Preview

FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

Advanced search

Pharmacoeconomic analysis of using empegfilgrastim for the treatment of early and locally advanced HER2+ breast cancer in the Russian Federation

https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.220

Abstract

Objective: to assess budget impact of using empegfilgrastim for the prevention of febrile neutropenia in patients with early and locally advanced human epidermal growth factor receptor 2 positive (HER2+) breast cancer who receive neoadjuvant “docetaxel / carboplatin / trastuzumab + pertuzumab” regimen, considering possible subsequent adjuvant therapy with trastuzumab emtansine or trastuzumab within the Russian healthcare system.
Material and methods. We searched and analyzed published clinical, epidemiological and pharmacoeconomic studies as well as regulatory and legal documents. A decision tree model was constructed to reflect the probabilities of switching to different adjuvant therapy regimens depending on the achievement of pathomorphological complete response in patients with early and locally advanced HER2+ breast cancer. The budget impact analysis was carried out comparing two primary prophylactic options, empegfilgrastim and filgrastim.
Results. Despite the higher costs of prevention with empegfilgrastim compared to filgrastim (249 vs. 134 thousand rubles), due to the higher rate of achieving a pathomorphological complete response and, accordingly, fewer cases requiring adjuvant therapy with the more expensive trastuzumab emtanzine, savings of 916 thousand rubles per 1 patient per 1 year of therapy are possible. In general, prophylaxis in the target population diagnosed with early and locally advanced HER2+ breast cancer using empegfilgrastim will result in a cost reduction of 9.4 billion rubles per 1 year compared to filgrastim.
Conclusion. Empegfilgrastim prophylaxis, despite its higher annual cost, is an efficient option within the Russian healthcare system. In addition to reducing the incidence of febrile neutropenia, the frequency and dose of chemotherapy are preserved, resulting in increased efficacy of the primary therapy.

About the Authors

M. V. Zhuravleva
Sechenov University; Scientific Center for Expert Evaluation of Medicinal Products
Russian Federation

Dr. Med. Sci., Professor, Chair of Clinical Pharmacology and Propaedeutics of Internal Diseases; Deputy Head of
Scientific Department of Clinical Pharmacology, Institute of Research and Development

Scopus Author ID: 5587891790 

8 bldg 2 Trubetskaya Str., Moscow 119048, Russia 

8 bldg 2 Petrovsky Bvrd, Moscow 127051, Russia 



K. A. Kokushkin
Scientific and Practical Center for Clinical and Economic Analysis of the Ministry of Health of the Moscow Region
Russian Federation

Scientific Adviser

4 lit. А Karbyshev Str., Krasnogorsk 143403, Russia 



E. A. Luchinin
Razumovsky Saratov State Medical University
Russian Federation

Member of Chair of Pathology, Hematology and Clinical Pharmacology

Scopus Author ID: 57220079650 

112 Bolshaya Kazachya Str., Saratov 410012, Russia



E. V. Luchinina
Razumovsky Saratov State Medical University
Russian Federation

MD, PhD, Associate Professor, Chair of Pathology,  Hematology and Clinical Pharmacology, Head of  Department of Control over the Circulation of Medicines and Medical Devices, Clinical Center

WoS ResearcherID: AAD-4774-2021; Scopus Author ID: 57217133083 

 112 Bolshaya Kazachya Str., Saratov 410012, Russia 



T. R. Kameneva
Research Institute of Healthcare Organization and Medical Management; Konchalovsky City Clinical Hospital
Russian Federation

MD, PhD, Associate Professor, Leading Expert, Organizational and Methodological Department of Clinical Pharmacology; Clinical  Pharmacologist

 9 Sharikopodshipnikovskaya Str., Moscow 115088, Russia 

 2 bldg 1 Kashtanovaya Alley, Moscow, Zelenograd 124489, Russia 



E. V. Kuznetsova
Research Institute of Healthcare Organization and Medical Management
Russian Federation

Head of Organizational and Methodological  Department of Clinical Pharmacology

9 Sharikopodshipnikovskaya Str., Moscow 115088, Russia 



V. S. Krysanova
Russian Biotechnological University
Russian Federation

Member of Chair of Therapy with a Course of  Pharmacology and Pharmacy, Medical Institute of Continuing Education

