Download CDR/04/05 South Essex Cancer Network Final Report

CDR/04/05
South Essex Cancer Network Response to National
Report on NICE Cancer Drug Usage
Published 14th June 2004
November 2004
EXECUTIVE SUMMARY
The following report details the key findings of a review of the processes and infrastructure within
South Essex Cancer Network (SECN) to support the prescription and administration of drugs used
in the treatment of cancer, in particular, those drugs recommended by the National Institute for
Clinical Excellence (NICE). The report also provides details of the extensive network-wide audit
programme which is underway on the prescription of NICE recommended drugs.
This review was initiated in response to a national report published 14th June 2004 entitled
“Variations in the usage of cancer drugs approved by NICE”. The national report reviewed usage
of 16 NICE recommended drugs and identified SECN as a low user in 12 of the drugs.
Conclusions arising from local review include:

Review of local infrastructure for prescription and administration of cancer drugs
demonstrates that there are no restrictions on the prescription and administration of cancer
drugs,

There are no financial restrictions on the prescription of Cancer Drugs in SECN

In the short term a detailed programme of audit has been agreed with Essex SHA and in the
long term information systems and mechanisms need to be put in place to support audit and
track NICE drug compliance.

There is recognition that the data used for the National Report has limitations: not all cancer
networks submitted their own local data on the prescription of these drugs; data submitted
did not include patients treated with these drugs on clinical trials or those treated in the
private sector; cannot be sure if data submitted nationally reflects accurately on the precise
NICE recommended usage.
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
The network are grateful that we have been afforded the opportunity to review cancer drug
prescribing practice and are confident that we will be able to demonstrate compliance with
NICE recommendations.
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1.
INTRODUCTION
The following details the processes and infrastructure within South Essex Cancer Network (SECN)
to support the prescription and administration of drugs used in the treatment of cancer, in
particular, those drugs that have been recommended by the NICE. NICE was set up to provide
national guidance on treatments and care for people using the NHS in England and Wales. It has
already appraised a wide range of cancer drugs. The large majority of these drugs have received a
positive appraisal from NICE and thousands of cancer patients are benefiting as a result.
This report was produced in response to a national report published 14th June 04 entitled
“Variations in the usage of cancer drugs approved by NICE”. The national report reviewed usage
of 16 NICE recommended drugs and identified SECN as a low user in 12 of these drugs.
2.
BACKGROUND
The Secretary of State for Health asked Professor Mike Richards (National Cancer Director) to
assess the apparent variation in uptake of cancer drugs approved by NICE across the country and
to take action where problems were identified to ensure that these drugs were nationally
available. Mike Richards’ report identified networks on a named basis on their usage against each
drug.
3.
SUMMARY OF REPORT FINDINGS
Headline findings from the review showed encouraging evidence that the overall uptake of NICE
approved cancer drugs increased following publication of recommendations and that variation in
usage did reduce over time. However, there remained unacceptable variations in the level of
uptake of these drugs across the country. SECN were ranked below the national median for 12 of
the cancer drugs positively appraised by NICE.
The report also suggested that variation did not appear to be due to direct funding restrictions on
cancer drugs. However, it did report that there may be issues around chemotherapy capacity and
clinician factors that need to be addressed.
4.
RESPONSE TO REPORT
Strategic Health Authorities (SHA) was asked to consider the findings of Professor Richard’s report,
as it related to the cancer networks for which they were responsible. Since SECN was identified as
a network in which the uptake of cancer drugs recommended by NICE appeared to be significantly
below the national average, Essex SHA have been working in partnership with SECN to undertake
this review and develop a robust plan outlining the action to be taken in response to the findings,
the outcome of which is detailed in this report.
The review covered the following key areas:
a) review of local processes in place that ensure NICE recommendations are adopted;
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b) description of infrastructure in place to ensure safe prescription and administration of
recommended drugs,
c) Commentary on the data used to inform this report
d) A qualitative local review of the 16 NICE recommended cancer drugs and where uptake is
below national average, commentary on possible reasons and action to be taken including the
local review/audit required.
5.
LOCAL PROCESSES
5.1
SECN Chemotherapy Board
There have always been robust processes to oversee the management of new drugs in cancer
treatment in South Essex. Currently this role is undertaken by the SECN Chemotherapy Board. The
agenda/work programme for the group is driven by the two acute trusts Drug and Therapeutics
Committees within the network, avoiding duplication of effort and the potential for differences in
recommendations across the network. The Terms of Reference of this board are detailed in
Appendix 1.
The chemotherapy board meets every 3 months with good representation from all prescribers of
cancer drugs. Introduction of new agents and/or protocols form a regular part of the agenda.
The prescribing consultant is encouraged to present data on new agents or regimens for
discussion. Mr Ken Kennedy, Oncology Pharmacist is notified in advance of each meeting which
new agents or protocols are to be discussed. The proposing consultant completes the first part of
the new/drug regimen submission (paperwork used is shown in Appendix 2) stating precisely the
dose, indication and predicted patient numbers for each new drug or regimen. Each new
submission is discussed separately and the chairman makes a recommendation based on the
