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Pharmacoeconomic aspects of oral vinorelbine application: a budget impact analysis considering the new registered price

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Objective: comparative assessment of the economic effect of oral vinorelbine when used as indicated, taking into consideration the new registered price.

Material and methods. A clinical-economic study was performed to compare active platinum-containing chemotherapy regimens of the first line for stage IV non-small-cell lung cancer with oral vinorelbine and pemetrexed as well as first-line chemotherapy regimens for metastatic breast cancer presented with oral vinorelbine and ixabepilone alone. A systematic search for information in medical databases was carried out, the cost estimate was made out in accordance with the recommendations of The Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation. The direct medical costs were estimated, formed on the basis of the dosage, frequency and dosage regimen of the compared drugs, based on the data of the State Register of maximum selling prices, clinical guidelines for the studied nosologies, and instructions for medical use. The comparison of the economic effect of the studied drugs was carried out in pairs using the cost minimization method with a sensitivity analysis. Further, the calculations of the amounts of reimbursement of medical care provided were made using each of the compared drugs. An economic assessment of the economic effect of oral vinorelbine was carried out taking into consideration the change in the price of the drug and a budget impact analysis with a sensitivity analysis.

Results. It was determined that the use of oral vinorelbine provides financial savings for a medical organization at the amount of 246,042.34 rubles per 6 cycles of chemotherapy for each patient with stage IV non-small-cell lung cancer compared with the use of pemetrexed, and 558,659.32 rubles per year – for the treatment of each patient with metastatic breast cancer compared with ixabepilone. The results of the budget impact analysis showed that the indication of oral vinorelbine saved 3,287,470.56 rubles for the budget fund considering the change in the cost of 1 mg of the drug for a hypothetical population of patients with stage IV non-small-cell lung cancer in 1000 people. This would create the possibility of therapy for additional 15 patients with this diagnosis. The indication of oral vinorelbine in first-line chemotherapy of metastatic breast cancer for a similar target population would save 18,355,043.96 rubles for the budget fund, which makes it possible to treat 15 more patients with this diagnosis.

Conclusion. The use of oral vinorelbine is associated with the saving of financial resources of a medical organization. In addition, the reimbursement for medical care provided from the compulsory medical insurance funds when using regimens with oral vinorelbine is primarily lower than for comparison drugs. Thus, the use of regimens with oral vinorelbine is more beneficial for the payer (the Federal Compulsory Health Insurance Fund) and for the medical organization. The change in the cost of the drug is associated with an increase in the availability of medical care for patients with stage IV non-small-cell lung cancer and patients with metastatic breast cancer.

About the Authors

D. A. Ivanov
Peoples’ Friendship University of Russia
Russian Federation

Dmitriy А. Ivanov – Master of Public Health, Clinical Pharmacologist. Scopus Author ID: 57219207293; RSCI SPIN-code: 2741-9334

10 corp. 3 Miklukho-Maklay Str., Moscow 117198, Russia

I. N. Dyakov
Scientific and Practical Research Center for Problems of Rational Pharmacotherapy and Pharmacoeconomics; Mechnikov Research Institute of Vaccines and Serums
Russian Federation

Ilya N. Dyakov – PhD (Biol.), Director General; Leading Reaercher. Scopus Author ID: 25723245000; WoS ResearcherID: K-2024-2018; RSCI SPIN-code: 1854-0958

50 bld. 2 Aviamotornaya Str., Moscow 111024, Russia
5A Malyy Kazennyy Pereulok, Moscow 105064, Russia

S. K. Zyryanov
Peoples’ Friendship University of Russia; City Clinical Hospital No. 24
Russian Federation

Sergey К. Zyryanov – Dr. Med. Sc., Professor, Chief of Chair of General and Clinical Pharmacology; Deputy Chief Physician. Scopus Author ID: 35796816700; WoS ResearcherID: D-8826-2012; RSCI SPIN-code: 2725-9981

10 corp. 3 Miklukho-Maklay Str., Moscow 117198, Russia
10 Pistsovaya Str., Moscow 127015, Russia


1. Kaprin А.D., Starinskiy V.V., Shakhzadova А.О. (Eds.) The state of cancer care in Russia in 2019. Мoscow; 2020 (in Russ.).

