Introducing RefluxStop device (Implantica) as a treatment option for gastroesophageal reflux disease (GERD) patients treated within the Italian National Health Service (Servizio Sanitario Nazionale, SSN), is likely to provide substantial clinical benefits at the expense of a marginal budget impact on the SSN over a five-year time horizon, according to researchers from Italy and the UK. The findings were reported in the paper, ‘The Economic Impact of Introducing RefluxStop for Refractory Gastroesophageal Reflux Disease on the Italian Healthcare System’, published in PharmacoEconomics – Open.
According the company, RefluxStop aims to restore the normal anatomy of the gastroesophageal junction, gastroesophageal flap valve, and angle of His without affecting passage of food. RefluxStop received a CE mark across European Union countries in 2018 based on favourable results of a prospective, single-arm, multi-centre trial assessing its safety and efficacy in 50 patients with chronic GERD requiring daily PPI therapy.
A recent health economic evaluation demonstrated the cost-effectiveness of RefluxStop from the perspective of the National Health Service in the United Kingdom The purpose of this paper was to estimate the budgetary impact of introducing RefluxStop as a therapeutic option from the SNN perspective.
A budget impact model was developed in line with the recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). The model structure was intended to estimate the budget impact of introducing RefluxStop over a five-year time horizon (beginning in 2021–2022). A time horizon of 1–5 years is commonly used as per these guidelines. The scenarios considered included (i) existing interventions (i.e., PPI-based medical management, laparoscopic Nissen fundoplication, and MSA using the LINX system) but without RefluxStop; and (ii) currently existing interventions as listed but with inclusion of RefluxStop.
All those with potential to benefit from the introduction of RefluxStop (i.e., GERD patients receiving PPI therapy and/or those without previous antireflux surgery that are eligible and willing to undergo an operation) were included in the modeled population. Both prevalent patients with GERD and incident cases (i.e., patients newly developing GERD during the model time horizon) were considered in the model.
The major cost categories captured included the following:
Treatment costs, comprising costs of PPI medication, surgical treatments (with the latter including procedural costs and, for MSA and RefluxStop only, device and training costs).
Costs of diagnosing and treating Barrett’s esophagus and esophageal cancer in those developing these conditions.
Costs of managing AEs associated with PPIs (i.e., chronic kidney disease, cardiovascular events, fractures, pneumonia, Clostridium difficile infection and gastric cancer.
Costs of managing AEs associated with surgical management (i.e., conversion from laparoscopic to open surgery, oesophageal dilation, additional surgery for major complications and, for RefluxStop and MSA only, device removal).
First-year costs were higher for surgical management options than for medical therapy due to surgery and device costs. Surgical costs incurred during years 2–5 were predominantly related to follow-up, and thus lower than costs for medical management.
In the first year of availability, the number of patients receiving RefluxStop was estimated at 42, which then increased to 177 in the fifth year, corresponding with a decline in the annual number of patients undergoing Nissen fundoplication (from 697 in year 1 to 550 in year 5). Introduction of RefluxStop was associated with improved clinical outcomes over the five-year time horizon of the model, with 95 surgical failures, 11 reoperations, and 64 endoscopic oesophageal dilations avoided relative to the scenario devoid of RefluxStop utilisation.
The individual 1-year, 3-year, and 5-year budget impacts of introducing RefluxStop were €242,641, €710,651, and €1,004,946 per year, respectively. This corresponded to 0.063%, 0.197%, and 0.316% increases per year in the overall Italian SSN expenditure for GERD, respectively.
In the described scenario in which the uptake rate of RefluxStop was halved (i.e., reduced from 42 to 21 patients in Year 1, or reduced from 177 to 89 patients in Year 5, see Table 3) relative to the base case, the 5-year reductions in the number of surgical failures, reoperations, and endoscopic dilations were 48, 5, and 32, respectively. The 1-year budget impact of RefluxStop introduction in this halved scenario was €121,320, corresponding to a 0.032% increase in overall SSN expenditure for GERD treatment in Italy. The 5-year budget impact was €502,473, corresponding to a 0.158% increase in Italian SSN expenditure for GERD.
The scenario exploring a doubled rate (i.e., increased from 42 to 84 patients in Year 1, or increased from 177 to 354 patients in Year 5, see Table 3) of RefluxStop uptake observed 5-year reductions in the number of surgical failures, reoperations, and endoscopic dilations of 190, 21, and 129, respectively. The budget impact associated with this scenario was €485,281 over 1 year, corresponding to a 0.126% increase in Italian SSN spending on GERD management. The 5-year budget impact in this scenario was €2,009,893, corresponding to a 0.632% increase in SSN spending.
In the scenario in which the increase of RefluxStop market share reduced the market share of both Nissen Fundoplication and MSA equally, the budget impact associated with this scenario was €75,402 over 1 year, corresponding to a 0.020% increase. The 5-year budget impact was €819,549, corresponding to a 0.258% increase in SSN spending.
In a scenario where the surgery rate per 100,000 population was halved (0.7%), the 5-year reductions in the number of surgical failures, reoperations, and endoscopic dilations were 48, 5, and 32, respectively. The budget impact associated with an increased uptake of RefluxStop in Italy was €121,320 over 1 year, corresponding to a 0.032% increase in Italian SSN spending on GERD management, and €502,473 over 5 years, corresponding to a 0.159% increase in spending.
In a scenario where the surgery rate per 100,000 population was doubled (2.78%), the 5-year reductions in surgical failures, reoperations, and endoscopic dilations were 190, 21, and 129, respectively. The budget impact associated with increased uptake of RefluxStop in Italy was €485,281 over 1 year, corresponding to a 0.125% increase in SSN expenditure for GERD management, and €2,009,893 over 5 years, corresponding to a 0.623% increase in spending.
“Introducing RefluxStop as a treatment option for GERD patients treated within the Italian SSN is likely to provide substantial clinical benefits at the expense of a marginal budget impact on the SSN over a 5-year time horizon,” the authors concluded. “Considering the arguably likely increase in both medical costs and the wider impact of GERD in Italy, an effective treatment option for GERD patients that is also economically acceptable in the short term is likely to bring forth substantial benefits to patients and the Italian SSN.”
The findings were reported in the paper, ‘The Economic Impact of Introducing RefluxStop for Refractory Gastroesophageal Reflux Disease on the Italian Healthcare System’, published in PharmacoEconomics – Open. To access this paper, please click here
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