MPs to debate the availability of cancer drugs in Parliament

I am pleased to announce that next Tuesday, 20th October, MPs will take part in a Westminster Hall Debate on the availability of cancer drugs. This has been sought by DUP MP Jim Shannon, a big advocate of cancer patients, following his attendance at a dinner to discuss access to medicines for blood and rarer cancers earlier in the year. The debate will give MPs the opportunity to discuss the significant problems many cancer patients in England are currently facing in terms of gaining access to the medicines they need.

You will have read about the fight I have taken up to help 43 year old Birmingham father of four, Khalid Younis, gain access to ponatinib for his resistant Chronic Myeloid Leukaemia (CML), including the meeting we had last week with his local MP, Roger Godsiff. I have alerted Roger to the fact that this debate is happening and asked if he can raise Khalid’s case with the Minister to see if we can progress the situation further with the Government and NHS England. In addition, an Access CML Drugs briefing has gone out to a number of MPs I’ve met before, or who have an interest in CML, stem cell transplantation or the ending of the Cancer Drugs Fund. The briefing highlights our key issues and the inequity of access English patients currently face compared to those in Scotland and Wales. You can download the briefing below.

Whilst the debate won’t focus solely on CML or blood cancer, I hope Khalid’s story will form part of the discussion and be used to demonstrate the problems which exist with the current evaluation methods used for cancer medicines in England, particularly with the Cancer Drugs Fund (CDF) refusing to appraise any new medicines between now and when the Fund ends in March 2016. I hope the issue of how the National Institute for Health and Care Excellence (NICE) and the CDF work (or don’t!) together will also be discussed; any future system of evaluation for cancer medicines needs to be able to work for cancers with small patient populations and previous drugs have, sadly, fallen down the gap between NICE and the CDF.

I would encourage everyone to contact their local MP and ask them to attend and contribute to the debate. You can find out who your local MP is here. The more MPs that attend, the greater the level of awareness there will be amongst parliamentarians of the issues we face.

I will post again following the debate.

Kris Griffin – founder of Access CML Drugs

ACCESS CML DRUGS – WESTMINSTER HALL DEBATE – BRIEFING

Cancer Drugs Fund Cuts CML Drugs (and what we can do about it)

Details from the recent announcement:

The Cancer Drugs Fund in England will no longer pay for 16 medicines, used in 23 separate cancer treatments.
All the drugs on the Cancer Drugs Fund list have been rejected by the NHS as a whole because they do not provide enough benefit for the amount they cost.
At the beginning of 2015, there were 84 funded therapies, but after a series of culls there are now just 41.
The fund was set up by Prime Minister David Cameron to provide access to such medication. However, NHS England announced that the fund was due to go £100m over budget in 2014-15.
The drugs will be formally removed on 4 November and the announcement will not affect patients currently receiving treatment through the fund.
Patients affected: Blood cancer – 1,759 patients.
The Rarer Cancers Foundation said the news was a “hammer blow” and estimated that 5,500 patients across a spectrum of cancers would miss out.

Source: Cancer drugs fund cuts 23 treatments from BBC News.
The official announcement from NHS England can be found here.

Before I start it is imperative to start that the announcement will not affect patients currently receiving treatment through the fund.

I’ve read a lot of things over the last few days. I’ve heard many opinions and chewed a lot of fat. Any way you look at this recent decision, it’s hard to take any positives from it; that’s clearly why emotions are running so high. But, let’s remember what Yoda taught us:

“Fear is the path to the dark side. Fear leads to anger. Anger leads to hate. Hate leads to suffering.“

This is not a situation for finger-pointing or blaming people, countries or administrations we perceive to be at fault or guilty for a variety of suspected sins. One of the silliest suggestions I’ve read is that if that if we weren’t talking so many refugees in to the UK we would be able to afford the CML drugs. Not the case. Health economics doesn’t work like this. I’m not a fan of the Trident programme but I’m not daft enough to think that by scrapping it and saving billions we’d immediately be rewarded with the drugs we need. No, it’s more likely we’d get another station for High Speed 2. Joke. And for the record, I’m in favour of the UK playing our part and taking refugees.

