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Anger as SMC rejects enzalutamide

Press Release   •   Aug 10, 2015 00:01 BST

Prostate Cancer UK has expressed anger at the Scottish Medicines Consortium’s (SMC) decision to reject the life-prolonging and life-enhancing drug, enzalutamide, for use on NHS Scotland for men with incurable advanced prostate cancer who have not received chemotherapy.

Enzalutamide was approved for routine use after chemotherapy on NHS Scotland in November 2013. However the drug is not routinely available to men with advanced prostate cancer who have not received prior chemotherapy, when it has been shown to extend life and delay the need for chemotherapy and its side effects (1).

The SMC’s decision means that men with incurable advanced prostate cancer that no longer responds to hormone therapy who are unable to undergo, or who wish to delay, chemotherapy have been denied routine access to a clinically effective treatment.

Today’s rejection follows shortly after the SMC’s rejection of abiraterone before chemotherapy, another life-prolonging and life-enhancing option for men with incurable prostate cancer that has previously been approved for use after chemotherapy.

Commenting on the decision Owen Sharp, Chief Executive of Prostate Cancer UK, said: “The SMC’s decision to deny enzalutamide on NHS Scotland before chemotherapy is yet another intolerable blow to hundreds of men with incurable advanced prostate cancer.

“Some men with this type of prostate cancer want the option to delay chemotherapy. Others can’t or don’t want to have chemotherapy at all. Men in these situations need to be given access to the full range of effective treatment options. Instead today’s cruel decision leaves hundreds of men without active treatment, and some men with nowhere to turn but palliative care. When effective treatments are on the market but denied to men, this makes the pain all the more difficult to bear.

“According to today’s announcement only men who are willing and able to have chemotherapy are allowed to routinely access enzalutamide on NHS Scotland. This is unacceptable.

“The SMC and the manufacturer must work together immediately to get this treatment approved, with the manufacturer being clear it is offering the best possible price.

“The men who need enzalutamide don’t have time to waste. Decency and common sense must prevail as soon as possible.”

-ENDS-

NOTES TO EDITOR

A. Enzalutamide prior to chemotherapy

Enzalutamide after chemotherapy was approved for routine use on NHS Scotland in November 2013, for men with advanced incurable prostate cancer that has stopped responding to hormone therapy. However the drug is not yet routinely available before chemotherapy for these men.

A phase III clinical trial(1) showed that enzalutamide increased the time before prostate cancer could be seen to progress in chemotherapy-naïve men with metastatic hormone-relapsed prostate cancer by an average of 8.4 months.

Giving enzalutamide before chemotherapy offers a ray of hope for men who are not physically or emotionally strong enough to endure a course of chemotherapy. Men on this treatment are often still able to work and enjoy their usual social activities, giving them priceless quality time. If a man wishes to delay the use of chemotherapy, enzalutamide offers an average 17 months delay before they need to consider chemotherapy.

Now that the SMC has rejected enzalutamide before chemotherapy men in Scotland wanting to access the drug will either have to take a course of chemotherapy (which many are not physically or emotionally fit to undergo) or make an Individual Patient Treatment Request (IPTR) application to cover the costs of enzalutamide, which can take weeks and is by no means guaranteed to be successful.

B. Prostate Cancer UK patient survey

Prostate Cancer UK conducteda survey of men who have been diagnosed with prostate cancer - as well as their family, friends and healthcare professionals. 402 people responded to the survey, which was presented to the SMC.

Asked how important they felt it was that enzalutamide should be available on the NHS Scotland prior to chemotherapy 92.6% said important or very important. 0.3% said it was not important. 7.1% were unsure.

C. Access to abiraterone before chemotherapy in England

Although the treatment has not been approved by NICE for routine use it is currently available to patients in England via the Cancer Drugs Fund.

Between Sept 2014 (when first made available) and March 2015 (most recent figures) 807 men in England have accessed enzalutamide before chemotherapy via this method, illustrating the faith patients and clinicians have in the treatment.

D. About Men United and Prostate Cancer UK:

  • Men deserve better. Men United is Prostate Cancer UK’s movement for everyone who believes that men are worth fighting for, to help us beat prostate cancer and keep friendships alive. Some 230,000 people have engaged with Men United since 2014.
  • This summer Men United has tons of fun ways for people to see their mates, from bike rides, sponsored walks, BBQs and quiz nights - all whilst doing something great for Prostate Cancer UK.
  • Search Men United, or visit prostatecanceruk.org/menunited
  • Prostate Cancer UK works to get men in all areas of the country the early detection, effective diagnosis and better treatments that will beat this disease.
  • Prostate cancer is the most common cancer in men. More than 10,000 men die every year from this male-only disease, and 300,000 men are living with prostate cancer in the UK.
  • Anyone with concerns about prostate cancer can contact Prostate Cancer UK's Specialist Nurses in confidence on 0800 074 8383 or via the online Live chat, instant messaging service: www.prostatecanceruk.org. The Specialist Nurse phone service is free to landlines and open from 9am to 6pm Monday to Friday with late opening until 8pm on Wednesdays.

Reference

1. Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424–33.