conclusion of the discussion to propose this new regimen to the Drugs and Therapeutics
committees at both Basildon and Southend hospitals. All formal appraisals of cancer drugs
published by NICE are tabled and agreed in this board.
5.2
Cancer Drug Prescription
The bulk of Cancer Chemotherapy administration is delivered at Southend Hospital, under the
auspices of the Oncology Directorate, with the Director of Oncology (Dr Colin Trask) having overall
clinical responsibility for the service. The Chemotherapy unit at Southend is managed day to day
by Oncology Nurse Consultant (Kathy Corcoran). Chemotherapy is also administered at Basildon
Hospital under the direction of Dr Paul Cervi, Consultant Haematologist.
All chemotherapy regimens are initiated by consultant clinical and medical oncologists and
consultant haematologists, and subsequent prescriptions for chemotherapy are verified by a
consultant (or a senior member of the team).
5.3
Commissioning Cancer Drugs in SECN
Commissioners in SECN have always been extremely receptive to the financial requirements for
the administration of chemotherapy. Since 2000/01 an additional £2 million has been allocated to
cancer drugs including NICE recommendations. There exists a Cancer Network Commissioning
Forum with membership from the two sub-economy commissioning directors.
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6.
INFRASTRUCTURE
6.1
Multi-disciplinary Team Meetings/Treatment Decisions
All new cancers are discussed in a site-specific Multi-disciplinary Team Meeting (MDTM). These
take place on a weekly basis ensuring that designated specialists work effectively together in
teams ensuring that decisions regarding all aspects of diagnosis, treatment and care are
multidisciplinary decisions. It is at the MDTM that treatment decisions to offer treatment with
cancer drugs will be made.
The oncologist or haematologist will then see the patient in clinic and discuss treatment options. If
patient agrees to cancer drug treatment then a mutually agreed date is set for patient to attend
for first course of treatment.
6.2
Chemotherapy Facilities within SECN
Southend Hospital: Delivers all solid tumour chemotherapy for the SECN and for
haematological cancers for patients from East of the network (Southend and Castle Point &
Rochford PCT).
Basildon Hospital: Delivers chemotherapy for patients with haematological cancers from west
of the network (Basildon, Thurrock and Brentwood, Billericay & Wickford PCTs)
6.2.1 Southend Hospital
The Southend Hospital unit opened in August 1995 now consists of a treatment area with nine
chairs and one bed, and a pharmacy reconstitution area. The chemotherapy service also utilizes
beds on Elizabeth Loury Ward – a 30-bedded Haemato-oncology ward that provides inpatient
oncology beds for SECN.
All chemotherapy is initiated during normal working hours, when maximum support is available
and there is less risk of error. Pre-printed charts for both in and outpatient regimens are available
for routine protocols used at Southend Hospital.
Cancer chemotherapy protocols (including trial protocols) are easily accessible to all staff, with
copies stored in the radiotherapy clinic, chemotherapy unit (adjacent to the oncology ward) and
pharmacy reconstitution unit.
Drug reconstitution is undertaken by the dedicated staff in the on-site centralised reconstitution
unit, which is located within the Chemotherapy Unit. This unit is ISO 9002 accredited, and holds
an MHRA licence. All parenteral chemotherapy is reconstituted and monitored through this unit.
All outpatient chemotherapy treatment is administered by the chemotherapy unit nursing staff.
Inpatient treatments are initiated by the unit staff and further infusion therapy is administered by
designated ward staff who have undergone specialised training and assessment.
There are local policies in place relating to safe handling, administration and reconstitution of
chemotherapy. These are reviewed regularly and amended as required.
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80-85% of chemotherapy at Southend is given on an outpatient basis. Patients are booked for
treatment to allow adequate time for safe drug administration and patient assessment, extra time
is allocated for new patients. Inpatient treatments are administered on the designated oncology
ward.
6.2.2 Basildon Hospital
The Basildon Hospital unit opened in 1997 and consists of 5 treatment chairs (4 recliner and 1
upright), and 1 treatment couch in a curtained off area. It is located on Mary Seacole ward. The
service administers chemotherapy to local haematology patients only to a BCSH level 1 service.
Patients with acute leukaemia requiring intensive chemotherapy are referred to Barts and the
London NHS Trust.
The Haematology chemotherapy area does not have allocated beds for inpatient treatments
however, where possible patients are admitted to Mary Seacole.
All chemotherapy is administered during normal working hours, when there is medical and
ancillary support available freely (i.e. doctors, pharmacy, transport and the laboratories).
Prescriptions for all chemotherapy regimens (as agreed by the SECN for use at Basildon Hospital)
are available pre printed via a computer programme in use for the past 7 years. This reduces the
risk of error when writing scripts and also to ensure that prescriptions are legible.
Drug reconstitution is undertaken by the dedicated staff in the on site chemotherapy/aseptic unit.
This is located on Level B at Basildon hospital.
Haematology Day Unit nursing staff administer outpatient chemotherapy. If a patient requires
chemotherapy treatment, as an inpatient then the Day Unit nursing staff will either administer
treatment on the unit or if the patient cannot come to the unit then the nursing staff will
administer treatment on the ward (from start to finish of treatment). The ward staff are given
written information regarding what side effects to look out for and the care that they can give the
patient once chemotherapy has finished.
Patients are booked for their treatment on the unit via a diary system to ensure the best use of
space and to ensure that there is adequate time for safe drug administration and patient
assessment.
There are local policies in place relating to safe handling, administration, and reconstitution of
chemotherapy. These are reviewed regularly and amended as required.
6.3
Chemotherapy Staffing
6.3.1 Southend Hospital
Currently 7.5 wte nurses deliver the service (6.5 funded). The skill mix consists of


