After complaining about the last Individual Funding Request (IFR) farce and finding the NHS complaints process was a farce as well, my oncologist re-submitted my IFR with additional evidence. Just before Christmas it was duly rejected by the IFR Screening Group.
As I know it isn’t worth complaining and there is no method for appealing or reviewing these decisions I’m writing this post as a reference for a public letter I intend to write to Simon Stevens (NHS England Chief Executive).
It contains detail that I don’t want to clutter up the public letter with, so it is possibly the dullest post I have ever written (please don’t disagree!) so I encourage you to stop reading unless bureaucratic nonsense is something you are interested in.
In order to make sense of this post you need access to 2 documents:
- The original IFR document submitted by my oncologist (click here). I’ve edited some names out of this.
- The response to the IFR from the IFR Screening Group (click here).
What I’m going to do is take the responses from the IFR Screening Group and examine them to hopefully show that they have been cherry picked, are nonsense or have actually been made up to support their decision. So I’ve included both documents so you can decide whether what I say is reasonable or the rantings of a lunatic. You may decide that a bit of both is the case and I wouldn’t blame you at all!
IFR Screening Group Responses
The response is actually a question and answer form and the Screening Group responses start at question 13, so that’s where I’ll start as well. The questions are stated then a Y / N / Unclear or an N/A response followed by the reasoning for the answer. So I’ll take each one and then discuss it.
Q14. If this is a drug, is it licensed for the requested indication? A: N Reason: The Screening Group noted that neither drug separately or in combination is licensed for treatment of metastatic squamous cell carcinoma of the skin.
An odd question as if they were licensed for use for the requested indication I wouldn’t need to request funding as one or both would already be available to treat me with. The key point to consider in my case is that there is no licensed treatment for the treatment of metastatic Cutaneous Squamous Cell Carcinoma (mCSCC) in the U.K.
Q15a. Does the requested treatment appear to be experimental? A: Y Reason: These drugs are licensed for other indications but neither is licensed for use in metastatic squamous cell carcinoma of the skin. The combination is not recognised clinical practice in England. The Screening Group noted that this treatment is novel and there is a lack of authoritative evidence to support it.
As we’ve already said, there is no licensed treatment for my condition but surely stating that something is experimental when it is already licensed for other indications is stretching the definition of experimental in my opinion. Anything that is licensed has gone through extensive trials in order to be licensed and these trials need to be repeated for every different “indication” so they are hardly experimental. The main reason there is no licensed treament for metastatic CSCC is that so few people get it so trials are difficult to populate and pharmaceutical companies would never recoup the money spent on the trials so they don’t bother.
They stated it is not recognised clinical practice in England, noted the treatment is “novel” and stated “there is a lack of authoritative evidence to support it “. It just gets more ludicrous; the reason we have asked for funding is because it isn’t recognised clinical practice. Just because it is novel shouldn’t preclude its use particularly on a patient who has already benefited from it. A lack of authoritative evidence is just ridiculous, the amount of academic reports available for immunotherapy on metastatic CSCC is quite surprisingly high given how rare it is. Google finds quite a few and quite a few were included in the submission. I think what they mean is that it hasn’t gone through clinical trials. At the risk of repeating myself; there is no licensed treatment for metastatic CSCC, the reason we have asked for funding is because this treatment is experimental and I have shown that it works on me. The evidence for use of Pembrolizumab on metastatic CSCC goes back to 2016 which was when it was licensed for use by NHS England on Squamous Cell Carcinoma of the head and neck.
The catch 22 here is that where there are a lot of patients (thousands or tens of thousands) who contract a particular form of cancer a lot of work is done to provide evidence that a treatment works. Pharmaceutical companies make a lot of money when they can treat thousands of people; where there are only a few dozen; nobody bothers. To refuse an application for special funding, where the criteria for approval is that the patient should show exceptionality, because “there is a lack of authoritative evidence to support it ” seems to me that everything can be refused for anyone with a rare condition as there will never be sufficient authoritative evidence, if there was then surely the NHS would already be treating people negating the need to ask for funding.
Q15b. Or Unproven? A: Y Reason: This intervention is at Stage 1 of the IDEAL framework.
