Note that this document is not NICE's final guidance on this technology. The recommendations in section 1 may change after consultation.
1 Appraisal Committee's preliminary recommendations
1.1 Pegloticase is not recommended within its marketing authorisation, that is, for treating severe debilitating chronic tophaceous gout in adults who may also have erosive joint involvement and in whom xanthine oxidase inhibitors at the maximum medically appropriate dose have failed to normalise serum uric acid or for whom these medicines are contraindicated.
1.2 People currently receiving pegloticase that is not recommended according to 1.1 should be able to continue treatment until they and their clinician consider it appropriate to stop.
What is "Nice" and can you please probide us a link to the source of the above. No pun intended but I just happened to notice the "authorisation" mispelling so, naturally, would like to see the actual reference to your post.
So basically, initial recco (and theres still three weeks to sort out the final decision) is that K is too expensive and the initial flare ups along with only 42% response rate is a concern.
Surprising given that 1 in 70 adults in the UK have gout.
H: If Takeda (Febuxostat) and AZN (RDEA 594) were ever bold enough to do a head-to-head study against Allopurinol, up to maximum dosing levels(1,000mg), I can guarantee you that their results would not look so rosy. That's why they only tested 300mg Allop.
H: I think the more relevant and important news is that the CEO of GENZ-the largest orphan drug co in the world-is now on bd and will help position SVNT for a sale sometime this yr. The consensus rev estimate for 2013 is currently $40M, double 2012's rev estimate, and Dialysis results are coming out around June of this yr, which can add value to K. Having an addtl "dialysis benefit" would allow Meeker and the bd to SIGNIFICANTLY.....raise the price of K by mid-yr. My humble guess is that they will have the green light to double the price of K if partnership terms are unreasonable and dialysis results mirror positive P3 Trial data. We are going up big next week. Have a good weekend everyone.
Sentiment: Strong Buy