Trial: Discontinuation of dasatinib

The results of this trial represent an incredible leap forward for CML patients who, like me, are on dasatinib (sprycel). For the patients in this trial, nearly 50% who stopped dasatinib maintained a deep molecular response. The other 50% started taking tablets again and all regained a deep molecular response.

This represents a huge benefit for the patient who could, effectively, remain drug-free but it also represent an economic benefit. What was once considered an expensive drug could soon be considered a drug-for-life for only half of the patients who take it. This could be enough to present a new case to NHS England over funding.

Thanks, Kris

Taken from The Lancet haematology

Summary
Background
First-line imatinib treatment can be successfully discontinued in patients with chronic myeloid leukaemia after deep molecular response has been sustained for at least 2 years. We investigated the safety and efficacy of discontinuing second-line or subsequent dasatinib after at least 1 year of deep molecular response.

Methods
The Dasatinib Discontinuation trial was a prospective multicentre trial done in Japan. Eligible patients taking dasatinib and with confirmed stable deep molecular response were enrolled between April 1, 2011, and March 31, 2012. All patients received dasatinib consolidation therapy for at least 1 year. In those with sustained deep molecular response, dasatinib was discontinued. Patients were followed up every month in year 1 (clinical cutoff), every 3 months in year 2, and every 6 months in year 3 for deep molecular response and immunological profiles. The primary endpoint was the proportion of patients with treatment-free remission at 6 months after discontinuation. Molecular relapse was defined as loss of deep molecular response at any assessment. This study is registered, number UMIN000005130.

Findings
88 patients were enrolled in the consolidation phase, 24 were excluded from the discontinuation phase due to fluctuations in BCR-ABL1 transcript levels. One patient was excluded because of positive expression of major and minor BCR-ABL1 transcripts in chronic myeloid leukaemia cells and the detection of minor BCR-ABL1 transcripts during consolidation. Thus, 63 patients discontinued dasatinib treatment. The 25 patients who were excluded from discontinuation continued to receive dasatinib and none showed disease progression. Median follow-up was 20·0 months (IQR 16·5–24·0). Of the 63 patients who discontinued and were not excluded, 30 patients maintained deep molecular response while 33 patients had molecular relapses, all within the first 7 months after discontinuation. The estimated overall treatment-free remission was 49% (95% CI 36–61) at 6 months. No severe treatment-related toxic effects were seen. Treatment was restarted in the 33 patients with relapse; rapid molecular responses were seen in all 33 patients, of whom 29 (88%) regained deep molecular response within 3 months, as did the remaining four by 6 months.

Interpretation
Dasatinib discontinuation after sustained deep molecular response for more than 1 year is feasible.

Funding
Epidemiological and Clinical Research Information Network (ECRIN).

Front page of the Independent: Cost of CML Drugs

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

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

 

Trial evidence shows that dasatinib works faster and deeper

I’m delighted to be able to share these results on the blog. The DASISION trial shows that dasatinib is more effective than imatinib. These findings prove that dasatinib works at twice the speed and with better results than imatinib and it makes the recent NICE decision and consultation completely irresponsible.
Many patients do extremely well on imatinib but this data shows how important it is to ensure our consultants have total access to dasatinib. In the meantime this serves as excellent evidence in persuading each SHA (Strategic Health Authority) to fund dasatinib locally and ensure we don’t allow this drug to become embroiled in a postcode lottery.

I urge you to, again, write to NICE and write to Sir Andrew Dillon updating them with this research and, again, ask them how they can justify their recent decisions, denying access to a drug that we now KNOW works better than the one they have recommended.

The original press release can be found here.

Results Presented at 17th Congress of the European Hematology Association;  June 14-17, 2012; Amsterdam, The Netherlands

Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceutical Europe Ltd., today announced results from the 3-year follow-up of the DASISION trial, which show that first-line treatment with SPRYCEL(R) 100 mg results in faster and deeper response rates compared with Glivec(R) (imatinib) 400 mg [as defined by time to achieve Complete Cytogenic Response (CCYR) or Major Molecular Response (MMR)].

Additionally, an exploratory landmark analysis of the study suggests that patients with a deeper molecular response at three months (defined as having a less than or equal to 10% BCR-ABL) show a trend towards improved outcomes [such as Progression Free Survival (PFS), Overall Survival (OS) and a lower risk of disease transformation to Accelerated Phase or Blast Phase (AP/BP)] than the patients who did not achieve this level of response at three months. In this analysis, a deeper molecular response at three months was achieved in 84% of dasatinib treated patients and 64% of imatinib treated patients.[1]

“These findings are meaningful for newly diagnosed patients with Chronic Myeloid Leukaemia (CML),” said Dr Andreas Hochhaus, Professor of Internal Medicine and Head of the Department of Hematology and Medical Oncology at the Jena University Hospital, Germany. “We are now seeing that, in general, in CML an early and deep level of response to treatment appears to be associated with a lower rate of disease progression, and may be a promising indicator of better long-term outcomes for patients. However, longer follow up is needed.”