We stand alone on this, fight our corner strategically and productively and make sure our voices are heard. Do I believe that campaigning hard will result in a reversal of this decision? No. But if we allow our voices to fall silent, when the day comes to start appraising drugs again, I want CML drugs to be at the front of people’s minds. I want people to understand that this is a poor decision about drugs that SAVE LIVES. I want the people responsible for the decisions to know that we are NOT faceless. I want them to know our names.

So what should we do? I believe there are two fundamental priorities to focus on:

1. To pressure the health administration groups in England to review decisions, open the appraisal process and ensure that we are part of the process moving forward – with respect to the reconfigured way of deciding which drugs to approve and which to reject.

2. To encourage pharmaceutical companies who manufacture our drugs to reduce their prices through Patient Access Schemes (PAS).

By playing this straight down the middle we position ourselves as the result of both health administration AND pharmaceutical company decisions. The decisions are unfair and unjust but that argument won’t win us any battles. A coordinated, strategic approach will. This means responding to requests for help with media enquiries, visiting Parliament to talk to MPs and writing letters to appropriate parties. It also means making yourself a more informed patient, understanding the process and contributing towards any changes. This is the only way we, as patients, will be part of any changes.

We’re doing this for our generation and the generation of patients that follow us. We’re doing this for the person diagnosed tomorrow who currently has fewer drugs available to them than when I was diagnosed 8 years ago. If that isn’t motivation enough to bring about change then I don’t know what is.

Thanks, Kris

Ponatinib: Scotland 1, Wales 1, England 0

In recent news I reported that Iclusig® (ponatinib) had been granted access to patients in Wales by NHS Wales. You can read the whole story here. I’m pleased to be able to write today to say that patients in Scotland have been given access to ponatinib too! Both countries are providing access for ALL phases of chronic myeloid leukaemia (CML).

In England ponatinib is only available on the Cancer Drugs Fund (CDF) IF the patient has the T315i mutation. We recently reported the majority of patients were being turned down in England after making individual funding requests; full story here.

Whilst you can read the full details of the appraisal by NHS Scotland I’ll draw your attention to this:

A non-comparative phase II study of ponatinib was conducted with primary outcomes of major cytogenetic response in patients with baseline chronic phase CML and major haematologic response in patients with baseline accelerated or blast phase CML or Ph+ALL. Ponatinib demonstrated efficacy in heavily pre-treated CML and Ph+ALL patients who had received dasatinib/nilotinib as second line or further line tyrosine kinase inhibitor therapy or who had the T315I mutation.

The studies of ponatinib show it to be very effective and NHS Scotland have recognised this, but NHS England remain steadfast and refuse to appraise ponatinib because the patient numbers are too low. We find ourselves in a situation where patients aren’t able to access a drug that could save their lives. How can the system be fair when, depending on which NHS authority you come under, will depend on the availability of a drug to you?

There is little that can be done at the moment but once Parliament reconvenes we’ll start to apply pressure and ask direct questions of the organisations that are allowing us to fall behind our counterparts in the United Kingdom.

Thanks, Kris

Advice: following a full submission considered under the orphan and end of life process:

ponatinib (Iclusig®) is accepted for use within NHS Scotland.

Indication under review: Adult patients with
• Chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

A non-comparative phase II study of ponatinib was conducted with primary outcomes of major cytogenetic response in patients with baseline chronic phase CML and major haematologic response in patients with baseline accelerated or blast phase CML or Ph+ALL. Ponatinib demonstrated efficacy in heavily pre-treated CML and Ph+ALL patients who had received dasatinib/nilotinib as second line or further line tyrosine kinase inhibitor therapy or who had the T315I mutation.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Taken from: www.scottishmedicines.org.uk/SMC_Advice/Advice/1032_15_ponatinib_Iclusig/ponatinib_Iclusig

Cancer Drugs Fund extended until 2016

Whilst I applaud and welcome the news that the Cancer Drugs Fund (CDF) has been extended until 2016 with a budget of £200m a year it’s important we don’t see this as a win and look for the next battle. It is likely that this ‘new’ £400m has been top-sliced from the NHS budget in a similar fashion to original CDF thereby creating a problem at another level.

