Empagliflozin demonstrates a major reduction in adverse CV events, CV death as well as hospitalisation for heart failure (HF) in patients who suffer from T2DM with known CVD, when administered as an add-on to usual care.6
Empagliflozin has shown to be superior to standard of care in reducing the composite of non-fatal stroke, non-fatal MI, and CV death as seen in Table 1.7
A study performed in patients with T2DM at high risk for CV events, demonstrated those who received empagliflozin along with the standard care had a significantly reduced risk of microvascular outcome events than those receiving a placebo, a difference that was driven by a lower risk of progression of kidney disease (as defined by incident or worsening nephropathy).8
The patients assigned empagliflozin showed a reduced risk of progression to macroalbuminuria as well as clinically relevant renal outcomes, such as a doubling of the serum creatinine level and initiation of renal-replacement therapy.8
The outcomes study by Wanner et al clearly demonstrated the benefit of empagliflozin over standard of care as depicted in Figure 1 below, in patients in patients suffering T2DM with high-risk cardiovascular disease. 9
A significant reduction in worsening of nephropathy, progression to macroalbuminuria, doubling of serum creatinine, and initiation of replacement therapy was observed. Given the costs associated with dialysis and renal transplants this translates into a major impact on, not only clinical but also, cost outcomes of the disease.
From Table 1, it is obvious that the impact of treating high risk CV patients with empagliflozin translates into meaningful and achievable outcomes within an acceptable number needed to treat eg exposure to benefit is realistically achievable.
Cost considerations in a South African context
With the introduction of newer molecules onto the market the questions are always ‘is this benefit large enough and is it fundable’?
To answer these questions, empagliflozin was specifically researched within the South African medical schemes environment where the product was subject to single exit priceregulation. Medical scheme data relating to incidence and prevalence then informed the models used in the analyses. 10
The aim was to assess the cost impact of adding empagliflozin to usual care in patients suffering from T2DM in South Africa over a one- to three-year time horizon. Affordability considered the budget impact and used as data sources Council of Medical Schemes (published) data as well as cost of typical care in South Africa medical scheme’s environment (claims data).
The event rate was based on the Empagliflozin, Cardiovascular Outcomes, and Mortality in T2DM study (EMPA-REG) outcomes.8,9 Furthermore, the incremental cost per life per month was calculated for CV death averted, and incremental cost per life saved.
South Africa’s self-insured population (2019 base year) was used as a base for model exposure (all individuals funded by medical schemes in South Africa) (n=8 953 076).5
A total of 49% of individuals were registered on scheme data as suffering from T2DM and 32% with established CV disease (model assumed, conservatively, the percentages to carry forward over three-year time horizon).
The assumption that empagliflozin will have a 6% baseline exposure with a 33% increase per annum (9 503, 12 670, and 16947 respectively per year) was used.
Drug use was based on IQVIA data 2019 and prices as per 2019 Drug Price file converted to United States dollar at November 2019 exchange rate and increased by 4.53%/year and the cost of consumables was based on Discovery Health Formulary 2019.
Figure 2 clearly demonstrates the budget impact of adding empagliflozin to usual care in patients with high-risk CVD. The cost is affected significantly by event rate reduction and the price of empagliflozin.
Event management cost decreased by 23%, the number of lives saved was 305 and the incremental cost per life saved was estimated at $17 999. The sensitivity analysis demonstrated sensitivity to cost of empagliflozin, proportion of patients suffering T2DM with increased CV risk, cost of CV death and insulin dose in usual care arm. The cost of renal dialysis per life saved is estimated at $30 531, which is well above the incremental cost calculated for a life saved at U$17 999 and should therefore fall within the medical schemes’willingness to fund threshold.
If South African Medical Schemes are willing to fund interventions at much higher costs than what will be incurred by a lifesaving intervention such as empagliflozin. The budget impact translates to 36 South African cents per beneficiary per month to achieve these outcomes, should all patients who qualify, as per model, receive empagliflozin in year three.10
Empagliflozin exhibits a low side effect profile when used in combination with other anti-diabetic medications.3 Patients with T2DM at high risk of CV events demonstrate a decreased progression of kidney disease when used in combination with the standard of care and isassociated with a lower risk of clinically relevant renal events.9
Considering the cost of care of CV death, CV event rate, and renal disease progression,empagliflozin should be used according to Society for Endocrinology, Metabolism and Diabetes of South Africa guidelines as it is highly cost-effective with marginal impact on the budget.
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