Scottish Medicines Consortium recommends Zytiga® (abiraterone acetate) in combination with prednisone and androgen deprivation therapy (ADT) for men with aggressive, early prostate cancer for use in NHS Scotland

The Janssen Pharmaceutical Companies of Johnson & Johnson today welcomed the Scottish Medicines Consortium (SMC) decision to recommend Zytiga (abiraterone acetate) with prednisone or prednisolone plus androgen deprivation therapy (ADT) for use in NHS Scotland for the treatment of adult men with newly diagnosed high-risk, metastatic hormone-sensitive prostate cancer (mHSPC).[1][2]

The SMC made its recommendation after considering evidence from the multinational, Phase 3 LATITUDE study^[3] (comparing abiraterone and ADT with ADT alone) alongside data from the ongoing STAMPEDE study^[4] where necessary (comparing abiraterone plus ADT with ADT alone, and with docetaxel plus ADT). Combining abiraterone with ADT consistently demonstrated superiority over ADT alone in terms of delaying disease progression, improving quality of life and extending overall survival.^2,3

Prostate cancer is the most common male cancer in the UK with around 47,700 new cases every year.[5] More men now die from prostate cancer than women from breast cancer in the UK.[6] Annually, there are 3,518 new cases of prostate cancer in Scotland,[7] with an estimated population of 460 who could be eligible for abiraterone acetate in combination with prednisone or prednisolone and ADT.¹ Life expectancy for those with newly diagnosed high-risk mHSPC is typically three years on conventional hormone therapy.[8]

“This is a landmark decision which has the potential for positively changing the lives of men in Scotland who have advanced prostate cancer when first diagnosed,” said Steve Allen, Patient Representative, Tackle Prostate Cancer. “They now have a choice of therapy that can be used in addition to standard hormone therapy. The SMC are to be applauded for this decision which will allow these patients to have an improved quality of life.”

The guidance was issued following a pragmatic review of the evidence within a six-month period. Following a full submission by Janssen in June 2019, the SMC assessed abiraterone through the Patient and Clinician Engagement (PACE) process due to the orphan-sized patient population.¹ The PACE committee recognised the severity of the condition, the need for alternative treatment options in this setting, and the particular value abiraterone offers to patients who are unsuitable for chemotherapy (docetaxel) at diagnosis.¹ It also highlighted the positive impact abiraterone has on patients’ quality of life and independence, as well as the considerable benefit to families and carers.¹

Abiraterone is the only licensed treatment for newly diagnosed mHSPC which can delay chemotherapy and disease progression, prolong survival and maintain patients’ quality of life.² Conventional chemotherapy (docetaxel) has been shown to provide significant benefit on overall survival, however it is associated with clinically significant toxicities[9] and, until the recommendation of abiraterone, patients had no other life-extending treatment option at this early stage in their treatment pathway. Abiraterone now fulfils this considerable unmet need in Scotland for patients unsuitable for treatment with docetaxel.¹

"Janssen is pleased that the SMC has accepted abiraterone for use within NHS Scotland for eligible patients and applauds the SMC’s pragmatic approach and flexibility in reaching this positive recommendation so quickly,” said Jennifer Lee, Director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy at Janssen UK. “We recognise this outcome results in a discrepancy in access between patients in Scotland and those in the rest of the UK and are currently working closely with NICE to ensure that men who need it will also be able to access abiraterone routinely within the NHS before their disease progresses.”

Abiraterone was submitted to the National Institute for Health and Care Excellence (NICE) in February 2018, but an outcome has yet to be reached.   Janssen continues to work with NICE and NHS England to find a solution for patients across the UK. Abiraterone is already recommended by NICE as clinically and cost effective later in the disease pathway as an option for treating metastatic castration-resistant prostate cancer before and after chemotherapy.[10]^,[11]

Discovered at the Institute of Cancer Research and first trialled at The Royal Marsden Hospital, abiraterone is widely recognised as a success story for the UK life sciences industry.

[1] SMC. Zytiga ((abiraterone acetate) 500 mg film-coated tablets. SMC2215. Available at https://www.scottishmedicines.org.uk/. Last accessed January 2020.

*Embargo lifts when the SMC document (see reference 1) appears on the SMC website, currently scheduled for the date and time specified at the top of the release

[3] Fizazi  K, Tran NP, Matsubara N, et al. Abiraterone acetate plus prednisone (AA+P) in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial. The Lancet Oncology 2019; 20 (5): 686-700.

[4] Sydes MR, Spears MR, Mason MD, et al. Adding abiraterone or docetaxel to long-term hormone therapy for prostate cancer: directly randomised data from the STAMPEDE multi-arm, multi-stage platform protocol. Annals of oncology : official journal of the European Society for Medical Oncology. 2018; 29(5):1235-48. Epub 2018/03/13

[5] Cancer research UK. Prostate Cancer Statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/prostate-cancer. Last accessed January 2020.

[6] Prostate Cancer UK. “We call on UK to step up as new figures show prostate cancer now a bigger killer than breast cancer”. Published 2 February 2018. Available here: https://prostatecanceruk.org/about-us/news-and-views/2018/2/we-call-on-uk-to-step-up-as-new-figures-show-prostate-cancer-now-a-bigger-killer-than-breast-cancer. Last accessed January 2020.

[7] ISD Scotland. Cancer Statistics. Cancer of the Prostate. Available at: https://www.isdscotland.org/Health-Topics/Cancer/Cancer-Statistics/Male-Genital-Organs/#prostate. Last accessed January 2020.

[8] Mottet N, et al. Updated Guidelines for Metastatic Hormone-sensitive Prostate Cancer: Abiraterone Acetate Combined with Castration Is Another Standard. European Urology. 2017.

[9] The European Medicines Agency (EMA). European Public Assessment Report. Abiraterone (Zytiga). 12/10/2017, EMEA/H/C/002321/II/0047 https://www.ema.europa.eu/en/documents/variation-report/zytiga-h-c-2321-ii-0047-epar-assessment-report-variation_en.pdf. Last accessed January 2020.

[10] National Institute for Health and Care Excellence Technology Appraisal Guidance for abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated. TA387 Published 27 April 2016. Available here: https://www.nice.org.uk/guidance/ta387/chapter/1-Recommendations. Last Accessed January 2020.

[11] National Institute for Health and Care Excellence Technology Appraisal Guidance for abiraterone for castration-resistant metastatic prostate cancer previously treated with docetaxel-containing regimen. TA259. Published June 2012. Available here: https://www.nice.org.uk/guidance/ta259/chapter/1-Guidance. Last accessed January 2020.