Clinical and economic analysis of macrocyclic gadolinium-based compounds for use in magnetic resonance imaging diagnostics
https://doi.org/10.24411/2588-0519-2019-10080
Abstract
Gadolinium-based contrast compounds are paramagnetic chemicals that allow enhancing contrast during magnetic resonance imaging (MRI) tomographic investigation. It`s known that linear gadolinium-based paramagnetic compounds cause permanent accumulation of gadolinium in tissues. This effect is less pronounced in macrocyclic gadolinium-based compounds, which makes them increasingly relevant.
Aim. Evaluate clinical and economic analysis of macrocyclic gadolinium-based contrast gadoteridol compared with gadobutrol for MRI diagnostics.
Methodology. Decision tree model with one-year time horizon was constructed. Model accounted for specific parameters of administration of each of compared contrasts. Only direct medical costs evaluated. The number of detected anomalies selected as effectiveness criterion. We used cost minimization analysis (CMA) because there were no differences in effectiveness. Then we performed the budget impact analysis (BIA), accounting to number of patients receiving MRI of brain in the Russian Federation. Relevant sensitivity analyses carried out.
Result. Gadoteridol was superior both in CMA (cost reduction reached 21.51 %) and BIA (budget burden reduced by 10.31 % which amounts to 15 735 332 rubles). Sensitivity analysis confirms the model robustness.
Conclusion. Clinical and economic analysis of gadoteridol compared with gadobutrol demonstrated that expansion of gadoteridol use in Russian healthcare is economically feasible.
About the Authors
A. E. CheberdaRussian Federation
Cheberda Alexey - PhD, MBA, Executive Director
SPIN-code: 6912-3783
Moscow
www.HealthEconomics.ru
D. U. Belousov
Russian Federation
Belousov Dmitry - General Director
SPIN-code: 6067-9067
Moscow
www.HealthEconomics.ru
References
1. Gombolevskij VA, Lajpan ASH, Badyul MI, et al. Osobennosti primeneniya kontrastnyh preparatov v luchevoj diagnostike / Seriya «Luchshie praktiki luchevoj i instrumental’noj diagnostiki». Vyp.15. Moscow: 2018. (In Russ).
2. Luchevaya diagnostika: Uchebnik Tom 1 / pod red. Trufanov G.M. Geotar-media; 2007. (In Russ).
3. Tyurin IE. Radiology in the russian federation in 2016. Journal of radiology and nuclear medicine. 2017;98(4):219-226. (In Russ). DOI: 10.20862/0042-4676-2017-98-4-219-226
4. Osnovy luchevoj diagnostiki i terapii: nacional’noe rukovodstvo. Seriya «Nacional’nye rukovodstva po luchevoj diagnostike i terapii» / pod red. Ternova SK. Geotar-media; 2012. (In Russ).
5. Murata N, et al. Gadolinium tissue deposition in brain and bone. Magn. Reson. Imaging. 2016;34(10):1359-1365. DOI: 10.1016/j.mri.2016.08.025
6. Maximova N, et al. Hepatic Gadolinium Deposition and Reversibility after Contrast Agent—enhanced MR Imaging of Pediatric Hematopoietic Stem Cell Transplant Recipients. Radiology. 2016;281(2):418-426. DOI: 10.1148/radiol.2016152846
7. Murata N, et al. Macrocyclic and Other Non—Group 1 Gadolinium Contrast Agents Deposit Low Levels of Gadolinium in Brain and Bone Tissue: Preliminary Results From 9 Patients With Normal Renal Function. Invest. Radiol. 2016;51(7):447-453. DOI: 10.1097/RLI.0000000000000252
8. Roberts DR, Holden KR. Progressive increase of T1 signal intensity in the dentate nucleus and globus pallidus on unenhanced T1-weighted MR images in the pediatric brain exposed to multiple doses of gadolinium contrast. Brain Dev. 2016;38(3):331-336. DOI: 10.1016/j.braindev.2015.08.009
9. European Medicines Agency. EMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans. Recommendations conclude EMA’s scientific review of gadolinium deposition in brain and other tissues 21 July 2017 EMA/457616/2017.
