Scottish cost regulators have opened the National Health Service door to Genzyme's Renvela for patients with kidney disease, but turned away Allergan's Botox for migraine and Bayer's contraceptive Yasmin.
The Scottish Medicines Consortium has endorsed the use of Renvela (sevelamer carbonate) as a treatment for second-line management of hyperphosphataemia in adult patients with chronic kidney disease (CKD) receiving haemodialysis, after deeming the drug a cost-effective use of resources for the NHS.
Hyperphosphatemia is caused by the inability of diseased kidneys to filter out phosphorous from the body, leading to excess levels causing calcification of tissues and leaving patients at greater risk from developing heart disease.
If left untreated, the condition can also cause bone pain, skeletal deformities and fractures, and so maintaining optimal levels of serum phosphorous is an important element in the care of patients with CKD, the firms notes.
Renvela is one of two phosphate binders on the market that do not contain either calcium or a metal, and regulatory approval (in 2009 in Europe) was based on clinical studies showing the drug's ability to control levels of phosphate so that they remain within the recommended range.
The manufacturer’s submission to the SMC was only related to the control of hyperphosphataemia in adult patients receiving haemodialysis, so the regulator was unable to recommend the use of Renvela in pre-dialysis patients or in peritoneal dialysis patients, it said.
Botox, Yasmin out
Meanwhile, the cost watchdog said it is not recommending the use of Allergan's Botox (botulinum toxin type A) in the prevention of headaches in adults with chronic migraine.
The SMC conceded that, in a pooled analysis of two Phase III studies, Botox was superior to placebo for the primary endpoint of headache days. "However, there were weaknesses in the clinical data that limit the ability to assess its likely clinical effectiveness in the target treatment population," it explained.
Elsewhere, Bayer's Yasmin (drospirenone/ethinylestradiol) was also turned away, because the regulator concluded that it has similar contraceptive effectiveness to other combined oral contraceptives in routine use with no significant differences in side effects.
"The manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC", it said.