Yes it is unproven, because it isn’t available in England to treat people with! I had to look up what the IDEAL framework is, essentially they are saying that this is at the idea stage when using immunotherapy on cancer is far from the idea stage. There is currently an immunotherapy drug (Cemiplimab) aimed specifically at metastatic CSCC at stage 2 trials (46% successful) which is considerably beyond the idea phase, but it is not available outside the trials and I am not eligible for trials as I have already had immunotherapy. The drugs I have requested are both licensed for use by NHS England for other very similar cancers and have been used successfully (both individually and in combination) on mCSCC in the U.S. for over 3 years now. I think what they are essentially saying that up to date cancer treatment is still at the idea stage as far as NHS England is concerned.
Q16. Are the incidence and prevalence figures clear and correct? A: U Reason: It is not clear which group of patients this refers to, as squamous cell carcinoma is more common and metastatic disease is also common. The Screening Group agreed that the submitted evidence suggested significantly higher numbers than stated in the application. The Ribero et al (2017) paper states 5% of all cutaneous squamous cell carcinomas will metastasise, suggesting a group size of around 250 patients.
This is where it started really annoying me as this is sheer pedantry, they have manipulated things and from what I can see they have simply plucked a figure from thin air.
On the Request form they ask the requesting clinician to estimate the number of patients expected to have this condition per million population per year and estimate the number of patients expected to have this condition per million population at any one time. My oncologist answered to both questions “1 per million”. We are requesting funding for treatment for mCSCC so why is it not clear to them which group of patients this refers to?
They then state that “squamous cell carcinoma is more common and metastatic disease is also common.”. Now this definitely isn’t clear because they have started generalising about the condition; squamous cell carcinoma is a form of cancer which itself is split into many other different conditions, at a guess I would say around 20 different types. Some are far more common than others, metastasis is much more common in some forms than others. So perhaps we should look specifically at mCSCC rather than just SCC as a blanket condition?
Interestingly, the fact that a company is developing an immunotherapy drug (Cemiplimab) targeted specifically at mCSCC means that NHS England have produced documents regarding its consideration for use. These documents discuss mCSCC in some detail and as there is such little information elsewhere in NHS England they essentially provide an up to date picture of mCSCC from NHS England’s point of view. I’ve referenced a couple of these documents before but for this post the interesting one is the NIHR Innovation Observatory Evidence Briefing: October 2017 – Cemiplimab for advanced cutaneous squamous cell carcinoma.
A few statements from this document:
- In the UK, more than 100,000 new cases of non‐melanoma skin cancer (NMSC) are diagnosed each year. It affects more men than women and is more common in the elderly.
- The incidence of NMCS is under reported in the UK due to inconsistent data collection.
- SCCs represents around 23% of NMSCs.
- Scotland, Northern Ireland and Ireland have noticeably higher rates of SCCs relative to the English cancer registries than for BCCs
- The rate of metastasis in cSCC has been estimated to be 2‐5%. These patients have a poor prognosis with a median overall survival of less than 2 years.
These are all pretty vague statements but they represent what NHS England knows about mSCC. So from what they say there are around 23,000 cases of cSCC (100,000 x 23%), with a metastasis rate between 2-5% this means roughly between 460 and 1150 cases will metastasise, which is an average of about 800. Given that Scotland and NI have noticeably higher rates then in England and Wales there will be around 200 say? Given that we don’t need to consider Wales we’re looking at a guesstimate of about 180 cases annually.
Admittedly this is all guesswork as there are no definite numbers, so nobody really knows, but it is somewhat less than the 250 stated by the screening panel (they don’t say where they get their figures from). And to be honest, to state that either 180 or 250 people within England getting this condition is “common” is essentially a lie. Rare Cancers Europe state “Rare cancers are generally classified in the group of rare diseases which is defined in the European Union as diseases with a prevalence of fewer than 5 cases out of a population of 10,000.” – that equates to 26500 cases in a population of 53 million (i.e. England), which is slightly more than 180 or 250, so it is reasonable to say that mCSCC is very rare.
