Men in England to finally have routine access to UK-discovered prostate cancer medicine Zytiga (abiraterone acetate) before chemotherapy
NICE gives the green light after years of deliberation
High Wycombe, 21 March 2016. The National Institute for Health and Care Excellence (NICE) has finally recommended the use of Zytiga® (abiraterone acetate) for the treatment of metastatic hormone-relapsed prostate cancer (mCRPC) before chemotherapy[i]. Today's decision means that eligible NHS patients in England will for the first time, be entitled to routine access to abiraterone before chemotherapy, a UK-discovered medicine already available to men in 95 countries worldwide[ii].
In its Final Appraisal Determination (FAD), NICE concluded that abiraterone is cost effective for use before chemotherapy in men with mCRPC. It has taken over three years[iii] for NICE to recommend a treatment which has been routinely available before chemotherapy for several years in most other European countries - including France[iv] and Germany[v] - and that was approved for use on the NHS in Scotland in October last year[vi]. During this time, Janssen proposed a number of different solutions to the Department of Health, NHS England and NICE so that abiraterone could be approved for routine use and removed from the Cancer Drugs Fund (CDF), freeing up resources for other innovative new medicines.
Mark Hicken, Managing Director Janssen UK & Ireland, said: "This long overdue but welcome decision means that patients in England will finally be able to access this innovative cancer medicine routinely on the NHS, putting them on a par with patients in many other European countries who have had access to abiraterone as an option before chemotherapy for some years. We have worked tirelessly for several years to ensure abiraterone, a UK-discovered medicine, which demonstrates long term survival and quality of life benefits for patients, is made widely available for men who cannot have or do not want chemotherapy and are delighted that this is now possible for them."
"Janssen has been successful in making abiraterone before chemotherapy available to men with prostate cancer in 95 countries worldwide, but the length of time taken to gain approval in the UK demonstrates a clear need for reform of the way NICE appraises innovative cancer medicines. We are concerned that the CDF changes recently approved by NICE and NHS England will only exacerbate these problems, resulting in even greater restrictions for cancer patients in England. Janssen will continue to work collaboratively with NICE, NHS England and the Department of Health to create a more flexible system which will support and improve patient access to the best care."
Abiraterone is already approved by NICE for routine use in mCRPC men after chemotherapy, where it is considered to be cost effective. It has been available for use before chemotherapy via applications to the CDF where it was the second most requested medicine on the Fund, demonstrating clear demand from patients and clinicians. Now eligible men in England will be entitled to access abiraterone routinely on the NHS, which, if used earlier on in a patient's disease, provides even greater benefits in delaying disease progression, prolonging life and giving a better quality of life with less fatigue and pain[vii],[viii].
Abiraterone is a success story for the UK life sciences industry, having been discovered at the Institute of Cancer Research and first trialled at The Royal Marsden Hospital[ix]. It has over four years of proven clinical efficacy and tolerability data from one of the largest and longest trials in prostate cancer7.
Professor Heather Payne, Consultant in Clinical Oncology at University College Hospital, London, said: "I am delighted that abiraterone will now be routinely available on the NHS for men with asymptomatic or minimally symptomatic progressive prostate cancer who have not yet been treated with chemotherapy. Abiraterone has been shown not only to significantly extend life expectancy but is well tolerated and enables these patients to live a better quality of life. This is very welcome news for men with prostate cancer, their families and the doctors and nurses who care for them."
Prostate cancer is the most common cancer in men. Across the UK, 47,300 men are diagnosed with prostate cancer each year – 40,372 in England and 2,634 in Wales[x]. Over 10,800 men die of prostate cancer each year, making it the second most common cause of cancer deaths in the UK - 9,133 of these are in England and 556 in Wales[xi].
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NOTES TO EDITORS
In December 2012, abiraterone received a licence from the European Medicines Agency (EMA) for use in conjunction with a steroid medication called prednisolone in patients with metastatic prostate cancer who have limited or no symptoms, whose disease is progressing despite hormone therapy but which is not so advanced that chemotherapy is necessary[xii]. Regulatory authorities in both Europe and the United States approved abiraterone for this indication in December 2012. Since then it has been prescribed to slow the progression of the disease and delay the need for chemotherapy in many thousands of patients across Europe and the United States.
The most common adverse reactions seen include peripheral oedema, hypokalaemia, hypertension and urinary tract infection12.
To access the full Summary of Product Characteristics (SmPC), please visit the electronic Medicines Compendium (eMC) at: https://www.medicines.org.uk/emc/medicine/24976.
About Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic castration-resistant prostate cancer occurs when cancer has metastasised (spread) beyond the prostate to other parts of the body and the disease progresses despite serum testosterone below castrate levels[xiii].
The prostate is a gland in men that produces part of the seminal fluid and is located around the urethra (under the bladder). In some cases, cancer of the prostate can grow slowly. However, depending on factors including characteristics specific to the patient and the tumour, prostate cancer also can grow very quickly and spread widely[xiv].
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. The legal entity for Janssen in the UK and Ireland is Janssen-Cilag Ltd. Please visit www.janssen.co.uk for more information.
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