A new prostate cancer drug by Bayer called Xofigo has received a negative recommendation from the National Institute for Care and Health Excellence (NICE) in the United Kingdom, for its widespread use for patients afflicted by said cancer that went on to spread to the bone.
NICE's draft guidance based its recommendation on the German manufacturers' failure to provide evidence that the specific drug's effectiveness in contrast to other drugs and therapies for prostate cancer, such as chemotherapy docetaxel and Janssen's Zytiga, now available for use in Wales and England.
Reports say Bayer instead supplied data from trials that compared the said drug to placebo.
"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," said NICE Chief Executive Andrew Dillon.
"We are disappointed not to able to recommend this drug, but we have to be confident that its benefits justify its considerable cost," Dillon also said.
With standard price at £24,240 or about $40,000 for a course of treatment, reports say Xofigo is a radioactive agent migrating to body parts with abnormal bone growth. Claims suggest that the drug can extend life survival by 3.6 months, showing only minor side effects to the patient. They say this internal radiotherapy treatment is also qualified for a discount rather undisclosed.
"It's a terrible kick in the teeth for men facing their last months, especially as other new treatments, such as enzalutamide, have restrictions on use in England and Wales," said Mikis Euripides, who is a director of policy and strategy at the Charity Prostate Cancer UK.
Issued on Monday, the draft guidance has ongoing consultation wherein Bayer has the opportunity to respond prior to publishing further guidance on the use of Xofigo.
Professor Jonathan Waxman, a leading prostate cancer specialist, said that the agency had impositions that are almost impossible conditions on the use of said drug.
"Doing trials to produce this data could bring delays of four, five or more years when some men could be benefiting right now," Waxman said, also emphasizing the need to cut back NICE's authority.
The other prostate cancer drug, Velcade or Bortezomib of Janssen, meanwhile received the green light from NICE's draft guidance for use in patients in Wales and England.
"Today's decision by NICE to approve Velcade induction treatment is fantastic news for myeloma patients in England and Wales. Clinicians can now choose between at least three options enabling them to tailor treatment to best suit the clinical situation at hand and also to reflect patient preference," said Myeloma UK's chief executive Eric Low.
Previously though, Velcade also received a negative recommendation from NICE after the latter found no full information as to whether the drug was a cost-effective one for National Health Service resources. The new but yet to be finalized recommendation, apparently, shows that Janssen at least tried to address the concerns raised by the health agency.
Advanced prostate cancer has unfortunately become resistant to standard hormone treatments, and approximately 10,500 British men suffer from the condition.