1.0 wte Clinical Nurse Specialist
3.5 wte ‘F’ grade nurses
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3.0 wte ‘E’ grade nurses

All of these staff have undertaken recognised cancer nursing courses, and prior to working in the
unit were experienced cancer nurses. On joining the unit, all underwent extensive in-house
training, and continue to be supported by the trust to complete higher and advanced level
education programmes.
The service is also supported by 2.0 wte reception staff and 0.6 wte secretarial support.
The



reconstitution unit is staffed by:
2.5 WTE pharmacy technicians
1.5 WTE pharmacy assistant
Approximately1 WTE pharmacist (who provide clinical support and drug information)
6.3.2 Basildon Hospital
Currently the staffing levels to administer chemotherapy to Haematology patients consists of:




1.0
1.0
1.4
1.0
wte
wte
wte
wte
Haematology Clinical Nurse Specialist (H grade)
Haematology Nurse Practitioner (G grade)
Senior Haematology Nurse (F grade)
Haematology nurse (E grade)
All nursing staff attend ‘The care of the patient having chemotherapy’ (N59) course. The nurses
have either experience of Haematology nursing prior to joining the unit or have developed skills
and knowledge through courses and work related experience whilst on the unit. The day unit has
an in-house training programme and nursing staffs are supported by the trust for further
education programmes/conferences.
Medical Staff consist of 2 wte Consultant haematologists and a staff grade (1 wte), which offer
support for this service.
The unit is also supported by 1.0 wte A&C 3 clerical staff. This ensures that medical notes are up
to date with filing and are available when patients receive treatment. It also ensures that patients
and other members of staff are greeted in a timely fashion should the nursing staff be engaged
with other patients.
The pharmacy support offered to the unit consists of 1.0wte dedicated Haematology/Oncology
pharmacist.
6.3.3 Cancer Network
Unfortunately, unlike many networks, SECN does not have funding for a lead cancer pharmacist.
This post would play a fundamental role in partnership with network management team, chairs of
the site specific tumour boards, GP cancer leads and Chief pharmacists and pharmacy staff
(primary and secondary care) to help ensure the delivery of a high quality oncology pharmacy
service across the whole network.
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The role would also facilitate network wide audit of NICE oncology medicines to measure
compliance with NICE guidelines plus any other relevant drugs of interest to the Network
Chemotherapy Board.
6.3.4 Chemotherapy Information Systems
Within SECN a key difficulty is that there are no dedicated information systems to monitor
chemotherapy administration. Information is the key lever to change clinical practice. A robust
mechanism should therefore be put in place to facilitate prospective audit and timely feedback to
network and individual clinicians on their usage of these drugs in comparison to a national
benchmark of usage. This should include assessments of the numbers of patients treated and the
indications for treatment, so that the appropriateness of treatment can be assessed against NICE
guidance on a continuous day to day basis.
To make this possible it is essential for electronic prescribing systems to be installed in every
hospital providing a chemotherapy service. The National report recommends the national
timetable for this ‘should be brought forward within the National Programme for IT from
its current delivery date of 2008-10’.
7.
REVIEW OF NICE RECOMMENDED DRUG USAGE
7.1
Data Used
IMS Health provided the main data for the National Report. IMS Health collects information on
drugs used in hospitals (direct from NHS Trusts). At present the data they collect covers hospitals
containing over 93% of acute beds in the UK. This includes all the major adult cancer centres in
England. The data provided related to the six months from 1 July to 31 December 2003.
The information provided by IMS had some recognised limitations (see Appendix 3) and cancer
networks were given the opportunity to validate the information and provide alternative figures if
necessary. Where networks provided alternative figures these were used in preference to IMS data
as they reflected local knowledge about sources of variation. The final dataset used for this
exercise was therefore a mixture of IMS and network data. SECN was one of the networks that
provided local alternative validated data. This did not include any patients treated with NICE drugs
on clinical trials or those treated in the private sector.
SECN provided local alternative precise data for this report in the tracking exercise in March 2004.
The SECN data was markedly less than the IMS data of perceived usage of NICE drugs. SECN only
reported on precise amount of drug prescribed, only reported use of the drug in the NICE
recommended setting and did NOT include wastage accumulated from partly used drug vials.
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7.2
Drugs Subject to Review & Submitted Data
The national review considered 16 cancer drugs appraised by NICE plus four standard cancer
drugs as comparators* and these are listed below in Table 1. The table also details the data used
for national report. The national report data was based on a SECN population of 709,494. Within
SECN, however, there may be some cross boundary patient flows from Brentwood area to
neighbouring network (North East London).
Column A is the national median amount of drug per 1000 population as used in the national
report. Column B is the original data provided by IMS Health to the network for validation using
proposed network population of 709,494. Column C is the revised local validated data submitted
by SECN and used in the national report.
Table 2: Data Used to inform National Report
A
National IMS
Median
NETWORK
POP'N:
DRUG
CAPECITABINE
CARBOPLATIN*
CISPLATIN*
DOCETAXEL
DOXORUBICIN*
EPIRUBICIN*
FLUDARABINE
GEMCITABINE
IMATINIB
IRINOTECAN
OXALIPLATIN
PACLITAXEL
PEG LIP DOX
RALTITREXED
RITUXIMAB
TEMOZOLOMIDE
TOPOTECAN
TRASTUZUMAB
URACIL/TEGAFUR
VINORELBINE
B
ORIGINAL IMS
DATA PROVIDED
FEB 04
C
ORIGINAL SECN
DATA PROVIDED
FEB 04
709,494
709,494
AMOUNT (mg PER AMOUNT (mg PER AMOUNT (mg PER
1000 POP'N.)
1000 POP'N.)
1000 POP'N.)
13,977.0
301.6
46.2
13.1
39.3
72.9
19.9
828.1
1,829.9
46.3
19.0
43.1
1.9
0.0
103.5
29.9
0.1
37.8
0.0
6.4
10,864.3
298.1
36.1
13.1
29.7
92.0
7.2
1,315.9
1,084.7
33.9
10.4
26.4
1.0
0.0
117.9
9.5
0.0
11.6
0.0
0.4
9,488.6
279.1
32.3
8.1
28.2
79.8
9.2
1,195.9
982.1
22.7
8.2
20.5
1.3
0.0
96.4
12.3
0.0
8.9
0.0
0.6
*These drugs have not been appraised by NICE and have been included in this work as comparators
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The 12 drugs identified in BOLD are those that are ranked 20% or more below the national
median from the 15 cancer drugs positively appraised by NICE in the national report. SECN needs
to demonstrate that:
 We are aware of these drugs where the uptake is below the national average and are taking
steps to investigate the reasons for this.
 We are taking remedial action to an agreed timescale to ensure that actual usage of NICE
approved drugs increases as appropriate.
7.4
Qualitative Review of Drugs
Appendix 4 presents a detailed qualitative analysis of the NICE drugs in question, outlining the
recommended NICE indication for each drug, followed by local clinician commentary, clarifying
reasons for low usage if indicated, and finally, identifying any further remedial action required.
Appendix 5 provides detail of a comprehensive programme of audit which has been drawn up in
partnership with Essex SHA for all 12 drugs including audit methodology, audit process and
timescale for completion
8.
Summary of Key Findings/ Recommended Actions

