In issuing final draft guidance on the coverage of treatment with denosumab (Xgeva) for patients with metastases to the bones, the National Institute for Clinical Excellence (NICE) in England again has excluded men with prostate cancer-induced metastases to bone.
The full text of the NICE media release is available on line. NICE (provisionally) recommends use of denosumab for the prevention of skeletal-related events in patients with bone metastases from breast cancer and in patients
with bone metastases from solid tumors (other than breast or prostate) who would otherwise be prescribed bisphosphonates.
According to the “fine print”, during consultation on the very first draft of guidance on the use of denosumab in England, NICE’s Appraisal Committee determined that
… bisphosphonates should not be used as the comparator for denosumab in people with bone metastases from prostate cancer. This is because, according to NICE guidelines [on management of prostate cancer] , bisphosphonates are recommended as a treatment for pain relief (a use which denosumab is not licensed for) and not to prevent skeletal-related events. Therefore, the Appraisal Committee concluded that the main comparator for this group of patients should be best supportive care.
Data submitted to the Appraisal Committee during the second consultation on this draft guidance did in fact suggest that
… bisphosphonates are prescribed for people with bone metastases from prostate cancer but the committee noted a wide variety of reasons for their use. The committee concluded that the data was not robust and there should continue to be regard for the recommendations included in the NICE guideline on prostate cancer.
NICE’s Appraisal Committee then concluded that best supportive care should remain the main comparator to denosumab and not bisphosphonates.
Something about this decision doesn’t seem right to The “New” Prostate Cancer InfoLink.