP.POP.TOTL. Accessed: 26.02.2016.
Review
For citations:
Mkrtchyan V.R., Sergeev A.M., Pochigaeva K.I., Shpak I.A. BUDGET IMPACT ANALYSIS OF PERAMPANEL FOR ADJUNCTIVE TREATMENT IN EPILEPSY PATIENTS 12 YEARS OF AGE AND OLDER FOR PARTIAL ONSET SEIZURES WITH OR WITHOUT SECONDARY GENERALIZATION AND PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN THE RUSSIAN FEDERATION. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2016;9(2):28-37. (In Russ.) https://doi.org/10.17749/2070-4909.2016.9.2.028-037
Views: 1688
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Email this article 