2. Breast cancer. Clinical guidelines; 2018. Available at: (in Russ.) (accessed 20.05.2021).

3. Breast cancer. Clinical guidelines; 2021. Available at: (in Russ.) (accessed 20.05.2021).

4. Malignant neoplasm of the bronchi and lung. Clinical guidelines. Available at: (in Russ.) (accessed 20.05.2021).

5. Rudakova A.V., Protsenko S.A. Oral vinorelbine therapy for nonsmall cell lung cancer: clinical and pharmacoeconomic aspects. Problems in Oncology. 2016, 62 (6): 812–6 (in Russ.).

6. Shabalkin P.I. Analysis of influence on the budget of the Russian Federation of the use of oral vinorelbine for the treatment of metastatic breast cancer. Farmateka. 2018, 7: 71–5 (in Russ.).

7. Bennouna J., Havel L., Krzakowski M., et al. Oral vinorelbine plus cisplatin as first-line chemotherapy in nonsquamous non-small-cell lung cancer: Final results of an international randomized phase II study (NAVotrial 01). Clin. Lung Cancer. 2014; 15 (4): 258–65.

8. Practical recommendations for the treatment of malignant tumors of the Russian Society of Clinical Oncology. Available at: https:// (in Russ.) (accessed 20.05.2021).

9. State Register of Medicines. Available at: https://grls.rosminzdrav. ru/GRLS.aspx (in Russ.) (accessed 20.05.2021).

10. Guidelines for evaluating the comparative clinical efficacy and safety of a medicinal product. Center for Expertise and Quality Control of Medical Care of the Ministry of Health of the Russian Federation. Мoscow; 2016 (in Russ.).

11. State register of maximum selling prices. Available at: https://grls. (in Russ.) (accessed 20.05.2021).

12. Federal Antimonopoly Service of the Russian Federation. The maximum size of wholesale allowances and the maximum size of retail allowances to the prices of vital and essential medicines established in the subjects of the Russian Federation (data as of 21.10.2020). Available at: (in Russ.) (accessed 20.05.2021).

13. Methodological recommendations of the Center for Expertise and Quality Control of Medical Care. Available at: (in Russ.) (accessed 20.05.2021).

14. PDQ Adult Treatment Editorial Board Non-Small Cell Lung Cancer Treatment (PDQ®): Health Professional Version. National Cancer Institute (US); 2002.

15. Goffin J., Lacchetti C., Ellis P.M., et al. First-line systemic chemotherapy in the treatment of advanced non-small cell lung cancer: a systematic review. J Thorac Oncol. 2010; 5 (2): 260–74.

16. Hernandez-Aya L.F., Ma C.X. Chemotherapy principles of managing stage IV breast cancer in the United States. Chin Clin Oncol. 2016; 5 (3): 42.

17. Rivera E. Management of metastatic breast cancer: Monotherapy options for patients resistant to anthracyclines and taxanes. Am J Clin Oncol. 2010; 33 (2): 176–85.

18. Caparica R., Lambertini M., De Azambuja E. How I treat metastatic triple-negative breast cancer. ESMO Open. 2019; 4 (Suppl. 2): e000504.

19. Jerusalem G., Rorive A., Collignon J. Chemotherapy options for patients suffering from heavily pretreated metastatic breast cancer. Futur Oncol. 2015; 11 (12): 1775–89.

20. Partridge A.H., Rumble R.B., Carey L.A., et al. Chemotherapy and targeted therapy for women with human epidermal growth factor receptor 2-negative (or unknown) advanced breast cancer: American society of clinical oncology clinical practice guideline. J Clin Oncol. 2014; 32 (29): 3307–29.


For citations:

Ivanov D.A., Dyakov I.N., Zyryanov S.K. Pharmacoeconomic aspects of oral vinorelbine application: a budget impact analysis considering the new registered price. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2021;14(2):103–114. (In Russ.)

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