NICE Response To Appeal Court Ruling On Herceptin

Commenting on today's appeal court ruling (12 April 2006) in the case of Swindon PCT vs Ann Marie Rogers, Andrew Dillon, Chief Executive said: "The most important thing about this judgement is that it is a step towards ending the uncertainty for Ms Rogers.


PLEASE NOTE NICE DOES NOT LICENSE DRUGS - THIS IS THE ROLE OF EITHER THE UK OR EUROPEAN DRUG REGULATOR


"Today's ruling is about how Swindon PCT made their decision. It doesn't reduce the importance of having a system for licensing drugs, to make sure we know they are safe to use, or the work that NICE does, in helping the NHS to use new drugs in the right way. Without these things, we risk exposing patients to risks and the health service to using its money unwisely.


"Herceptin still isn't licensed and it won't be until the summer. If and when it is, NICE stands ready to advise patients and those who care for them on the best way to use it. This will be advice for all the women who might potentially benefit from it and for all the primary care trusts who may need to make the funds available to enable its use. It's only in this way that consistent decisions can be taken to bring an end to the uncertainty that faces both patients and the NHS."


NICE is expecting to issue guidance to the NHS on the use of Herceptin in July 2006, subject to the drug receiving a license. NICE is actively tracking the licensing process and will be in a position to go public on its recommendations quickly once the drug has been licensed for use in the UK.


1. NICE is the independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health.
About the process for licensing medicines in the UK


2. Licensing is carried out by the Medicines and Healthcare Products Regulatory Agency (MHRA) in conjunction with the European Medicines Agency (EMEA). All medicines are assessed to determine whether they work and are safe before they are made available for widespread use in the UK.


3. Roche pharmaceuticals have made a submission for Marketing Authorisation to the European Medicines Agency (EMEA) for Herceptin (trastuzumab) as adjuvant treatment for early-stage HER2-positive breast cancer on February 17 2006.


4. NICE cannot issue guidance for the NHS on new drugs until they have been licensed.


About process for appraising medicines in the UK


5. NICE issues guidance on the clinical and cost effectiveness of selected new and existing drugs for the NHS in England.


6. Both Scotland and Wales have introduced systems to provide local advice on new drugs. Both Scotland and Wales take NICE guidance and apply it even where they have previously issued local advice.


7. NICE is introducing a new, shorter process to enable more rapid guidance to be issued in England and help Scotland and Wales avoid duplication in their own processes.


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View drug information on Herceptin.