NICE: lack of head-to-head data scuppers Xofigo

Bayer’s prostate cancer and bone metastases treatment Xofigo has been rejected by NICE, the cost effectiveness body saying the lack of data comparing it with rival treatments let it down.

NICE has considered Xofigo (radium-223 dichloride) for its licensed indication, in men with hormone relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases.

Its conclusion that Bayer’s data is not sufficient because it lacks a head-to-head with any alternative treatment is a frequent refrain from NICE. The cost effectiveness body requires data comparing a drug to existing alternatives wherever possible, rather than the placebo-controlled trials which are sufficient to gain regulatory approval.

NICE’s appraisal looked at how well Xofigo works to treat bone metastases, which the drug, a kind of internal radiotherapy, specifically targets.

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 (Janssen’s Zytiga) as a second-line treatment when the disease has progressed. However, Bayer did not provide the Committee with any data on how well radium-223 works compared to docetaxel or abiraterone or, only comparing it to a placebo.”

NICE says stakeholders can now comment on the preliminary recommendations, and the manufacturer can also ask to submit additional evidence if it is considered appropriate.

Sir Andrew added: “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.”

Bayer’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 four weeks for six injections (giving the average cost of a course of treatment of £24,240 estimated by the manufacturer).

Bayer has agreed a patient access scheme with the Department of Health which makes radium-223 available with a discount applied to all invoices, but as usual the size of the discount is commercial in confidence.

Phase III data shows the drug added 3.6 months to median overall survival compared to placebo.

A similar placebo controlled trail of Janssen’s Zytiga suggested that Janssen’s drug produced superior overall survival results of 14.8 months compared with 10.9 months,

Approved by Cancer Drugs Fund

Despite the bad news from NICE, Xofigo has already been given funding clearance by England’s parallel reimbursement channel, the Cancer Drugs Fund. This means patients in the rest of the United Kingdom may well be denied, however, because of different funding mechanisms.

Meanwhile, NICE is facing fierce criticism for proposing restricted access to another new prostate cancer, Astellas’ Xtandi (enzalutamide). NICE’s draft guidance recommends the drug as an option only if prostate cancer patients’ disease has progressed during or after a docetaxel-containing chemotherapy regimen, and if they have not been treated with Zytiga (abiraterone). Campaigners say this final restriction is unfair and not based on good evidence. The final ruling on Xtandi is expected within the next six weeks.

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