Incidentally I asked Cancer Research UK what the prevalence was of mSCC in the UK and they responded:
I’m afraid we do not have morphology data available for the number of people diagnosed, as metastatic cutaneous squamous cell carcinoma comes under a morphology (a rare cancer)email dated 15/10/2018
The metastasis rate is also given in the NHS document as 2-5%; lower than the blanket figure of 5% given by the IFR Screening Group. They quote a paper referenced in the original request for this figure so lets go and have a look at the full text of “Ribery et al (2017)” as it says some quite interesting things.
The most pertinent thing it says is “Although only 5% will become locally advanced, recur or metastasize …”. Now the screening group have taken this statement and used the figure as relevant only to metastasis which it clearly isn’t. So they have manipulated information in the hope it looks good and nobody checks.
So in the answer they have stated that what everyone else considers to be a rare cancer, they consider it to be common. They have exaggerated the number of people who are likely to get this condition in any year and have manipulated figures from academic documents to suit their arguments.
They have referenced “Ribero et al (2017)” only for this figure and have happily ignored everything else it says about the use of immunotherapy on mCSCC. Lets pick out some examples as it was submitted as evidence that this treatment is considered beneficial:
- The general condition of the patient, patient’s age, associated comorbidities and immunosuppression state are important variables that should be considered for appropriate management – this part was put forward as part of the exceptionality claim; I am relatively fit, I am much younger than the average age of patients, I have no comorbidities, my previous experience of this treatment shows I am responsive to it and my immune system works.
- (page 133) All these observations provide strong rationale for the use of immunotherapy for advanced cSCC. Specifically, checkpoints inhibitors, which are able to activate a T-cell-specific immune response, have shown antitumor activity in different malignancies including malignant melanoma, non small-cell lung cancer and head and neck SCCs [71,72]. However, there are almost no data regarding the use of either the anti-CTLA4 antibody ipilimumab or antiPD-1 agents, such as nivolumab or pembrolizumab, for cSCC – this demonstrates that for any condition with a large patient base there is good evidence but where there is low patient numbers there is no data. So this paper says there is a strong rationale for the use of immunotherapy on mCSCC and mentions both drugs in the request. Given that I have had this treatment twice and shown excellent responses, surely there is enough here to justify my treatment?
- Since the first positive observation in a 72-year old patient with metastatic cSCC and melanoma, in which four cycles of ipilimumab resulted in clinical benefit and durable remission with a progression free survival of 8 months, there have been other single case reports of adaptive immunotherapy in the form of anti-PD-1 for advanced unresectable or metastatic cSCC (Table 2). We have used anti-PD-1 inhibitors as rescue therapy in five cases with progressing advanced cutaneous squamous cell or basosquamous carcinoma. Our heavily pretreated patients with refractory tumors were given either nivolumab or pembrolizumab and showed clinical benefit including PRs and stable disease. Noteworthy in two cases with PR to anti-PD-1 inhibitors, PD-1L expression failed to reliably predict response. Anti-PD-1 therapy was well tolerated despite multiple comorbidities, including HIV infection. These findings are in line with the reported favorable side-effect profile of anti-PD-1 inhibitors. These observations suggest that immune checkpoint inhibitors may represent a promising new treatment option for aggressive cSCC.
- Advanced cSCC remains a challenging disease with poor clinical outcome. In cases of extensive disease with local invasion and/or metastasis, surgery, antineoplasmatic agents and/or radiotherapy are often of limited value and efficacy. Comprehensive genomic profiling with identification of genomic targets and characterization of immunological pathways involved in cSCC development are currently providing the rationale for the development of novel targeted therapies and immunotherapies. The final goal is to optimize clinical outcomes through the effective personalization of treatment.
Essentially Ribero et al say that this form of treatment is extremely promising and could be the way forward for treating a condition for which there is currently no licensed treatment. But all the above was ignored by the IFR Screening Group, they clearly read the paper as they managed to cherry pick, then manipulate, a statistic that they thought would back up their decision to refuse treatment. This is just one paper, it references many others and there were many other papers included in the funding request, all positive about the use of immunotherapy and possible combination therapies, all stating that the way forward is personalised treatment. All ignored by the IFR Screening Group.
Q17. Is this patient part of a larger group of patients with similar circumstances? Please provide details A: Y Reason: The Screening Group agreed this patient belongs to a larger group of patients with metastatic squamous cell carcinoma of the skin who have failed to respond, progressed or are intolerant of standard therapy.
