Update: MPs debate availability of cancer medicines

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Following my previous blog post about Tuesday’s Westminster Hall Debate on the availability of cancer medicines, here’s an update on what happened.

A number of MPs from different political parties participated in the debate, sought by Jim Shannon, an MP committed to improving patient access to cancer drugs. This included two MPs I am scheduled to meet with on my next Westminster day in November, Mark Durkan and Nic Dakin, so it’s great to see they already have a good grasp of the issues we face.

Other MPs contributing to the debate included:

The debate focussed on the general inequity of access to cancer medicines which patients face, and the recent delisting of drugs from the Cancer Drugs Fund (which included a number of drugs for CML). Jim Shannon highlighted the need to develop a long-term, sustainable solution to the issue of the evaluation and funding of cancer medicines, in order to benefit patients.

Life Sciences Minister, George Freeman MP, responded to the debate on behalf on the Government and cited the commitment NHS England has made to implementing the Cancer Taskforce recommendations, which is encouraging. His view was very much that if NICE has recommended a medicine then NHS England has a duty to fund it, which brings into question drugs which NICE has chosen not to even consider appraising due to small patient numbers – such as ponatinib for CML and ALL. He also mentioned the Government’s Accelerated Access Review (AAR), which was due to report this September, but has now been postponed until 2016. Time will tell if the recommendations of the AAR live up to the Minister’s promises but an accelerated scheme that has consistently been delayed doesn’t fill me with great confidence.

Many readers of this blog sent me messages when we announced this Westminster Hall debate, they had written to their MP telling them about it and asking them to attend. If you did this and the name of your MP isn’t on the attendee list above please write to them again and ask why they didn’t attend; urge them to look into the issues surrounding the delisting of drugs from the Cancer Drugs Fund. I’d be happy to speak to them on your behalf or perhaps we can meet them together. It’s vitally important that as a small community we have a voice and are listened to.

Thanks, Kris

28/10/15 – ADDITION – you can watch a recording of the debate on Parliament Live TV here: http://parliamentlive.tv/event/index/6c473be6-564a-43d2-92e8-65aa6cec067d?in=09:30:00

MPs to debate the availability of cancer drugs in Parliament

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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

Leukaemia Man – not exceptional (follow up)

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This is turning into a rather extraordinary day and I hope that you don’t mind me publishing a brief update. I hope that you’ve seen my previous post regarding the situation Khalid Younis finds himself; he is unable to access ponatinib – a drug that is essentially his last resort.

The media have picked the story up. I’ve just been interviewed for ITV Central News, that’ll be going out this evening and I’ll be doing a live interview on BBC WM Drivetime around 1715. Please tune in if you are able and spread the word on social media.

The story has also been covered by the Daily Mail and the Daily Mirror, links below:

Mirror – Dying dad denied ‘life-saving cancer drug’ by NHS in postcode scandal is told his case ‘not exceptional’

Mail – Dying father-of-four is denied life-saving cancer drug by the NHS in postcode lottery scandal that’s outraged doctors

We’re breaking ground here and bringing, what is essentially a tiny disease, to public consciousness. We can and will make a difference. Khalid and his family deserve our support. Please help.

Cancer Drugs Fund extended until 2016

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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

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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

Front page of the Independent: Cost of CML Drugs

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Well, look here. Front page of The Independent yesterday with “the news” that CML drug prices are way too high. It’s something we’ve known for ages and it’s fantastic that the damaging price of these drugs is being brought to public attention.
I think it is important that we consider the other side of the argument for a moment though, and this is not an attempt to justify the prices and defend the pharmas. These drugs are saving lives and, in some cases, curing a form of cancer. What price on that? These drugs have revolutionised CML treatment and have certainly kept me alive. Do I care about the price? No. I care that they’ve saved my life and it helps that I live in the UK and don’t have to find that money. Do I care that there are people on this planet dying from CML. YES – and this is the issue.   Morally these pharmaceutical companies have an obligation to service each territory to ensure these drugs are available at an affordable price. There are plenty of opportunities to cover research costs but there is bigger picture stuff here…even bigger than the shareholders of these companies. Let’s not use these prices as a stick to beat the industry with, after-all they’ve come up with something truly amazing that is going to change the face of healthcare forever. Instead let’s appeal to their common decency, their moral compass and put the pressure on them to deliver a fair solution. This applies to you too BMS. Your failure to provide a Patient Access Scheme in the England has meant the NHS has not been able to deliver dasatinib as a standard treatment.
What a fantastic opportunity for people to do the right thing. Will it happen? Probably not but I must have faith in the human condition. We can put pressure on the pharmaceuticals,  we can write, ask the awkward questions and make sure they know every time a CML patient dies because they can’t afford the treatment they need. Let’s be brave about this, we thank the industry with all our heart, but the time has come to be bigger than the bottom line.  Kris

The wounded surgeon plies the steel
That questions the distempered part;
Beneath the bleeding hands we feel
The sharp compassion of the healer’s art
Resolving the enigma of the fever chart.
T.S. Eliot (1888-1965) – Four Quartets ‘East Coker’ (1940) pt. 4

The real cancer killer: rip-off prices for drugs set by ‘profiteering’ Big Pharma giants

An influential group of cancer experts has warned that the high prices charged by pharmaceutical companies for cancer drugs are effectively condemning patients to death.

