Ferring Pharmaceuticals confirmed that, following an oral hearing in London, the panel upheld Ferring’s appeal against the National Institute for Health and Care Excellence (NICE)’s final appraisal determination for the use of Firmagon (degarelix) as an option for treating advanced hormone-dependent prostate cancer.
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.”
In addition to Ferring, appeals were successfully made by the British Uro-oncology Group (BUG) and Tackle Prostate Cancer. 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 are “at risk” of spinal compression) lacked transparency and failed to give adequate reasons.
The original FAD, issued on 15 April, restricted the use of Firmagon to prostate cancer patients who present 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.
Ferring looks forward to working with NICE to re-present the advantages of Firmagon in advanced hormone-dependent prostate cancer. Through this process, Ferring hopes to expand treatment options for men living with this disease in England, to be in line with those already available in Wales and Scotland.
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, which is indicative of tumour activity in the bones), and significant reduction in PSA progression. All these factors point towards improved disease control. Furthermore, clinical studies have demonstrated fewer musculoskeletal events and a lower incidence of urinary tract events in men treated with Firmagon, than in those treated with LHRH agonists. Firmagon has shown significantly longer progression-free survival and a more rapid response, compared with agonist treatment. Firmagon is also associated with a significantly reduced risk of cardiovascular disease compared with LHRH agonists.
Date: August 18, 2014
Source: Ferring Pharmaceuticals