Many of you will have seen the articles in The Times this weekend which have revealed an issue of immense importance to people living with Chronic Lymphocytic Leukaemia by highlighting NHS England's denial of patient access to ibrutinib despite NICE approval.
What has The Times revealed?
NHS England is currently failing to fund ibrutinib in line with NICE guidance. NICE recommends that ibrutinib alone is recommended within its marketing authorisation as an option for treating CLL in adults:
who have had at least 1 prior therapy or
who have a 17p deletion or TP53 mutation, and in whom chemo-immunotherapy is unsuitable and
only when the company provides ibrutinib with the discount agreed in the patient access scheme
There is no reference to a remission timeframe within this NICE recommendation, yet The Times has revealed that NHS England has said that it will not prescribe ibrutinib if CLL patients have been in remission for more than three years.
CLLSA's response
CLL is an incurable blood cancer and the most common form of leukaemia in adults in the UK. CLL is not treatable using surgery or radiotherapy, so access to effective and well-tolerated drug treatments is essential.
Priority recommendations from the All-Party Parliamentary Group (APPG) on Blood Cancer highlighted that “blood cancer is more dependent on the development of new drugs and being able to access them, in order to continue improving patient outcomes.” There is already enough emotional damage with having to live with cancer for the rest of our lives, compounded by the fear of the future and disease progression and the unpredictability of the disease – it is unacceptable for NHS England to compound this fear and anxiety further by denying patients access to NICE-approved medicines with the introduction of arbitrary rules.
CLLSA will be doing everything in its power to ensure this intolerable situation is fully investigated and overturned to ensure that patients have access to ibrutinib in line with the criteria outlined by NICE. We will be contacting NHS England, NICE and Jeremy Hunt, Secretary of State for Health and Social Care, and the APPG on Blood Cancer to demand that NHS England follow their legal obligations to fund drug indications considered by NICE to be cost-effective.
How you can help
You can help my contacting your local MP and NHS Trusts to highlight this issue and put pressure on them to ensure CLL patients have access to ibrutinib in line with NICE guidance. The qualifying criteria for patient access detailed within the NICE recommendations for ibrutinib make no reference to a remission period to qualify for treatment.
You can find your MPs contact details and message them at writetothem.com.
Thank you for your support at this crucial time.
The following copy may help you to write to your MP but please make this letter personal as copy and paste emails are often blocked:
Dear MP,
The Times newspaper has this weekend revealed that NHS England is failing to fund patient access to ibrutinib despite NICE approval.
NICE recommends that ibrutinib alone is recommended within its marketing authorisation as an option for treating Chronic Lymphocytic Leukaemia (CLL) in adults:
- who have had at least 1 prior therapy or
- who have a 17p deletion or TP53 mutation, and in whom chemo-immunotherapy is unsuitable and
- only when the company provides ibrutinib with the discount agreed in the patient access scheme
There is no reference to a remission time frame within this NICE recommendation, yet The Times has revealed that NHS England has said that it will not prescribe ibrutinib if CLL patients have been in remission for more than three years.
NHS England has a legal obligation to fund drug indications considered by NICE to be cost-effective.
CLL is an incurable blood cancer and the most common form of leukaemia in adults in the UK. CLL is not treatable using surgery or radiotherapy, so access to effective and well-tolerated drug treatments is essential.
Priority recommendations from the All-Party Parliamentary Group (APPG) on Blood Cancer highlighted that “blood cancer is more dependent on the development of new drugs and being able to access them, in order to continue improving patient outcomes.”
As a CLL patient and member of the Chronic Lymphocytic Leukaemia Support Association (CLLSA) - the only UK charity dedicated to providing education, support, and advocacy to help empower people living with CLL – please can I call upon your support to raise this issue in Parliament and demand that NHS England fund CLL patient access to ibrutinib for all patients for whom NICE has deemed it to be cost-effective so that patients in [insert your locality] have the access they need and deserve.
Yours sincerely,
[insert name]
Written by
Jm954
Administrator
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Yes a good start, but let's get other organisations such as Bloodwise involved.
The more pressure on this the better.
Through family connections I have some contacts with executives in the big Pharma companies, and I passed this newspaper article from The Times to them.
One reply just arrived and I quote exactly:-
‘ Wasn’t aware of the NHS decision, indeed didn’t know it could block a NICE decision. Absolutely a step backwards; with my work I see many second world markets accessing drugs earlier and more broadly than here in the UK. ‘
For a big Pharma company executive to comment this way is very worrying…
Time for some pressure on the NHS, and for a more critical view of the workings of NICE in the UK.