Now the reason this question is on the form is because it is the main reason why NHS England get to turn down nearly all Individual Funding Requests and in my opinion, that is the IFR Screening Group’s sole purpose in life; to reject requests, effectively denying many people for whom an IFR is the only route to treatment.
Somehow you have to show that you are different to other people with the same condition, this is known as exceptionality (I don’t think it is a real word either). Its the Catch-22 of all Catch-22s. How, if you have the same condition as other people, are you supposed to show that you are different from them?
In the case of mCSCC nobody responds or progresses with standard therapy because it doesn’t work. If we go back to our NHS document (referenced above) it states that for patients where there is metastasis “For advanced cSCC there is no standard of care and no licenced treatment available. Available guidelines suggest chemotherapy and EGFR inhibitors may be used in this population.” so you can have chemotherapy but just because it is generally available, not because it is effective. It also states “These patients have a poor prognosis with a median overall survival of less than 2 years”. Again this is a pretty vague figure, but from it we can say that the majority of people die withing 18 months of diagnosis. So, there is no effective treatment, and nearly everyone dies within 2 years. Its very difficult to find figures on survival rates for mCSCC but the figure for 5 year survival has been stated as 0.02% (so not many!)
The reasons put forward to state that I am exceptional to others with the same condition were as follows:
- I am relatively young in comparison to the average age of patients in whom CSCC metastasises (I was 57 when diagnosed, the average is 70).
- I am fit and healthy with no comorbidities. Usually, patients over 70 have various other serious illnesses and are nowhere near as fit and healthy as I am.
- I have now lived for 5 years since diagnosis where the mean prognosis is “less than 2 years”. Without doing the sums I’m fairly sure that is well outside any statistical norm and standard deviation.
- I have had the treatment before (twice) and responded exceptionally well (this is why I’m still here after 5 years).
But apparently none of that is enough to make me exceptional (see later).
Q18. Is the supporting clinical evidence provided by the requester relevant to the case and have they indicated which points within them are specifically relevant to the case? A: N Reason: The Screening Group noted that the submitted evidence involved the use of the drugs as single intervention or in combination with another drug. There was no evidence supplied with the application to support the use of the combination of drugs requested. It was also noted that the patient received a number of other interventions alongside ipilimumab and pembrolizumab. These other interventions may have been wholly or partly responsible for changes seen in the patient and not the requested combination.
So apparently, none of the evidence supported the use of combination of the drugs as requested?
Perhaps they missed the fact that I had been treated with them from March to June 2017. Immediately before the treatment I had tumours in every major organ in my body apart from my lungs and liver (including two in my brain), I had tumours throughout my lymphatic system (many of which were visible on the surface of my body), one of my lungs wasn’t expanding fully due to a tumour outside it, the cancer was in my spine, i had lost 4 stone in weight because I could hardly eat as tumours were blocking my digestive system and I was so short of breath I could barely get up the stairs of my house. I think at that time I had a few weeks to live, if that. 5 months later after treatment a scan showed the majority of tumours had simply disappeared and what was left was small and of low activity. I was fit and healthy again and started to gain weight and strength.
Perhaps they missed the fact that in July a Professor of Immunology in Southampton stated that the active components in my treatment were most likely to be the combination of drugs as the other elements were there simply to add to the effect of fighting my cancer. I was treated with the same combination of drugs 4 times in Southampton and afterwards a scan “demonstrated maintenance of excellent response.”. I have an extremely aggressive cancer which is prone to mutation yet from June 2017 to Jan 2018 I “demonstrated excellent response” (the words of my oncologist in the IFR), I received no other treatment than the combination of drugs requested. A scan in June 2018 showed that some areas had grown while some had got smaller, A scan in December 2018 showed I have started deteriorating again.
Unfortunately I cannot put up a list of links to all the published references that were included to support the use of the drugs requested as many are not freely available to the general public. The example I have referenced further up this post (Ribero et al) is, so it can be seen how positive the global medical profession is about immunotherapy.