Faster and Deeper Response by 3 Months

Research suggests that achieving a deep response earlier may predict better long-term outcomes for patients.[2,3] In this 3 year follow up of the DASISION study, the median time to response (Complete Cytogenic Response, or CCYR) for dasatinib was 3.2 months vs 6.0 months for imatinib. The median time to major molecular response (MMR) was 15 vs 36 months, respectively.[4]By 3 years, MMR was achieved in 68% of dasatinib treated and in 55% of imatinib treated patients (p<0.0001)[1]

Additional exploratory analyses of the three year follow-up of DASISION show:

    - At 3 months, 84% of evaluable patients receiving dasatinib achieved less than or equal to 10% BCR-ABL levels vs 64% of imatinib treated patients (p=0.0001)[1]
    - A higher probability of 3-year PFS and OS was seen in patients achieving less than or equal to 10% BCR-ABL compared to patients who had >10% BCR-ABL levels at 3
      months[1]
    - A lower level of transformation to AP/BP was seen in patients achieving less than or equal to 10% BCR-ABL (dasatinib 3%: 6 of 198 patients; imatinib 2.6%: 4 of 
      154 patients) compared with patients who had >10% BCR-ABL levels at 3 months (dasatinib 13%: 5 of 37 patients; imatinib 13%: 11 of 85 patients) during this three year
      follow-up.[1]

Continued Tolerability at 3 Years

The overall three-year data also showed that the safety profile for dasatinib continues to be generally well-tolerated. Specifically, the data show:

    - Minimal changes in the tolerability profile at three years and with a similar pattern of adverse events as previously observed[1]
    - Rates of grade 3/4 non-hematologic AEs at 3 years in both arms remained low (0-3%)[1]
    - By the third year of treatment, 11% of patients discontinued dasatinib and 6% discontinued imatinib due to intolerance[5]

Efficacy and safety Results in the European Subpopulation

Results of an exploratory analysis of the European subpopulation (defined as patients treated in the European Union) of DASISION were also presented at the 17th Congress of the European Hematology Association. This analysis demonstrated that the efficacy and safety profile of dasatinib in the European population (170 out of 519 included in DASISION) appeared comparable to that seen in the total study population. The exploratory data for the EU subgroup show:

    - Rates of MMR (65% for dasatinib and 56% for imatinib by 3 years)[5]
    - Level of transformation; no patients treated with dasatinib vs 3 patients on imatinib had transformation of CP-CML to AP/BP at or by 3 years [5]
    - Tolerability generally consistent with previously reported at 3 years for entire population[5]

For full information on SPRYCEL (dasatinib) please refer to SmPC at http://www.ema.europa.eu.

About the DASISION Trial

The DASISION trial is a pivotal Phase 3, randomised open-label study looking at the efficacy and safety of dasatinib versus imatinibin newly diagnosed, treatment-naïve CP-CML patients. Patients were randomised to receive treatment with dasatinib 100 mg once-daily (n=259) or imatinib 400 mg once-daily (n=260).[6] Dasatinib was superior to imatinib for the primary endpoint of the study, confirmed complete cytogenetic response (cCCyR) by 12 months (77% vs 66%; p=0.007).[6] Given the established relationship between achieving CCyR by 12 months and improved survival rates, longer follow-up may demonstrate that dasatinib improves long-term outcomes.[6] Three-year data is now available. Patients will be followed for a planned 5 years.

About SPRYCEL(R)

Discovered and developed by Bristol-Myers Squibb, dasatinib was initially approved by the FDA and the European Commission in 2006 as a treatment for adults for all phases of Ph+ CML (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including imatinib and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) intolerant or resistant to prior therapy. In the U.S., dasatinib received accelerated FDA approval for this indication. Since then, dasatinib has been approved for this indication in more than 60 countries worldwide.

In 2010, dasatinib 100 mg once daily was approved by the FDA and European Commission for the treatment of adult patients with newly diagnosed Ph+ CML in chronic phase. In the U.S., dasatinib received accelerated FDA approval for this indication. The effectiveness of dasatinib is based on cytogenetic response and major molecular response rates. Now, more than 50 countries have approved dasatinib for this indication.

About Chronic Myeloid Leukemia

CML is a slow-growing type of leukaemia in which the body produces an uncontrolled number of abnormal white blood cells.[7] CML accounts for 15% of all leukaemias.[8] The incidence is estimated at 1-2 cases per 100,000.[9]

CML occurs when pieces of two different chromosomes (9 and 22) break off and attach to each other. The new chromosome is called the Philadelphia chromosome, which contains an abnormal gene called BCR-ABL that signals cells to make too many white blood cells. There is no known cause for the genetic change that causes CML.