10. FDA Identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue Safety announcement [Электронный ресурс]. URL: https://www.fda.gov/downloads/drugs/drugsafety/ucm559654.pdf (дата обращения: 24.01.2019).
11. Pis’mo Ministerstva Zdravoohraneniya Rossijskoj Federacii Zayavitelyam registracii i proizvoditelyam linejnyh gadolinij-soderzhashchih lekarstvennyh preparatov ot 15.08.2018 goda nomer 20-3/1541. (In Russ).
12. Kolbin AS, Vilum IA. Assessment of the economic evaluation of the contrast agent MultiHance. Kachestvennaya klinicheskaya praktika. 2014;(1):57-67. (In Russ).
13. Postanovlenie Pravitel’stva № 871 ot 28 August 2014 «Ob utverzhdenii Pravil formirovaniya perechnej lekarstvennyh preparatov dlya medicinskogo primeneniya i minimal’nogo assortimenta lekarstvennyh preparatov, neobhodimyh dlya okazaniya medicinskoj pomoshchi». (In Russ).
14. Otraslevoj standart «Kliniko-ekonomicheskie issledovaniya. Obshchie polozheniya» Prikaz Minzdrava RF ot 27.05.2002 №163 vmeste s ost 91500.14.0001-2002. [Electronic resource]. (In Russ).
15. Metodicheskie rekomendacii po provedeniyu sravnitel’noj kliniko-ekonomicheskoj ocenki lekarstvennogo preparata. Utverzhdeny prikazom FGBU «CEKKMP» Minzdrava Rossii ot «23» december 2016 № 145-od [Electronic resource]. (In Russ). URL: http://rosmedex.ru/ocenka-texnologij-zdravooxraneniya/metodicheskie-rekomendacii/ (дата обращения: 02.12.2018).
16. Metodicheskie rekomendacii po ocenke vliyaniya na byudzhet v ramkah realizacii programmy gosudarstvennyh garantij besplatnogo okazaniya grazhdanam medicinskoj pomoshchi. Utverzhdeny prikazom FGBU «CEKKMP» Minzdrava Rossii ot «23» december 2016 145-od [Electronic resource]. (In Russ). URL: http://rosmedex.ru/ocenka-texnologij-zdravooxraneniya/metodicheskie-rekomendacii/ (дата обращения: 02.12.2018).
17. Koenig M, et al. Intra-individual, randomised comparison of the MRI contrast agents gadobutrol versus gadoteridol in patients with primary and secondary brain tumours, evaluated in a blinded read. Eur. Radiol. 2013;23(12):3287-3295. DOI: 10.1007/s00330-013-2946-3
18. Gutierrez JE, et al. Safety and Efficacy of Gadobutrol for Contrast-enhanced Magnetic Resonance Imaging of the Central Nervous System: Results from a Multicenter, Double-blind, Randomized, Comparator Study. Magn. Reson. Insights. 2015;8(8):1-10. DOI: 10.4137/MRI.S19794
19. Maravilla KR, et al. Are There Differences between Macrocyclic Gadolinium Contrast Agents for Brain Tumor Imaging? Results of a Multicenter Intraindividual Crossover Comparison of Gadobutrol with Gadoteridol (the TRUTH Study). Am. J. Neuroradiol. 2015;36(1):14-23. DOI: https://doi.org/10.3174/ajnr.A4154
20. Kanal E, Maravilla K, Rowley HA. Gadolinium Contrast Agents for CNS Imaging: Current Concepts and Clinical Evidence. Am. J. Neuroradiol. 2014;35(12):2215-2226. DOI: 10.3174/ajnr.A3917
21. Sajt Gosudarstvennogo reestra lekarstvennyh sredstv. Preparat Gadoteridol [Electronic resource]. (In Russ). URL: http://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=e691a00f-04f6-4539-bb2b-88f170de6ca2&t= (дата обращения: 15.02.2019).