The group of more than 100 leading cancer physicians from around the world, including nine from the UK, accuse the drug industry of “profiteering” – making a profit by unethical methods such as by raising the cost of grain after a natural disaster.

Of the 12 drugs approved by the Food and Drug Administration in the US in 2012, 11 were priced above $100,000 (£65,000) per patient per year. In addition the price of existing drugs of proven effectiveness has been increased by up to threefold.

The specialists say: “What determines a morally justifiable ‘just price’ for a cancer drug? A reasonable drug price  should maintain healthy pharmaceutical industry profits without being viewed as ‘profiteering’. This term [profiteering] may apply to the trend of high drug prices where a life threatening medical condition is the disaster.”

The high prices mean the drugs may not be approved by the National Institute for Clinical Excellence in the UK forcing doctors to fill in a 14 page application apply to the Cancer Drugs fund for British patients who could benefit from them.

In addition, the rising cost of existing drugs in a cash limited health service such as the NHS means treatment is denied to other patients with other conditions.

The authors of the article, published in the journal Blood, are all specialists in blood cancers such as leukaemia, where cancer drugs have proved most effective.

One of the best known – imatinib, whose brand name is Glivec – has proved so successful in chronic myeloid leukaemia that patients who a decade ago survived for a few years can now look forward to a near-normal life expectancy.

But the cost of Glivec has risen from £18,000 per patient per year to around £21,000 in the UK, and from $30,000 to $92,000 in the US. This is despite the fact that all research costs were covered by the original price, and the number of patients treated and the length of time they are on the drug have both vastly increased because of the drug’s success.

Daniel Vasella, former chairman and chief executive of Novartis, the manufacturer, said the original price charged for Glivec in 2001 was considered “high but worthwhile” and was estimated to yield annual revenues of $900 million, enough to cover its development cost in two years. A decade later Its annual revenues in 2012 were $4.7 billion (£3 billion).

The cancer specialists say the revenue earned by Glivec over the last ten years “represent generous profits to the company”. But this has put heavy pressure on those who have to foot the bill. “Grateful patients may have become the financial victims of the treatment success, having to pay the high price annually to stay alive”.

In the US even those with health insurance may pay an average of 20 per cent of drug prices out of pocket. Drug prices are the single most frequent cause of personal bankruptcies in the US.

Three new drugs have been approved for chronic myeloid leukaemia in the last year by the FDA but the prices are “astronomical” the authors say at up to $138,000 a year per patient.

Worldwide only about a quarter of the patients with chronic myeloid leukaemia who could benefit have access to drugs because of the cost. “A small fraction are rich enough to pay individually, and most are treated intermittently or not at all. The effects of these financial pressures on long term survival… are yet unknown.”

In the UK, patients are shielded from the “direct economic anxieties of illness”, the article says.  But Professor Jane Apperley, chair of the Department of Haematology at Imperial College, London, and one of the authors, said high drug prices were still a cause of harm in Britain .

“The price of a drug heavily influences the decision of NICE whether we can prescribe it on the NHS. I am chief of service at Imperial College and we are constantly being asked to reduce our spending. We have to look very carefully at the cost of the drugs we use.”

“Of course we need the pharmaceutical industry to go on developing new drugs. It is very exciting that a number of cancers are now becoming susceptible to these new drugs. But the rising cost is unsustainable. “

“The drugs are very effective at keeping people alive. But if they are priced out of what you can afford you know that you can keep people alive but you can’t afford to do so. It is completely unsustainable for the NHS because the costs are going up every year. We need a serious dialogue about whether we can sustain these costs.”

The authors of the article in Blood conclude: “We believe the unsustainable drug prices may be causing harm to patients. Advocating for lower drug prices is a necessity to save the lives of patients who cannot afford them. We believe drug prices should reflect objective measures of benefit, but should not exceed values that harm our patients and societies.”

The group say they intend to organise regular meetings and campaign for lower cancer drug prices.