Response to treatment can be measured either by Complete Cytogenetic Response (CCYR) or Major Molecular Response (MMR). CCYR is the absence of Philadelphia+ chromosomes in a Cytogenetic Testing made from a bone marrow aspiration. MMR is a 3-log reduction of BCR-ABL compared to a standardized baseline sample usually measured in peripheral blood.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over seriousdiseases.

About Otsuka Pharmaceutical Co., Ltd.

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: ‘Otsuka-people creating new products for better health worldwide.’ Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group has business operations in 23 countries and regions around the world.

Visit Otsuka Pharmaceutical Co., Ltd. at http://www.otsuka.co.jp/en.

References:

1. Hochhaus A, et al. Molecular response kinetics and BCR-ABL reductions in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) receiving dasatinib vs imatinib: DASISION 3-year follow-up. To be presented at: 17th Congress of the European Hematology Association (EHA); June 14-17, 2012; Amsterdam, The Netherlands.

2 Hanfstein B, et al. Early molecular and cytogenetic response is predictive for long-term progression-free and overall survival in chronic myeloid leukemia (CML). Leukemia accepted article preview 26 March 2012; doi: 10.1038/leu.2012.85.

3. Marin D, et al. Assessment of BCR-ABL1 transcript levels at 3 months is the only requirement for predicting outcome for patients with chronic myeloid leukemia treated with tyrosine kinase inhibitors. J Clin Oncol. 2012;30:232-8.

4. Jabbour E, et al. An exploratory analysis from 3-year DASISION follow-up examining the impact on patient outcomes of early complete cytogenetic response at 3 months and major molecular response at 12 months. To be presented at: 17th Congress of the European Hematology Association (EHA); June 14-17, 2012; Amsterdam, The Netherlands

5. Mayer J, et al. Efficacy and safety of dasatinib vs imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): European subpopulation analysis of the phase 3 DASISION trial. To be presented at: 17th Congress of the European Hematology Association (EHA); June 14-17, 2012; Amsterdam, The Netherlands.

6. Kantarjian H et al. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010; 362:2260-2270.

7. Macmillan Cancer Support. Leukaemia Overview.

Available at: http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Leukaemia/Leukaemiaoverview.aspx . Last accessed April 2012.

8. National Comprehensive Cancer Network (NCCN). Chronic Myelogenous Leukemia – Clinical Practice Guidelines in Oncology – v.1.2007.

9. Baccarani, M. and Dreyling, M. Annals of Oncology. 2010;21:165-167.

A reply from Sir Andrew Dillon

I simply had to write today to let you know about the reply I have received from Sir Andrew Dillon by way of Janet Fahie from the Enquiry Handling Team. I’ve scanned the letter in below but I will bring to your attention this:

“In this case Dasatinib and high-dose imatinib did not provide enough benefit to patients to justify their high cost, so NICE did not recommend them.”

I have to ask exactly what benefits NICE are looking for from Dasatinib? This is a drug that is saving lives and allowing people, like me to live normal healthy existences. These aren’t in isolated incidences, all over the world, every day lives are being saved by Dasatinib. In the UK we are in danger of relying on old drug therapy. At a recent conference I attended Dr Jorge Cortes stated that he had not used imatinib since 2001 because there were more effective treatments to use. Jorge Cortes, MD, is deputy chair and professor of medicine in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston Texas where he directs the CML Program.

It is estimated that 1 in 5 patients will benefit from dasatinib treatment yet NICE once again insist on their gold standard of research which, as we know, is impossible to conduct on such a rare disease.

I will be writing back to Sir Andrew with these points and I’d urge you to do the same.

Sir Andrew Dillon CML reply

All my best wishes,

Kris

Dasatinib PAS PQ

A Dasatinib PAS (Patient Access Scheme) PQ (Parliamentary Question) has been answered. We have a stock response indicating that it is for the manufacturer to choose to submit a PAS and nothing has yet been submitted to DH (Department of Health) by BMS:

Karl McCartney: To ask the Secretary of State for Health if he will encourage Bristol Myers Squibb to introduce a patient access scheme to discount the price of dasatinib.

Mr Simon Burns: It is for the manufacturers of a drug to decide if they wish to submit a patient access scheme proposal to the Department for potential consideration as part of a National Institute for Health and Clinical Excellence appraisal. The manufacturer of dasatinib has not approached the Department regarding the possibility of a patient access scheme for this drug.

Parliamentary Business – Daily Hansard – Written Answers – 19th April 2012 http://www.publications.parliament.uk/pa/cm201212/cmhansrd/cm120419/text/120419w0001.htm#120419w0001.htm_sbhd43

I urge all readers, again, to write to BMS to introduce a PAS. We know that their line is still ‘exploring all options’, so some more pressure might help them make a decision sooner rather than later.

Thanks,

Kris

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.