NICE does an about-face, nixing cancer nod on Xgeva

The U.K.'s cost-effectiveness watchdog is having second thoughts about Amgen's ($AMGN) new bone drug. The National Institute for Health and Clinical Excellence says it no longer believes that Xgeva is cost-effective for use in prostate cancer, to prevent or delay bone-related problems. NICE had recommended the drug, in earlier draft guidance, for patients whose cancer had spread to their bones.

The agency said expert comments "shed new light" on the original draft guidance. NICE's original appraisal had compared Xgeva to bisphosphonates for that use, but as experts pointed out, bisphonsphonates such as Novartis' ($NVS) Zometa aren't used to prevent bone issues, just to relieve pain. And so, the cost and efficacy of Xgeva has to be compared to "best supportive care"--which is, of course, very cheap--rather than the more expensive bone-strengthening drugs.

And so Xgeva looks much more expensive by comparison. "As a result, the committee reconsidered the evidence and revised the draft guidance," NICE's Carole Longson said in a statement.

Xgeva is still recommended for breast cancer patients with bone metastases. It's also recommended for patients with other solid-tumor cancers that have spread to bone, provided bisphosphonates would normally be prescribed for those patients. In both cases, the recommendation hinges on Amgen's previously proposed discount, NICE says. It's not the end of the line for Xgeva in prostate cancer, though. NICE is taking comments on this new draft.

As PM Live points out, the NICE decision is another blow to Amgen's hopes for Xgeva. The FDA declined to approve a similar use in prostate-cancer patients in February, after its expert advisors determined that the drug didn't significantly impact survival or change the course of the disease.

- get the statement from NICE
- read the PM Live coverage