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UK: NICE Revises Guidance on Amgen's Denosumab

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By Louise Zornoza, RegLink

The UK’s National Institute for Health and Clinical Excellence (NICE) has reversed an earlier decision and now plans to recommend the use of Amgen’s new cancer drug denosumab, used in the treatment of bone metastases from solid tumors, to the National Health Service (NHS).

Physicians would be prohibited from prescribing the drug under the recommendation unless Amgen agrees to a cut in the price of the drug.

The original recommendation not to use the drug was reportedly based on the incorrect assumption that a less expensive bisphosphanate, zoledronic acid, was going to be approved for the same indication.

The revised draft guidance recommends denosumab for adults with bone metastases from breast cancer and for adults with bone metastases from solid tumors other than breast and prostate only if zoledronic acid or disodium pamidronate would otherwise be prescribed for these patients. It does not recommend the use of denosumab for bone metastases from prostate cancer.


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