Let’s also not forget that the CDF was established in order to provide a means by which National Health Service (NHS) patients in England can get cancer drugs that are not routinely available on the NHS. This includes drugs like dasatinib (treatment for CML – Chronic Myeloid Leukaemia) that effectively saves lives (like mine) but for some misguided reason are rejected by NICE (National Institute for Health and Care Excellence). The new value based pricing (VBP) system that we were expecting next year appears to have been swept under the carpet, presumably because when the government did the sums it was going to cost them more than £400m. So our new £400m is a stay-of-execution. Get the next election out-of-the-way, note that this 2 year extension ties very nicely into the coalition term, and make an unpopular decision at the beginning of the next term if the election is won. In the meantime the Conservative party can bang their drums over the next few days at the party conference to the tune of being saviours of cancer patients everywhere. Not sure how people who are suffering with other illnesses are going to feel about that one.

Even I’m astounded by the level of my own cynicism but in this case I feel it is well founded. The complete and utter failure of VBP to even emerge from the starting blocks and the countdown to the end of the CDF left the coalition with no alternative.

Patients deserve the best treatment. We should not be held hostage by pharmaceutical companies or be pawns in politics. Much of the problem lies with NICE, their flawed processes and their reliance on limited information about the clinical effects of new products supplied to it by the pharmaceutical industry. There is much to unpick. In the short-term we’ll save lives and I can’t be angry about that but in the long-term the system will still be in a mess. What we’ve been presented isn’t a solution, it is another finger in the dam and I’m losing count of the number of holes.

Kris Griffin

BBC NEWS: Cancer drugs fund ‘to be extended’ until 2016

SKY NEWS: NHS’ Life-Extending Cancer Drug Fund Extended

The Guardian: Cash injection to keep cancer drugs fund running for two more years

 

Cancer drugs survey

Sharing this from Leukaemia and Lymphoma Research. K

CANCER DRUGS FUND SURVEY
The Cancer Drugs Fund has been in the papers a lot recently as its future after 2014 is uncertain. Established in 2010, it provides £200m each year to enable patients with cancer in England to access drugs that are not routinely funded by their local NHS.

As the leading UK blood cancer research charity we want to ensure the needs of blood cancer patients are being heard by decision makers.

This short survey will help us gain insights into the impact of Cancer Drugs Fund on the blood cancer community and will inform our policy position on access to medicines, new treatments and clinical trials for blood cancer patients.

The Cancer Drugs Fund (CDF) applies to patients eligible for NHS services in England so the survey is therefore aimed at blood cancer patients, their carers and families, and clinicians based in England only. For more information on the Fund please visit NHS England website.

The survey is anonymous and will take no more than 5 minutes to complete.

Your input is important to us so thanks in advance for your time and help with this!

https://leukaemialymphomaresearch.org.uk/form/cancer-drugs-fund-survey

Dasatinib continues to be available on CDF

Good news today. Dasatinib has been included on the cohort list for the Cancer Drug Fund (CDF). This means that dasatinib will continue to be available on the CDF…whilst we have a CDF. It does provide some short term reassurance. Details follow. Kris.

· NHS England (formally the NHS Commissioning Board) has now released details of the single drugs fund list, which list the 28 treatments that would be available for fast track funding on the CDF. Dasatinib is included on this list, for use in the treatment of CML and ALL.

· The reason for developing a single operating list is to reduce regional variation in delivery of the CDF and to ensure that value for money is best achieved. This may (although far from certain) have the effect of reducing some of the regional prescribing variations that we identified through our earlier FOI campaign in 2012.

· Whilst this is positive news, it is important that we continue to monitor this issue and seek clarification if further drugs will be removed from the list. It has been suggested by leading figures within this process that decisions on whether drugs would be downgraded would not be made until later this year.

I will continue to seek clarification from NHS England and continue to keep relevant stakeholders updated on this process.

The full NHS England announcement can be found via http://www.england.nhs.uk/2013/04/04/cdf/ and the list of fast track treatments can be found via http://www.england.nhs.uk/ourwork/cdf/.

Letter to Rt. Hon. Andy Burnham MP

Further to the media attention we received yesterday in trying to get some answers on the Cancer Drug Fund and the future funding for dasatinib I’m sending the Shadow Secretary of State for Heath, Andy Burnham another letter. I didn’t receive an answer to my February correspondence with him. K.