In the short term a detailed programme of audit has been agreed with Essex SHA and in the
long term information systems and mechanisms need to be put in place to support audit and
track NICE drug compliance on a continuous day to day basis.

There are no financial restrictions on the prescription of Cancer Drugs in SECN

There are comprehensive reliable processes in place to ensure network agreement on the
prescription and administration of NICE recommended cancer drugs, overseen by a fully
constituted Network Chemotherapy Board.

There are well developed facilities, medical, nursing and pharmacy manpower to support the
safe administration of chemotherapy drugs.

Local information systems are not suitably developed to enable accurate monitoring and
reporting cancer drug usage and NICE drug compliance. Currently such monitoring is all done
manually, which requires significant time by busy clinical staff.

The network does not have funding for a lead cancer pharmacist, this post would play a
fundamental role in providing ongoing measurement of compliance with NICE guidelines plus
any other relevant drugs of interest to the Network Chemotherapy Board.
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Appendix 1
SOUTH ESSEX CANCER NETWORK CHEMOTHERAPY BOARD
TERMS OF REFERENCE
The Chemotherapy Board will work across the South Essex Cancer Network to ensure best
practice in the administration of chemotherapy to patients in accordance with the NHS Cancer
Plan, the Manual of Cancer Services Standards, National Institute for Clinical Excellence (NICE)
Guidance including their “Improving Outcomes Guidance” series. The group will achieve this
through the following mechanisms:
1. To develop, agree and implement evidence based guidelines/protocols across the network, to
include:
 Specified chemotherapy regimens
 Delivery of chemotherapy
 The prevention and management of side effects
 The reconstitution of cytotoxic drugs
 Training and education policies.
 To develop guidelines and protocols for primary care practitioners related to complications
of chemotherapy.
2. To review and update the above guidelines.
3. To develop and agree recommendations for the most appropriate workforce for chemotherapy
administration including implications for training.
4. To develop and agree appropriate network wide clinical audit mechanisms.
5 To act as a forum for discussion of new chemotherapy regimens, including trials, and make
recommendations/advise the South Essex Cancer Network Leads Group accordingly.
6 Develop robust mechanisms to enable monitoring of oncology drug activity and ensure
equitable patient access to NICE recommended cancer chemotherapy across the network.
7 To oversee the production of timely information on Oncology Drug activity including
performance monitoring and financial information to inform PCT Commissioning leads in order
to influence and facilitate high quality effective decision-making
8 Members of this committee agree to adhere to the guidelines and protocols adopted by this
Group, in practice both in the NHS and non-NHS settings.
Structure
1. The group will elect a chair person who will serve for a minimum of two and a maximum of
three years.
2. The group will meet at least four monthly.
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3. The South Essex Cancer Network Leads Group will formally agree guidelines and
recommendations made by the group.
4. The minutes of the meetings will be sent to the South Essex Cancer Network Leads Group.
Core membership
 Medical Oncologist (s)
 Clinical Oncologist (s)
 Haematologist(s)
 Lead Chemotherapy Nurses from each cancer unit/Centre (i.e. Southend and Basildon)
 Oncology pharmacist(s)
 South Essex Cancer Network lead manager
 South Essex Cancer Network lead consultant in public health medicine
 South Essex Cancer Network lead clinician
 CSC SI representative
 Oncology Nurse consultant
The group will involve others as appropriate.
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Appendix 2
DRUG DEVELOPMENT SUBMISSION
For consideration by the Drugs & Therapeutics Committee
For completion by Requesting Clinician
Approved name of drug
Brand name
Form and strength
Consultant(s) requesting
Clinical directorate
Treatment indication
Yes / No
Is this indication
licensed?
Current treatment for
indication
Expected clinical
benefits compared to
current treatment
Is this drug for use in a
clinical trial?
Yes / No
How drug is to be used
For
assessment
only?
Number of patients to be
treated
Assessment
period?
Anticipated effect of drug
on hospital costs/patient
(enter actual costs if
known)
Increase
If Yes, has Ethics Committee approval
been obtained?
Yes / No
………….months
£
Yes / No
Generally
available?
Yes / No
No. patients in
assessment
period?
……………patients
Decrease
£
Other supporting information – please attach
Please declare any conflict of interest, inc.
relevant sponsored meetings.
Signed
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Date
For completion by Pharmacy
Summary
Review
Estimated costs
Drug
cost/patient
Hospital
£
Drug cost for expected no.
patients
Pilot period
Community
£
Difference in cost
compared with
current full treatment
cost
+/- £
Hospital
Community
Difference in cost
compared with
current drugs cost
in hospital
£
£
+/- £
Comments
