Health and economic impact of dapagliflozin for type 2 diabetes patients who had or were at risk for atherosclerotic cardiovascular disease in the Italian general practitioners setting: a budget impact analysis.

Publisher: Springer Verlag Country of Publication: Germany NLM ID: 9200299 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-5233 (Electronic) Linking ISSN: 09405429 NLM ISO Abbreviation: Acta Diabetol Subsets: MEDLINE

Publication: Berlin : Springer Verlag
Original Publication: Berlin : Springer International, c1991-

Diabetes Mellitus, Type 2*/drug therapy ; Diabetes Mellitus, Type 2*/economics ; Diabetes Mellitus, Type 2*/complications ; Benzhydryl Compounds*/economics ; Benzhydryl Compounds*/therapeutic use ; Glucosides*/therapeutic use ; Glucosides*/economics ; Atherosclerosis*/economics ; Atherosclerosis*/drug therapy; Humans ; Italy/epidemiology ; General Practitioners/statistics & numerical data ; General Practitioners/economics ; Budgets/statistics & numerical data ; Cost-Benefit Analysis ; Cardiovascular Diseases/economics ; Cardiovascular Diseases/prevention & control ; Cardiovascular Diseases/epidemiology ; Sodium-Glucose Transporter 2 Inhibitors/therapeutic use ; Sodium-Glucose Transporter 2 Inhibitors/economics ; Hypoglycemic Agents/economics ; Hypoglycemic Agents/therapeutic use ; Male ; Female ; Middle Aged

Aim: In 2022, in Italy, general practitioners (GPs) have been allowed to prescribe SGLT2i in Type 2 Diabetes (T2D) under National Health Service (NHS) reimbursement. In the pivotal clinical trial named DECLARE-TIMI 58, dapagliflozin reduced the risk of hospitalization for heart failure, CV death and kidney disease progression compared to placebo in a population of T2D patients. This study evaluated the health and economic impact of dapagliflozin for T2D patients who had or were at risk for atherosclerotic cardiovascular disease in the Italian GPs setting.
Methods: A budget impact model was developed to assess the health and economic impact of introducing dapagliflozin in GPs setting. The analysis was conducted by adopting the Italian NHS perspective and a 3-year time horizon. The model estimated and compared the health outcomes and direct medical costs associated with a scenario with dapagliflozin and other antidiabetic therapies available for GPs prescription (scenario B) and a scenario where only other antidiabetic therapies are available (scenario A). Rates of occurrence of cardiovascular and renal complications as well as adverse events were captured from DECLARE-TIMI 58 trial and the literature, while cost data were retrieved from the Italian tariff and the literature. One-way sensitivity analyses were conducted to test the impact of model parameters on the budget impact.
Results: The model estimated around 442.000 patients eligible for the treatment with dapagliflozin in the GPs setting for each simulated year. The scenario B compared to scenario A was associated with a reduction in the occurrence of cardiovascular and renal complication (-1.83%) over the 3 years simulated. Furthermore, the scenario A allowed for an overall cost saving of 102,692,305€: 14,521,464€ in the first year, 33,007,064€ in the second and 55,163,777€ in the third. The cost of cost of drug acquisition, the probability of cardiovascular events and the percentage of patients potentially eligible to the treatment were the factor with largest impact on the results.
Conclusions: The use of dapagliflozin in GPs setting reduce the number of CVD events, kidney disease progression and healthcare costs in Italy. These data should be considered to optimize the value produced for the T2D patients who had or were at risk for atherosclerotic cardiovascular disease.
(© 2024. The Author(s).)