WoS ResearcherID: AAE-2346-2019; Scopus Author ID:
57193874403 

 11 Volokolamskoe Shosse, Moscow 125080, Russia 



E. V. Makarova
Yevdokimov Moscow State University of Medicine and Dentistry
Russian Federation

MD, PhD, Researcher

Scopus Author ID: 57201075018 

 20 bldg 1 Delegatskaya Str., Moscow 127473, Russia



L. G. Zhukova
Loginov Moscow Clinical Research and Practical Center
Russian Federation

Dr. Med. Sc., Corresponding Member of RAS, Deputy Director for Oncology

1 corp. 1 Novogireevskaya Str., Moscow 111123, Russia 



References

1. U.S. Department of Health and Human Services, Food and Drug Administration, Oncology Center of Excellence, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval guidance for industry. 2020. Available at: https://www.fda.gov/media/83507/download#:~:text=Pathologic (accessed 02.11.2023).

2. Mayordomo J.I., López A., Viñolas N., et al. Retrospective cost analysis of management of febrile neutropenia in cancer patients in Spain. Curr Med Res Opin. 2009; 25 (10): 2533–42. https://doi.org/10.1185/03007990903209563.

3. Aapro M.S., Bohlius J., Cameron D.A., et al. 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer. 2011; 47 (1): 8–32. https://doi.org/10.1016/j.ejca.2010.10.013.

4. Smith T.J., Khatcheressian J., Lyman G.H., et al. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol. 2006; 24 (19): 3187–205. https://doi.org/10.1200/JCO.2006.06.4451.

5. Lyman G.H., Eckert L., Wang Y., et al. Venous thromboembolism risk in patients with cancer receiving chemotherapy: a real-world analysis. Oncologist. 2013; 18 (12): 1321–9. https://doi.org/10.1634/theoncologist.2013-0226.

6. Denduluri N., Lyman G.H., Wang Y., et al. Chemotherapy dose intensity and overall survival among patients with advanced breast or ovarian cancer. Clin Breast Cancer. 2018; 18 (5): 380–6. https://doi.org/10.1016/j.clbc.2018.02.003.

7. Green M.D., Koelbl H., Baselga J., et al. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003; 14 (1): 29–35. https://doi.org/10.1093/annonc/mdg019.

8. Holmes F.A., O'Shaughnessy J.A., Vukelja S., et al. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002; 20 (3): 727–31. https://doi.org/10.1200/JCO.2002.20.3.727.

9. Kononenko I.B., Snegovoy A.V., Grebennikova O.P., et al. Reduction of febrile neutropenia by using long-acting granulocyte colonystimulating factors in patients with solid tumors receiving every-2-week chemotherapy. Journal of Modern Oncology. 2020; 22 (3): 133–41 (in Russ.). https://doi.org/10.26442/18151434.2020.3.200279.

10. Mitchell S., Li X., Woods M., et al. Comparative effectiveness of granulocyte colony-stimulating factors to prevent febrile neutropenia and related complications in cancer patients in clinical practice: a systematic review. J Oncol Pharm Pract. 2016; 22 (5): 702–16. https://doi.org/10.1177/1078155215625459.

11. Cornes P., Gascon P., Chan S., et al. Systematic review and metaanalysis of short- versus long-acting granulocyte colony-stimulating factors for reduction of chemotherapy-induced febrile neutropenia. Adv Ther. 2018; 35 (11): 1816–29. https://doi.org/10.1007/s12325-018-0798-6.

12. Instructions for the medical use of Extimia® (empegfilgrastim). Available at: https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=7c6855ba-f8b2-4e37-bc14-06a45435d948 (in Russ.) (accessed 02.11.2023).

