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NICE Appraisal of Cabazitaxel and other things

Dear Prostate Cancer Support Group Leader

(this is numbers 2 and 3 and an update to number 1 of the important messages I mentioned in my last email)

First, we now have a date for Mike Lockett’s funeral. It will be at 1:30pm on 12th October, at St. ’s, St. ’s Road, Buxton. Post Code SK17 6XN and afterwards at – Lee Wood Hotel, The Park, Buxton SK17 6TQ, please notify Jane at Funeral Services, Macclesfield, 01625 433853, if you plan to go to the hotel. I hope to see many of you there.

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Secondly, you may or not be aware that NICE announced a few days ago that their first pass for Cabazitaxel (Jevtana) is ‘Not Approved’. This is not a final ‘Not Recommended’ and NICE have requested responses both from registered stakeholders (the Federation is one such and will make further representation) but also from individuals such as your members who are actually affected by the decision.

It is our belief that the analysis that backs up the review by NICE is basically flawed and we will be making that point in our response. More important though are factors that NICE has not considered (because they cannot be quantified in terms that NICE can understand and use for the entirely mechanistic approach they adopt). For the want of a better word we can call these factors “emotional”, and it is important now that they get registered, by patients, in a way that cannot be ignored. I am asking you to ask your members therefore to make representation to NICE on this issue by sending an email to jeremy.powell@..., asking NICE to take other factors into account before making a final recommendation.

It is important that this is not seen to be some sort of “concert party” and so we do not offer any specific points to be made, but below is a summary of the important facts, and some opinions (ours), about this drug:

Cabazitaxel is recommended for Hormone Refractory Prostate Cancer (the Federation strongly deplores the term “Castration Resistant” for this condition, as an insult to men who’ve had hormone therapy, and we will not use it), where previous chemo-therapy (Docetaxel) has failed.

In trials (of mostly very sick men) it showed on average a 3 month extension of good quality life over standard treatment. In men who probably have a less than 6 month life expectancy at this point, this is highly significant.

It is the ‘last port of call’ for men in this condition. Denial of this treatment is a cruel blow to such men.

Docetaxel during the phase 3 trial and consultative process had a similarly high £££per QALY ( Quality Adjusted Life Year) but in practise it has proved to extend life considerably to those people who it was designed for, rather than the near dead who could not tolerate the side effects. Because trials tend to be conducted on the very ill, the effect on a more representative cross-section of patients is normally much better than that shown on trials.

The approval of Herceptin for breast cancer (a drug of very limited application) 4 years ago (which may or may not have been strongly influenced by the strong support from a lady cabinet member) happened on very flimsy evidence; are men to be excluded the benefits because the’re men?

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Finally (for the moment - item 4 will follow next week)

There are still places available at our Workshop “Lifestyle and Prostate Cancer”, sponsored by Prostate Action, to be held at the University of Leicester on 27th October. We have a very strong team of presenters, a new marching song for all prostate cancer sufferers (and their wives) to sing, and the prospect of an interesting forum addressing the question: "What can we do to minimise prostate cancer’s impact on our lifestyles?”. Please encourage your members to book for this event, by emailing bookings@..., or phoning 0.

Sandy Tyndale-Biscoe

Hon Chairman, Prostate Cancer Support Federation

Cedarcroft, Sunnyway, Bosham, CHICHESTER, W. Sussex, PO18 8HQ, UK

Charity Registration Number: 1123373

Phone: +44 1243 57 22 23

Mobile: +44 7802 41 68 67

e-mail: chairman@...

www: www. prostatecancerfederation.org.uk

skype id: sandytb

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