FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

Advanced search

What is the role of antineoplastic drug safety in reimbursement decision making?

Full Text:


Rationale. From 2014 to 2017, the portion of antineoplastic drugs dossiers submitted to reimbursement in Russia has grown from 15% to 28%. This group of drugs is characterized by severe adverse events (Aes). The question whether drug safety is taken into consideration by decision makers is still open.

Aim: To evaluate the role of drug safety in making the decision on reimbursement.

Materials and methods. The data were taken from the reports of expert committees concerning the dossiers submitted between 2014 and 2016. The year of submission, the international drug name, the total safety score and the final decision of the committee were entered into our database. Parametric and non-parametric statistics were used to calculate the difference between the mean safety scores plotted by years and by inclusion/noninclusion into VeD lists.

Results. The mean safety score for all drugs of this group was -4,67 (95% CI from -5,04 to -4,29); for the drugs included into VeD lists it was -4,05 (95% CI from -4,68 to -3,42), that was significantly higher (p = 0,01) compared to the non-included medications (-5,03; 95% CI from -5,49 to -4,58). The mean safety scores year-by-year for the non-included drugs were lower than those for the VeD-included drugs, but the difference reached significance only in 2015 (p = 0,01). The safety scores were mainly based on Aes of type A.

Conclusion. our analysis shows that the drug safety data play a role in the decision making on reimbursement and inclusion/noninclusion into VeD lists. Yet the total safety score contributes much less than other criteria in the decision making process. The safety analysis is usually based on Aes of type A, whereas the data on Aes of types C and D are insufficient. 

About the Authors

A. S. Kolbin
Pavlov First Saint Petersburg State Medical University ; Saint-Petersburg State University.
Russian Federation
Kolbin Aleksei Sergeevich – MD, Professor, Head of the Department of Clinical Pharmacology and evidence-based Medicine, First Pavlov State Medical University; Professor, Department of Pharmacology, Saint-Petersburg State University.  6-8 L’va Tolstogo Str., Sankt-Peterburg 197022; 7-9 Universitetskaya emb., Sankt-Peterburg 199034.

A. A. Kurylev
Pavlov First Saint Petersburg State Medical University.
Russian Federation

Kurylev Aleksei Aleksandrovich – Assistant at the Department of Clinical Pharmacology and evidence-based Medicine, First Pavlov State Medical University. 

6-8 L’va Tolstogo Str., Sankt-Peterburg 197022.


1. Cao B., Bray F., Beltrán-Sánchez H. et al. Benchmarking life expectancy and cancer mortality: global comparison with cardiov ascular disease 1981-2010. BMJ. 2017; 357: j2765.

2. Practical recommendations for the treatment of malignant tumors of the Russian Society of Clinical Oncology [Prakticheskie rekomendatsii po lecheniyu zlokachestvennyh opuholey Rossiyskogo obschestva klinicheskoy onkologii (in Russian)]. 2017; [electronic resource]. Accessed: 10.07.18.

3. Vlasov V. V., Plavinskiy S. L. Options for drug provision in Russia: lessons from countries in europe and around the world [Varianty lekarstvennogo obespecheniya dlya Rossii: uroki stran evropy i vsego mira (in Russian)]. Moscow. 2013.

4. Decree of the Government of the Russian Federation of August 28, 2014 N 871 “On approval of the Rules for the formation of lists of medicinal products for medical use and the minimum range of medicines required for the provision of medical care” [Postanovlenie Pravitel’stva RF ot 28.08.2014 N 871 “ob utverzhdenii Pravil formirovaniya perechney lekarstvennyh preparatov dlya meditsinskogo primeneniya i minimal’nogo assortimenta lekarstvennyh preparatov, neobhodimyh dlya okazaniya meditsinskoy pomoschi” (in Russian)].

5. Prasolov A. V., Kolbin A. S., Maksimkina e. A., Golant Z. M., Kurylev A. A., Vilyum I. A., Balykina Yu.e., Polushin Yu.S. Zhurnal o rossiyskom rynke lekarstv i meditsinskoy tekhnike (in Russian). 2015; 4: 58-64.

6. Kolbin A. S., Kurylev A. A. kachestvennaya klinicheskaya praktika. 2017; 4: 38-44.

7. Giezen T. J., Mantel-Teeuwisse A.K., Meyboom R. H. et al. Mapping the safety profile of biologicals: a disproportionality analysis using the WHO adverse drug reaction database, VigiBase. Drug Saf. 2010; 33 (10): 865-78.

8. ebbers H. C., Al-Temimi e., Moors e., et al. Differences Between Post-Authorization Adverse Drug Reactions of Biopharmaceuticals and Small Molecules. BioDrugs. 2013; 27 (2): 167-74. DOI: 10.1007/ s40259-013-0012-y.

9. Federal Law “On circulation of medicines” of 12.04.2010 N 61FZ (last version) [Federal’nyy zakon “Ob obraschenii lekarstvennyh sredstv” ot 12.04.2010 N 61-FZ (poslednyaya redaktsiya) (in Russian)]. Accessed: 10.07.18.

10. Clinical pharmacology: national leadership / ed. Yu.B. Belousova, V. G. Kukes, V. K. Lepakhin, V. I. Petrov. (Series “National guidelines”) [klinicheskaya farmakologiya: natsional’noe rukovodstvo / pod red. Yu. B. Belousova, V. G. kukesa, V. k. Lepahina, V. I. Petrova. (Seriya “Natsional’nye rukovodstva”) (in Russian)]. Moscow. 2014; 976 sec. ISBN 978-5-9704-2810-8.

11. Singh J. A., Wells G. A., Christensen R. et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev. 2011 Feb 16; (2): CD008794. DOI: 10.1002/14651858.CD008794.pub2.

12. Boucaud-Maitre D., Altman J. J. Do the eMA accelerated assessment procedure and the FDA priority review ensure a therapeutic added value? 2006-2015: a cohort study. eur J Clin Pharmacol. 2016; 72 (10): 1275-1281.

13. Nagai S., Ozawa K. Drug approval based on randomized phase 3 trials for relapsed malignancy: analysis of oncologic drugs granted accelerated approval, publications and clinical trial databases. Invest New Drugs. 2018; 36 (3): 487-495.

14. Mostaghim S. R. et al. Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study. BMJ. 2017; 358: j3837.


For citation:

Kolbin A.S., Kurylev A.A. What is the role of antineoplastic drug safety in reimbursement decision making? FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2018;11(3):38-42. (In Russ.)

Views: 495

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