Amgen sales and marketing update

The U.K.’s NICE issued a final appraisal determination (FAD) recommending Imlygic talimogene laherparepvec from Amgen to treat unresectable melanoma that is regionally or distantly metastatic with no bone, brain, lung or other visceral disease in patients for whom systemically administered immunotherapies is not suitable -- its approved indication. In its March draft guidance, NICE recommended against the therapy’s use and had said it was not possible to determine if therapy was a “cost-effective use of NHS resources given the uncertainty about its effect on overall survival.” In the FAD, NICE said that it “could not be confident in establishing a reliable estimate” of Imlygic’s effectiveness vs. immunotherapies but concluded that the drug is “clinically and cost effective” in the subset of melanoma patients unsuitable for immunotherapies. The recommendation is contingent on Amgen providing Imlygic at an undisclosed discount under a patient access scheme. ...