Economic consequences of mandatory price re-registration for medicines from the high-cost nosology program

The Government Decree, approved in December 2019, required registration certificates holders of reference drugs, included in the essential drug list (EDL), submit applications for mandatory price re-registration. Drugs included in the high-cost nosology list (high-cost list) must be included in the EDL.

Objective: to assess the budget impact of price re-registration for high-cost list drugs.

Material and methods. The comparing economic analysis of high-cost nosology program before and after price re-registration based on the Government Decree N 1683 (effective from 16.12.2019). 125 reference stock keeping units (SKUs), included in the high-cost list, were evaluated.

Results. The analysis showed, that after re-registration the prices of 66 SKUs will remain the same. The prices of 43 reference SKUs will be reduced after setting a single maximum selling price («equalization»). Prices for 16 SKUs will be reduced due to lower registered prices in the reference countries. Considering the contracts executed in 20192020, the budget of the high-cost program is up to 74.430 billion rubles, and after re-registration it will be equal to 64.162 billion rubles, so the savings will amount 10.267 billion (13.8 %). The main drivers of re-registration prices savings are: Advagraf (1.175 billion rubles), Elizaria (2.083 billion rubles) and Revlimid (2.247 billion rubles). Separately, we analyzed the consequences ofprices re-registration in the V-thgroup ofhigh-cost list, which are provided topatients with malignant neoplasms of lymphoid, hematopoietic and related tissues. It was calculated, that in 2019 the contracts for V-th group of high-cost list were signed for 19.217 billion rubles, and after the price re-registration for the purchase of the same number of drugs 16.762 billion rubles will be spent, so the savings from the price re-registration will amount to 2.455 billion rubles (12.8 %), among which 2.247 billion rubles will be provided by price re-registration of Revlimid.

Conclusions. The pricing policy implemented in the Russian Federation is aimed at increasing the availability of highly effective medical care to the population of the Russian Federation and significantly reduces the burden on the budget of the healthcare system.

1. Resolution of the Government of the Russian Federation of 16.12.2019 N 1683 «O vnesenii izmenenij v nekotorye akty Pravitel’stva Rossijskoj Federacii v chasti gosudarstvennoj registracii i pereregistracii predel’nyh otpusknyh cen na lekarstvennye preparaty, vklyuchennye v perechen zhiznenno neobhodimyh i vazhnejshih lekarstvennyh preparatov». (In Russ). Available from: https://fzakon.ru/postanovleniya-pravitelstva/postanovlenie-pravitelstva-rf-ot-16.12.2019-n-1683/

2. Federal law of 03.08.2018 N 299-FZ « O vnesenii izmenenij v Federal’nyj zakon «Ob osnovah ohrany zdorov’ya grazhdan v Rossijskoj Federacii». (In Russ). Available from: http://www.consultant.ru/document/cons_doc_LAW_304049/

3. Prilozhenie N 3. Perechen lekarstvennyh preparatov, prednaznachennyh dlya obespecheniya lic, bol’nyh gemofiliej, mukoviscidozom, gipofizarnym nanizmom, boleznyu Goshe, zlokachestvennymi novoobrazovaniyami limfoidnoj, krovetvornoj i rodstvennyh im tkanej, rasseyannym sklerozom, gemolitiko- uremicheskim sindromom, yunosheskim artritom s sistemnym nachalom, mukopolisaharidozom I, II i VI tipov, lic posle transplantacii organov i (ili) tkanej. Government order No. 2406 of October 12, 2019 (In Russ). Available from: http://static.government.ru/media/files/K1fPEUszF2gmvwTkw74iPOASarj7KggI.pdf

4. Gosudarstvennyi reestr predel’nykh otpusknykh tsen proizvoditelei na lekarstvennye preparaty, vklyuchennye v perechen zhiznenno neobkhodimykh i vazhneishikh lekarstvennykh preparatov (po sostoyaniyu na 24.01.2020). (In Russ).

5. The National Health Insurance Fund (OEP). Available from: http://www.oep.hu/

6. Ministry of Health (Greece). Available from: https://www.moh.gov.gr/

7. National Institute of Health Insurance and Disability (INAMI). Available from: https://www.inami.fgov.be/fr/Pages/default.aspx

8. General Council of Official Colleges of Pharmacists. Available from: https://www.portalfarma.com/Paginas/default.aspx

9. Achmea. Available from: https://www.achmea.nl/

10. Ministry of Health (Poland). Available from: https://mz.gov.pl/

11. Ministry of Health (Romania). Available from: http://www.ms.ro/

12. Ministry of Health (Slovakia). Available from: https://www.health.gov.sk/Titulka

13. Ministry of Health (Turkey). Available from: https://www.saglik.gov.tr/

14. National Health Insurance Agency (AMELI). Available from: https://www.ameli.fr/

15. State Institute for Drug Control (SUKL). Available from: http://www.sukl.eu/

16. Informatsionno-analiticheskaya sistema «IHS Markit». (In Russ). Available from: https://ihsmarkit.com/index.html] Ссылка активна на 25.03.2020.

17. 2019 Medicine Price Index Medbelle. Available from: https://www.medbelle.com/medicine-price-index-usa

18. Oficial’nyj sajt edinoj informacionnoj sistemy v sfere zakupok v informacionno-telekommunikacionnoj seti Internet [Internet]. (In Russ). Available from: https://zakupki.gov.ru/epz/main/public/home.html

19. Informacionno-analiticheskaya Sistema «Headway company» [Internet]. (In Russ). Available from: https://www.hwcompany.ru/