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UK NICE guidance recommends FIRMAGON only in people with spinal metastases who present with signs or symptoms of impending spinal cord compression

The National Institute for Health and Care Excellence (NICE) has issued its Final Appraisal Determination (FAD) recommending FIRMAGON® (degarelix) as an option for treating advanced hormone-dependent , only in adults with spinal metastases who present with signs or symptoms of spinal cord compression. Both Ferring 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 them1 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 to men treated with LHRH agonists3, have been demonstrated in clinical studies. FIRMAGON® has shown significantly longer progression-free survival4 and a more rapid response5 compared to 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”.

About FIRMAGON®

FIRMAGON® (degarelix) was approved for the treatment of advanced hormone-dependent prostate cancer in both the EU and US in 2009. Today it is available in approximately 40 countries around the world, including a growing number in Asia, Latin America and the Middle East.

FIRMAGON® has chemical characteristics and a novel mechanism of action, different from traditionally used hormonal therapies. Administered as a deep subcutaneous injection, FIRMAGON® rapidly reduces levels of testosterone by blocking the GnRH receptors in the pituitary gland. Blocking the receptors suppresses the release of the luteinising hormone and follicle-stimulating hormone, resulting in a decrease in production of testosterone by the testicles to castration levels within three days. Prostate cancer is dependent on testosterone for its growth, and reducing testosterone levels slows the growth of cancer cells.

In clinical trials, FIRMAGON® decreased the production of testosterone in a rapid and sustained way4,5,6. FIRMAGON® also maintains the PSA control over the long term and reduces the risk of PSA progression2.

In clinical trials FIRMAGON® was generally well tolerated. Common side effects are hot flushes, injection site pain and erythema, increased weight, nasopharyngitis, fatigue and back pain4.

Source

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. Crawford ED, et al. A Phase III Extension Trial with a 1-Arm Crossover from Leuprolide to Degarelix: Comparison of Gonadotropin-Releasing Hormone Agonist and Antagonist Effect on Prostate Cancer. The Journal of Urology September 2011;186(3):889-897. Available at: http://jurology.com/article/S0022-5347(11)03864-X/abstract

3. 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. doi:10.1016/j.eururo.2013.12.063. Available at: http://www.ncbi.nlm.nih.gov/pubmed/24440304

4. Van Poppel H, De La Rosette JJ, Persson B.E 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.) Euro Urology Supplement 2007;6(2):28

5. Klotz L, Boccon-Gibod L, Schröder FH 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):1531-1538.

6.Firmagon (degarelix). Summary of product characteristics. November 2013 (last accessed on emc website March 2014).

Ferring Pharmaceuticals