U.K.'s NICE To Re-Review Ferring's Firmagon
By Cyndi Root
Ferring Pharmaceuticals confirmed the U.K.’s National Institute for Health and Care Excellence (NICE) Appeals Panel has upheld Ferring’s appeal regarding Firmagon (degarelix). The panel listened to Ferring’s oral arguments at a hearing in London and agreed that the agency’s Final Appraisal Determination (FAD) was improper. Appeals by the British Uro-Oncology Group (BUG) and Tackle Prostate Cancer were also upheld.
The controversy arose in April 2014 when NICE issued an approval for Firmagon that Ferring and others found restrictive. Steven Howson, Ferring U.K. General Manager, said, "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.”
Appeal Panel Decision
Ferring’s position when it filed an appeal is that Firmagon has distinct advantages over other treatments and is cost-comparable. The appeals panel did not address those issues. Instead, the panel focused on procedural grounds. The panel said that NICE did not issue a second Appraisal Consultation Document (ACD) following a substantial change to the preliminary recommendations. Secondly, NICE’s decision to restrict Firmagon’s use in patients with spinal compression but not those at risk of spinal compression was a failure in transparency as it did not give adequate reasons for the restriction.
NICE’s FAD
NICE issued the original FAD in April 2014. The decision restricted Firmagon to patients with signs and symptoms of spinal cord compression and not those at risk, reducing by a third the number of patients eligible according to the prior ACD. Ferring and the healthcare community, especially prostate cancer groups and physicians, were disappointed that the recommended use was so restrictive. In the U.K., prostate cancer is common with over 40,000 men diagnosed each year.
Dr. Patrick Davey, Consultant Cardiologist, Northampton General Hospital, spoke on Firmagon’s association with a significantly reduced risk of cardiovascular disease compared with LHRH agonists, saying, “Given the high U.K. prevalence of prostate cancer and also cardiovascular disease (CVD), it means that approximately 1 in 3 men with prostate cancer would have experienced a cardiovascular event. Patients with pre-existing CVD are most at risk and the evidence shows that Firmagon has a higher chance of reducing that.”
Firmagon has been shown to induce a rapid reduction in prostate specific antigen (PSA), more control of serum alkaline phosphatase, a significant reduction in PSA progression, fewer musculoskeletal events, and a lower incidence of urinary tract events. Interested parties can view an overview of the regulatory process at NICE for Firmagon.