NICE Rejects Novartis’ Xolair In Harbinger Of Cost Reevaluation Process
This article was originally published in The Pink Sheet Daily
Draft guidance from NICE concludes that Novartis’ asthma drug Xolair, which was previously viewed as cost-effective, is no longer worth the expense based on new independent economic modeling and mortality data. The re-evaluation process is spreading through Europe as governments move to restrain costs, and that may spell trouble for manufacturers.
You may also be interested in...
Novartis essentially makes volume trade-off in the most recent NICE assessment, adding a claim for ages 6-11 but offering pricing concessions as well; if the firm’s experience is any indication, even older products that come under NICE’s cost-effectiveness scrutiny will need discounts and additional data to stay in the authority’s good graces.
NICE’s analysis found that omalizumab was only useful in reducing the rate of clinically significant exacerbations in children with asthma who were having three of more exacerbations per year.
MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins
In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.