Many were just supporting the single use of anti-PD1 immunotherapy (Pembrolizumab) but others suggested that a combination of checkpoint inhibitors (Ipilimumab is anti CTLA-4) may give better results. I went to Germany specifically to get Pembrolizumab after reading of the success doctors in the U.S. had had using it on my specific condition. It was the German oncologist who came up with a multiple treatment option as he believes that with aggressive cancers that are prone to mutation; the more ways to attack the cancer the better. I was actually in such a bad state when I got to Germany that some of the list of treatment given to me was designed to stop me getting any worse to give enough time for the immunotherapy drugs to work.
I do believe that as well as the immunotherapy drugs, a key aspect of my treatment in Germany was the vaccinations I had. Ideally I should have had Genome sequencing and a biopsy of my tumour tissue taken for testing so that a personalised vaccine could have been produced, but the cost of this at a private clinic was prohibitive. I therefore had a generic vaccine which unfortunately I could not obtain details of. When I was being treated in Southampton there was talk of Genome testing, a biopsy and possible vaccination but this never happened. I took part in a research project in Southampton at the same time as being treated and with hindsight feel that this was the only reason they were interested in me; they lost all interest after i had donated a large number of white blood cells for their project and so everything else just remained talk.
It should be remembered that Immunotherapy is a relatively new treatment and so there is not much experience of its use (particularly in the UK), many drugs are still at the trials stage. Its also the case that these drugs have or are being trialled on types of cancer with large populations not on rare cancers, so evidence regarding mCSCC is not around in abundance. But you would think that the promise shown as illustrated by the various papers referenced, together with my personal experience, would be enough evidence to show they are effective on me, it is an Individual Funding Request after all. Apparently none of that is enough for the IFR Screening Group.
The comment ” These other interventions may have been wholly or partly responsible for changes seen in the patient and not the requested combination.” is possibly the most disingenuous comment in the whole response. Maybe it was the fresh air of the German Black Forest that cured me? All the evidence from my treatment shows that these two drugs are largely responsible for my continued survival. The whole tone of the IFR Screening Group’s response is negative and here they are simply scraping the barrel for more negative comments.
Q19. Has a strong clinical rationale for the treatment been made for this individual patient e.g. diagnosis, biological pathway, evidence, treatment pathway and expected outcomes? A: N Reason: Whilst the Screening Group appreciate there is some clinical rationale for the approach, no published evidence was submitted to demonstrate this combination of drugs.
This is a pretty telling comment, they “appreciate there is some clinical rationale for the approach” – presumably the fact that I’ve had the treatment and it worked! But they just repeat that no published evidence was submitted, which isn’t what was asked.
The question asks about “diagnosis, biological pathway, evidence, treatment pathway and expected outcomes?”; from the IFR it can be seen that my oncologist has commented on all these things but his comments have been ignored by the IFR Screening Group.
- diagnosis – Metastatic squamous cell cancer of skin
- biological pathway (not entirely sure what this means) – Squamous cell carcinoma of the skin with distant metastases is rare and incurable. Prognosis is considered limited depending upon disease extent and patient fitness/comorbidity. Generally from the time of diagnosis of distant metastases prognosis would have been expected to have been in the order of 12-18 months.
- evidence – a number of papers were listed that all supported the use of immunotherapy on my condition, some discussed the promise of combination therapies. There is also my personal experience of receiving the treatment. My oncologist also made the point; “As a rare condition the evidence base for any treatment is very limited.”
- treatment pathway – here’s the NICE pathway for Cutaneous Squamous Cell Carcinoma. You’ll notice that there isn’t much in the way of treatment and the guidance is nearly 5 years old. In the IFR this is summed up by my oncologist; “Combination platinum-based chemotherapy eg. cisplatin or carboplatin combined with 5-flurouracil (or capecitabine) would be a standard approach to first line systemic therapy with limited expectation of response and no proven survival benefit.“. There obviously isn’t a pathway for immunotherapy for my condition which is why we have submitted an IFR. As my oncologist says: “There is no standard therapy at the stage of disease with the prior immunochemotherapy treatment for this patient “.
- Expected outcomes – my oncologist lists all my treatment (including a private trial of re-purposing common drugs which I only tolerated for 3 weeks). He points out that standard treatment failed and says of my treatment with immunotherapy; ” Tolerated with no significant side effects. Excellent clinical/radiological response at all sites of disease.“. With regard to outcomes for the requested treatment he states “Further disease response or increased time to symptomatic progression.” which means that it would continue to clear my body of cancer or at the very least slow it down thus prolonging my life.
