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www.fdanews.com/articles/171626-nice-endorses-one-of-two-prostate-cancer-drugs

NICE Endorses One of Two Prostate Cancer Drugs

June 11, 2015

The UK’s National Institute for Health and Care Excellence has issued draft guidance on two prostate cancer drugs, recommending Bayer’s Xofigo while declining to endorse Ferring Pharmaceuticals’ Firmagon.

NICE proposes reimbursing Xofigo (radium-223 dichloride) for patients whose prostate cancer has spread to their bones and who have stopped responding to hormone therapy, as long as Bayer provides the drug at a discount.

Clinical studies showed a significant improvement of 3.6 months in median overall survival, and an overall cost of $72,864 per quality-of-life year gained. The drug appears to be particularly effective for patients previously treated with the chemotherapy drug docetaxel, NICE says.

The second drug, Firmagon (degarelix depot), was deemed not cost-effective when compared with the current standard treatment, LHRH agonists.

NICE’s appraisal committee had previously issued a provisional recommendation for the drug to treat people whose prostate cancer had spread to the spine and who might develop spinal cord compression. However, clinical experts concluded that using the treatment at this stage would not be proper because it isn’t possible to identify patients who may develop spinal cord compression, the guidance says.

Comments on the draft recommendation for Xofigo are due June 25. The consultation on the Firmagon draft guidance closes June 26.

Read the final draft guidances at www.fdanews.com/06-08-15-Xofigo.pdf and www.fdanews.com/06-08-15-Firmagon.pdf. — Kellen Owings