Tag Archives: NICE

NICE deny Leukaemia Patients Life Saving Cancer Drugs

NICE (National Institute for Health and Clinical Excellence) have recently returned their provisional results on Nilotinib and Dasatinib as alternative therapy for Imatinib (Glivec / Gleevec) intolerant patients. Basically they are denying these patients a chance of life on what I can see as purely a cost issue.

The CML Support Group has set up an Online Petition against this which I implore you to sign.

A representative of the CML Support Group said ‘Patients are angry, frightened and very frustrated by the provisional recommendation by the NICE appraisal committee- a recommendation that seems to us to have much more to do with cost cutting than with a rational appraisal of two highly effective and innovative therapies.

If the recommendation is upheld, and NHS funding of these therapies is refused in cases of imatinib intolerance, it will undoubtedly cost lives. It is a shocking prospect that UK citizens, who prove to be intolerant to standard dose imatinib (Glivec) will be denied access to such effective and life-saving alternatives. Clinicians will find themselves unable to offer these therapies to their patients in the knowledge that expert clinicians in Germany, France, the Netherlands and other EU countries, will continue to treat CML patients with these life-saving therapies. NICE have clearly acknowledged that both nilotinib (Tasigna) and dasatinib (Sprycel) are clinically effective and very well tolerated oral therapies.

It is difficult to understand why NICE have singled out imatinib (Glivec) intolerant patients in chronic or accelerated phase CML (but not blast phase) for a provisional recommendation that they alone should be denied access to these life-saving therapies. As a consequence, this group of patients, who currently represent around 30-40 British citizens of all ages, will suffer an appalling injustice that puts them at great risk of dying from acute (blast) phase CML.

We call upon the Secretary of State for Health to ensure all CML patients intolerant of Glivec (imatinib) have equality of access to these life-saving drugs.

This reminds me of the issues I had back in 2001 when trying to get Glivec. You can read the outcome on My Leukaemia Story.

It is difficult to put into words how this makes you feel as a patient. Jed’s story on the video below sum’s up the issues and feelings and I strongly recommend watching the short clip.

This also has potential significance for me personally. If I was to become intolerant to Glivec then I would effectively be denied the opportunity to try what is showing to be a successful alternative. For me it is my Plan B.

I (and all other CML patients) would appreciate if you could show your support by signing the petition:

Sign The Online Petition By Clicking This Link!

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Filed under chronic myeloid leukaemia, gleevec, glivec, imatinib, leukaemia, NICE

CML – NICE – epetition response – Dasatinib (DS) & Nilotinib (NL)

Just a quick post to show the reply to 10 Downing Street’s latest reply to the Dasatinib and Nilotinib petiton and challenge to acceptance as 2nd line therapy for resistant / intolerant Imatinib (aka Glivec, Gleevec).

I am not going to comment directly here at this stage, as in my opinion there are huge flaws in the study for the judgement, however we await the full reply and go from there.

Direct quote from 10 Downing Street:

We received a petition asking:

“We the undersigned petition the Prime Minister to overturn the decision by NICE to refuse 2nd generation life saving drugs to CML patients.”

Details of Petition:

“Chronic myeloid leukaemia is a form of blood cancer. The current treatment is Imatinib (IM).

Approx. 40% of individuals may display resistance to IM. Dasatinib (DS) & Nilotinib (NL) are licensed for the treatment of adults with chronic & accelerated phase CML with resistance or intolerance to IM.

DS is also effective for Blast Crisis CML. Both received approval by the FDA & EMEA.

NICE do not accept the evidence supplied in the initial report, as they consider open label, non blinded trial designs seriously flawed.

Cost of supply is the issue. We are urging NICE to reassess their decision NOT TO fund the use of these EFFECTIVE treatments on the basis of cost – without the need for 4 arm (DS, NL, high dose IM) double blind randomised studies including a control group receiving ‘best supportive care’ – allowing none of them to crossover and no dose escalations according to how they respond.

The NICE assumed average age for CML is 60. Would you accept such a trial would be morally/ethically correct if it was aimed at young children with CML? What if your National Insurance scheme now doesn’t treat you with the best drugs because the cost is considered too high?.”

Read the Government’s response

In response to the concerns that many people have about the availability of dasatinib and nilotinib for the treatment of chronic myeloid leukaemia, the Department of Health should stress that the National Institute for Health and Clinical Excellence (NICE) has not yet published final guidance on the use of dasatinib and nilotinib.

NICE has recently issued draft guidance that does not recommend the use of dasatinib and nilotinib for the treatment of chronic myeloid leukaemia and registered stakeholders had until 7 December 2009 to submit comments.

NICE’s Appraisal Committee is considering the responses to the consultation and the Institute currently expects to issue its final guidance to the NHS in April 2010.

NICE is an independent body, which makes decisions on the clinical and cost effectiveness of products based on a thorough assessment of the available evidence involving extensive consultation with stakeholders and in the context of a finite NHS budget.

Some of these treatments cost thousands of pounds, so NHS bodies must find a balance between funding expensive drugs for a limited number of patients and providing services and treatments that will benefit many other people.

The Department recognises that the Institute’s decisions have serious implications for patients and their carers. These are very difficult decisions and they are made only after careful consideration.

It would therefore not be appropriate for Ministers or officials to intervene in an ongoing appraisal. However, several patient groups are registered stakeholders in this appraisal and concerned parties may wish to raise concerns about NICE’s guidance with one of these organisations. Details of stakeholder organisations can be found at: http://www.guidance.nice.org.uk/TA/Wave17/18

Where NICE guidance is not yet available for a treatment, the NHS Constitution gives patients a right to expect local funding decisions on the availability of drugs and treatments to be made rationally and on the basis of the available evidence. NHS organisations are also required to have processes in place for the consideration of exceptional cases, even where NICE has not recommended a particular drug or treatment.”

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Filed under chronic myeloid leukaemia, gleevec, glivec, imatinib, leukaemia, leukaemia research