So, the IFR pretty much states that standard therapy didn’t work, I should have died sometime within 2 years after it was confirmed I had distance metastasis; this was May 2015 so I should have died by May 2017, so it was pretty accurate, I didn’t die because I had immunotherapy in Germany, my treatment with the requested treatment throughout 2017 was “Tolerated with no significant side effects” and resulted in “Excellent clinical/radiological response at all sites of disease”. If I continue to receive this treatment the expected outcome is “Further disease response or increased time to symptomatic progression.“
All this has pretty much been sneered at by the IFR Screening Group who have decided that none of this construes “a strong clinical rationale for the treatment”. If it doesn’t, you start to wonder what would? My opinion is that nothing would please them as the IFR Screening Group’s role in the overall IFR process is to prevent IFR’s reaching a National Panel; decisions by the National Panel can be appealed by anyone whereas there is no route for anyone to appeal a decision by the IFR Screening Group.
Q22. Are there sufficient grounds put forward by the referring clinician making an arguable case suitable for IFR Panel consideration in line with the IFR Policy including clinical rationale for exceptionality and stated factors indicating likelihood or uncertainty of anticipated outcomes being achieved? A: N Reason: The Screening Group agreed:
- This patient belongs to a larger group of patients with metastatic squamous cell carcinoma of the skin who have failed to respond, progressed or are intolerant of standard therapy.
- There is no clinical evidence that this patient is likely to benefit more from this combination than anyone else in this larger group if they too had been able to access the requested combination.
- There is no clinical evidence to suggest this patient is so unusual that they could not be considered to be part of a defined group of patients in the same or similar clinical circumstances for whom a service development should be undertaken.
These are the IFR Screening Group’s reasons for refusing the request. I don’t think they have actually answered the question and if you look back to my previous post on the last IFR that was refused they have simply repeated the reasons why they refused that one.
I appreciate that I am not the only one with this condition, so the first part is true. Yet as my oncologist states, the standard therapy has “limited expectation of response and no proven survival benefit.”. Essentially, standard treatments are used but are accepted as useless and they are only the standard therapies because there is no other licensed treatment for mCSCC. In other words; everyone dies and most of them go within 2 years of diagnosis.
The second point is nearly valid; I actually think that if they gave immunotherapy treatment all the 180 (or 250, whatever the number is) patients whose cutaneous squamous cell carcinoma metastasises each year, some of them would survive rather than all of them dying. What they are actually saying here is that I can’t have this treatment because everybody else with the same condition might want it and would benefit from it too! That’s no reason to deny people treatment is it? It is actually incorrect, because current belief is that only around 20% of people respond to immunotherapy (I have a letter from Professor Larkin of The Royal Marsden Hospital stating this) so around 200 of the 250 estimate would gain less benefit than me. My previous treatment with immunotherapy shows I respond very well.
They have added the statement “There is no clinical evidence to suggest this patient is so unusual that they could not be considered to be part of a defined group of patients in the same or similar clinical circumstances for whom a service development should be undertaken.” Now this is pretty crucial as it is actually the wording included in the NHS’s Commissioning Policy: Individual Funding Requests to decide if someone is exceptional and should receive treatment.
This came into force just after my last IFR was considered so this wasn’t considered for that one. My oncologist made a statement in the IFR itself as follows: “The patient’s clinical presentation/prior treatment is so unusual that he cannot be considered to be part of a defined group of patients in the same or similar clinical circumstances for whom a service development should be undertaken.”. So the IFR Screening Group are directly contradicting him, yet they don’t say why. Using that sentence effectively refuses my treatment, which is why it has been put into the response.
But is it true? Well, clinical presentation is something personal to each patient, so you have to consider what the clinical presention is of other patients with the same condition in England and compare them to mine.
- The median prognosis from diagnosis is less than 2 years (according to the NHS), my oncologist states in the IFR “Generally from the time of diagnosis of distant metastases prognosis would have been expected to have been in the order of 12-18 months“. I am now nearly 5 years from diagnosis and 3.5 years from diagnosis of distant metastasis. I very much doubt that there are many patients with the same condition who could claim this, I’d be surprised if there were 5.