When ibrutinib was introduced as an expensive and possibly forever medication, it was easy to see that paying for it long-term for every patient who might benefit from it was going to be a problem – especially in the UK outside of clinical trial programs.
US: Big Co-Pay for Ibrutinib Forever vs.
UK: “Free” Ibrutinib for 3 Years Only
The last two or three days reopened the discussion – of whether any private or public health care financing system can afford to pay super-high medical expenses for everyone forever. In the old days, when the super-high-cost medicines were not available, people just died. Maybe “the truth lies somewhere in between”. As with many other medical conditions, it may be that the super-expensive approaches will be reserved for when less expensive measures already have been exhausted. In the early days of kidney transplants, the super-expensive procedures wee saved for those who proved that they could adhere to very strict diets and priority was given to the mothers of young children; that is, not everyone who needed a new kidney got one. Currently, the US and the UK are taking very different approaches to the "specialty medication" problem.
US: trying to get price competition vs
UK: trying to get longer price discount.
US: Feds Influencing Private Companies vs
UK: NHS Strong-Arming Private Companies.
US: Leading Price Change with a “Carrot” vs
UK: Leading Price Change with a “Stick”.
It is not clear how all of this is going to shake out, but the core problem is that there is not enough money in any system to cover everything for everyone.
To the extent possible, perhaps "daily treatment" has be considered as a reasonable alternative to "dramatic treatment" -- and less expensive "dramatic treatment" has to be considered as a means of avoiding or delaying more expensive "dramatic treatment". healthunlocked.com/cllsuppo...
I absolutely buy that we need an honest discussion of what the NHS can/cannot afford to provide - I have seen too many friends suffer the last 6 months of life with nothing but pain because the NHS would not take the (appallingly difficult moral) decision to gently let them die. But this decision by NHS England to curtail access to ibrutinib was made behind closed doors with no consultation with the experts.
And I am not convinced by the economic argument at all. A second round of FCR would give 18-24 months of remission (and further compromise the patient's immune system thus storing up larger longer term expensive problems) and then the patient would be eligible for ibrutinib under the new guidelines. So it looks very much like short term gain at a significantly enhanced long-term cost.
Plus 1. FCR is not cheap and 2. the associated costs of neutrophenia collapse are extremely high. During my FCR I had to be rushed to hospital in ambulance and stay there for 4 days - also not cheap!
Thank you for everything you're doing on this and for the template wording. I hope that many people on this forum will support by writing to their local MP and doing anything else they can. It's worrying the budget constraints the NHS is facing in many areas but as a young patient with CLL (37) this is of great concern and I will be writing to my local MP.
Hi folks. Here’s the email I just sent to my MP. Feel free to use bits of it if relevant. I think that the more personal a message like this is the more likely they are to respond.
Subject: Will my CLL affected life be sacrificed by NHS England?
Dear X
I wanted to write to you as one of your constituents. A year ago I was diagnosed with the blood cancer CLL and placed on watch and wait.
The anxiety of being told you have cancer and there is nothing to be done just yet cannot be overstated.
I do not think that the effect on people of this kind of situation is fully appreciated. I am too sick to work currently at the age of 47, but not so sick I should yet be treated. Particularly if the only treatment that would be funded is toxic chemotherapy when less toxic alternatives are already available.
Watch and wait is only bearable when you believe that the NHS will treat you appropriately when you finally do need treatment.
Imagine my horror then this weekend to hear in the Times that NHS England are breaching their legal duty to fund treatments that are deemed cost effective by NICE. It is unconscionable that they think because CLL is mostly a disease of older people nobody will care. It is also the thin end of the wedge.
Already NICE put some limits on the availability of ibrutinib that are more restrictive than the license. According to the EMA the drug should be available for anyone with CLL. In the USA it is routinely used first line and some patients report an improvement in their symptoms and getting back to work.
When used first line it allows 92% of people to continue profession free for at least five years. In the uk almost nobody gets to use it first line.
NICE does have a duty to consider cost, however, and has done this. They have agreed a sub population of people with CLL who should be offered this newer drug.
Why then do NHS England feel they can get away with ignoring NICE and even further restricting access to this life saving drug?
Would you be willing to take this matter up?
I feel that NHSE has a blatant disregard for the good of patients in this matter.