Rt Hon Andy Burnham MP
Shadow Secretary of State for Health
House of Commons
London    SW1A 0AA

5th April 2013

Dear Mr Burnham,

My name is Kris Griffin and I am the founder of the Access CML Drugs Blog, which campaigns to improve patient access to treatments for Chronic Myeloid Leukaemia (CML). I wrote to you about the issues facing CML patients in early February, however I have not yet received a response. You may remember that we briefly discussed this issue at the Britain Against Cancer conference back in December and I would welcome the opportunity to have an exchange of views about the availability of treatment for the disease and current access to medicines arrangements.

You will be aware that the future of the Cancer Drugs Fund is an issue that has received significant media attention this week. A number of patient groups have raised concerns that when the fund ends in April 2014, patient access to medicines will be severely restricted. This is certainly true for CML patients as the only NICE approved drugs available are imatinib and nilotinib. However for a number of patients, including myself, these two treatments are not effective.

There are now fewer drugs available for the treatment of CML than when I was diagnosed five years ago. Due to the vagaries of the NICE appraisal process, the drug that has kept me alive, dasatinib, is no longer available via the NHS. In the majority of cases, access through the Cancer Drugs Fund is the only way that patients can receive life-saving treatments such as dasatinib.

Whilst I understand that you do not support the continuation of the Cancer Drugs Fund, I would be keen to hear your views on how patient access to treatments could be improved. Particularly, I would be interested to hear how this issue sits within Labour’s recently announced health policy review. Similarly, I was also interested to hear your recent policy announcement on the future of the NHS and the prospect of “whole person care”. While I hope that your plans to change local commissioning of services can lead to less geographical variation in the treatment of rarer cancers, I would be very keen to hear your views on how access to medicines arrangements would operate under this system. I would be more than happy to work with you on this issue and help ensure that patients are able to have access to the widest range of cancer treatments.

The situation I have described is not unique to CML and many people suffering from rarer cancers will experience the same trouble accessing potentially life-saving medicines. That is why access to medicines programmes such as the Cancer Drugs Fund are so important. I would be delighted to discuss the issue of Chronic Myeloid Leukaemia and access to medicines with you further at a later date.

Kind regards,

 

Kris Griffin
Access to CML Drugs

Cancer Drug Fund Running Dry

The Cancer Drug Fund (CDF) is big news today, it’s all over the news and as I type this I am waiting for my local BBC radio station to call for an interview. The problem is that
this story has been brewing for a long time now and as we approach the moment funding will run out in 2014 the panic has started to set in.

The £650 million fund has paid for treatment for over 28,000 patients nationally since 2010. This is money the Government has set aside to pay for cancer drugs that haven’t been
approved by NICE (National Institute for Health and Care Excellence) and aren’t available within the NHS in England. For some it brings quality of life, others it gives precious time and for many it is truly life-saving.

The drug that I take for my leukaemia is called dasatinib. I receive it through the NHS, free at the point of delivery, as I should. But recently, since a change in NICE  guidelines, dasatinib is only available to patients who apply for it through the CDF. There are alternative treatments available but by restricting access we are restricting progress and potentially putting lives at risk. For patients who rely on the CDF for their medication this news will bring cause for concern and unnecessary worry on top of a cancer diagnosis.  They don’t know how their drugs will be funded post-2014 and no-one is reassuring them.

When I managed to catch up with Shadow Secretary of State for Health Andy Burnham MP and Secretary of State for Health Jeremy Hunt MP before Christmas neither man was willing to commit to extending the funding for the CDF and nearly 4 months later we still don’t have an answer or an alternative. I have written to both men and am still waiting for a response.

I am getting support. My local MP Mark Garnier, as always, is being very helpful as is the All Party Political Group (APPG) on Cancer. I hope that today is the start of the real pressure. Laura Weir, head of policy and campaigns at the MS Society and chair of the Patients Involved in NICE group, concerns me with her view that other conditions needed to be considered too. I wonder if Laura is aware that dasatinib is currently considered a breakthrough treatment for MS (see link here) and without the CDF no one would receive it, no funding, no drugs, no progress, no cures. For once I believe that we really are all in this together.

There is no point in us all fighting over funding, this is healthcare and if it benefits the patient we must all get behind it. 1 in 3 of us will be affected by cancer at some point in our lives, I was 32 when I was diagnosed. Those numbers are too high for us to sit back and do nothing.

