You are here

Reply to my MP from the Minister of State (Reposted 27/09/07)

Please find copy of the wording received my my MP and forwarded to me.

Quote
"Thank you for your letter of 29 May to Patricia Hewitt enclosing correspondence from your constituent about the availability of the drug dasatinib for the treatment of chronic myeloid leukaemia. I am replying as the Minister responsible for cancer policy issues.
I was sorry to learn of Mr Davies' illness and realise that this is a distressing time for him. I appreciate his wish for people with chronic myeloid leukaemia to receive the most effective treatment.
Dasatinib was licensed for use in the treatment of chronic myeloid leukaemia in the European Union by the European Medicines Agency in November 2006. As this licence covers the use of dasatinib in the UK, clinicians are able to prescribe the use of the drug on the NHS.
The National Institute for Health and Clinical Excellence (NICE) is an independent organisation that was set up in April 1999 to give advice for the NHS on best clinical practice, including the clinical and cost effectiveness of drugs and other treatments. NICE helps tackle the variations in prescribing practice by issuing robust guidance developed after careful consideration of the available evidence and in consultation with stakeholders. Its processes have been developed through wide consultation, are transparent and have been endorsed by the World Health Organization. NICE reviews its processes regularly in order to identify opportunities for efficiencies in the way they are applied.
Once NICE guidance is published, Primary Care Trusts (PCTs) must provide funding for the uses recommended by NICE within three months of publication to allow clinicians to follow the guidance. However, NICE guidance does not replace the knowledge and skills of individual health professionals who treat patients. It is still up to them to make decisions about a particular patient in consultation with the patient and/or their guardian or carer when appropriate.
In the interim period between a drug being licensed and NICE guidance being available, we have made clear to NHS organisations that they should not refuse to fund specific drugs or treatments simply because they have not yet been appraised by NICE. In August 1999, the Department issued Health Service Circular 1999/176 which asks NHS bodies to continue with local arrangements for the managed introduction of new technologies where guidance from NICE is not available at the time the technology first becomes available. In these circumstances, health bodies should make their decision based on their own assessment of the available evidence. In December 2006, the Department issued updated guidance on managing the introduction of new healthcare products in the absence of NICE guidance.
It is not acceptable to cite a lack of NICE guidance as a reason for not providing a treatment. A key role of the NHS is to make decisions about the use of new interventions and this has always been the case, long before NICE was established.
Mr Davies mentions his wish for dasatinib to be referred to NICE for appraisal. Last year, the Department of Health carried out a public consultation on the topic selection process. As a result, NICE was asked to manage the administration of the early stages of the topic selection process on behalf of the Department of Health and now all suggested topics are managed by NICE. Your constituent may be interested to know that members of the public may suggest a topic for NICE to consider developing guidance. Details can be found on the NICE website at: www.nice.org.uk (typing 'suggest a topic' in the search facility).
Mr Davies mentions that dasatinib has been approved for use in Scotland. Guidance for the NHS in Scotland is developed by NHS Quality Improvement Scotland (technology appraisals) and the Scottish Intercollegiate Guidelines Network. The Scottish Medicines Consortium conducts rapid appraisals of medicines as soon as possible after they are launched and, thus, assesses them before NICE. However, the Consortium does not consult as widely nor does it consider the same depth of evidence as NICE, resulting in a shorter timeframe. Once finalised, the NICE guidance is issued to NHS Scotland by NHS Quality Improvement Scotland, which considers any specific implications for Scotland. If NICE were to come to a different conclusion to the Scottish Medicines Consortium about a medicine both have assessed, the NICE decision will normally take precedence since it will usually have been informed by more evidence on clinical effectiveness.
Should Mr Davies have any concerns about his own treatment, he may wish to contact West Hertfordshire PCT, which is responsible for commissioning services to meet the healthcare needs of people in his local area. The contact details are:
West Hertfordshire PCT
Charter House
Parkway
Welwyn Garden City
AL8 6JL
Tel: 01707 390855

Department of Health
West Hertfordshire PCT has a Patient Advice Liaison Service (PALS), which is designed to provide information and on the spot advice to patients, their families, and their carers, helping them to resolve problems and concerns quickly. Mr Davies' local PALS can be contacted on 01707 361281 or by e-mail at pals@herts-pcts.nhs.uk.
I hope this reply is helpful".

Your comments would be greatly appreciated.
STEVEN D

This is a good letter from Rosie Winterton and will give some ammunition to those seeking funding for Dasatinib. Thank you Steven.
Is there anyone out there having trouble with Dasatinib funding ? I would like to suggest that all of you at your next clinic appointment make your nurses and consultants aware that CML Support is active in fighting for Dasatinib funding for patients. If they have patients with funding difficulties, as well as appealing themselves to the PCT and drug company - which is the recommended route - they should direct the patients to CML Support. Support Nurses at various clinic centres could download the template letters and copy them for patients - not everyone has the internet at home. Likewise if anyone would like these letters by snail mail, I am happy to print them and post - contact me erees@hotmail.com
Best wishes
Elizabeth

Stephen

Thank you for posting this letter here. As Elizabeth says, it is helpful.

I have a few additional comments.

A lot of the letter re-iterates what we already knew but there are many helpful things in it for CML patients.

Firstly, she puts in robust terms that it is not acceptable for NHS bodies to cite a lack of NICE guidance as a reason for not providing a treatment, if it is licenced as Dasatinib is. That part of her letter will be useful to anyone who has that particular problem with Dasatinib or any other licenced drug where there is no NICE guidance.

Secondly, she says NICE now manages the administration of the early stages of the topic selection process on behalf of the Department of Health and all suggested topics are managed by NICE. Well, a lot of us have suggested Dasatinib as a topic on the NICE web site so NICE should now be picking up on that. However, on the "administration of the early stages of the topic selection process" now being managed by NICE for the Department of Health, I have received what appears to be irreconcilably different information in a letter from Andrew Dillon, Chief Executive of NICE, to my MP, John Bercow! That NICE letter reads in part "At present we have not been asked by the Dpartment of Health to develop guidance on Dasatinib. The Department determines which drugs to refer to NICE..." I wonder whether you might want to ask your MP to raise it with Rosie Winterton, Stephen? In other words, who, precisely, is stopping NICE from assessing Dasatinib: is it NICE itself or is it the Department of Health? Stephen, I have sent you by Email a copy of the NICE letter that I have just referred to.

Thirdly, although expressed in rather imprecise terms with much room for political manouvre, the idea that later NICE evaluations on particular drugs take precedence over earlier Scottish Medicine Consortiums decisions is interesting. Is it really being said that those who are currently receiving Dasatinib in Scotland, where it is approved for funding in the most important situation of Glivec intolerance, would have to stop having it prescribed if NICE came to a different decision from the SMC. That would be a wholly unacceptable and cruel outcome and demonstrates the lack of rational thinking about national drug funding in our National Health Service. If in the real world of practical politics NICE takes notice of a prior SMC decision when making its own decisions, then I feel a little more relaxed about it, but not very relaxed.

I hope those comments are helpful.

regards

David C