I haven’t posted anything since early June and the last real information on my progress was posted in May so I thought its about time to post something a bit more up to date.
Treatment & York Press
Back in February my oncologist told me that the hospital would treat me if I funded the drugs. I jumped at the chance! Staying alive is my priority and although the money is difficult to find we still can and the public have been very generous on my fundraiser.
In March, just before I started treatment at the beginning of April, York Press became interested in my case and did an excellent piece on my plight. From that a guy called Stephen Phillips contacted me and said he’d like to raise money for me. Amazing! Stephen is a triathelete and said he had one scheduled for August and would try and use that to raise some money for me. York Press did a piece on that too. They also took a before picture of the rather large tumour that was on the back of my head at the time, with a view to doing an “after” piece at the end of my treatment.
From April to June I spent a day every 3 weeks having these incredible immunotherapy drugs pumped into me (4 in total) and the results were quite spectacular. Normally there i not much to see from these treatments as the cancer spreads within my body. I had a CT scan in early July and got the results in August: every tumour site in my body had reduced considerably! But more impressive was the visble large tumour on the back of my head. Over the course of the treatment it had gradually reduced to almost nothing! Pictures below:
So that’s the visible evidence of what treatment with immunotherapy does to me. Some radiotherapy on the tumour in December 2018 (which caused the hair loss) may well have weakened it, but the immunotherapy almost got rid of it. Yet NHS England continue to refuse to fund my treatment.
I’ve written before about Cemiplimab before, essentiall it is an immunotherapy drug that Sanofi has trialled very successfully on my condition. I’ve been following its progress through trialls andthe approval process for some time. Our strategy had become to try and stay alive until something got approval in the the UK as NHS caught with the rest of the developed world.
Cemiplimab was approved for general use in Oct 2018 and given restricted authorisation in May 2019 by the European Medicines Agency in May 2019. Cancer Research UK reported in July 2019 that it had been added to the Cancer Drugs Fund thus making it available to patients.
But The Cancer Drugs Fund (CDF) is not as straight forward as it first seems. NHS England explains it here. It describes it as “an interim funding source” and says:
NHS England and the National Institute for Health and Care Excellence (NICE) work in partnership with pharmaceutical companies to address uncertainty about the effectiveness of new cancer treatments. This usually involves the collection of additional data, during a managed access period when patients are able to access the treatment. The additional data helps NICE to decide whether a new treatment should be routinely funded.
So despite having gone through 2 separate very successful trials, despite The US fast tracking it for general use in Oct 2018 and despite the fact that there there is no other authorised treatment in the UK, NICE and NHS England want more information.
In order to gain relevant information; restrictions are put on who can have access to a drug on the CDF list. How these restrictions are devised is not explained, but the usual process is for NICE to use the original clinical trial exclusion criteria, presumably because that requires the least effort on their party.
Unfortunately when you look at the (almost unreadable) CDF list which lists the criteria and find the entry for Cemiplimab, this one blocks my access immediately:
10. The patient has not received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or antiCytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody unless the patient has been entered into the Sanofi cemiplimab early access scheme and all other treatment criteria on this form are fulfilled (eg ECOG performance status). Please mark below whether the patient was previously enrolled in the Sanofi early access scheme: – not enrolled in Sanofi early access scheme ie patient is cemiplimab-naive or – previously enrolled in Sanofi early access scheme and all other treatment criteria on this form are fulfilledNational Cancer Drugs Fund List ver1.148 08-Aug-19 , Cemiplimab
I have had an anti-PD-1 and a CTLA-4 antibody so that makes me ineligible for treatment as it did for the trials. It talks about the “early access scheme” (which again i was ineligible for the same reason). There is a managed access agreement which also has the same restrictions and depressingly says that NICE will continue collecting data until July 2021 before making a decision on whether to make Cemiplimab generally available.
I actually anyone in the UK with my condition had actually had immunotherapy so it seems nonsensical that this is on the list of criteria for access. My 3 funding refusals demonstrate how difficult it is to obtain in the UK. Cancer Research UK make the claim that up to 560 people per year will have early access to Cemiplimab. I doubt that very much.
So I’m now trying to work out how I’m going to fund staying alive until late 2021, 3 years after it was made generally available in the US. Grateful for any advice. I think I’ll have to win the lottery to be honest.
I’m reasonably fit and well, I feel much better than I did in February this year. I have had some side effects, and side effects from the drugs I was given for the side effects, but I am slowly recovering. I’ve been for a couple of sails in my dinghy, but I don’t think I’ll be getting any trophies this year.
Anyway, I’m still here and still fighting, maybe I will make it to the end of 2021?
Onwards and upwards!