Page 109 - GHES-2-4
P. 109

Global Health Economics and
            Sustainability
                                                                           Cost-effectiveness of oral semaglutide in Greece


            manifests in adulthood, its prevalence among younger   with insulin, to achieve glycemic control (Davies et al.,
            populations has risen significantly in recent years, placing   2018; Buse et al., 2020).
            a substantial burden on health systems globally. Diabetes is   The American Diabetes Association (ADA) and the
            particularly prevalent in Greece, with a reported prevalence   European Association for the Study of Diabetes (EASD)
            of 11.9% (Makrilakis et al., 2021), which is higher than the   highlight the importance of managing cardiovascular risk in
            average prevalence among adults in Europe (IDF, 2021).   diabetic patients as early as possible, recommending the use
            According to data from the Greek e-prescription system,   of medications that reduce this risk. The ADA Standards of
            there were 1.17 million diabetes patients in Greece in 2022,   Care (2022) specifically recommend GLP-1 receptor agonists
            with 91.84% of these cases being Type 2 diabetes.
                                                               or sodium-glucose cotransporter-2 (SGLT-2) inhibitors for
              If not controlled in its early stages, Type 2 diabetes can   diabetic patients with established cardiovascular disease.
            lead to numerous complications, including macrovascular   In April 2020, the European Medicines Agency (EMA)
            and microvascular issues. Cardiovascular diseases are the   granted marketing authorization for the first GLP-1 analog
            most common diabetes-related complications, severely
            affecting approximately 32% of patients (Einarson et al.,   that  is orally  administered  daily. According  to  the EMA,
                                                               oral semaglutide is indicated for the treatment of Type  2
            2018). These complications are the primary causes of death   diabetes patients who are inadequately controlled, either
            among patients with Type 2 diabetes, with cardiovascular   as monotherapy when metformin is not appropriate or
            diseases responsible for half of these deaths (Morrish   in combination with other medications. The efficacy and
            et al., 2001). Patients with Type 2 diabetes are more likely
            to succumb to cardiovascular diseases than those without   safety of oral semaglutide were evaluated in the PIONEER
            Type  2 diabetes (Huxley et al., 2006). Unsurprisingly,   clinical trial program, specifically in PIONEER 2, 3, and
            diabetes-related complications negatively impact patients’   4, which were 52-week, double-blind, double-dummy,
                                                               active-  and placebo-controlled, parallel-group, multicenter,
            health-related quality of life (HRQoL), with uncontrolled
            patients  experiencing  significant  deteriorations  in  their   multinational trials. These trials compared oral semaglutide
            quality of life compared to those who are well-managed   14  mg with empagliflozin 25  mg, sitagliptin 100  mg, and
            (Rubin & Peyrot, 1999; UKPDS, 1999).               liraglutide 1.8 mg (Pratley et al., 2019; Rodbard et al., 2019;
                                                               Rosenstock  et al., 2019). The treatment policy estimand
              Diabetes imposes a substantial financial burden on   was used to consider clinical efficacies for all patients,
            health systems and societies, with the IDF estimating   regardless of treatment discontinuation. The PIONEER trials
            that approximately USD 850 billion was spent globally on   examined a range of single and composite outcomes over
            treating diabetes and its related complications in 2017. This   52 weeks, providing a clinically meaningful assessment of the
            figure is predicted to exceed USD 1 trillion by 2030 (IDF,   effectiveness of these different treatments (Pratley et al., 2019).
            2021). The majority of diabetes-related costs are attributed
            to complications, which can be avoided through access to   The present analysis investigated the cost per patient
            innovative treatments that ensure effective disease control.   of achieving seven treatment goals with oral semaglutide
            A report by Kanavos et al. (2012) showed that in the EU5,   14 mg versus empagliflozin 25 mg, sitagliptin 100 mg, and
            the cost of pharmacotherapies used to treat diabetes-  liraglutide 1.8 mg from the perspective of the Greek third-
            related complications  was 3  times  higher  than  the  drug   party payer (EOPYY). The treatment targets examined were:
            acquisition costs for treating diabetes.           (i) HbA1c ≤6.5%, (ii) HbA1c <7%, (iii) ≥1%-point HbA1c
                                                               reduction, (iv) HbA1c <7% without hypoglycemia and no
              The primary aim of diabetes therapy is to prevent   weight gain, (v) weight loss ≥5%, (vi) weight loss ≥10%, and
            the manifestation of diabetes-related complications   (vii) ≥1%-point HbA1c reduction and weight loss ≥3%.
            and  to improve  patients’ HRQoL, which  requires
            adequate glycemic control (Hemoglobin A1C [HbA1c]   2. Data and methods
            <7%). Current therapeutic options for Type 2 diabetes   2.1. Clinical effectiveness
            include biguanides, sulfonylureas, thiazolidinediones,
            dipeptidyl peptidase-4 inhibitors, sodium-glucose   Clinical effectiveness data on the percentage of patients
            co-transporter-2  inhibitors,  meglitinides,  glucagon-  achieving the seven examined treatment targets were
            like peptide-1 (GLP-1) receptor agonists, and insulin.   retrieved from the PIONEER 2, 3, and 4 clinical trials, where
            Metformin, along with lifestyle modifications, is the   oral semaglutide 14 mg was compared with empagliflozin
            most commonly employed first-line treatment. However,   25 mg, sitagliptin 100 mg, and liraglutide 1.8 mg (Rodbard
            due to the progressive and chronic nature of the disease,   et al., 2019; Rosenstock et al., 2019; Pratley et al., 2019).
            most patients require therapy intensification with the   This  study utilized  data  on  the  percentage of  patients
            coadministration of injectable or oral therapies, along   achieving treatment goals at 52 weeks (Table 1).


            Volume 2 Issue 4 (2024)                         2                        https://doi.org/10.36922/ghes.3032
   104   105   106   107   108   109   110   111   112   113   114