b'Guidance for Semaglutide 2mg (OZEMPIC) Injection June 2022 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist ExecutivesSemaglutide 2mg (OZEMPIC) is now available in an 8mg/3mL prefilled pen.1 This guidance is not intended to replace the National criteria for use.The FDA approval was based on the 40-week SUSTAIN FORTE trial comparing semaglutide 2mg to semaglutide 1mg as add-on to metformin +/- sulfonylureas in 961 patients with type 2 diabetes.2Patient demographics include mean age 58 years, 59% men, 88% white,mean duration of diabetes 9.5 years, mean A1C 8.9%, mean fasting plasma glucose 194mg/dL, mean weight 99.3kg, and 53% on sulfonylureas.The primary outcome was change from baseline at week 40 in A1C. The estimated treatment difference between 2mg and 1mg was 0.2%.Changes in select glycemic outcomes and weight are shown in the table.Semaglutide 2mgSemaglutide 1mgETD [95%CI] Change in A1C (%) All pts-2.1-1.9-0.2 [-0.31 to -0.04] Metformin only-2.3-2.1-0.2 [-0.4 to -0.04]Metformin + SU-2.0-1.8-0.2 [-0.41 to -0.06] A1C 7% (%pts)64 56- FPG (mg/dL)(kg)-59-55- Change in BW All pts-6.4-5.6-0.77[-1.55 to 0.01] Metformin only-7.7-6.6-1.15 [-2.24 to -0.06]Metformin + SU-6.2-5.5-0.72 [-1.7 to 0.31] % weight loss7.26.2-0.98% [-1.75 to -0.2] BW=body weight; ETD=estimated treatment difference; FPG=fasting plasma glucose; SU=sulfonylurea Not statistically significantMean changes in blood pressure from baseline at week 40 were 5.3 mmHg systolic and 08 mmHg diastolic with Source: https://www.va.gov/formularyadvisor/DOC/328semaglutide 2.0 mg and 4.5 mmHgsystolic and 0.4 mmHg diastolic with semaglutide 1.0 mg. u From Page 92Adverse events including gastrointestinal (nausea, vomiting, diarrhea) and hypoglycemia were comparable.Other weights at 3 months, give or take 1 month, and didin weight loss between the two doses prescribed, 0.5 adverse events of interest (diabetic retinopathy complications, hepatobiliary, acute gallstone disease, pancreatitis, not have one of the exclusionary conditions. mg and 1 mg, also was negligible.cardiovascular disease, allergic reactions) were not increased with the 2mg dose compared to the 1mg dose. The 177 veterans included 111 participants age 65Adverse events that led to discontinuation or dose or older and 66 between the ages of 18 and 64. Thedecreaseoccurredatahigherrateintheyounger older group had lower baseline A1c (8.2% vs. 8.9%),group. Two of the elderly veterans discontinued the Suggestions when considering semaglutide 2mg as an intensification option for patients with type 2 diabetes higher average age (72 vs. 56) and higher rate ofmedication because of nausea, vomiting, abdominal treated with semaglutide 1mg in need of additional glycemic control heart failure (26.1% vs. 10.6%). The elderly veteranspain or decreased appetite, while three of those under 1.Verify adherence to current therapy were 95.5% male and 51% white, while the youngerage 65 discontinued for similar gastrointestinal (GI) 2.Optimize current non GLP1 agonist anti-glycemic medications as appropriateA cohort was 87.9% male and 42% white.reasons.Onealsoexperiencedhypoglycemia.The demographics are fairly typical of thefl A pop- r insulin i veteran in the younger group decreased the 3. Consider addition of empagli V ozin o fourthf appropriate ulation, the researchers noted. The overall veterandose from 0.5 mg to 0.25 mg because of GI issues.4.Consider using 2 injections of 1mg national contract semaglutide, if appropriate and as a shared decision population in the United States of America is mostlyBased on the results of this study, age is likely with the patient. 3comprised of non-Hispanic white, elderly male vet- notarobustpredictorofsemaglutidesinfluence erans, they said. The sample population reflectson weight in veterans diagnosed with T2DM, the 1 Semaglutide ( OZEMPIC) is available on VANF, with doses up to 1 mg on National Contract (2mg dose is not on National similar characteristics and supports the studys rel- VA team concluded. Larger, higher-powered pro-Contract) evance to the larger veteran population. spectivestudiesdesignedtoaccountformultiple 2 The researchers found that, while the elderly veter- confounders would be necessary to further explore Fras JP, et al. Efficacy and safety of once-weekly semaglutide 20 mg versus 10 mg inpatients with type 2 diabetes (SUSTAIN ans lost slightly less weight at 3 months and slightlythis endpoint, especially with the recent approval of FORTE):a double-blind, randomized, phase 3B trial. Lancet Diabetes Endocrinol. 2021 Sep;9(9):563-574.more at 6 months as measured by both percentage ofsemaglutide 2 mg SC weekly for T2DM.3 PBM weight shedntee adequate supply of se than1body cannot guara and reduction in kilogramsmaglutide 1mg should use be increased significantly beyond contract estimatesHuynh G, Runeberg H, Weideman R. Evaluating Weight Loss With younger veterans, the differences were not statisti- Semaglutide in Elderly Patients With Type II Diabetes. J Pharm Tech-cally significant. The presence of heart failure alsonol. 2023 Feb;39(1):10-15. doi: 10.1177/87551225221137493. Epub did not affect the results of the study. The difference2022 Nov 30.98'