Signed
Date
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IMS Heath Data - Caveats
1.
2.
Appendix 3
The information provided by IMS Health (on which the national report is largely based) has
some limitations:
a.
Around 5% of NHS Trusts in England do not supply information to IMS Health.
Fortunately none of these are major adult cancer centres but some of the missing
Trusts may provide a chemotherapy service – networks were asked to address this
in their response.
b.
It was not possible in the data provided to differentiate between drugs prescribed
for NHS patients and those prescribed to private patients within NHS Trusts.
Networks were therefore asked to provide an estimate of the proportion of overall
usage which related to the treatment of private patients. However few did this.
c.
No information is available on the numbers of patients treated or on the type of
cancer for which the drugs are being used – it is not therefore possible to tell if a
NICE appraised cancer drug has a high usage for one indication but a low usage for
another.
d.
The information does not take into account patient flows across network boundaries
i.e. that patients residing in x network may receive y drug at a Trust in z network.
Therefore x network may appear a low user of y drug even though its patients do
have access to it.
e.
Some drugs supplied by companies providing a reconstitution service for
chemotherapy drugs may be excluded from the IMS figures – networks were asked
to address this in their response.
f.
Drugs prescribed in the community are not included in the IMS figures (though
these are available from Prescription Pricing Authority database). However,
community prescribing has only a minimal impact on the NICE approved cancer
drugs.
g.
Where networks are, or have been, involved in clinical trials of drugs these drugs
may be supplied direct to the chemotherapy units and not through the hospital
pharmacy. IMS data may therefore be lower than usage in the network.
As these limitations may impact on figures for usage in some/all networks e.g. artificially
deflating their figures, networks were given the opportunity to address these when validating
the data. There will be some variation between networks in the effect of these issues. For
this reason it is inappropriate to regard small differences between networks as significant.
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Appendix 4
NICE recommended Indication and Local Commentary.
DRUG
CAPECITABINE
DOCETAXEL
Drug ranked
20% or
more below
the national
median in
report Yes/No
Yes
Yes
NICE INDICATION
LOCAL COMMENTARY
(including reasons for apparent
low usage)
Further
Remedial
Action and/or
Review Audit
Required
Advanced Colorectal Cancer;
Recommended as option for the first line
treatment of metastatic colorectal cancer as
alternative to 5FU and folinic acid.
Current local practice is to first enter such
patients into a relevant clinical trial. From July
2003 – Dec 2003 all patients were offered
entry into the FOCUS study which looked at
the use and sequencing of Irinotecan and
Oxaliplatin. Off study patients are given a
choice of 5 Flourouracil and Folinic acid as an
infusional regimen known as modified de
Gramont or oral capecitabine for the first line
treatment in metastatic colorectal cancer.
Advanced Colorectal
prospective audit
Advanced breast cancer:
In the treatment of locally advanced or
metastatic breast cancer, recommended in
combination with Docetaxol where
anthracycline containing regimen unsuitable
or have failed.
Monotherapy is recommended as an option
where drug previously not received in
combination, or where anthracycline and
taxane containing regimens have failed or
contraindicated.
Advanced Breast Cancer
Recommended as an option for the
treatment of advanced breast cancer where
initial cytotoxic therapy (including an
anthracycline) has failed or is inappropriate.
Use of Docetaxel in combination with an
anthracycline in first line treatment of
advanced breast cancer is currently not
Used as directed
Used as directed
Advanced Breast
cancer Prospective
Audit
Advanced Breast
cancer Prospective
Audit
recommended.
DOXORUBICIN
Yes
FLUDARABINE
Yes
IMATINIB
Yes
Lung Cancer
Docetaxel monotherapy should be
considered where second line
treatment is appropriate for patients
with locally advanced or metastatic NSCLC
when relapse has occurred after prior
chemotherapy.
Non NICE drug
B-cell chronic lymphocytic leukaemia
Oral preparation recommended as secondline therapy for B-cell CLL, for patients who
have failed or are intolerant of first line
chemotherapy, and who otherwise would
have received combination chemotherapy of
either CHOP, CAP or CVP (COP)
Chronic Myeloid Leukaemia
September 2002; Imatinib recommended
as a treatment option for the management
of Philadelphia-chromosome positive CML in
chronic phase adults who are intolerant
of interferon-alpha, or where
interferon has failed to control the
disease.
Recommended as an option for the
treatment of adults with PH+ve CML in
accelerated phase or blast crisis provided
they have not received Imatinib treatment
at an earlier stage.
October 2003: Imatinib is recommended
as first-line treatment for people with
PH+ve CML in the chronic phase.
IRINOTECAN
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Yes