A spokesperson for the UK charity Beating Blood Cancers said: “As a charity we want to see an ethical approach to drug pricing . There is no point in us investing in research if the pricing policy means drugs won’t be available to patients.”

In a statement to The Independent, Novartis said: “We recognize that sustainability of health care systems is a complex topic and we welcome the opportunity to be part of the dialogue.  Our critical role, as one of many parties working towards improving cancer care, is to discover and develop innovative treatments.”

“ Novartis innovation in chronic myeloid leukemia (CML) has changed the course of the disease. Before Glivec(imatinib)* and Tasigna (nilotinib), the five-year survival in CML was only 30 percent. Today, nine out of ten patients with CML have a normal lifespan and are leading productive lives.”

“Over the years, our programs have evolved to improve patient access to our medicines. We work together with government health care systems, charities and other payers to build successful cost-sharing models.”

Expert view: ‘Price of drugs is harming patients’

The following is an extract from an article, contributed to by more than 100 leading cancer physicians from around the world, including nine from the UK, published in the journal, Blood.

This perspective reflects the views of a large group of CML experts, who believe the current [high] prices of drugs may compromise access of needy patients to highly effective therapy, and are harmful to the sustainability of our national healthcare systems…

If drug price reflects value, then it should be proportional to the benefit to patients in objective measures, such as survival prolongation, degree of tumour shrinkage, or improved quality of life. For many tumours, drug prices do not reflect these endpoints, since most anti-cancer drugs provide minor survival benefits, if at all.

As physicians, we… believe the unsustainable drug prices in CML and cancer may be causing harm to patients. Advocating for lower drug prices is a necessity to save the lives of patients who cannot afford them … For CML, and for other cancers, we believe drug prices should reflect objective measures of benefit, but should also not exceed values that harm our patients and societies.”

An ethical price tag? Cancer drugs

Brands used for the treatment of chronic myeloid leukaemia

Imatinib (Glivec) £21,000 per patient per year – Novartis
Designed from first principles, it proved hugely effective and unexpectedly turned into a blockbuster, earning billions of pounds for its makers.

Nilotinib (Tasigna) £21,000 – Novartis
Designed for patients who fail to respond to Glivec, Novartis reduced the cost to get it past Nice, whilst increasing the cost of Glivec.

Dasatinib (Sprycel) £31,000 – Bristol Myers Squibb
Also designed for patients who cannot take Glivec. But it has not been approved by Nice for use on the NHS because of its high cost.

Bosutinib (Bosulif) £76,000 – Pfizer
For patients who suffer side-effects from the other drugs. It won approval in the US in 2012 but is awaiting a licence in the UK.

Omacetaxine (Synribo) £100,000 – Teva
For patients who cannot tolerate other drugs. Approved in US in 2012 but awaiting licence in the UK.

Ponatinib (Iclusig) £90,000 – Ariad
A third-generation drug which works in a different way. Approved in the US in 2012 but awaiting a licence in the UK.

JEREMY LAURANCE    MONDAY 29 APRIL 2013

http://www.independent.co.uk/news/uk/home-news/the-real-cancer-killer-ripoff-prices-for-drugs-set-by-profiteering-big-pharma-giants-8591825.html

4 written Parliamentary Questions tabled: Chronic Myeloid Leukaemia treatment

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I’m happy to announce today that we have 4 written Parliamentary Questions (PQs) tabled about Chronic Myeloid Leukaemia treatment.

They can be found here, you need to scroll down to 112, 113, 114 and 115: http://www.publications.parliament.uk/pa/cm201213/cmordbk2/120713o01.htm

My local MP Mark Garnier has been kind enough to submit these and I am very grateful to him for this.

I will update you when these questions have been answered by the Secretary of State for Health. I have posted them below for information.

All my best wishes,

Kris

Mark Garnier (Wyre Forest): To ask the Secretary of State for Health, how many people were diagnosed with chronic myeloid leukaemia in (a) 2007, (b) 2008, (c) 2009, (d) 2010, (e) 2011 and (f) 2012 to date.

Mark Garnier (Wyre Forest): To ask the Secretary of State for Health, what steps his Department plans to take to ensure that chronic myeloid leukaemia patients have a wide range of treatment options (a) when newly diagnosed and (b) at the second line of treatment.

Mark Garnier (Wyre Forest): To ask the Secretary of State for Health, how many patients have received the drug Dasatinib on the Cancer Drugs Fund since the fund was created in 2010.

Mark Garnier (Wyre Forest): To ask the Secretary of State for Health, what long-term plans his Department has to ensure that those diagnosed with chronic myeloid leukaemia have access to a wide range of treatment options after the end of the Cancer Drugs Fund in 2014.