22. Sajt Gosudarstvennogo reestra predel’nyh otpusknyh cen. Preparat Gadobutrol [Electronic resource]. (In Russ).] URL: http://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=d7d04ed2-156d-451e-a81b-77ac7499f785&t= (дата обращения: 15.02.2019).
23. Tarifnoe soglashenie na oplatu medicinskoj pomoshchi, okazyvaemoj po territorial’noj programme obyazatel’nogo medicinskogo strahovaniya goroda Moskvy na 2019 god ot «27» december 2018 goda, s prilozheniyami, Moscow [Electronic resource]. (In Russ). URL: http://www.mgfoms.ru/strahovye-kompanii/tarifi (дата обращения: 05.02.2019).
24. Shellock FG, et al. Safety characteristics of gadobenate dimeglumine: Clinical experience from intraand interindividual comparison studies with gadopentetate dimeglumine. J. Magn. Reson. Imaging. 2006;24(6):1378-1385. http://dx.doi.org/10.1002/jmri.20764
25. Schneider G, et al. Safety and adverse effects during 24 hours after contrastenhanced MRI with gadobenate dimeglumine (MultiHance) in children. Pediatr Radiol. 2013;43(2):202-211. DOI: 10.1007/s00247-012-2498-8.
26. Sajt Gosudarstvennogo reestra predel’nyh otpusknyh cen. Preparat Gadobutrol [Electronic resource]. (In Russ). URL: http://grls.rosminzdrav.ru/PriceLims.aspx?Torg=&Mnn=гадобутрол&RegNum=&Mnf=&Barcode=&Order=&PageSize=8&orderby=pklimprice&orderType=desc&pagenum=1 (дата обращения: 11.02.2019).
27. Sajt Federal’noj Antimonopol’noj Sluzhby [Electronic resource]. (In Russ). URL: https://fas.gov.ru/ (дата обращения: 22.02.2019).
28. Kliniko-ekonomicheskij analiz / pod red. Vorob’ev PA. N’yudiamed, 2008. (In Russ).
29. Guidelines on HealTheconomic Evaluation Consensus paper. Evelyn Walter, Susanne Zehetmayr. April 2006 [Электронный ресурс]. URL: http://www.ipf-ac.at/fileadmin/template/PDFalt/Konsens_Guidelines_en.pdf (дата обращения: 24.01.2019).
30. Baza dannyh «Kursor» soderzhashchaya konsolidirovannye dannye o tenderah i aukcionah lekarstvennyh sredstv [Electronic resource]. (In Russ). URL: http://www.cursor-is.ru (дата обращения: 22.10.2018).
31. Wang SY, et al. Risk of cerebral metastases for postoperative locally advanced non-small-cell lung cancer. Lung Cancer. 2009;64(2):238-243. DOI: 10.1016/j.lungcan.2008.08.012
32. Naskhletashvili DR, et al. Targetnaya terapiya ili obluchenie vsego golovnogo mozga pri mnozhestvennyh (>3 ochagov) metastazah: s chego nachinat’ lechenie? Malignant tumours. 2016;4(1):67-73. (In Russ). DOI: 10.18027/2224—5057—2016—4s1—67—73
33. Zlokachestvennye novoobrazovaniya v Rossii v 2017 godu (zabolevaemost’ i smertnost’). /pod red. Kaprin AD, Starinskij VV, Petrova GV. Moscow; 2018 (In Russ).
34. Tessen HW, Hutzschenreuter U, Steffens CC, et al. The treatment of lung cancer in German outpatient centres. Data from a clinical registry — TLK Registry. Onkologie. 2011;34(s6):90-184.
35. Howlader N. SEER (Surveillance, Epidemiology, and End Results) Cancer Statistics Review, 1975 — 2010 [Электронный ресурс]. URL: http://seer.cancer.gov/csr/1975_2010/ (дата обращения: 19.10.2018).
Review
For citations:
Cheberda A.E., Belousov D.U. Clinical and economic analysis of macrocyclic gadolinium-based compounds for use in magnetic resonance imaging diagnostics. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2019;(3):23-31. (In Russ.) https://doi.org/10.24411/2588-0519-2019-10080