New Chemotherapy Regimens to Benefit the Network

Transcription

1 Procedure for adding new chemotherapy regimens to the Network agreed treatment algorithms Document Detail Document Type Procedure Document location Hosted on South East London Cancer Network Website Version V1.0 Draft Effective from October 2011 Review date later than October 2013 Owner Chair of Network Drugs and Therapeutics Advisory Committee Prepared by Jacky Turner, Macmillan Network Pharmacist Approved by, date Relevant external law, 1. Manual for Cancer Services, revised Chemotherapy regulation, standards Measures Chemotherapy Services in England: Ensuring quality and Safety, A report from the National Chemotherapy Advisory Group, National Cancer Action Team August For better, for worse, A review of the care of patients who died within 30 days of receiving systemic anticancer therapy. NCEPOD vember 2008 Revised October 2011 Page 1 of 7

2 Background It is a requirement of the Manual of Cancer Services, revised Chemotherapy Measures (DH June 2011) for each Trust and Network to maintain agreed treatment algorithms, which will include the list of chemotherapy regimens for each tumour site which delivers systemic anti-cancer therapy as part of its treatment pathway. There is also a requirement for a process to be in place to monitor the use of regimens not on the agreed algorithms. In SELCN the process for this is described in this procedure. One-off regimen usage is monitored via the SELCN Drugs and Therapeutics Advisory Committee. The agreed treatment algorithms which include the chemotherapy regimens and the Policy for Preventing the Regular Deviation from Agreed Treatment Algorithms for SELCN are hosted on the Network website at: Chemotherapy regimen This is defined by the therapeutic chemotherapy drugs used, often expressed as an acronym e.g. FEC. A change of one or more of these drugs themselves would usually be necessary for it to be classed as a change of regimen. In some cases major changes in the dose or route of administration of one or more of the drugs effectively changes the regimen. Chemotherapy treatment algorithm This is defined as a guideline which specifies the acceptable regimen or range of regimens which may be used for named steps on the patient pathway. Treatment algorithms are cancer site-specific. They are not specific to individual patients, i.e. they are not individual treatment plans. Thus, a change of regimen or order of regimens may no longer comply with a previous treatment algorithm, but a change of one of the minor aspects of a treatment protocol would still comply. Changes to Treatment algorithms and the chemotherapy regimens Changes to the content of Treatment algorithms and the chemotherapy regimens contained within them may be initiated as follows. At annual/bi-annual review of the Tumour Site Specific Working Group (TWG) treatment guidelines, or when a new chemotherapy regimen needs to be made available within the Network. Once a one-off regimen has been used on three or more occasions, then the process to consider whether the drug/regimen should be added to the agreed list needs to occur. Revised October 2011 Page 2 of 7

3 Procedure to add regimens to the agreed treatment algorithms The agreed treatment algorithms will be reviewed every two years by the relevant TWG/medical/clinical or haemato-oncology lead for that tumour site, as part of the review of the treatment guidelines for that tumour site. This will highlight regimens which will no longer be required and new regimens that will need to be added to the algorithm. In addition to this, one-off use of chemotherapy regimens will be monitored via the SELCN Drugs and Chemotherapy Advisory Committee. When it is evident that a new regimen is being used, the tumour lead for that tumour site will be asked to discuss addition of this regimen to the treatment algorithm and to follow the process outlined below. The following will need to be considered in relation to the new regimen, see Appendix 1: The evidence base for the new regimen. Is this an entirely new regimen, or is it a tweak to an existing regimen, required to meet an individual patient s clinical need. Is the regimen NICE approved? Is the regimen on the London Cancer Drugs Fund list? Has the regimen been highlighted via the prioritisation process for the current year? If so has a London Cancer New Drugs Group positive recommendation been made? If not, there will need to be an application made for the prioritisation for the following year. The funding implications for the new regimen. If the regimen has been NICE approved, if so funding in place. Has the regimen been highlighted via the prioritisation process for the current year? If so, has the regimen been highlighted for funding (i.e. listed Green, light green or Blue) within the process? Has the regimen received a positive recommendation from LCNDG? If so, funding is in place. Is the new regimen on the Cancer Drugs Fund List for London,. If so, funding is in place If no funding mechanism is in place, a submission to the Prioritisation process for the following year may need to be submitted, in order for a funding stream to be identified. Consultant to agree, with relevant medical, clinical and haemato-oncology consultants via the relevant Tumour Working Group (TWG), the place in practice within the treatment algorithm for the new regimen. This will include the place in the treatment pathway and the potential for existing regimens to move within the pathway, should evidence be available for this to occur. Consultant to complete application form (Appendix 2 to this document) to add a new regimen to the list. Revised October 2011 Page 3 of 7

4 Appendix 1 Procedure for adding new Chemotherapy regimens to the agreed treatment algorithms, place in pathway approved by TWG/Lead oncologist Funding implications for new regimen Funding stream in place, discuss with Cancer services pharmacist New regimen to be added to TWG agreed treatment algorithm highlighted during prioritisation for the current year Complete application to add new regimen to the treatment algorithm colour coded. Green Revised October 2011 Page 4 of 7 NICE approved or on Cancer Drugs Fund List for London Light Green Blue has positive recommendation from LCNDG? Amber on list for ICDF Red Consider Additional Private Care NHS Funding stream identified to be put forward for funding for next years prioritisati If an individual patient is on round exceptional -funding may be obtained via the independent funding request route A summary of New regimens per tumour site will be discussed at the Network Drugs and Therapeutics Advisory Committee.

5 APPENDIX 2 Application Form for addition of new chemotherapy regimen to an agreed treatment algorithm To be completed by the Consultant Discuss the content required in the form below with your Trust Lead Cancer Services pharmacist Indication/diagnosis: Drugs/dosage: Reference (source of information for this protocol in this indication): Administration details: Radiotherapy: For chemo-radiation regimes, specify details of Radiotherapy Emetogenic Potential (please tick): Regular Investigations required (Please tick): Number of Cycles Intended: Very High High Moderate Low FBC LFT s U & E s Other (please specify) Cr.Clearance EDTA (prior to 1 st course) Dose Modifications for toxicity: Comments/ additional drugs (e.g. folinic acid rescue): Consultant Name: Signature: Date: Tumour site/twg lead: Signature: Date: Date Received by Network Pharmacist Date agreed by DTAC Chair: Date added to treatment algorithm Send completed form to jacky.turner@gstt.nhs.uk Revised October 2011 Page 5 of 7

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