LONDON, UK (News Release) - March 24, 2014 - NICE, the healthcare guidance body, has issued new draft guidance not recommending radium-223 dichloride (Xofigo, Bayer), for treating adults with hormone relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases.
Metastatic prostate cancer describes when the primary cancer has spread from the prostate to other parts of the body, such as the bone. This appraisal looks at how well radium-223 dichloride works to treat bone metastases specifically.
Commenting on the draft guidance, Sir Andrew Dillon, NICE Chief Executive, said: “At the beginning of the appraisal process, NICE works with stakeholders to identify the most appropriate treatments for the new drug to be compared to. Clinical specialists told the committee that radium-223 would be used as an alternative treatment option to docetaxel as an initial treatment, and abiraterone as a second-line treatment when the disease has progressed. However, Bayer did not to provide the Committee with any data on how well radium-223 works compared to docetaxel or abiraterone or, only comparing it to a placebo.”
Stakeholders, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. The manufacturer also has an opportunity to request permission to submit additional evidence if it is considered appropriate.
Sir Andrew continued: “Bone metastases are very distressing for patients and their families, particularly as a result of bone pain and fatigue, which have a profound effect on patients' quality of life, by limiting their mobility and meaning full-time care would often be needed for daily activities. We know how important this could be to patients and we are disappointed not to able to recommend this drug, but we have to be confident that its benefits justify its considerable cost.”
Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.
Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.
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For more information call the NICE press office on 0845 003 7782 or out of hours on 07775 583 813.
Notes to Editors:
About the Guidance
- The draft guidance will be available at http://guidance.nice.org.uk/TAG/345 from 24 March 2014. Embargoed copies of the draft guidance are available from the NICE press office on request.
- The Committee noted that radium 223 was associated with a statistically significant median overall survival benefit of 3.6 months, and statistically significant reductions in median time to first skeletal related event (SRE), median time to prostate specific antigen (PSA), and total alkaline phosphatase progression compared with placebo. It also noted that radium 223 was associated with health-related quality of life benefits compared with placebo.
- The Committee noted that the manufacturer's base case ICER for radium 223 compared with best supportive care was £55,500 per QALY gained and that the ERG's adjustments to the model increased the base-case ICER to £57,400 per QALY gained. The Committee considered that addressing its concerns around the time horizon, utilities and costs would be likely to increase the ICER further. However, it concluded that it was not possible to determine whether radium 223 could be considered a cost-effective use of NHS resources, because the appropriate comparison with docetaxel and abiraterone had not been presented. However, based on the comparison with best supportive care, the Committee concluded that radium-223 could not be considered a cost-effective use of NHS resources.
- The manufacturer's submission states that radium 223 is available at a radioactivity of 6 MBq in a 6 ml vial at a net price of £4040 (excluding VAT). It is administered by intravenous injection at a recommended dose of 50 kBq/kg body weight every 4 weeks for 6 injections (giving the average cost of a course of treatment of £24,240 estimated by the manufacturer). The manufacturer of radium-223 (Bayer) has agreed a patient access scheme with the Department of Health which makes radium-223 available with a discount applied to all invoices. The size of the discount is commercial in confidence.
- The drug does not meet the criteria to be considered under end-of-life.
- SMC is not currently looking at Radium-223.
About NICE
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.
Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).
Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.
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The National Institute for Health and Care Excellence (NICE)
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