BindRen colestilan regulatory update
Germany's Federal Joint Committee (G-BA) said in a final benefit assessment that BindRen colestilan from Mitsubishi Tanabe has "no additional benefit" vs. sevelamer or calcium- or aluminum-containing phosphate binders to treat hyperphosphatemia in patients with stage 5 chronic kidney disease (CKD) receiving hemodialysis or peritoneal dialysis. The European Commission approved BindRen for the indication in January. In a July preliminary assessment, Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said BindRen is worse than sevelamer to treat patients in whom a calcium- or aluminum-containing phosphate binder is contraindicated (see BioCentury, July 15).
G-BA said that after legislation eliminating the requirement to use the lowest-cost comparator in assessments went into effect, it evaluated BindRen vs. sevelamer for BindRen's approved indication, rather than just the subpopulation of patients for whom other treatments are contraindicated. ...