If it would be helpful to talk about this further please feel free to call me on xxxxx
Certainly a good idea for all of us to lobby our MP’s individually and collectively. Just to point out a bit of a typo in your excellent letter Adrian because I think it should say ‘progression free’ and not ‘92% of people to continue profession free’. (Freudian slip perhaps?) 😊
I’m not even entering into the politics of this because having paid massively (and continuing to do so) through National Insurance, on this occasion I’m putting self survival before social altruism. Yes I appreciate the financial implications of Ibrutinib funding just as I understand the cost of services having to maintain me as a sick person who couldn’t be relied on to continue saving the country hundreds of thousands of pounds a year in care costs for my dependent son. (That rant isn’t directed at you incidentally Adrian).
On this occasion I’m not taking one for the team or the country!
Adrian, your email reads as protesting about Ibrutinib not being available for first line use but this doesn't apply in this situation as NICE have approved it only for salvage treatment after at least one prior therapy and this is what the NHS England guidance has affected.
Unless you were able to access a clinical trial or are 17p/TP53 then the first line therapy for patients such as yourself is still FCR as the gold standard.
Well actually, what if I get FCR first then get a remission for longer than three years then it would apply to me. I’m also mentioning that NICE has already restricted the availability of the drug which is bad enough. To then be told NHS England is limiting it further is irritating. I’m not just annoyed at NHSE I’m also annoyed at NICE. Why should we have to be forced to use chemo? The only silver lining for uk patients is that a large number of patients will have the ability to go into FLAIR for first line treatment if they are prepared to travel.
Also don’t forget the 17p del people are still able to get ibrutinib first-line.
Thank you jm, used your letter and topped/tailed it with a bit of personal background. A good way to introduce myself to my MP in the constituency I've just moved into.
My take on it is that whilst the guidelines and evidence based advice NICE offer to NHS England wouldn’t appear to be legally enforceable, recent caselaw where the CCG (Central Commissioning Groups) have acted against NICE advice have been successfully challenged in the Courts.
The NHS can use lack of resources as a reason not to supply certain health services (unlike Social Services for instance who must meet assessed need) but the crux here seems to be their deviation from the advice offered by NICE on prescribing Ibrutinib. Unless of course NICE review their position.
I think the NHS England people are desperately trying to break the link between a nice assessment leading to an obligation on them to fund which was always the intent. But if that happens then there is no point of having NICE at all....
Thank you for doing all this work to make it easier for us to protest. Just one thing, is the post locked, or can I send the link to friends and family and ask them to write to their MPs too?
As a Yank, I don't mean to butt in on the NHS ibrutinib/Imbruvica issue, and I am not yet a candidate for Imbruvica, so I don't yet have a horse in the race, yet. But I've been looking at the costs of drugs lately.
I would like to call everyone's attention to an article in the NY Times from September, 2017:
"Since the companies also were developing other drugs that did not receive approval from the F.D.A., the researchers were able to include the companies’ total spending on research and development, not just what they spent on the drugs that succeeded.
One striking example was ibrutinib, made by Pharmacyclics. It was approved in 2013 for patients with certain blood cancers who did not respond to conventional therapy.
Ibrutinib was the only drug out of four the company was developing to receive F.D.A. approval. The company’s research and development costs for their four drugs were $388 million, the company’s S.E.C. filings indicated."
Vinay Prasad is an interesting guy to follow on Twitter, by the way.
Wikipedia cites a figure nearer to $1B US for the full development:
"Ibrutinib was created by scientists at Celera Genomics as a tool compound for studying BTK function; ...
In 2006, in the course of acquiring an HDAC-focused program from Celera after its own initial discovery program had failed, Pharmacyclics also picked up Celera's small molecule BTK inhibitor discovery program for $2M in cash and $1M in stock and named the tool compound PCI-32765. In 2011 after the drug had completed Phase II trials, Johnson & Johnson and Pharmacyclics agreed to co-develop the drug, and J&J paid Pharmacyclics $150 million upfront and $825 million in milestones."
Even so, Ibrutinib has been hugely profitable, and has certainly paid for its development and marketing. I believe that it is now paying for other deeds or misdeeds by the company owners:
2016 revenues for Ibrutinib were $1.6B. I seriously doubt that manufacturing costs exceed $1B, but I could not nail down the cost without paying several thousand dollars to a market analyst.
"AbbVie (ABBV) has projected Imbruvica’s annual revenues to reach $5 billion by 2020. That would be driven mainly by a rapid uptake in the first line chronic lymphocytic leukemia (or CLL) segment due to its high sustained efficacy, resulting in superior survival compared to the current standard of care regimens. The drug has already changed the treatment paradigm in the second line plus CLL segment and for CLL patients with 17p deletion.
