Ferring Pharmaceuticals confirmed today that Firmagon (degarelix) will be the subject of an appeal hearing by the National Institute for Health and Care Excellence (NICE) on 25 June. NICE issued its Final Appraisal Determination (FAD) on 15 April, recommending Firmagon as an option for treating advanced hormone-dependent prostate cancer in adults with spinal metastases who present with signs or symptoms of spinal cord compression. Ferring and a number of organisations within the healthcare and patient community have expressed their concerns over the FAD and the restrictive guidance being proposed.

Ferring UK, General Manager Steven Howson commented, "We welcome NICE's decision to conduct an oral appeal hearing. We believe that it is vital that the right patients have access to this important treatment and that healthcare professionals are given clear guidance on its appropriate use".

The original Appraisal Consultation Document (ACD) issued by NICE in January 2014 recommended the use of Firmagon for patients atrisk of spinal cord compression. However, the FAD restricts 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 reducing the number of patients to less than a third of those eligible for treatment per the 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, 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 mentreated 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, which is not currently reflected in the FAD

For more details, go to: http://www.fiercepharma.com/press-releases/uk-nice-hold-oral-appeal-hearing-firmagon-degarelix-treatment-advanced-horm#ixzz357YeX6Te