Press release -

Anger at SMC abiraterone decision

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

Abiraterone after chemotherapy was approved for routine use on NHS Scotland in August 2012. However the drug is not routinely available to men who have not received chemotherapy, when it has been shown to extend life and delay or avoid the need for chemotherapy and its devastating side effects (1,2). The SMC’s decision means that men with incurable prostate cancer who are unable to undergo, or want to delay, chemotherapy cannot now gain routine access to the treatment on NHS Scotland.

The SMC has ignored the emphatic support from clinicians and patients for this treatment. Clinicians consulted by the SMC described abiraterone before chemotherapy as “a paradigm shift” in the treatment of prostate cancer as an effective drug treatment is now available to men who no longer respond to other treatments and who can’t have chemotherapy. Prostate Cancer UK also made clear the overwhelming support of patients (see notes to editors B). Despite this the SMC still rejected the drug.

Commenting on the decision Owen Sharp, Chief Executive of Prostate Cancer UK, said: “The SMC’s decision to deny abiraterone on the NHS in Scotland is an intolerable blow to hundreds of men with incurable prostate cancer. We are saddened to see that, once again, men are being denied treatment because it’s deemed to be too expensive. The manufacturer, Janssen, must make sure its product is sensibly priced so that men aren’t caught in a situation where a drug exists that could improve and extend their lives, but they just can’t get it.

“Men with advanced prostate cancer deserve the right to routinely access a treatment that can delay chemotherapy and its devastating side-effects. No man should be told they must endure and survive chemotherapy before they are allowed to routinely access abiraterone. And that is why I urge both the SMC and the manufacturer to work together immediately to get this drug approved.

“Men United is our movement for everyone who believes that men are worth fighting for, and we have that whole movement behind me when we call on both the SMC and the manufacturer to immediately take the actions needed to get this drug routinely available to the men who need it throughout Scotland. We will not rest until this is the case both in Scotland and throughout the rest of the UK.”

-ENDS-

Topics

  • Health Organisations

Categories

  • drug appraisal
  • owen sharp
  • zytiga
  • abiraterone
  • smc
  • scottish medicines consortium
  • men united
  • nhs scotland
  • scotland

Regions

  • Scotland

NOTES TO EDITOR

A. Abiraterone prior to chemotherapy

Following an award winning campaign from Prostate Cancer UK, abiraterone after chemotherapy was approved for routine use on NHS Scotland in August 2012. However the drug is not yet routinely available before chemotherapy. Men cannot understand why they have to endure chemotherapy before they are allowed to routinely access abiraterone in Scotland.

The phase III trial of abiraterone prior to chemotherapy illustrated a highly significant benefit for men and their loved ones. The drug was shown to:

  • delay the start of chemotherapy by an average of 9.7 months and
  • increase overall survival by an average of 4.4 months (34.7 months vs 30.0 months with prednisone alone) (2).

Giving abiraterone 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.

Although the treatment has not been approved by NICE for routine use south of the border, it is widely available to patients in England via the Cancer Drugs Fund. Around 4,500 men have accessed the drug in England via this method since March 2013, illustrating the faith patients and clinicians have in the treatment.

To quote one patient who has accessed the drug via England’s Cancer Drugs Fund, without having had chemotherapy:

“I have had prostate cancer for 3 years it has spread to lymph nodes and liver. I was prescribed abiraterone 6 months ago before chemotherapy and it has made a tremendous difference to my life. I have been able to take up running and swimming again and have been virtually pain free. I just cannot bear to think about what will happen if this drug is denied to me.”

Now that the SMC has rejected abiraterone 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 gamble on an Individual Patient Treatment Request (IPTR) application, 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 in Scotland who have been diagnosed with prostate cancer - as well as their family, friends and healthcare professionals. 176 people responded to the survey. Key findings include:

  • A)Over 91% said it was “important” or “very important” that abiraterone should be available on NHS Scotland prior to chemotherapy. Only 1 % said it was “not important.” 8% were “unsure.”

B)Respondents were asked how they would feel if abiraterone was not made available on the NHS. Words most commonly used in response include: “Cheated,” “angry,” “dismayed,” “bitter,” “horrified,” “marginalised,” “abandoned,” “deflated,” “hurt,” “furious” and “betrayed.” Two example quotes follow:

“I would feel disgusted and cheated that a drug that is available to men in England via the CDF is being denied to men in Scotland.”

“Very disappointed for men and their families affected by this disease and also, from a clinical point of view, that we have an effective treatment …that we are not able to prescribe.”

  • C)Survey respondents were extremely keen for this treatment to be approved in order to avoid or delay chemotherapy.Respondents who had undergone chemotherapy described it as “terrible,” “debilitating,” “blunderbuss treatment,” “devastating wipe out treatment” and “truly hellish.” Consequently it was argued that approving abiraterone before chemotherapy was extremely important as it would do two things:
  • i.Provide men who are not physically or emotionally fit enough to undergo chemotherapy with another treatment option other than palliative care.
  • ii.Provide men who may be fit enough for chemotherapy with an option to delay it, and the significant physical and psychological side effects that so often come with it.

In short, patients cannot understand why they are forced to endure chemotherapy before they are allowed to routinely access abiraterone. It seems both cruel and counterproductive.

C. Access to abiraterone before chemotherapy in England

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

Around 4,500 men have accessed the drug via this method since March 2013, illustrating the faith patients and clinicians have in the treatment.

Prostate Cancer UK is calling for the price of the drug to be reduced so that NICE can re-review it with a view to approving routine NHS access in England and Wales.

D. About Men United and Prostate Cancer UK:

Prostate Cancer UK’s Men United campaign aims to 'keep friendships alive.' People are being urged to search ‘Men United’ and sign up.

Prostate Cancer UK’s new Men United TV advert can be viewed here:http://prostatecanceruk.org/get-involved/men-united

  • oMen 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. Over 200,000 people engaged with Men United in 2014.
  • oSearch Men United, or visit prostatecanceruk.org/menunited
  • oProstate 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.
  • oProstate cancer is the most common cancer in men. More than 10,000 men die every year from this male-only disease, and over 250,000 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.

References

1. Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, Shore ND, de Souza P, et al. Updated Interim Efficacy Analysis and Long-term Safety of Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer Patients Without Prior Chemotherapy (COU-AA-302). Eur Urol. 2014 Mar 6;

2. Ryan C, Smith M, Fizazi K, Miller K. 753O - Final overall survival (OS) analysis of COU-AA-302, a randomized phase 3 study of abiraterone acetate (AA) in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) without prior chemotherapy [Internet]. [cited 2014 Sep 26]. Available from: https://www.webges.com/cslide/library/esmo/browse/search/3gg#9f9k02Lm