Introduction
In common with other local health communities, the Leicestershire Medicines Strategy Group (LMSG) has identified the need and benefits of having a Leicestershire Health Community-wide strategy for the managed entry of new drugs and related technologies. This strategy will be implemented through a “Traffic Light” list which will define the level and mechanisms of recommended use for new medicines-related innovations which become available. This form of primary and secondary care control is commonly used by other health communities.
Leicestershire Health Community comprises the six Primary Care Trusts, University Hospitals of Leicester (UHL) NHS Trust and Leicestershire Partnership NHS Trust, amongst which there is a total consensus on the way forward for this strategy, which has evolved over a two year period.
The Traffic Light list comprises of four categories, the definitions of which are:
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Black |
Drugs not recommended for use in the Leicestershire Health Community because of lack of evidence of clinical effectiveness, cost prioritization or concerns over safety.
All new drugs will be black until they have been through the appropriate approval process - then they will appear as a specific entry |
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Red |
Drugs which should be prescribed only by hospital specialists |
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Amber |
Drugs which would initially be prescribed by a hospital specialist and then by a GP where full agreement to share the care of each specific patient has been reached under a LMSG Shared Care Agreement (SCA) requiring either [1] specific patient monitoring or intervention (Full SCA) or [2] general patient monitoring (Simple SCA). - see comments under individual entries for status |
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Green |
Drugs for which GPs would normally take full responsibility for prescribing and monitoring. Drugs included in this category are newer drugs which have been specifically considered by LMSG. Green status does not imply that they are superior to existing first-line drugs. All drugs not included in this Traffic Light list are considered as Green by default. |
The Process
New drugs will be added to the list as they become available, normally at the time of marketing. They will normally automatically assume a BLACK status, unless an evidence-based assessment and cost prioritisation has been made previously. They will undergo a detailed evidence-based scrutiny, either as part of UHL internal process or specifically for LMSG. After ratification by a standing LMSG subgroup, the new drugs will then be reclassified as either RED (hospital specialist use only), AMBER (shared care or similar arrangement to be in place for primary care prescribing) or GREEN (unrestricted use). All local decisions will take full account of NICE and other national or superceding guidelines. Decisions on Traffic Light classification are made in accordance with the Leicestershire Traffic Light Criteria Guidelines
The Traffic Light List will be a dynamic tool, with evidence being reviewed on an ongoing basis and drugs reclassified when appropriate.
The list will be maintained as comprehensive as possible. However, it will not be exhaustive, especially at the restricted (RED) or GREEN (unrestricted) end of the list. The majority of commonly prescribed drugs will be in the GREEN category, but will not appear on the list. If a drug does not appear, and there is a question on where it is categorized, prescribers should consult their PCT Pharmaceutical Adviser or the Leicestershire Medicines Information Service (tel:0116 258 6491).
Interim arrangements
For an interim period arrangements will be in place for those drugs which are currently prescribed in primary care but which are to move to the hospital specialist only (RED) category. LMSG has established a commissioning group to work through and agree how any resource transfer should take effect and the date at which implementation will happen. The drugs involved are:
- Apomorphine (for Parkinson’s Disease)
- Immunosuppressants for transplantation
- Leflunomide (for rheumatoid arthritis)
- Somatropin
Publication
The Traffic Light list will be updated regularly, the most recent version, and any changes to the previous version, will be available on the LM<SG website at
www.lmsg.nhs.uk
Enquiries
Enquiries or suggestions regarding this strategy and the Traffic Light system should be addressed to :
- Primary care: PCT Pharmaceutical Adviser
- UHL: Medicines Information Service
- LPT: LPT Chief Pharmacist
Produced by: Peter Golightly/LMSG Published: June 2005
Version: 1.1 (final) To be revised: June 2006
Enquiries to: Trent Medicines Information Service, Leicester Royal Infirmary. Tel: 0116 255 5779
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