13. Krivorotko P.V., Burdaeva O.N., Nechaeva M.N., et al. Efficacy and safety of Extimia® (empegfilgrastim): results of a double-blind controlled phase III study in patients with diagnosis “breast cancer” receiving myelosuppressive chemotherapy. Journal of Modern Oncology. 2015; 17 (2): 45–52 (in Russ.).

14. Snegovoy A., Dergunov A., Tatyanenko A., et al. Defendor: Realworld evidence of primary prolonged G-CSF prophylaxis by empegfilgrastim for relative dose intensity compliance in patients with solid tumors – the primary analysis. J Clin Oncol. 2022; 40 (16 Suppl.): e18788. https://doi.org/10.1200/JCO.2022.40.16_suppl.e18788.

15. Ministry of Health of the Russian Federation. The federal project “Fight against oncological diseases”. Available at: https://minzdrav.gov.ru/poleznye-resursy/natsproektzdravoohranenie/onko (in Russ.) (accessed 02.11.2023).

16. Gradishar W.J., Moran M.S., Abraham J., et al. NCCN Guidelines® Insights: Breast Cancer, Version 4.2023. J Natl Compr Canc Netw. 2023; 21 (6): 594–608. https://doi.org/10.6004/jnccn.2023.0031.

17. Sullivan S.D., Mauskopf J.A., Augustovski F., et al. Budget impact analysis-principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health. 2014; 17 (1): 5–14. https://doi.org/10.1016/j.jval.2013.08.2291.

18. Zhukova L., Ibragimova T., Ganshina I., et al. Defendor special: interim analysis of TCHP with primary empegfilgrastim prophylaxis (long-acting G-CSF) for treatment outcomes in early HER2+ breast cancer. J Clin Oncol. 2023; 41 (16 Suppl.): e12586. https://doi.org/10.1200/JCO.2023.41.16_suppl.e12586.

19. Rubricator of clinical recommendations. Breast cancer. 2021. Available at: https://cr.minzdrav.gov.ru/schema/379_4 (in Russ.) (accessed 02.11.2023).

20. Rudakova A.V., Tolkacheva D.G., Gavrilova O.N., Vaganov A.S. Costeffectiveness of empegfilgrastim (Extimia®) in the prevention of severe neutropenia in patients with malignant neoplasm of female breast. Journal of Modern Oncology. 2016; 8 (2): 48–51 (in Russ.).

21. Sacco J.J., Botten J., Macbeth F., et al. The average body surface area of adult cancer patients in the UK: a multicentre retrospective study. PLoS One. 2010; 5 (1): e8933. https://doi.org/10.1371/journal.pone.0008933.

22. Kaprin A.D., Starinskiy V.V., Shakhzadova A.O. (Eds.) The state of oncological care for the population of Russia in 2021. Мoscow: Herzen Moscow Research Oncological Institute – branch of National Medical Research Center of Radiology; 2022: 239 pp. (in Russ.).

23. Naoum V., Antonaki M., Kakouros M., et al. Cost-effectiveness analysis of trastuzumab emtansine for the adjuvant treatment of patients with residual invasive HER2+ early breast cancer in Greece. Available at: https://www.ispor.org/docs/default-source/euro2022/isporeu22ouzounelli-pdf.pdf?sfvrsn=b7acbb4_0 (in Russ.) (accessed 02.11.2023).

24. Li S., Wu J., Huang O., et al. HER2 positivity is not associated with adverse prognosis in high-risk estrogen receptor-positive early breast cancer patients treated with chemotherapy and trastuzumab. Breast. 2020; 54: 235–41. https://doi.org/10.1016/j.breast.2020.10.002.

25. Cortazar P., Zhang L., Untch M., et al. Meta-analysis results from the collaborative trials in neoadjuvant breast cancer (CTNeoBC). Cancer Res. 2012; 72 (24 Suppl.): S1–11. https://doi.org/10.1158/0008-5472.SABCS12-S1-11.

26. Bear H., Anderson S., Smith R.E., et al. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2006; 24 (13): 2019–27. https://doi.org/10.1200/JCO.2005.04.1665.