Advanced colorectal cancer
NICE guidance March 2002, ‘’ on balance of
clinical and cost effectiveness, neither
Irinotecan nor Oxaliplatin in combination
Lung Cancer Audit
Used as comparators in this exercise
Doxorubicin usage, especially in breast cancer
decreasing in favour of Epirubicin.
Participation in Clinical Trials CLL 4 and 5)
influences total patient numbers.
All patients with Philadelphia positive CML in
South Essex are prescribed Imatinib.
However, GIST patients have been excluded
from this local data – as not NICE directed.
Audit – total patient
numbers and
number in studies –
Timescale for
completion
Confirm that ALL
patients are given
Imatinib
Low incidence of CML
Only first line treatment since Oct 2003 which
will affect numbers in this report (Jul-Dec
2003)
Usage for the reviewed time period in relation
to published data was currently confined to
clinical trials as per CR08.
17
with 5-Fluorouracil and folinic acid are
recommended for routine first line therapy
for advance colorectal cancer.’’
OXALIPLATIN
Yes
Irinotecan monotherapy is recommended in
patients who have failed an established 5FU
containing treatment regimen.
Advanced colorectal cancer
NICE guidance 2002, ‘’ on balance of clinical
and cost effectiveness, neither Irinotecan
nor Oxaliplatin in combination with 5Fluorouracil and folinic acid are
recommended for routine first line therapy
for advance colorectal cancer.’’
Oxaliplatin should be considered for use as
first line therapy in combination with 5 FU
and folinic acid, to ‘down stage’ metastases
confined solely to the liver which may
become respectable.
PACLITAXEL
Yes
Advanced Breast Cancer
Recommended as an option for the
treatment of advanced breast cancer where
initial cytotoxic therapy (including an
anthracycline) has failed or is inappropriate.
Lung Cancer
Gemcitabine, Paclitaxel and
vinorelbine should be considered as
part of first line chemotherapy options for
advanced NSCLC. Combination of these
three agents individually with platinum
based chemotherapy, where tolerated, is
likely to be the most effective approach.
Initially single agent Irinotecan was offered to
suitable patients in the second line setting.
From February 2004 following discussion at the
chemotherapy tumour board we changed to
the combination of Irinotecan & 5FU/FA. as it
is better tolerated by patients.
Given routinely to patients with liver only
metastatic disease in the neo-adjuvant setting.
The aim is to down size their disease so a liver
resection may be possible. as per NICE
indication
Treated 4 patients for this indication of study
on the 6 month period Jul-Dec 03
More Docetaxel used than Palitaxel within this
setting.
Prospective Audit to
be set up?
Gemcitabine, is currently the preferred first line
treatment in combination with Carboplatin for
NSCLC
Advanced Ovarian Cancer
Updated guidance 22nd January 2003,
recommends that women with ovarian
cancer should be offered the choice of either
Paclitaxel in combination with a platinum-
FINAL: 24th Nov 2004
18
based compound or a platinum based
compound alone. This is a change from
previous guidance which recommended that
paclitaxel in combination with platinum
therapy was the standard therapy following
surgery.
Paclitaxel should be considered as second
line treatment for women who have not
received it previously as part of their second
line treatment.
PEG LIP DOX
Yes
TEMOZOLOMIDE
Yes
TOPOTECAN
Yes
TRASTUZUMAB
Yes
FINAL: 24th Nov 2004
Advanced Ovarian Cancer
Should be considered as one option for
the second-line
(or subsequent) treatment, where disease
is initially resistant or refractory to first line
platinum based chemotherapy.
Malignant Glioma
Recommended for recurrent disease who
have failed first-line chemotherapy.
Not recommended for first line
chemotherapy outside the context of a
clinical trial
Not licensed for adjuvant treatment of
malignant glioma.
Advanced Ovarian Cancer
Should be considered as one option for
the second-line
(or subsequent) treatment, where disease
is initially resistant or refractory to first line
platinum based chemotherapy.
Advanced Breast Cancer
Monotherapy recommended as an option
for people with tumours expressing HER2
3+, who have received at least two
chemotherapy regimens for metastatic
breast cancer. Prior treatment must have
included at least one anthracycline and a
taxane, where these treatments are
Current practice is that potential risks and
benefits of treatment options are discussed
with patient. Patients who receive single
agent treatment, sign consent forms to
indicate that they are aware of the treatment
options and that Paclitaxel is available to them.
One of several treatment options available
Note: high usage in neuro-oncology tertiary
centres.
Rare tumours – small numbers
One of several treatment options available. 5
day regimen, high toxicity / myelosuppression.
NICE guidance recommends usage with
ongoing audit, with careful documentation of
indications, clinical outcomes and adverse
events.
NICE Guidance strictly adhered to locally.
However, figures identify low compared to
national figures.
Audit required –
Clarify if audit
information
available from
tertiary centre
Further local
investigation / audit
required
19
appropriate. It should also have included
hormonal therapy in suitable oestrogen