AbbVie expects that in the future, nearly eight out of ten CLL patients will benefit from an Imbruvica-based therapy at one point or another. The company is also studying this first-in-class Bruton tyrosine kinase (or BTK) inhibitor, either as a monotherapy or in various combination regimens, in the CLL indication across differentiated patient populations such as young and fit patients or wait and watch patients."
The dosage change as been covered at length in another thread, but I'd like to emphasize the cynical manufacturer's motivation. An April 18, 2018 article in the Washington Post claimed that the manufacturers strategically tripled the price for lower dosages to thwart the anticipated effect of studies which indicated lower dosages would be just as effective for most patients after the initial regular dose:
"Then they learned of a new pricing strategy by Janssen and Pharmacyclics, the companies that sell Imbruvica through a partnership. Within the next three months, the companies will stop making the original 140-milligram capsule, a spokeswoman confirmed. They will instead offer tablets in four strengths — each of which has the same flat price of about $400, or triple the original cost of the pill.
Just as scientific momentum was building to test the effectiveness of lower doses, the new pricing scheme ensures dose reductions won't save patients money or erode companies' revenue from selling the drug. In fact, patients who had been doing well on a low dose of the drug would now pay more for their treatment. Those who stay on the dose equivalent to three pills a day won't see a change in price."
Dr. Koffman wrote on this topic in his blog in March, 2018:
These prices are of course for the American market. Presumably, current foreign contracts will be honored. But I expect future contracts will be affected, and the NHS decision may have been at least partially guided by this extortion.
I was pointing out that given the manufacturer's unjustified changes in U.S. pricing, pricing elsewhere may be expected to rise. Note that Medicare in the U.S. also negotiates prices, and their price is expected to increase as well, according to this:
"The Medicare patient co-pay will be about double the current $5,000 and the cost to Medicare will rise ~$100K, exclusive of rebates."
In addition, the president has announced an initiative to force foreign buyers of U.S. phamaceuticals to pay more in an attempt to lower costs to American consumers:
I believe that American pharmaceutical companies are raising their prices in the U.S. so that they will make even greater profits whether this blueprint survives the expected international criticism or not. If the blueprint succeeds, they will then be able to lower prices a little in the U.S. compared to spring price increases, and success will be declared by everyone except consumers around the world - including the U.S.
National medical plans and insurance companies have little negotiating leverage as long as a company has a monopoly. Even with two sources, the temptation for the second source to also increase prices is still quite strong.
This all makes me quite angry, and strong emotions are not good for my immune system.
Well, it looks like the outcry from patients and doctors helped! Hurrah for our side!
The article you cite says:
'"We have received feedback regarding the availability of Imbruvica capsules, and as a result will continue to offer 140 mg Imbruvica capsules as an option in addition to our one pill, once-a-day tablet," Pharmacyclics, which is owned by the drug giant AbbVie, said in a statement.'
I am confused by all of this. I was treated with Clorambucil in 2007 and have only begun treatment with Ibrutinib for the last two months. So it has been 11 years before I relapsed, considerably longer than the 3 mentioned. Also being treated in a London Hospital, like the writer of the article.
Thank you for prompt reply. I am 68 but have also been diagnosed with P17 deletion, which I assume will also play a part in the decision? Will be writing to my MP and getting friends and family to do the same.
Regards
Colette
PS MsLockYourPosts.
I had trouble swallowing Ibrutinib to start due to swollen neck,throat and tongue and Hospital Pharmacist told me no plans for new packaging as yet. I thought that would be easier for me.
Thank you ! I wrongly thought that being older would have been a negative ! One of my step daughters used to work for an MP so she is going to construct my letter.
Jm, and others who understand the system there, how can those of us outside of the UK help with this movement? Will the new packaging and pricing in the US affect other countries as well? Things were starting to look so good, both with Ibrutinib alone and with it in combinations. This is very discouraging!
It is difficult and I'm not sure what we can do to influence each other's parts of the world. I hope NHS England will think again about this as the weight of negative opinion grows.
The issue of new dosing tablets and price is particularly frustrating and, in my opinion, looks like gaming the system at the expense of patients.
Since ibrutinib/Imbruvica recently tripled in price in the U.S., we in the U.S. can write to our senators and congressional representatives.
Given the recent announcement by the president to address high costs in the U.S. by increasing costs to places like the U.K., Canada, and Australia, we can also weigh in on what a profit grab that is.