27. Mieog J.S., van der Hage J.A., van de Velde C.J. Preoperative chemotherapy for women with operable breast cancer. Cochrane Database Syst Rev. 2007; 2007 (2): CD005002. https://doi.org/10.1002/14651858.CD005002.pub2.

28. Rastogi P., Anderson S.J., Bear H.D., et al. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J Clin Oncol. 2008; 26 (5): 778–85. https://doi.org/10.1200/JCO.2007.15.0235.

29. State Register of Marginal Selling Prices. Available at: https://grls.rosminzdrav.ru/pricelims.aspx (in Russ.) (accessed 02.11.2023).

30. You Z., Zhang H., Huang Y., et al. Assessing the optimal regimen: a systematic review and network meta-analysis of the efficacy and safety of long-acting granulocyte colony-stimulating factors in patients with breast cancer. Cancers. 2023; 15 (14): 3675. https://doi.org/10.3390/cancers15143675.

31. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Increasing the dose intensity of chemotherapy by more frequent administration or sequential scheduling: a patient-level meta-analysis of 37 298 women with early breast cancer in 26 randomised trials. Lancet. 2019; 393 (10179): 1440–52. https://doi.org/10.1016/S0140-6736(18)33137-4.

32. Gromova G.A. Prevention and treatment of neutropenia in routine clinical practice. How to improve the quality of cancer care and reduce treatment costs? Tumors of Female Reproductive System. 2023; 19 (2): 69–81 (in Russ.). https://doi.org/10.17650/1994-4098-2023-19-2-69-81.

33. MacDonald K., McBride A., Alrawashdh N., Abraham I. Costefficiency and expanded access of prophylaxis for chemotherapyinduced (febrile) neutropenia: economic simulation analysis for the US of conversion from reference pegfilgrastim to biosimilar pegfilgrastimcbqv. J Med Econ. 2020; 23 (12): 1466–76. https://doi.org/10.1080/13696998.2020.1833339.

34. Cornes P., Kelton J., Liu R., et al. Real-world cost-effectiveness of primary prophylaxis with G-CSF biosimilars in patients at intermediate/high risk of febrile neutropenia. Future Oncol. 2022; Mar 31. https://doi.org/10.2217/fon-2022-0095.

35. Ashour A.Z., Litovkin A.V., Belov V.G., et al. Analysis of health and social needs of cancer patients of older age groups in palliative care. Modern Problems of Science and Education. 2015; 5: 335 (in Russ.).

36. Litovkin A.V., Parfenov Yu.A., Parfenov S.A., Sapozhnikov K.V. Forms of palliative care for older people with cancer. Modern Problems of Science and Education. 2017; 4: 58 (in Russ.).

37. Klastersky J.A., Dal Lago L., Lalami Y. Use of granulocyte-colony stimulating factors in older patients: a review of recently published data. Curr Opin Oncol. 2020; 32 (4): 258–61. https://doi.org/10.1097/CCO.0000000000000632.

38. Cornes P., Gascon P., Chan S., et al. Systematic review and metaanalysis of short- versus long-acting granulocyte colonystimulating factors for reduction of chemotherapy-induced febrile neutropenia. Adv Ther. 2018; 35 (11): 1816–29. https://doi.org/10.1007/s12325-018-0798-6.

39. Sapozhnikov K.V., Sorokina I.V., Gusev A.V., et al. Prevention of febrile neutropenia in oncological patients: real-world data. Journal of Modern Oncology. 2023; 25 (1): 115–22 (in Russ.). https://doi.org/10.26442/18151434.2023.1.202138.


Review

For citations:


Zhuravleva M.V., Kokushkin K.A., Luchinin E.A., Luchinina E.V., Kameneva T.R., Kuznetsova E.V., Krysanova V.S., Makarova E.V., Zhukova L.G. Pharmacoeconomic analysis of using empegfilgrastim for the treatment of early and locally advanced HER2+ breast cancer in the Russian Federation. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2023;16(4):537-549. (In Russ.) https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.220

Views: 1091


ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)