I implore the Department for Health to either extend the CDF or provide us with plans for a real alternative now.

www.news.sky.com/story/1073672/cancer-drugs-fund-patients-to-lose-out
www.bbc.co.uk/news/health-22013399

Cancer Drug Fund usage from October 2010 – October 2012

FOI results on dasatinib for CML patients

I wanted to share the results of the Freedom of Information (FoI) request today. The results speak for themselves but it is concerning that there is such disparity between prescribed medication. For the East Midlands to have funded 74 cases of dasatinib and the East of England to have prescribed none is worrying. This means that depending on which part of the country you live the clinician you see will have a different opinion on the type of drug you receive, perhaps some don’t even bother with dasatinib because of the NICE decision. This has truly become a postcode lottery.

Whilst I am in favour of personalised treatment this level of disparity is not good for patients. We are finalising our Cancer Drug Fund document that provides patients and clinicians information on how to apply for drugs through the CDF. It saddens me to think that there are areas of the UK where patients are not receiving the full range of CML treatments but I will continue to do all I can to ensure that our voice is heard.

Kris

Trusts who have dasatinib on their approved list.

Number of applications for dasatinib on CDF

 

Britain Against Cancer 2012 report

Recently I attended Britain Against Cancer, a one day conference in London where politicians, clinicians and patients come together to talk about the issues surrounding cancer policy in the UK.

I attended this conference as I wanted a chance to explain why CML patients need access to a wide range of treatments.  Regular readers will know that I am currently being treated for Chronic Myeloid Leukaemia (CML) with dasatinib. Whilst other treatments, including imatinib and nilotinib, are available having been approved by NICE, dasatinib is only available on the Cancer Drugs Fund (CDF).

I am concerned that, across the country, patients have variable access to dasatinib and other non NICE approved treatments through the CDF.  It is important that CML patients have access to a wide range of treatments as for some, neither imatinib nor nilotinib prove clinically effective or patients find the side effects too severe.  This is the reality for CML patients and I wanted to make sure that attendees at the conference were aware of this.

The first speech I heard was from the Labour Shadow Health Secretary Andy Burnham and what struck me most were his comments about the Cancer Drugs Fund (CDF).  The CDF is designed to give patients access to cancer drugs that have not been approved by NICE and this is the route that many CML patients take in order to access dasatinib.  In his speech Burnham explained that he did not support the continuation of the CDF and he did not view it as a funding priority for the NHS.

I disagree with this.  My personal experience of the CDF is that patients can receive drugs that they otherwise would not. If the CDF is removed and nothing is put in its place then there is a risk that access to CML drugs will get worse, not better.

I raised this issue with Andy shortly after his speech and explained that it is critical that patients have access to as broad a range of treatment options as possible.  He agreed that this is indeed important and requested that I write to him following this conference.  I will of course write to him and make this case in more depth.

After taking part in a session about including the patient voice where I highlighted the need for patients to be involved with cancer networks, we took a break for lunch.  Refuelled and refreshed I then heard from Sir Mike Richards who was the former National Clinical Director for Cancer and the now Director of Domain One of the NHS Outcomes Framework.  I explained to him that it was important that not only were the right treatments available, but that the NHS didn’t lose sight of treating rarer cancers such as CML.  Sir Mike agreed and pointed to the recent figures on CML, as reported on this blog post , which showed that the deaths from CML have halved.

We then heard from the Secretary of State Jeremy Hunt who gave a wide ranging speech that focused on the importance of improving patient outcomes and even covered dementia.  It was interesting to hear him speak so much about dementia, as it is expected that this will be a core focus of the Government in the run up to the next general election in 2015.  I managed to catch up with him afterwards and made clear my views about the importance of the CDF.  He told me that whilst the Government is very proud that 23,000 people have currently received treatment through the CDF, he could not yet give further details as to whether the scheme would be extended post 2014.  I intend to write to Mr Hunt to raise this issue again and to ensure that access to CML drugs is at the forefront of his thinking in the run up to the next election.

I found Britain Against Cancer to be a very rewarding experience and I welcomed the opportunity to express the views I raise on this blog, in person to politicians and key decision makers.  I am keen to use the momentum from this event to further my campaigning activity and I will continue to post details on this blog.    Kris

Meeting Labour Shadow Health Secretary Andy Burnham MP at the Britain Against Cancer conference.

LINK: All Party Parliamentary Group on Cancer – website