Ibrutinib and NHSE current position.

[Mick491]

Dear all

As you know I am fighting for the right to be prescribed the drug my consultant thinks is the best treatment for me which is Ibrutinib. However because my relapse is after the 3 year point (3.8 years) I am denied that treatment. As part of the invite for a review in July by NHSE I emailed my personal experiences. Below is thier response.

Dear Michael

Thank you for your email of 16th July 2018.

Your enquiry has been allocated a reference number of CAS-465362. Please quote this reference number in any further communication regarding this issue.

NHS England commissions or buys primary care services for local communities. For example GPs, dentists, opticians, and pharmacy services. We also commission health and justice and military health services plus some specialised services.

The NHS England Customer Contact Centre is primarily set up to handle general enquiries, complaints & Freedom of Information requests from members of the public regarding primary care services.

I can confirm that I have provided below a document from the NHS England website regarding the provision of Ibrutinib. Within this it does confirm that any recently submitted evidence regarding the current treatment criteria is going to be reviewed by the end of July 2018.

england.nhs.uk/wp-content/u...

If you require any further information or wish to speak to someone about your enquiry, please contact NHS England at the email address and telephone number shown below.

Regards

Jennifer

NHS England

PO Box 16738 | Redditch | B97 9PT

0300 3 11 22 33

[e-mail]

england.nhs.uk

From: Michael Smith MBE [mailto:[e-mail]]

Sent: 16 July 2018 17:07

To: CONTACTUS, England (NHS ENGLAND)

Subject: NHSE and JULYS review of Ibrutinib Evidence.

Sir/Madam

My I am Michael Smith MBE JP and a sufferer of CLL. I have already gone through first line treatment with FCR. After the third treatment i was hospitalised for 3 days as o had a reaction. Fortunately through good care I was able to continue. However, I was so ill after the 5th treatment i could not continue. The treatment had limited success and shortly after I had a massive heart attack requiring immediate surgery. The cardiologist put it down to the strain of the chemotherapy. My consultant informs me I came out of remission after 3 years 8 months.

I am now very ill and my consultant says I now need treatment. In line with policy at Nottingham City Hospital a case review was done on me. Every consultant/clinician stated the best treatment for me is Ibrutinib. However, because of the conditions NHSE have imposed which go against NICE guidelines which have no timeframe for relapsed patients, I feel NHSE are in breach of thier own constitution and putting my life prematurely at risk.

I am asking NHSE to follow the guidelines laid down by NICE removing the 3 year timeframe as soon as possible. This will allow your highly skilled doctors to treat their patients with all the tools on thier armoury for the advantage of thier patients.

I am also aware of the content of a letter sent by the CLLSA and Bloodwise and I fully support thier argument.

Would you please acknowledge receipt of this email and confirm it will be presented as part of the patient evidence use in July review of Ibrutinib.

Yours faithfully

Michael Smith MBE JP

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[Flabal]

It looks to me they are taking their time and pushing the situation as far as possible. Honestly feeling quite angry. Why not just give you the treatment?

[Mick491 in reply to Flabal]

Thanks for the support.

[Flabal in reply to Mick491]

No problem at all. Honestly I wish I could do more.

[AdrianUK in reply to Mick491]

Unfortunately NHSE do not deal well with individual cases. If I was you I would reply to this email and ask for specific confirmation that your case will be considered. Also given the wording “unsuitable for chemotherapy” I would have a solicitor write to them demanding your immediate treatment on pain of your estate suing. Also perhaps email or post this whole correspondence to Lord O Shaugnessy and the new health and social care advocate. He seems a resonable man. We can clearly see how NHSE are trying to wiggle out of their responsibility here. The critical thing is they are confusing guidelines from reimbursement decisions. What they are doing is not stating that some people might benefit from FCR a second time they are requiring that nobody gets it a second time unless they meet a certain arbitrary criteria.

[HAIRBEAR_UK Founder Admin]

Hi Mick

Just back in after a few days leave following Leukaemia Care, CLLSA and UK CLL Forum meeting on Friday at Bloodwise HQ with Prof Peter Clark, (Chair of NHS England Chemotherapy Clinical Reference Group & National Clinical Lead, Cancer Drugs Fund).

The CLL clinical research group provided extensive clarification of new data supporting a strong case for access and patient group representatives were able to share patient responses and perspectives, which were commented on as 'clear'. We should receive feedback of next steps by the end of the month after Peter Clark shares and discusses with NHSE

[Mick491 in reply to HAIRBEAR_UK]

Hi Hairbear

On my own behalf and I'm sure all other CLL sufferers appreciate the hard work you David Innes and all the team are doing on our behalf. Having spoken to jm954 it really is a massive team effort that's been put in which unfortunately not everyone is aware of. I'm hoping my individual efforts have added some slight weight to the overall argument and not a hinderence.

I'm back for a review next week where I believe my consultant is planning a week on IV steriods to get me through to August when the trial of Ibrutinib and venetoclax may be available. If not are all your hard work is successful Ibrutinib may be available to me was I'm reluctant for another round of FCR, my consultant said it would be a last resort.

Again please thank all the team for their concerted efforts.

Mick

[Jm954 Administrator in reply to Mick491]

Hang in there Mike, we’re all desperate for this to be approved in time for you.

[Hidden in reply to Mick491]

I hope the steroids can hold you together for a few more weeks Mick.. if you can get on that trial of I/V all being well that’s like a lottery win.

I know lots of people are doing everything they can to make things happen but fingers crossed for you you get that trial so your suffering won’t have been in vain.

Stuart

[Mick491 in reply to Hidden]

Thanks Stuart.

[carnvellan]

I agree with Adrian - send the correspondence to Lord O'Shaughnessy. Would you also give me permission to pass it to my friend, Baroness Prosser, who is pursuing the issue in the Lords for me?