Ferring Pharmaceuticals confirmed that FIRMAGON® (degarelix) will be the subject of an appeal hearing by the National Institute for Health and Care Excellence (NICE) on 25 June.
Ferring Pharmaceuticals confirmed 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 at risk 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 men treated with FIRMAGON, than in those treated with luteinising-hormone-releasing hormone (LHRH) agonists.(1) FIRMAGON has shown significantly longer progression-free survival and a more rapid response, 3compared 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.(4,5)
Dr Patrick Davey, Consultant Cardiologist, Northampton General Hospital, commented: “Patients with prostate cancer with pre-existing cardiovascular disease are at risk of a cardiovascular event, with approximately 1 in 3 men in the UK with prostate cancer already experiencing an event. The evidence shows that degarelix is associated with a significantly reduced risk of cardiovascular disease compared with agonists in advanced hormone-dependent prostate cancer, so it is important to have the opportunity to review this evidence with NICE.”
FIRMAGON has been available in the UK since 2009 but was only reviewed by NICE as part of a Single Technological Appraisal (STA) in 2014. FIRMAGON has been previously reviewed and recommended by the Scottish Medicines Consortium (SMC) in 2011 and by the All Wales Medicine Strategy Group (AWMSG) in 2012 for all patients with prostate cancer. While the FAD will not change the guidance in Scotland, the FAD guidance would supersede the current recommendation from AWMSG and reduce the approved availability of this treatment for men in Wales.
An appeal to NICE can be lodged by any of the appraisal consultees and can be considered at an oral hearing, if submitted in writing within 15 working days from the date of when the FAD is issued to consultees and commentators. Appeals must fall within one or more of two grounds of appeal: ground one– that NICE has failed to act properly or exceeded its powers; ground two – that the recommendation is unreasonable in the light of the evidence submitted to NICE. Further details on the FIRMAGON appeal hearing can be found at:http://www.nice.org.uk/guidance/index.jsp?action=folder&o=67693.
References
- Klotz L, et al. Disease control outcomes from analysis of pooled individual patient data from five comparative randomised clinical trials of degarelix versus luteinising hormone-releasing hormone agonists. Eur Urol 2014 [Epub ahead of print].
- Klotz L, et al. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int 2008;102(11):1531–8.
- Keating NL, O’Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol 2006;24(27):4448–56.
- Gandaglia G, et al. The impact of the androgen deprivation therapy on the risk of coronary heart disease in patients with non-metastatic prostate cancer: a population-based study. BJU Int 2014 [Epub ahead of print].
- Albertson P, et al. Cardiovascular morbidity associated with gonadotropin releasing hormone agonists and an antagonist. Eur Urol 2014;65(3):565–73.
