UK NICE to hold oral appeal hearing for FIRMAGON® (degarelix) for the treatment of advanced hormone-dependent prostate cancer
WEST DRAYTON, England, 17 June, 2014 – 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 atrisk –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.1FIRMAGON® has shown significantly longer progression-free survival2 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.4–6
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. Whilst 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.
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 3 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 way.2,3,7 FIRMAGON® also maintains the PSA control over the long term and reduces the risk of PSA progression.2
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 pain.2
About Prostate Cancer
Prostate cancer is the most common form of male cancer in the Western world,8 and the second leading cause of cancer death in men in some countries.9 In the UK, one man dies from prostate cancer every hour – that's more than 10,000 every year.10 Around 400,000 new cases of prostate cancer are diagnosed in Europe each year.8 Worldwide, this figure rises to 900,000 new cases.11 For further media information and news alerts on prostate cancer please visit Ferring's information website:www.ProstateCancerLiving.com.
Headquartered in Switzerland, FerringPharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology and endocrinology. Ferring has its own operating subsidiaries in 50 countries and markets its products in more than 90 countries. To learn more about Ferring or its products please visit www.ferring.com.
1. Klotz L,Miller K, Crawford ED 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. EurUrol 2014. [Epub ahead of print] doi:10.1016/j.eururo.2013.12.063. Available at: http://www.ncbi.nlm.nih.gov/pubmed/24440304.
2. Van Poppel H. et al. Int J Urol 10.1111/k.1442-2042.2012
3. Klotz L, Boccon-Gibod L, Shore NDet 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.
4. Keating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J ClinOncol 2006;24(27):4448–56. Available at: http://jco.ascopubs.org/content/24/27/4448.full.pdf
5. GandagliaG, Sun M, Popa I 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] doi: 10.1111/bju.12732. Available at: http://www.ncbi.nlm.nih.gov/pubmed/24612110
6. Albertson PC, Klotz L, Tombal Bet al. Cardiovascular morbidity associated with gonadotropin releasing hormone agonists and an antagonist. EurUrol2014;65(3):565–73. Available at: http://dx.doi.org/10.1016/j.eururo.2013.10.032
7. FIRMAGON® (degarelix). Summary of Product Characteristics. November 2013 [Available at: [insert emc website URL]. AccessedMarch 2014].
8. Cancer Research UK. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/keyfacts/prostate-cancer/. Accessed June 2014.
9. American Cancer Society. Available at: http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-key-statistics.Accessed March 2014.
10. Prostate Cancer UK. Prostate cancer facts and figures. Available at:http://prostatecanceruk.org/information/prostate-cancer-facts-and-figures. Accessed 24 March 2014.
11. Cancer Research UK. Available at http://www.cancerresearchuk.org/cancer-info/cancerstats/types/prostate/incidence/.Accessed June 2014.
© 2013 Ferring B.V.
FIRMAGON® is a trademark owned by Ferring B.V.
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