- The average age of patients who are diagnosed with mCSCC is 70 and many of them have comorbidities which affect their chances of survival. I was 57 when diagnosed with metastasis, I was (and now am again) fit and healthy with no comorbidities.
- I can confidently state that no other patient in England with my condition has received the treatment I have had and am requesting. Standard treatment is what everyone else will have had (as I did) and standard therapy has “limited expectation of response and no proven survival benefit.”. The treatment requested for me isn’t licensed for use on my condition and The IFR Screening Group state in their response: “The combination is not recognised clinical practice in England.“. My oncologist stated in the IFR: “Based upon available knowledge the ipilimumab and pembrolizumab are by far the most likely active components of the experimental schedule he received. He can be expected to be much more likely to respond to further immunotherapy on the basis of his excellent previous durable response. We have not come across other patients in our practice or in the medical literature who have received prior immunotherapy of this type. He is therefore far more likely to benefit from this treatment than other patients with metastatic squamous cell carcinoma of the skin as they will not have had similar prior treatment.” In other words, I’ve already proved this treatment works on me and nobody else in England has even had it.
Yet according to the IFR SCreening Group none of these things make my clinical presentation any different to anybody else with the same condition. That statement is simply ludicrous.
In fact at the bottom of the IFR Response is the statement “The Screening Group noted the patient’s improvement, however, other patients in similar clinical circumstances may not have had that opportunity to access the treatment or self-fund and this does not demonstrate grounds for exceptionality“. Actually it does! Having had the treatment and demonstrating that it works on me is one of the main reasons I’m different to other patients with the same condition. Its available to all of them if they want to try it, they just have to head to Germany and spend about £175,000 to give it a go.
Also at the bottom of the resonse is the following gem:
It is important to note that having self-funded treatment does not mean the NHS must continue funding. NHS England cannot assume responsibility for a funding decision in which it played no part, and no other body or individual can commit NHS England to fund any healthcare intervention. There are clear principles and considerations regarding continuing privately funded treatment even if that treatment has been shown to have clinical benefit for the individual patient. The Commissioning Policy: Ethical framework for priority setting and resource Allocation (April 2013 Ref: NHSCB/CP/01) https://www.england.nhs.uk/wpcontent/uploads/2013/04/cp-01.pdf has further details on these principles and considerations.
Now we have never tried to justify treatment based on the fact that it was previously self funded. The fact I’ve had the treatment, and it worked, has been included because it justifies the request for funding.
This comment was included in the previous IFR rejection and I’m not sure why they keep including it. It is far outside the remit of the IFR Screening Group as they are only supposed to screen for admin (has the form been filled in correctly) and patient exceptionality.
I went for private treatment in Germany because at the time it was the only place I could find who would treat me with immunotherapy, I had been refused it in England even if I paid for it myself. Perhaps they are including this point because the NHS are a bit miffed that they said there was no treatment available and I was going to die within 3 to 18 months and I’ve shown that to be incorrect. This is along the same tone as saying that there is no evidence that immunotherapy will work on me (despite all the evidence included to the contrary) when it is obvious to anyone that it will.
The whole tone of the IFR Screening Group’s response is negative. I would suggest that the meeting held on 21st December was not to consider my request but to think of as many reasons as possible (no matter how ludicrous and no matter what evidence was provided to them) to reject this IFR. I firmly believe that rejecting IFRs is why they exist, it should be noted that the Screening Group was only introduced into the IFR process around 2011 after some high profile, successful challenges were made to IFR decisions which were then being made by the local Clinical Commissioning Groups (CCGs).
The whole IFR process and policy seems to have been put together to ensure patients are denied treatment. The set of requirements you have to meet is pretty much impossible to meet.
- It seems to be a requirement that there is overwhelming body of evidence that the treatment requested has been proven to work on many patients before they will grant it to one. With rare conditions there will not be overwhelming evidence unless the treatment has been through clinical trials. If the treatment met this condition it would surely already be approved as the standard treatment.
- The patient has to be shown to be different to everyone else with the same condition (no matter how few there are). This is pretty much impossible. Types of cancer are already categorised to quite a detailed degree, so somebody with the same condition will have the same symptoms by definition.
