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

NICE reviewing Dasatinib!

Okay. Let’s not get our hopes up TOO much but I’ve come across an agenda for the NICE Technology Appraisal Committee meeting on Tuesday 15 January 2013. Listed as point 6 on the agenda is:

6. Rapid review of TA251 – dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid leukaemia (part review of technology appraisal guidance 70)

This would indicate to me that something has changed, perhaps BMS have offered a Patient Access Scheme (discounted price) for dasatinib and that NICE are duty bound to review the guidance. This is NOT a formality but there is a chance that the guidance could change. It would be wonderful to think we all had a small part to play in this, but the big thanks has to go to Leukaemia Care and the group of charities who have supported and worked with them – their unwavering pressure has been vital…so far.

If I hear anything else then I will post here, but let’s keep the pressure up and keep our fingers crossed.

Original link here: http://www.nice.org.uk/newsroom/publicmeetings/TAC15January2013.jsp

Kris

Final set of Parliamentary Questions answered

The final set of PQs tabled by Mark Garnier MP were answered by the now former health minister Paul Burstow MP and relate to the number of patients receiving dasatinib on the CDF (Cancer Drug Fund), access that patients have at different stages of disease progression and the Department of Healths long-term plans on funding Dasatinib. Full details of these results can be found below.

A huge note of appreciation to Mark Garnier, the MP for Wyre Forest, who has been so supportive of my efforts to ask the right question to the right people.

Although the answers are the same stock response trotted out at every opportunity, in particular hiding behind NICE decisions, there are some reassurances given about availability of dasatinib.

Kris

Mark Garnier: 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. [117336]

Paul Burstow: Under the interim cancer drugs funding arrangements in 2010-11 (from October 2010 to the end of February 2011), five patients received dasatinib. Patient numbers by drug for March 2011 are not available. Based on the latest available information, a further 56 patients have received dasatinib under the Cancer Drugs Fund (from April 2011 to the end of February 2012).

http://www.publications.parliament.uk/pa/cm201213/cmhansrd/cm120903/text/120903w0009.htm#12090429002131

Mark Garnier: To ask the Secretary of State for Health (1) 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; [117335]
(2) 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. [117337]

Paul Burstow: ‘Improving Outcomes in Haematological Cancers’, published by the National Institute for Health and Clinical Excellence (NICE) in 2003, makes recommendations on the treatment, management and care of patients with haematological cancers. The guidance makes recommendations on first and second line treatments for chronic myeloid leukaemia (CML). Our Cancer Outcomes Strategy, published on 12 January 2011, makes it clear that the NICE guidance will continue to be a feature of all commissioned services.

This year, NICE has made recommendations regarding a number of drugs for first and second line treatment of CML. On 25 April 2012, NICE published final guidance that recommended nilotinib and standard-dose imatinib for first line CML but did not recommend dasatinib. This followed final guidance, published by NICE on 13 January 2012, that recommended nilotinib but did not recommend dasatinib or high-dose imatinib for patients who are resistant or intolerant to standard-dose imatinib.

Both NICE recommendations concerning nilotinib are subject to a patient access scheme agreed between the manufacturer and the Department that reduces the price of the drug.

There is a statutory obligation on the national health service to provide funding for treatments and drugs recommended by NICE technology appraisal guidance within three months of the NICE technology appraisal guidance being published.

Once NICE publishes guidance, health professionals and the organisations that employ them are expected to take it fully into account when deciding what treatments to give people.

However, NICE guidance does not replace the knowledge and skills of individual health professionals who treat patients. If a clinician feels that a certain treatment would be particularly beneficial to a patient, they can recommend it, even if it has not been approved by NICE, subject to the primary care trust (PCT) agreeing to fund the treatment.

The NHS Constitution states that patients have the right to expect local decisions, on the funding of drugs and treatments: “to be made rationally following a proper consideration of the evidence.”

If a PCT decides not to fund a drug, then it should explain that decision.

We will ensure that there are arrangements in place to protect individual patients who are receiving treatment with drugs funded by the Cancer Drugs Fund as the end of the Fund approaches.

From January 2014, under our plans for value-based pricing, we want all patients, including those with CML, to have better access to effective and innovative new drugs at a price that reflects the value they bring to patients and the NHS.

http://www.publications.parliament.uk/pa/cm201213/cmhansrd/cm120903/text/120903w0010.htm#12090429002263

 

FDA approves Pfizer leukeamia drug – Bosutinib / Bosulif

Whilst I desperately want to celebrate a new CML drug coming into the marketplace I find it hard when I think about the dasatinib debacle we currently find ourselves in here in the UK. If Pfizer do not offer a PAH we will find ourselves lagging even further behind in CML treatment, this being said even a PAH will not guarantee availability.

This does prove to us that developments are still being made and that we must do all we can to ensure patients get access to the drugs they need, regardless of where they live.

