It was three yeas and two nays from the National Institutes of Health and Clinical Excellence today.
Allergan ($AGN) got approval for a new use for Botox, Johnson & Johnson's ($JNJ) Janssen unit won a nod for its prostate cancer drug Zytiga, and Roche ($RHHBY) got split decisions. NICE approved its Tarceva for some lung cancer patients but said no to Herceptin for use in some breast cancer patients. GlaxoSmithKline ($GSK) also lost in that decision, with its Tyverb also being turned down for the same breast cancer use. NICE evaluates drugs on their cost-effectiveness and then recommends whether the National Health Service in the U.K. should buy them.
Here is the rundown:
In the case of targeted cancer drugs, Herceptin and Tyverb, the regulator said there was no indication they would work better than existing drugs as a first-line treatment. And because they are not cheaper, there is nothing to recommend them. Herceptin has already been approved by NICE for treatment in later stages. As for GSK and Tyverb, this was perhaps the third time it has failed to get approval; NICE just doesn't like the price.
Roche's Tarceva got a NICE recommendation to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have tested positive for the EGFR mutation. Roche in February was asked to provide additional information, PM Live reports, and that seemed to do the trick.
Zytiga from Johnson & Johnson is recommended in combination with prednisone or prednisolone as a treatment option for castration-resistant metastatic prostate cancer that has progressed on or after one docetaxel-containing therapy. This is further bad news for Dendreon ($DNDN) and Provenge, which requires a complex treatment process, compared with the Zytiga pill, and which costs about $93,000 for a treatment course.
The NICE recommendation on Botox was nip and tuck. The agency in February asked for additional information about its effectiveness. It is a big win for Allergan, which is looking to medical uses of Botox to pump up sales going forward. Sanford C. Bernstein analysts have said that the migraine use could help to almost double Botox's annual sales to $2.3 billion.