Sevelamer

5.1 The PBAC recommended the General Schedule and Section 100 (Highly Specialised Drugs Program – Public and Private Hospital) Authority Required listing of sevelamer carbonate, as powder for suspension, for hyperphosphataemia in patients undergoing dialysis for chronic kidney disease.PSD · Nov 2017

5.2 The PBAC considered that the proposed restriction was appropriate, noting that it was similar to the current PBS listing for sevelamer hydrochloride tablets. The PBAC advised that episodicity, severity and condition requiring the indication to be ‘chronic’ and of a ‘severe’ nature in ‘adult patients with stage 4 and 5 chronic kidney disease’, respectively, be removed from the indication to maintain consistency with the current PBS listing for …PSD · Nov 2017

4.3 The TGA-approved Australian Product Information (PI) indicated that the recommended dosage of the 2.4 g powder for suspension of sevelamer carbonate is with each meal, three times a day, resulting in a daily administration of up to 7.2 g (2.4 g x 3) of powder for suspension. However, the PI also recommended a starting dose of between 2.4 g to 4.8 g per day.PSD · Nov 2017

4.4 The submission stated that two of the efficacy and safety cross over studies considered by the TGA were relevant to support the PBS listing of sevelamer carbonate on a cost-minimisation basis to sevelamer hydrochloride (Study SVCARB00205 and Study GD3-163-201). The Pre-PBAC response (p1) clarified that although not implicitly stated, the submission sought for price parity on the basis of a per milligram equivalence.PSD · Nov 2017