NICE to re-evaluate Firmagon for advanced hormone-dependent prostate cancer

A successful appeal against NICE's decision on prostate cancer drug Firmagon (degarelix) means the UK's cost-effectiveness regulator will re-examine the evidence for its use in advanced cases of the disease.

At an oral hearing held in London on 25 June, appeals by Ferring Pharmaceuticals, the British Uro-oncology Group (BUG) and Tackle Prostate Cancer were upheld against NICE's final appraisal. If the new assessment is positive, the drug will be made available in England, bringing it in line with treatment options already available in Wales and Scotland.

NICE has been in the firing line over another prostate cancer treatment decision recently, when it rejected Janssen's Zytiga for broader use last week on the grounds that the price was too high for the benefit it offered.

In the Firmagon case, the appeals were upheld on two grounds: that NICE failed to issue a second Appraisal Consultation Document (ACD) following a substantial change to the preliminary recommendations and that the decision in the Final Appraisal Determination (FAD) to restrict the use of Firmagon to patients with spinal compression (as opposed to those who were 'at risk' of spinal compression) lacked transparency and failed to give adequate reasons.

Ferring UK general manager, Steven Howson, commented, "We welcome the appeal panel's decision that the way in which the recommendation for Firmagon was issued was unfair and lacked transparency. Treatment options for men with advanced prostate cancer are limited and NICE has continued to restrict access to new treatments. Firmagon has distinct advantages over other first-line recommended treatments in advanced hormone-dependent prostate cancer and is offered at a comparable cost, which is why Ferring, alongside representatives of healthcare professionals and patients, appealed against NICE's recommendations."

The original FAD, issued on 15 April, restricted the use of Firmagon to prostate cancer patients who presented with signs and symptoms of spinal cord compression, rather than those considered at risk - thereby significantly reducing the number of patients to less than a third of those deemed eligible for treatment, compared to the prior ACD.

Firmagon has shown several advantages over existing hormonal therapies, including a more rapid reduction in prostate specific antigen (PSA), better control of serum alkaline phosphatase (S-ALP), and significant reduction in PSA progression. Furthermore, clinical studies have demonstrated fewer musculoskeletal events and a lower incidence of urinary tract events than in those treated with LHRH agonists. Firmagon has shown significantly longer progression-free survival and a more rapid response, compared with agonist treatment. It is also associated with a significantly reduced risk of cardiovascular disease compared with LHRH agonists.

Firmagon has chemical characteristics and a novel mechanism of action, different to hormonal therapies. Administered as a deep subcutaneous injection, it rapidly reduces levels of testosterone by blocking the GnRH receptors in the pituitary gland. Reducing testosterone levels slows the growth of cancer cells.

The drug was approved for the treatment of advanced hormone-dependent prostate cancer in the EU and US in 2009.

Prostate cancer is the most common form of male cancer in the Western world. In the UK, one man dies from prostate cancer every hour, equivalent to more than 10,000 every year.

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