I’ve started off with an excellent video interview with Dr. Carlo Gambacorti-Passerini, a prominent CML researcher from the University of Milan:

In this video interview from ASH 2011, Dr. Carlo Gambacorti-Passerini, a prominent CML researcher from the University of Milan Bicocca, gives us an update on bosutinib, a newer Tyrosine Kinase Inhibitor (TKI) that he has studied in-depth.  Once approved, bosutinib may provide one more option for patients and their physicians to better treat the disease while managing side effects.

WASHINGTON | Tue Sep 4, 2012 5:33pm EDT – LINK TO ORIGINAL ARTICLE

(Reuters) – Health regulators on Tuesday approved a Pfizer Inc pill for a rare type of leukemia, another step in the company’s effort to expand its oncology business.

The medicine, called Bosulif, treats chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults. About 26,000 Americans live with the cancer, and 5,430 people in the United States expected to be diagnosed with it annually, the U.S. Food and Drug Administration said.

Most people with CML have a specific type of genetic mutation called the Philadelphia chromosome. This mutation causes bone marrow to make an enzyme that triggers the abnormal growth of white blood cells. Bosulif, known generically as bosutinib, blocks the enzyme’s signal that causes the white blood cells to grow.

“We are seeing improvements in the treatment of CML based on a better understanding of the molecular basis of the disease,” Dr. Richard Pazdur, head of the FDA’s cancer drugs center, said in a statement.

Pfizer’s drug is meant for people who have CML with the Philadelophia mutation who cannot tolerate other medicines, such as Novartis AG’s Gleevec, or whose cancer has stopped responding to the older treatments.

The FDA gave Bosulif orphan status, which means it treats a condition or disease that affects fewer than 200,000 people in the United States. The designation comes with a seven-year period of marketing exclusivity.

The medicine is expected to reach peak global sales of $341 million in 2016, according to the average forecast of analysts polled by Thomson Reuters.

Bosulif is the second Pfizer cancer drug to get the FDA’s nod this year, after its kidney cancer drug Inlyta. Investors are looking for signs of the company’s research productivity, to help replace lost revenue from its cholesterol fighter Lipitor. The world’s top-selling drug began facing generic competition last year.

Shares of Pfizer were largely flat at $23.85 in after-market trading on Tuesday.

(Reporting by Anna Yukhananov, additional reporting by Bangalore equities newsroom; Editing by Leslie Gevirtz)

ACTION – Letters to NICE and BMS

Further to my post this evening I think we have to register our incredulity with BMS and NICE for these terrible decisions. These decisions will cost lives and I’m really not sure they realise the implications they will have on human lives, our lives. Let’s put faces to these lives.

Can I ask you to write 2 letters. The first to Sir Andrew Dillon who is the Chief Executive of NICE:

National Institute for Health and Clinical Excellence
MidCity Place
71 High Holborn
London WC1V 6NA

Perhaps telling him YOUR story and how important FULL access to these life changing drugs are. It may be worth asking him in terms of his “cost effectiveness” just how much is a human life worth. Finally you could ask him how he feels to be in charge of an organisation that is restricting access, to what is effectively, a cure for cancer. Today it’s CML but with usage and research it could be lung, brain, colon, any type of cancer. Just how will history judge such a decision? Why are we restricting access to life saving treatment. To ensure a balanced argument it is important that you mention that you will write to BMS about their reluctance to offer a Patient Access Scheme (PAS).

I have cut and pasted the first part of the responsibility statement of BMS by Lamberto Andreotti, where their declared ambition is to, “strive to do the right thing for the benefit of the patients.”  My question is how can this be the case when they are denying patients access to treatment by stubbornly refusing to offer patient access scheme to CML patient in the UK in the face of recalcitrance of NICE.

Béatrice Cazala has control over what happens to BMS products in Europe, we should ask her to explain this contradiction in their stance to patients in the UK and the declared responsibility message (below).  Patients need access to dasatinib, and this reluctance to negotiate is helping no one.

Béatrice Cazala
Executive Vice President
Commercial Operations
Bristol-Myers Squibb Corporate Headquarters
345 Park Avenue
New York
New York 10154
USA

Responsibility Message from Lamberto Andreotti, Chief Executive Officer At Bristol-Myers Squibb: “We are firmly focused on our Mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. In addition, we are steadfast in our Commitment to economic, social and environmental sustainability.

Integrity is the foundation from which we operate. As a BioPharma leader, we take our responsibilities seriously, and always strive to do the right thing for the benefit of the patients we serve around the world, our company, our employees, our shareholders and our communities.”

If you need help in writing a letter please contact me but I do urge you to write. It is important our voices are heard. Further to this I think our battle continues with the Cancer Drug Fund (CDF) and ensuring it meets the needs of patients accessing ALL CML drugs.

Thank you.