Pharma likes to claim that it provides the necessary innovation that brings new drugs to market. The evidence is clearly the opposite. Drug companies look for ways to even increase the price of drugs that have long been off of patent:
Consumers fund every strategy that pharma uses to extract more money from us. Whether a drug is successful or not is irrelevant, pharma has no reason to research or test carefully, because they know they can pass on the cost through other products, and justify it by saying, in effect, "Don't tie these hands that are guided by God!"
I really need to step away from this for a few days.
Wow - truly scary. How long until other drugs come on stream? And will these put downward pressure on these prices? Or do we just have to wait until the Indians start to produce generic versions?
In most parts of the world the Rituxan biosimilar Reditux, from Dr. Reddy in India is used in place of Rituxan... done nothing to the price of Rituxan... in Europe and North Anerica.
Even now biosimilars for Rituxan are available in Europe and soon in the U.S. doubt there will be a penny difference in Rituxan prices...
There is no price competition in cancer drugs unfortunately.... ain't happening.
It's different in different countries. But I think the same forces that have inflated patented drugs, also inflate generics now - lack of manufacturing cost and sourcing information for consumers and lawmakers, layers of distributors obscuring many details, consolidation of manufacturers, and in general, greed.
Who else is directly affected by this? Ie you live in the uk and are in remission from FCR and now worried you will be forced to repeat it? We simply can’t let this stand and on Twitter the journalist has stated he’s considering triggering a judicial review.
Thanks for all the work that is going in to this campaign. Does anyone know what the Scottish position is on this? Scotland has its own health authorities and it is my MSP I would write to in the normal way even though there is also an MP.
I do agree wholeheartedly with the comments on the cynical, profit-focused approach of the drug companies.
My understanding is that in Wales and Scotland Ibrutinib is being prescribed as per NICE guidance. It's only England that the NHS England edict affects. More health inequalties!
Thank you for this, as I was going to ask the same question of Wales NHS.
I do wonder who we should ask this info from, as we rarely get mentioned in the main media. (Thank goodness for this forum and the volunteers and knowledgeable ones!)
Actually Scotland has their own body called the SMC. Their guidance seems to be being adhered to and is similar to what NICE said: scottishmedicines.org.uk/me...
"Thank you for getting in touch, and for bringing this to my attention. I understand your concerns of course, and I will very gladly raise them with Secretary of State for Health, and Simon Stevens, CEO of NHS England.
Neat idea, will share IF I get a response. however, haven’t we all based our letters on a standard letter? I know last time we all wrote I received a standard letter that was topped and tailed with specifics for me reflecting what I sent.
Well pleased to see people getting responses. I sent my email on 10th May at 16:08 to my ‘for the many’ MP and have not heard a peep yet. Outperformed by my previous MP (surprisingly) when we last had a ‘write to your MP’ campaign.
Difference is last time I used snailmail and this time email. Perhaps a follw-up snailmail letter is due.
I know it is bad to reply to one’s own posts however, I was just wondering (sitting in a central Manchester garden between appointments), does an MP have to reply to FOI(Freedom Of Information) requests, anyone know?
“how many constituent letters (email and mail) do you get? How many do you respond to?”. or something like that.
CLLSA have issued a FOI notice to NHSE about the Ibrutinib advice asking for the evidence and process papers. Watch this space, will post more when I know more.
"Thank you for your recent correspondence to Lord O’Shaughnessy and Jeremy Hunt about ibrutinib for chronic lymphocytic leukaemia (CLL). I have been asked to reply.
I was sorry to read of your ill health and I appreciate your concerns.
As you are aware, the National Institute for Health and Care Excellence (NICE) has published technology appraisal guidance that recommends ibrutinib for the treatment of patients with CLL who have had at least one prior therapy, or who have a 17p deletion or TP53 mutation, and in whom chemo-immunotherapy is unsuitable. NHS commissioners are legally required to fund NICE-recommended treatments in line with its recommendations.
NHS England is an independent body and has processes in place to transfer NICE’s technology appraisal recommendations into its commissioning systems.
Lord O’Shaughnessy, Parliamentary Under Secretary of State for Health, is investigating this issue. He recently met officials from NICE and NHS England, and will continue to take a keen interest in this matter. NHS England has committed to receiving, and reviewing by the end of July, any further evidence that patients and clinicians wish to submit on this issue.
You may wish to write to NHS England with any further information that you think may be helpful for the review, at england.contactus@nhs.net.
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