receptive positive patients.
VINORELBINE*
Yes
Combination treatment with Paclitaxel is
recommended as an option for HER2 3+
patients, who have not received
chemotherapy for metastatic breast cancer
and in whom anthracycline chemotherapy is
inappropriate.
Advanced Breast Cancer
Monotherapy not recommended as a
first line treatment for advanced breast
cancer
Recommended as one option for secondline or later therapy when anthracycline
based regimens have failed or are
unsuitable.
Lung Cancer
Gemcitabine, Paclitaxel and
vinorelbine should be considered as
part of first line chemotherapy options for
advanced NSCLC. Combination of these
three agents individually with platinum
based chemotherapy, where tolerated, is
likely to be the most effective approach.
CARBOPLATIN
No
Non NICE drug
CISPLATIN
No
Non NICE drug
FINAL: 24th Nov 2004
One of several treatment options available.
Vinorelbine with either cisplatin or carboplatin
is used as part of the LU22 protocol for the
neoadjuvant management of operable lung
cancer in SECN. In stage 3A disease
vinorelbine plus carboplatin is used as part of a
chemo-radiation schedule. It is offered as a
single agent to all advanced lung cancer
patients who cannot tolerate a combination
with platinum regimen.
Used as comparators in this exercise. Wide
indications for use.
Multiple vial sizes used in manufacture –
therefore minimal wastage of drug
Currently used widely in SECN for lung and
ovarian
Used as comparators in this exercise. Wide
indications for use.
Previous usage in the treatment of lung cancer
now replaced by carboplatin.
Ongoing clinical trial in upper GIT patient has
reduced usage of Cisplatin in favour of trial
material.
20
EPIRUBICIN
No
Non NICE drug
GEMCITABINE
No
Pancreatic Cancer;
Advanced /metastatic adenocarcinoma of
Pancreas, first line therapy option in patients
with Karnofsky performance score > 50.
Little evidence for use as second line
therapy.
RALTITREXED
No
RITUXIMAB
No
Lung Cancer
Gemcitabine, Paclitaxel and
vinorelbine should be considered as
part of first line chemotherapy options for
advanced NSCLC. Combination of these
three agents individually with platinum
based chemotherapy, where tolerated, is
likely to be the most effective approach.
Advanced Colorectal Cancer
Raltitrexed is not recommended for the
treatment of advanced colorectal cancer.
Its use should be confined to appropriately
designed clinical trials.
Aggressive Non-Hodgkin’s Lymphoma
Recommended for use in combination with
CHOP chemotherapy for first line treatment
of people with CD20-positive diffuse largeB-cell lymphoma at stage 2, 3 or 4.
Used as comparators in this exercise
Details as above. Widely used in Breast and
upper GI malignancies.
Offered to all patients with pancreatic cancer.
Over 50% of all presenting patients enter the
ongoing NCRN supported GEM-CAP study
None
Gemcitabine is currently our preferred first line
treatment for all patients with stage 1V
disease. Navelbine in combination with
platinum is given to those with locally
advanced disease. We do not routinely use
Paclitaxel in combination with carboplatin for
the first line treatment of advanced disease.
This drug is not used within SECN as
recommended.
Raltitrexed use not recommended by NICE,
however some network usage high – this will
therefore lower the ‘average’ for those
adhering to the guidelines.
None
Current use as specified
Use for localised disease as part of ongoing
or new clinical studies.
Stage 3 / 4 Follicular NHL
Use for third-line or subsequent line, but not
‘last-line’ treatment of patients with
recurrent or refractory Stage 3 /4 Follicular
lymphoma is not recommended.
Last line treatment on the basis of a
‘prospective case series’.
FINAL: 24th Nov 2004
21
URACIL/
TEGAFUR
FINAL: 24th Nov 2004
No
Advanced Colorectal Cancer;
Recommended as option for the first line
treatment of metastatic colorectal cancer as
alternative to 5FU and folinic acid.
Of the two oral treatment options
recommended by NICE for colorectal cancer,
Capecitabine is the drug of choice for SECN.
22
APPENDIX 5
Report on usage of NICE Cancer Drugs
Audit Programme
AUDIT PROGRAMME OCT 2004 – APRIL 2005
All audits will be supported by the network acute trust Research and Audit Departments
Clinical Drug /Tumour NICE Indication
Outline Methodology
Lead
type
1.
2.
Dr Ayed
Eden
Dr Colin
Trask
The
use
of
Imitanib
(glivec)
in
Chronic Myeloid
Leukaemia
(CML)
The
use
of
Trastuzumab
(Herceptin) in
Advanced
Breast cancer
FINAL: 24th Nov 2004
Chronic Myeloid Leukaemia
September 2002; Imatinib
recommended as a treatment
option for the management of
Philadelphia-chromosome positive
CML in chronic phase adults
who are intolerant of
interferon-alpha, or where
interferon has failed to
control the disease.
Recommended as an option for
the treatment of adults with
PH+ve CML in accelerated phase
or blast crisis provided they have
not received Imatinib treatment
at an earlier stage.
October 2003:
Imatinib is
recommended
as
first-line
treatment for people with PH+ve
CML in the chronic phase.
Monotherapy recommended as
an option for people with tumours
expressing HER2 3+, who have
received at least two
chemotherapy regimens for
metastatic breast cancer. Prior
treatment must have included at
least one anthracycline and a
taxane, where these treatments
