“…First, CS is a component of a rare disease, and the number of total prevalent and incident patients eligible for TE was estimated at approximately 80 patients each year over the 5 years; according to market share assumptions, only 44 patients would initiate treatment with TE by year 5. This aligns with findings from a 2014 study assessing the budget impact of orphan medicinal products in Sweden and France, in which the low overall number of annual sales made the costs associated with these treatments sustainable [53]. Further to this, the TE budget impact model assumed that patients who responded to TE would gradually discontinue treatment either as the disease progressed, TE -without TE scenario Total costs, € 2,793,111 2,742,376 2,659,435 2,574,530 2,494,143 13,263,595 SSA + TE drug costs 1,565,879 1,534,877 1,486,779 1,438,271 1,392,723 7,418,528 TE 250 mg ------SSA Second, the improved diarrhoea symptom control resulting from treatment with TE translated into overall healthcare system cost savings that offset the pharmacy cost of TE, an outcome previously reported for other treatments in rare chronic diseases [54,55].…”