NICE is recommending radium-223 dichloride (also called Xofigo) as a treatment for some people with prostate cancer which has stopped responding to hormone therapy (known as hormone relapsed) and has spread to the bone (bone metastases).
The draft guidance says the drug, which is manufactured by Bayer, appears to be particularly effective for those who have already been treated with the chemotherapy drug, docetaxel. It also says the drug should only be prescribed if the company makes the treatment available at a discounted rate.
Professor Carole Longson, director of the NICE Health Technology Evaluation Centre, said: “Prostate cancer is the most common cancer in men and this disease is responsible for more than 1 in 10 male cancer deaths. It is important that the NHS can provide these people with affordable treatments that will make the most difference to their lives
“We are pleased that the evidence for radium-223 dichloride was strong enough to issue a provisional recommendation. The information provided by Bayer suggests that radium-223 is effective in delaying the progression of prostate cancer and can prolong survival. The evidence also suggests that radium-223 has similar effectiveness to abiraterone.”
Meanwhile, NICE has issued draft guidance not recommending degarelix depot - also called Firmagon and manufactured by Ferring Pharmaceuticals - to treat advanced, hormone dependent prostate cancer. The draft NICE guidance says it is not a cost-effective drug compared with the currently available standard treatment - LHRH agonists - and there is also no way of identifying the people who would benefit the most from it.
Professor Longson explained: “Clinical experts highlighted that degarelix depot could be particularly beneficial to people whose prostate cancer had spread to their spine and who might develop spinal cord compression.
“The independent Appraisal Committee had previously made a provisional positive recommendation for degarelix to treat people who already present with signs and symptoms of spinal cord compression, but clinical experts said that using the treatment at this stage would not be appropriate.
“The committee discussed if it could be possible to reliably identify people with spinal metastases who have a higher risk of spinal cord compression. Unfortunately, based on the evidence and inputs from the experts, it concluded that it was not possible to identify the people who may develop spinal cord compression beyond those people with spinal metastases.
The committee could therefore not recommend the drug.”
Professor Longson added: “It is always disappointing when NICE is unable to recommend a treatment. People who are currently taking the drug can continue with it until they and their doctor consider it suitable to stop.”
The draft guidance for both treatments is now with consultees. Once the consultations close, the NICE Appraisal Committees will consider all comments received and develop further draft guidance for both drugs. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.
Notes to Editors
About the draft guidance
- The consultation on the provisional recommendation for radium-223 dichloride will remain open until Thursday 25 June 2015.
- The consultation on the degarelix depot draft guidance will close on Friday 26 June 2015.
Background to the degarelix depot appraisal
- In previous draft guidance, NICE had recommended that degarelix depot be funded by the NHS for people with prostate cancer which has spread to the spine and who have signs or symptoms of spinal cord compression.
- Experts noted that spinal cord compression may be exacerbated by the testosterone flare associated with initiating treatment with LHRH agonists and said that degarelix could be particularly beneficial because it does not produce this flare.
- Experts also acknowledged that degarelix is not a treatment for spinal cord compression.
- Appeals were received against the final draft guidance from the pharmaceutical company and two other organisations which were unhappy with the wording of the recommendations.
- These appeals were partially upheld by an independent panel and the committee appraising the drug was asked to clarify the wording and the reasoning behind its decision to recommend degarelix depot for these specific patients.
- When the committee met again to discuss the treatment, it heard from clinical and patient experts that giving degarelix depot to people when signs and symptoms of spinal cord compression are already present would be inappropriate because it would be too late to stop the complication occurring.
- The committee then discussed if it could be possible to reliably identify people with spinal metastases who have a higher risk of spinal cord compression as a result of the testosterone flare. It concluded that it was not possible to precisely define and identify this subgroup of patients.
- Ferring Pharmaceuticals did not submit any information on how well degarelix depot works for people with prostate cancer which has spread to the spine and who may develop spinal cord compression.
- NICE commissioned the Decision Support Unit (DSU) to undertake further work on the subgroup of people with hormone-dependent prostate cancer which has spread to the spine.
- The DSU did not find any evidence in the subgroup of patients whose prostate cancer has spread to the spine, and did not find any evidence relating to the incidence of spinal cord compression in people who had treatment with degarelix.
- The Committee concluded that the work presented by the DSU provided further confirmation of the fact that it is not possible to clearly identify and define a subgroup of people who may develop spinal cord compression as a result of a testosterone flare from those people whose prostate cancer has spread to the spine.
- The DSU concluded that the best available evidence suggested that the rate of spinal cord compression was 0.96% in people with advanced prostate cancer. At this rate the incremental cost-effectiveness ratios of degarelix compared with LHRH agonists were outside the range which is normally considered to be a cost-effective use of NHS resources.
- Following these discussions, NICE could not recommend the drug for use in the NHS in this draft guidance.
Facts and figures
- Prostate cancer is the most common cancer in men with more than 35,500 people diagnosed in England during 2011.
- NICE updated its clinical guideline on the diagnosis and treatment of prostate cancer in 2014 and is due to publish a quality standard to support high quality prostate cancer care later this month.
- NICE currently recommends the following treatments for advanced prostate cancer:
- Enzalutamide for men with metastatic hormone-relapsed prostate cancer, who have already had treatment with docetaxel-containing chemotherapy.
- Docetaxel for the treatment of hormone-refractory metastatic prostate cancer;
- Abiraterone for some adults with metastatic prostate cancer who have already had treatment to reduce testosterone and have had docetaxel chemotherapy.