Primary care trust reverses decision not to fund trastuzumab
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《英国医生杂志》
An NHS primary care trust in England last week reversed its decision not to pay for treating a woman with early breast cancer with trastuzumab (Herceptin). It said that after further consideration and intervention by the secretary of state for health it had decided to fund the anticancer drug because of her "exceptional circumstances."
North Stoke Primary Care Trust in Staffordshire initially rejected an appeal by 41 year old Elaine Barber to be prescribed trastuzumab, even though her specialist had recommended treatment with the drug. The trust said its decision was based on the fact that its safety and cost effectiveness was currently unconfirmed. It had said, "At this stage the evidence of this as a cost effective use of the finite health resources available for North Stoke patients is not confirmed. It would therefore be premature to agree to introduce it as a routine treatment." Trastuzumab is not yet licensed for use in early breast cancer
However, the trust reversed its decision after a meeting between Ms Barber and the trust抯 chief executive and after Patricia Hewitt, the health secretary, released a press statement saying that the trust抯 ruling conflicted with decisions made by other trusts. Ms Hewitt said: "On the basis of the published evidence other PCTs have agreed to fund Herceptin for individual women with early stage breast cancer whose clinicians recommend that the drug is suitable for them providing they are aware of the potential risks."
In a statement announcing its change in decision the trust said: "In the light of her particular exceptional circumstances the PCT has now agreed to uphold her appeal." The statement continued: "North Stoke PCT is confident that the process that has been followed in considering Elaine抯 appeal has been thorough and rigorous and soundly based upon the evidence that is currently available and is happy to share their analysis with the Department of Health and others in relation to this treatment."
The trust said that its original decision in this case was not based on the absolute cost of the product, as had been suggested in the media. However, it acknowledged that it was necessary "to make difficult choices about which services represent the best use of finite resource" (https://www.northstaffs.nhs.uk/nsPortal/portal/cn/home/NS_Home).
It added, "The introduction of any new expensive treatment inevitably provokes a review of the PCT抯 investment priorities. There is no contingency budget in this financial year for the prescribing of adjuvant Herceptin."
An editorial published last week in the Lancet said that claims over the effectiveness and safety of trastuzumab should be treated with caution. It warned that political and media pressure should not undermine the usual process of checking new drugs (2005;366:1673).
Nigel Edwards, director of policy at the NHS Confederation, which represents most NHS organisations, said: "We are concerned that primary care trusts are being put in an almost impossible position by growing pressure to bypass systems established to protect patients." He continued: "Processes to both license new drugs and approve them for use in the NHS have been put in place to protect patients, and so primary care trusts must be able to feel confident that these processes will be followed at all times."
Sue Noyce, director of corporate affairs at North Stoke Primary Care Trust, said that the trust is currently working to a position statement produced by the West Midlands cancer networks, which states that trastuzumab is currently not for routine use in early breast cancer but can be approved for patients on an individual patient basis "in exceptional personal circumstances." The trust is now working with the local provider and cancer network to develop a policy for treating women with early breast cancer with trastuzumab.
She said: "We are concerned to ensure that patients put forward for treatment on an individual basis fully meet the inclusion criteria used in clinical trials with Herceptin." She added: "We are also putting in place measures to ensure that patients treated with Herceptin give fully informed consent and receive appropriate monitoring."
The trust is discussing the longer term implications for cancer and other services if the National Institute for Health and Clinical Excellence recommends the use of the drug in early breast cancer once it has been licensed.(London Susan Mayor)
North Stoke Primary Care Trust in Staffordshire initially rejected an appeal by 41 year old Elaine Barber to be prescribed trastuzumab, even though her specialist had recommended treatment with the drug. The trust said its decision was based on the fact that its safety and cost effectiveness was currently unconfirmed. It had said, "At this stage the evidence of this as a cost effective use of the finite health resources available for North Stoke patients is not confirmed. It would therefore be premature to agree to introduce it as a routine treatment." Trastuzumab is not yet licensed for use in early breast cancer
However, the trust reversed its decision after a meeting between Ms Barber and the trust抯 chief executive and after Patricia Hewitt, the health secretary, released a press statement saying that the trust抯 ruling conflicted with decisions made by other trusts. Ms Hewitt said: "On the basis of the published evidence other PCTs have agreed to fund Herceptin for individual women with early stage breast cancer whose clinicians recommend that the drug is suitable for them providing they are aware of the potential risks."
In a statement announcing its change in decision the trust said: "In the light of her particular exceptional circumstances the PCT has now agreed to uphold her appeal." The statement continued: "North Stoke PCT is confident that the process that has been followed in considering Elaine抯 appeal has been thorough and rigorous and soundly based upon the evidence that is currently available and is happy to share their analysis with the Department of Health and others in relation to this treatment."
The trust said that its original decision in this case was not based on the absolute cost of the product, as had been suggested in the media. However, it acknowledged that it was necessary "to make difficult choices about which services represent the best use of finite resource" (https://www.northstaffs.nhs.uk/nsPortal/portal/cn/home/NS_Home).
It added, "The introduction of any new expensive treatment inevitably provokes a review of the PCT抯 investment priorities. There is no contingency budget in this financial year for the prescribing of adjuvant Herceptin."
An editorial published last week in the Lancet said that claims over the effectiveness and safety of trastuzumab should be treated with caution. It warned that political and media pressure should not undermine the usual process of checking new drugs (2005;366:1673).
Nigel Edwards, director of policy at the NHS Confederation, which represents most NHS organisations, said: "We are concerned that primary care trusts are being put in an almost impossible position by growing pressure to bypass systems established to protect patients." He continued: "Processes to both license new drugs and approve them for use in the NHS have been put in place to protect patients, and so primary care trusts must be able to feel confident that these processes will be followed at all times."
Sue Noyce, director of corporate affairs at North Stoke Primary Care Trust, said that the trust is currently working to a position statement produced by the West Midlands cancer networks, which states that trastuzumab is currently not for routine use in early breast cancer but can be approved for patients on an individual patient basis "in exceptional personal circumstances." The trust is now working with the local provider and cancer network to develop a policy for treating women with early breast cancer with trastuzumab.
She said: "We are concerned to ensure that patients put forward for treatment on an individual basis fully meet the inclusion criteria used in clinical trials with Herceptin." She added: "We are also putting in place measures to ensure that patients treated with Herceptin give fully informed consent and receive appropriate monitoring."
The trust is discussing the longer term implications for cancer and other services if the National Institute for Health and Clinical Excellence recommends the use of the drug in early breast cancer once it has been licensed.(London Susan Mayor)