Download Procedure for adding new chemotherapy regimens to Network

Procedure for adding new chemotherapy regimens to
the Network agreed treatment algorithms
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Revised October 2011
Document Detail
Procedure
Hosted on South East London Cancer Network Website
www.selcn.nhs.uk
V1.0 Draft
October 2011
No later than October 2013
Chair of Network Drugs and Therapeutics Advisory Committee
Jacky Turner, Macmillan Network Pharmacist
1. Manual for Cancer Services, revised Chemotherapy
Measures 2011
2. Chemotherapy Services in England: Ensuring quality
and Safety, A report from the National Chemotherapy
Advisory Group, National Cancer Action Team August
2009
3. For better, for worse, A review of the care of patients
who died within 30 days of receiving systemic anticancer therapy. NCEPOD November 2008
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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: www.selcn.nhs.uk.
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
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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
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Appendix 1 Procedure for adding new Chemotherapy regimens to the agreed treatment algorithms
Regimen, place in pathway
approved by TWG/Lead
oncologist
Regimen
highlighted during
prioritisation for
the current year
Regimen
colour coded.
No
Yes
No
Funding implications
for new regimen
Yes
No
Green
Regimen NICE
approved or on Cancer
Drugs Fund List for
London
Funding stream in
place, discuss with
Cancer services
pharmacist
Yes
Consider Additional
Private Care
Red
Amber
Light Green
Blue
Regimen
on list for
ICDF
Regimen has
positive
recommendation
from LCNDG?
Yes
New regimen to be
added to TWG agreed
treatment algorithm
Revised October 2011
No NHS
Funding
stream
identified
Complete application to
add new regimen to the
treatment algorithm
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Regimen
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
No
A summary of New regimens per tumour
site will be discussed at the Network Drugs
and Therapeutics Advisory Committee.
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:
Frequency:
Number of Cycles
Intended:
Radiotherapy:
For chemo-radiation
regimes, specify details of
Radiotherapy
Emetogenic Potential
Very High
(please tick):
Regular Investigations required (Please tick):
FBC
High
Frequency:
LFT’s
U & E’s
Low
Frequency:
Cr.Clearance
Frequency:
Other
(please specify)
Moderate
Frequency:
Frequency:
EDTA (prior to 1st
Frequency:
course)
Dose Modifications
for toxicity:
Comments/
additional drugs
(e.g. folinic acid
rescue):
Consultant Name:
Tumour site/TWG lead:
Signature:
Signature:
Date:
Date:
Date Received by Network Pharmacist
Date agreed by DTAC Chair:
Date added to treatment algorithm
Send completed form to [email protected]
Revised October 2011
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