The National Institute for Health and Care Excellence (NICE) issued its Final Appraisal Determination (FAD) regarding FIRMAGON® (degarelix).
It recommended the drug as an option for treating advanced hormone-dependent prostate cancer, only in adults with spinal metastases who present with signs or symptoms of spinal cord compression.
The National Institute for Health and Care Excellence (NICE) issued its Final Appraisal Determination (FAD) regarding FIRMAGON® (degarelix).
It recommended the drug as an option for treating advanced hormone-dependent prostate cancer, only in adults with spinal metastases who present with signs or symptoms of spinal cord compression.
Both Ferring, the manufacturer, and members of the healthcare community are disappointed that the recommended use is so restrictive.
Prostate cancer is common in the UK, with more than 40,000 men diagnosed every year. This decision will limit the number of treatment options available to them(1) and restrict access to what is an innovative class of treatments.
FIRMAGON has shown several advantages over existing hormonal therapies, including more rapid reduction in prostate specific antigen (PSA), better control of serum alkaline phosphatase (S-ALP), which denotes tumour activity in the bones, and significant reduction in PSA progression. All of these factors point towards improved disease control.
It is also associated with a significantly reduced risk of cardiovascular disease. Furthermore, fewer musculoskeletal events and a lower incidence of renal or urinary tract events, compared with men treated with luteinising-hormone-releasing hormone (LHRH) agonists,(2) have been demonstrated in clinical studies. FIRMAGON has shown significantly longer progression-free survival(3) and a more rapid response(4) compared with agonist treatment.
Commenting on the NICE decision, Dr Patrick Davey, Consultant Cardiologist, Northampton General Hospital said: “Given the high UK 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. It is unfortunate that NICE has chosen not to recommend it in a wider patient group. I should, and need, to be able to offer my patients the most appropriate therapy to reduce the risk of CV events as well as, of course, death.”
Professor James Green, Consultant Urological Surgeon, Whipps Cross University Hospital, UK said, “I have seen transformational changes in my own practice with prostate cancer patients on degarelix treatment. NICE’s decision is frustrating as I would like to be able to give more of my prostate cancer patients the hope of positive outcomes from degarelix treatment.”
Ferring UK General Manager Steven Howson commented, “Whilst we are pleased that NICE has recommended FIRMAGON® for certain prostate cancer patients, it is obviously disappointing for the English and Welsh prostate cancer community and their physicians that full access has not been granted in all the patient groups where proven efficacy and safety benefits have been demonstrated over existing therapies. We now need to consider what our response to this will be.”
References
1. Prostate Cancer UK. Prostate cancer facts and figures. Available at http://prostatecanceruk.org/information/prostate-cancer-facts-and-figures (accessed 24 March 2014).
2. 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].
3. Van Poppel H et al. Degarelix Study Group; Long-term evaluation of degarelix, a gonadotrophin-releasing hormone (GnRH) receptor blocker, investigated in a multicentre randomised study in prostate cancer (CAP) patients. Abstract (23). Eur Urol Supplement 2007;6(2):28.
4. 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.
