JANSSEN EXPRESSES DISAPPOINTMENT WITH NICE FINAL APPRAISAL DOCUMENT DENYING MEN WITH AGGRESSIVE, EARLY PROSTATE CANCER ACCESS TO ZYTIGA® (ABIRATERONE ACETATE)

 

FOR UK TRADE, MEDICAL AND CONSUMER MEDIA Under embargo until NICE publishes decision on 26th June 2020, after 09:00 BST

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JANSSEN EXPRESSES DISAPPOINTMENT WITH NICE FINAL APPRAISAL DOCUMENT DENYING MEN WITH AGGRESSIVE, EARLY PROSTATE CANCER ACCESS TO ZYTIGA^® (ABIRATERONE ACETATE)

 

Men in England and Wales with newly diagnosed high-risk, metastatic hormone-sensitive prostate cancer (mHSPC) denied access to a life-extending treatment option, in contrast with those in Scotland where abiraterone acetate was recommended earlier this year

 

High Wycombe, 26 June 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today expressed disappointment with the National Institute for Health and Care Excellence (NICE) Final Appraisal Document (FAD) that does not recommend Zytiga® (abiraterone acetate) with prednisone or prednisolone plus androgen deprivation therapy (ADT), within its marketing authorisation, for treating newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adults.[1][*]

 

Janssen believes this decision does not accurately reflect the evidence submitted to the Committee. This outcome highlights the discrepancy in routine access between patients in England and Wales, and those in Scotland, where the Scottish Medicines Consortium (SMC) approved abiraterone acetate for use in the full licensed population earlier this year, based on the same evidence base.

 

Janssen is considering its options for appealing the decision and believes NICE could have reached a positive decision for patients who are not suitable to receive chemotherapy. Indeed, it has taken this approach to reimbursement elsewhere in the prostate cancer pathway and in other disease settings, such as multiple myeloma.[2]^,[3] 

 

“We are extremely disappointed with this decision, and particularly for those patients and clinicians who were anticipating access to this innovative therapy. It is particularly surprising in light of the recent decision by NHS England which, due to the current COVID-19 pandemic, has recognised abiraterone acetate as an alternative option by agreeing to provide it for an interim period to those who are intolerant to other treatments.”[4] commented Sarah Scanlon, Business Unit Director Oncology, Janssen-Cilag Limited. “We are currently reviewing the FAD in detail and we will assess our options for a potential challenge to this decision, particularly given the evidence supporting the value of abiraterone in patients who are ineligible for chemotherapy.”

 

Abiraterone acetate is approved for the treatment of newly diagnosed, high-risk mHSPC patients and clinical trial data have demonstrated that abiraterone acetate plus prednisone/prednisolone can delay disease progression and the need for chemotherapy, prolong survival and improve patients’ quality of life.[5] Currently, ADT alone is the only reimbursed, licensed treatment available for routine use in mHSPC patients in England, with conventional chemotherapy (docetaxel) used off-label in patients who are fit enough and willing to receive it. Indeed, data from the National Prostate Cancer Audit 2020 has shown that only 27 percent of patients diagnosed with metastatic disease received docetaxel in England between April 2017 and March 2018 and age is a significant factor in its uptake.[6] Moreover, the current COVID-19 pandemic has reinforced the urgent need for a life-extending therapy that does not involve hospital attendance for administration of chemotherapy.

 

Prostate cancer is now the most commonly diagnosed cancer in the UK bringing the total number of annual diagnoses to 57,192.[7] More men now die from prostate cancer than women from breast cancer in the UK.[8] There are approximately more than 4,000 patients in England who could be eligible for abiraterone acetate in combination with prednisone/prednisolone and ADT in this mHSPC setting.[9] Current life expectancy for these patients is only three years on conventional hormone therapy⁴ and up to three and a half years if patients are fit enough and willing to receive additional chemotherapy.[10] Patients treated with ADT and abiraterone acetate plus prednisone survived for over four years (53.3 months median overall survival), compared to patients treated with ADT and a placebo (36.5 months).⁵

 

Abiraterone acetate plus prednisone/prednisolone has been established over the past eight years through its use in the NHS for later stage disease and has been added to the WHO list of essential medicines in 2019.  When used earlier in mHSPC, abiraterone acetate plus prednisone/prednisolone provides patients with a life-extending treatment option capable of improving their quality of life, delaying disease progression, delaying the need for chemotherapy and ultimately prolonging their survival.⁴ Patients with metastatic castration-resistant prostate cancer (mCRPC) continue to benefit from abiraterone acetate plus prednisone/prednisolone as it is already recommended by NICE as a clinically- and cost-effective option in this indication, before and after chemotherapy.[11]^,[12]

 

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

 

-ENDS-

About abiraterone acetate

Indications[13]

Abiraterone acetate plus prednisone/prednisolone is indicated for:

• the treatment of newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT)
• the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
• the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

 

For a full list of side effects and for further information on dosage and administration, contraindications and other precautions when using abiraterone acetate, please refer to the summary of product characteristics, available at: https://www.medicines.org.uk/emc/product/2381/smpc.

 

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

 

Learn more at www.janssen.com/uk. Follow us at www.twitter.com/JanssenUK.  Janssen-Cilag Limited is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

 

# # #

 Date of preparation: June 2020

 Job number: CP-162255

References:

[1] National Institute for Health and Care Excellence. Final appraisal document for abiraterone for treating newly diagnosed high risk metastatic hormone-naive prostate cancer [ID945]. Published June 2020. Available here: https://www.nice.org.uk/guidance/indevelopment/gid-ta10122/documents Last accessed June 2020

[2] National Institute for Health and Care Excellence. Technology Appraisal Guidance for radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases. TA412. Published September 2016. Available here: https://www.nice.org.uk/guidance/TA412/chapter/1-Recommendations Last accessed June 2020

[3] National Institute for Health and Care Excellence. Technology Appraisal Guidance for lenalidomide plus dexamethasone for previously untreated multiple myeloma. TA587. Published June 2019. Available here: https://www.nice.org.uk/guidance/TA587 Last Accessed June 2020

[4] National Institute for Health and Care Excellence. Interim treatment change options during the COVID-19

pandemic, endorsed by NHS England. Published June 2020. Available here: https://www.nice.org.uk/guidance/ng161/resources/interim-treatment-change-options-during-the-covid19-pandemic-endorsed-by-nhs-england-pdf-8715724381 Last accessed: June 2020

[7] Prostate Cancer UK. Prostate cancer becomes the most commonly diagnosed cancer in UK, but research is at a standstill. Available at: https://prostatecanceruk.org/about-us/news-and-views/2020/6/most-common-cancer-in-uk  Last accessed June 2020.

[8] 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 at: 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 June 2020

[10] Clarke NW, Ali A, Ingleby FC, et al. Addition of docetaxel to hormonal therapy in low- and high-burden

metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDEtrial. Annals of

oncology : official journal of the European Society for Medical Oncology 2019 doi: 10.1093/annonc/mdz396

[published Online First: 2019/09/29]

[11] 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 June 2020

[12] 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 June 2020

[13] Zytiga 500mg UK , Summary of Product Characteristics Dec 2019 Available at: https://www.medicines.org.uk/emc/product/2381/smpc/print Last accessed: June 2020