Diabetes Obes Metab. 2018 Feb;20(2):344-351. (PMID: 28771923)
Diabetes Obes Metab. 2020 Dec;22(12):2364-2374. (PMID: 32744392)
J Manag Care Spec Pharm. 2023 Sep;29(9):1045-1053. (PMID: 37610112)
Value Health. 2011 Jul-Aug;14(5 Suppl 1):S137-40. (PMID: 21839888)
World J Diabetes. 2015 Jun 25;6(6):850-67. (PMID: 26131326)
J Med Econ. 2023 Jan-Dec;26(1):547-553. (PMID: 36987694)
Int J Cardiol. 2011 Jul 1;150(1):111-2. (PMID: 21605921)
Med Decis Making. 2012 Sep-Oct;32(5):722-32. (PMID: 22990087)
Eur Heart J. 2023 Oct 14;44(39):4043-4140. (PMID: 37622663)
Lancet. 2019 Jan 5;393(10166):31-39. (PMID: 30424892)
Circulation. 2019 May 28;139(22):2516-2527. (PMID: 30882239)
Inform Prim Care. 2011;19(4):251-5. (PMID: 22828580)
N Engl J Med. 2019 Jan 24;380(4):347-357. (PMID: 30415602)
Obes Facts. 2017;10(3):261-272. (PMID: 28601866)
Diabetes Ther. 2018 Jun;9(3):1037-1047. (PMID: 29600505)
Diabetes Obes Metab. 2023 Oct;25(10):3020-3029. (PMID: 37435776)
Cureus. 2023 Apr 10;15(4):e37388. (PMID: 37181972)
Eur Heart J. 2021 Mar 31;42(13):1216-1227. (PMID: 33792669)
Diabetes Care. 2024 Jan 1;47(Supplement_1):S5-S10. (PMID: 38078579)
Diabetes Technol Ther. 2019 Aug;21(8):415-422. (PMID: 31339784)
Arterioscler Thromb Vasc Biol. 2019 Apr;39(4):558-568. (PMID: 30786741)
J Gerontol A Biol Sci Med Sci. 2011 Jan;66(1):66-7. (PMID: 20980360)
Drugs Real World Outcomes. 2024 Mar;11(1):81-90. (PMID: 37898577)
Lancet Diabetes Endocrinol. 2017 Sep;5(9):709-717. (PMID: 28781064)
Kidney Int. 2022 Nov;102(5):990-999. (PMID: 36272755)
N Engl J Med. 2017 Aug 17;377(7):644-657. (PMID: 28605608)
JAMA Netw Open. 2021 Jul 1;4(7):e2114501. (PMID: 34313742)
Diabetes Metab Syndr Obes. 2022 Nov 15;15:3533-3541. (PMID: 36411790)
J Med Econ. 2020 Mar;23(3):271-279. (PMID: 31526202)
Nat Commun. 2023 Dec 14;14(1):8318. (PMID: 38097619)
Am Heart J. 2018 Dec;206:11-23. (PMID: 30290289)
N Engl J Med. 2015 Nov 26;373(22):2117-28. (PMID: 26378978)
Lancet Neurol. 2015 Jan;14(1):57-64. (PMID: 25435387)
Circulation. 2021 Jul 6;144(1):74-84. (PMID: 34228476)
J Epidemiol Glob Health. 2018 Dec;8(1-2):1-7. (PMID: 30859780)
Eur J Health Econ. 2017 Sep;18(7):847-858. (PMID: 27699568)
Int J Cardiol. 2023 Apr 1;376:83-89. (PMID: 36736672)
Diabetes Obes Metab. 2021 Apr;23(4):1020-1029. (PMID: 33368855)
Endocrinol Metab Clin North Am. 2021 Sep;50(3):337-355. (PMID: 34399949)
J Am Heart Assoc. 2023 Aug 15;12(16):e030578. (PMID: 37581396)
Eur J Heart Fail. 2017 Nov;19(11):1551-1553. (PMID: 28849615)
BMJ. 2021 Jan 13;372:m4573. (PMID: 33441402)
N Engl J Med. 2019 Nov 21;381(21):1995-2008. (PMID: 31535829)
Diabetes Obes Metab. 2019 May;21(5):1136-1145. (PMID: 30609272)
N Engl J Med. 2002 Feb 7;346(6):393-403. (PMID: 11832527)
Circulation. 2019 May 28;139(22):2528-2536. (PMID: 30882238)
J Am Coll Cardiol. 2009 May 26;53(21):1925-32. (PMID: 19460605)
Int J Endocrinol. 2015;2015:832484. (PMID: 25883650)
Clin Ther. 2023 Jul;45(7):627-632. (PMID: 37270374)
J Epidemiol Glob Health. 2015 Dec;5(4 Suppl 1):S35-43. (PMID: 26073574)
Value Health Reg Issues. 2023 Jan;33:91-98. (PMID: 36327769)
Diabetes Care. 2018 Jan;41(Suppl 1):S38-S50. (PMID: 29222375)
JAMA Cardiol. 2021 Aug 1;6(8):926-935. (PMID: 34037681)
Lancet. 2014 Mar 22;383(9922):1068-83. (PMID: 24315620)

No number AstraZeneca

Keywords: Budget impact analysis; Dapagliflozin; General Practitioners; Italy

0 (Benzhydryl Compounds)
1ULL0QJ8UC (dapagliflozin)
0 (Glucosides)
0 (Sodium-Glucose Transporter 2 Inhibitors)
0 (Hypoglycemic Agents)

Date Created: 20240418 Date Completed: 20240816 Latest Revision: 20240819

20240819

PMC11329540

10.1007/s00592-024-02276-3

38634912