- It has to be shown that the patient will benefit more from the requested treatments than other patients with the same condition. This contradicts the first requirement; how can a person with the same condition as other patients demonstrate an abundance of evidence that the treatment works on many patients with the same condition AND demonstrate that they will benefit more than the other patients with the same condition. You can’t do both.
My oncologist, who has been involved with my treatment from the start, and witnessed my incredible recovery after my treatment in Germany, told me in 2016 that submitting an IFR was a waste of time as they are all turned down. Every clinician I have spoken to during my treatment and also informally has told me that the IFR system is a waste of time and set up to ensure funding requests fail, most are reluctant to engage with the process which ultimately denies people treatment. Its pretty cynical of NHS England to do this but clearly they have. It takes up a lot of a clinician’s time to put an IFR together (My oncologist has now done it twice) and each request requires a lot of people at the local Trust level to support it before it goes to NHS England (have a look at the end of the IFR to see who signs it off as supported and approved). For some faceless set of bureaucrats who have never seen the patient and probably have no experience of the condition or the requested treatment to then take an hour or so to find spurious reasons to turn it down is appalling.
It suggests to me that NHS England has made a conscious decision to save money by denying people treatment regardless of whether that treatment would save their life. Perhaps they have taken this logic a step further; not treating people in their 60’s, ensuring that they die, means they won’t be around to be a “burden” to the NHS in their old age. Its all pretty cynical but is hard to deny.
So what can I do? There is no available route to appeal the IFR Screening Group’s decision unsurprisingly. If an IFR gets past them to a National Panel and the National Panel turn down the request then anybody can appeal it. (Still think the IFR Screening Group hasn’t been inserted into the IFR process to block requests?).
The IFR Team will not engage with patients, it is up to your clinician to explain the IFR Screening Group’s decision. When my first IFR was refused my oncologist was unable to explain their reasons for the decision and so wrote to them, they never replied. I complained about this with an official complaint and was told the IFR Team “had no record of receiving his letter) but now I had included it in my complaint they would reply but to date they have still not done so. Although I was sent a letter from the NHS Complaints Team (they have a lot of Teams) saying there would be an “investigation process”, what actually happened was that my complaint was forwarded to the IFR Team who responded directly to me. I contacted the Complaints Team and asked about the lack of investigation and the told me they “didn’t have the expertise so just carry out an administrative function in cases like this”. They also said if I didn’t like it I should take it to the Ombudsman. So I know now that complaining to NHS England is as big a waste of time as submitting an IFR (try finding the NHS England Complaints Procedure).
So what I’ve decided to do is write a letter to Simon Stevens (Chief Executive of NHS England) and put it to him that the IFR Process is deliberately engineered to deny patients treatment. Now my MP wrote to him in early 2018 about my case and he didn’t bother replying, so why would he bother to reply to me? He probably won’t. So I intend to make it an open letter and send copies to every major newspaper, the various TV news channels, Private Eye and anyone else I can think of (I’ll do a blog post on it as well).
My hope is that someone will pick this up and publicly challenge Simon Stevens about the IFR Policy. This does not just affect me, there are many people with rare conditions for which there is no licensed or effective treatment, their only route to treatment is via an IFR. The IFR process is designed to deny patients treatment so many people die each year as they cannot access useful treatment.
One of the arguments regularly raised at this point is that the NHS is underfunded and so can’t afford to treat everyone. Steve Brine MP (a health minister) said exactly that in a reply to another of my MP’s letters; “The NHS does not have unlimited resources”. I appreciate that but my application has not been turned down because of lack of funds (the total cost was just over £31,000). Also, its worth considering where NHS funds actually go; my opinion is that the bureaucratic behemoth that is NHS England soaks up a large chunk of the funds so they are not available for treatment. It id worth noting that whilst GPs, doctors and nurses are increasingly difficult to recruit and staffing levels in most hospitals are dire, the number of NHS managers and administrators has increased by 15% since 2012 (The Times, Jan 12 2019). So no shortage of bureaucrats.
You might just think I’m having a petulant moan because I can’t get the treatment I want, but for me (and many others) getting access to this treatment is a matter of life and death. Without this treatment it is highly likely I will die this year, with this treatment my life would be considerably prolonged and there is a chance of a full cure.