NICE to issue faster guidance on use of drugs by NHS
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《英国医生杂志》
The National Institute for Health and Clinical Excellence (NICE), which advises the NHS in England on the use of medical treatments, has developed a more rapid process for assessment that will be used initially for lifesaving medicines, including several cancer drugs.
The new "single technology appraisal" process will enable NICE to develop guidance on drugs selected for rapid assessment within eight weeks—much more quickly than the current average of 18 months. It will initially be applied to lifesaving drugs that have already been licensed and to new lifesaving medicines close to the time that they first become available.
In the faster appraisal system, NICE will ask for a single submission of evidence from the manufacturer of the drug being appraised. The institute will then independently assess this evidence and move rapidly to the final stage of the process—in which organisations can appeal against the decision—in cases for which the draft recommendations are in agreement with the drug's licence. Currently, after deciding the scope of the appraisal, NICE commissions an independent academic centre to report on the published evidence, which is then considered by an independent committee.
Their appraisal is widely circulated for comment before the final guidance is produced. Patients' and carers' groups, bodies representing health professionals, and the manufacturers of the drug being appraised are also invited to submit evidence.
The new appraisal process will initially be applied to 14 drugs—13 of which are cancer drugs—that have already been referred to NICE. These include docetaxel (Taxotere) for breast cancer; paclitaxel (Taxol) for breast cancer; rituximab (MabThera) for non-Hodgkin's lymphoma; trastuzumab (Herceptin) for breast cancer; and bortezomib (Velcade) for multiple myeloma. NICE estimates that the more rapid process will result in guidance being published 6-15 months earlier than with the existing process, with more than half of appraisals being published at least eight months earlier.
The first guidance developed using the new process will appear by June 2006, NICE hopes. Guidance on bortezomib and trastuzumab (subject to it being granted a licence by regulatory bodies) will appear shortly afterwards.
Delays in the development of NICE appraisals—particularly in relation to cancer drugs—have attracted widespread criticism because they have led to delays in the use of drugs by the NHS. Andrew Dillon, chief executive of NICE, said, "We are aware of the need for timely advice on the use of new medicines, particularly for life threatening conditions such as cancer. The proposals we have set out mean NICE can deal with the current backlog much quicker than planned and that we will be able to issue guidance to the NHS rapidly in the future, once a drug is licensed."
Joanne Rule, chief executive of the cancer information charity CancerBACUP, said, however, "These proposals represent a bold reform package for the future, but they don't solve the problem of the backlog of new cancer treatments currently held up at NICE." She added, "NICE should issue interim guidance on cancer treatments already approved for use in Scotland, and it's crucial that the government make it crystal clear that doctors can prescribe licensed cancer drugs now."(Susan Mayor)
The new "single technology appraisal" process will enable NICE to develop guidance on drugs selected for rapid assessment within eight weeks—much more quickly than the current average of 18 months. It will initially be applied to lifesaving drugs that have already been licensed and to new lifesaving medicines close to the time that they first become available.
In the faster appraisal system, NICE will ask for a single submission of evidence from the manufacturer of the drug being appraised. The institute will then independently assess this evidence and move rapidly to the final stage of the process—in which organisations can appeal against the decision—in cases for which the draft recommendations are in agreement with the drug's licence. Currently, after deciding the scope of the appraisal, NICE commissions an independent academic centre to report on the published evidence, which is then considered by an independent committee.
Their appraisal is widely circulated for comment before the final guidance is produced. Patients' and carers' groups, bodies representing health professionals, and the manufacturers of the drug being appraised are also invited to submit evidence.
The new appraisal process will initially be applied to 14 drugs—13 of which are cancer drugs—that have already been referred to NICE. These include docetaxel (Taxotere) for breast cancer; paclitaxel (Taxol) for breast cancer; rituximab (MabThera) for non-Hodgkin's lymphoma; trastuzumab (Herceptin) for breast cancer; and bortezomib (Velcade) for multiple myeloma. NICE estimates that the more rapid process will result in guidance being published 6-15 months earlier than with the existing process, with more than half of appraisals being published at least eight months earlier.
The first guidance developed using the new process will appear by June 2006, NICE hopes. Guidance on bortezomib and trastuzumab (subject to it being granted a licence by regulatory bodies) will appear shortly afterwards.
Delays in the development of NICE appraisals—particularly in relation to cancer drugs—have attracted widespread criticism because they have led to delays in the use of drugs by the NHS. Andrew Dillon, chief executive of NICE, said, "We are aware of the need for timely advice on the use of new medicines, particularly for life threatening conditions such as cancer. The proposals we have set out mean NICE can deal with the current backlog much quicker than planned and that we will be able to issue guidance to the NHS rapidly in the future, once a drug is licensed."
Joanne Rule, chief executive of the cancer information charity CancerBACUP, said, however, "These proposals represent a bold reform package for the future, but they don't solve the problem of the backlog of new cancer treatments currently held up at NICE." She added, "NICE should issue interim guidance on cancer treatments already approved for use in Scotland, and it's crucial that the government make it crystal clear that doctors can prescribe licensed cancer drugs now."(Susan Mayor)