Men with advanced hormone-dependent prostate cancer and spinal metastases are to gain routine access to Ferring's Firmagon on the NHS after a u-turn by the National Institute for Health and Care Excellence saw the cost regulator issue final draft guidance endorsing its use.
In a somewhat bumpy review timeline spanning three years, NICE as recently as June rejected use of Firmagon (degarelix) as an option for patients with signs and symptoms of spinal cord compression, arguing that it failed to offer value for money compared with standard treatment, after having provisionally backed its use.
The drug was actually first approved by the European Medicines Agency for men with advanced hormone-dependent prostate cancer in 2009, and has been available in the UK since 2010. But ongoing changes to NICE's guidance since then have resulted in great variations in access to Firmagon across the UK, the firm noted.
According to Ferring, the testone-lowering therapy drug has shown significantly longer progression-free survival compared with luteinising hormone-releasing hormone (LHRH) agonists, an existing hormonal therapy. Also, clinical studies have demonstrated that men treated with Firmagon "have a significantly reduced risk of cardiovascular disease, fewer musculoskeletal events and a lower incidence of urinary tract events than those treated with LHRH agonists".
Prostate cancer is the most common cancer in men in the UK, affecting around one in eight men at some point in their lives. In the UK, one man dies from prostate cancer every hour, which equates to more than 10,800 deaths every year.
"It is great news for patients with advanced hormone-dependent prostate cancer that Firmagon has finally been approved by NICE," said Professor Roger Kirby, Professor of Urology, University of London, UK. "As a urologist, I am pleased that this rapidly acting and effective treatment is now available for men whose disease has spread to the spine."
"Prostate cancer is still one of the lead killers of men living in the UK, and there is a need for much greater urgency in making treatments available," said Rowena Bartlett, chief executive of Tackle Prostate Cancer, also noting that the decision comes "at a particularly challenging time for prostate cancer treatment in the UK, with access to cancer drugs in England becoming increasingly impacted by cuts to the Cancer Drugs Fund."