are appropriate. It should also
have included hormonal therapy
Identify all CML patients diagnosed
between July and Dec 2003 via
Haematology Dept records and
review notes
Audit Criteria
Timescale
for
completion
To determine that all the patients
received glivec as per NICE
indication as 2nd line therapy up to
Oct 2003, and;
December 2004
To confirm that presenting patients
from Oct 2003 onwards were
offered glivec as 1st level treatment
Identify all new Southend Breast
cancer patients over 6 month
period that have been tested for
HER2 3+ and review notes
Were all the metastatic HER2+
receptive patients offered Herceptin
as clinically indicated?
i.e. having already received at least
Audit
already
completed
Report
November 2004
two chemotherapy regimens for
metastatic breast cancer.
23
in suitable oestrogen receptive
positive patients.
Combination treatment with
Paclitaxel is recommended as an
option for HER2 3+ patients, who
have not received chemotherapy
for metastatic breast cancer and
in
whom
anthracycline
chemotherapy is inappropriate.
3.
Dr
Pauline
Leonard
4.
Dr Colin
Trask
The
use
of
Capecitabine,
Irinotecan,
Oxaliplatin
in
Advanced
Colorectal
Cancer
The
use
of
Capecitabine,
Docetaxel,
Paclitaxel,
Vinorelbine in
Advanced
Breast Cancer
Capecitabine: as option for the
first line treatment of metastatic
colorectal cancer as alternative
to 5FU and folinic acid.
Irinotecan: in patients who have
failed
an
established
5FU
containing treatment regimen.
Oxaliplatin: first line therapy in
combination with 5 FU and folinic
acid, to ‘down stage’ metastases
confined solely to the liver which
may become respectable
Capecitabine: recommended in
combination with Docetaxol
where anthracycline containing
regimen unsuitable or has failed;
also Monotherapy is
recommended as an option
where drug previously not
received in combination, or where
anthracycline and taxane
containing regimens have failed
or contraindicated.
Docetaxel: as an option for the
treatment of advanced breast
cancer where initial cytotoxic
therapy (including an
anthracycline) has failed or is
inappropriate.
FINAL: 24th Nov 2004
Identify 50 deceased colorectal
cancer patients who died in 2004
(25 from East and 25 from west)
from local databases, review notes
and identify those patients that had
chemotherapy.
If received chemotherapy which
regimen? capecitabine; irinotecan;
oxaliplatin,
or;
De
Gramont
regimen.
If patient not given chemotherapy
identify reasons.
Identify deceased breast cancer
patients who died between Jan –
July 2004 (from both East and
west) from local databases, review
notes and identify those patients
that had chemotherapy.
If received chemotherapy for
metastatic disease identify their 1st,
2nd and 3rd line (and 4th line if
applicable) treatment regimen?
1. Were the indications for giving
patients either De Gramont or
Capecitabine indicated in the notes?
End of February
2005
2. Was 2nd line treatment offered
(irinotecan)
in
patients
who
progressed
following
1st
line
treatment?
3. Were patients suitable for liver
resection offered Oxaliplatin in
combination with 5FU and folinic
acid?
Were patients with advanced breast
cancer that progressed following
anthracyclines (or were contraindicated) given Capecitabine /
Docetaxel / Paclitaxel / Vinorelbine
as single agents or in combination
as per the specific NICE indication
for each drug?
End of January
2005
If no chemotherapy given identify
reasons.
24
Paclitaxel: as an option for the
treatment of advanced breast
cancer where initial cytotoxic
therapy
(including
an
anthracycline) has failed or is
inappropriate.
5.
6.
Dr
Pauline
Leonard
Dr Alan
Lamont
The use of
Gemcitabine,
Paclitaxel,
or
Vinorelbine,
Docetaxel
in Lung Cancer
The
use
of
Paclitaxel,
Pegylated
Liposomal
Doxorubicin,
and Topotecan
in
Advanced
Ovarian Cancer
FINAL: 24th Nov 2004
Vinorelbine: Monotherapy not
recommended as a first line
treatment for advanced breast
cancer. Recommended as one
option for second-line or later
therapy when anthracycline based
regimens have failed or are
unsuitable.
Gemcitabine, Paclitaxel and
vinorelbine
should
be
considered as part of first line
chemotherapy
options
for
advanced NSCLC. Combination
of
these
three
agents
individually with platinum based
chemotherapy, where tolerated, is
likely to be the most effective
approach.
Docetaxel: monotherapy should
be considered where second
line treatment is appropriate
for patients with locally advanced
or metastatic NSCLC when
relapse has occurred after prior
chemotherapy.
Paclitaxel: women with ovarian
cancer should be offered the
choice of either Paclitaxel in
combination with a platinumbased compound or a platinum
based compound alone.
Paclitaxel should be considered as
Identify deceased lung cancer
patients who have died between
Jan – July 2004 (from both East
and west) from local databases,
review notes and identify those
NSCLC
patients
that
had
chemotherapy.
If received chemotherapy which
regimen? Docetaxel, Gemcitabine,
paclitaxel, or Vinorelbine.
What was the 1st line chemotherapy
regimen for NSCLC?
End
of
December 2004
Were all patients who subsequently
progressed
following
1st
line
nd
treatment
offered
2
line
Docetaxel, if not identify reasons
i.e. patient preference, patient
performance
status,
contraindications to 2nd line drug?
If no chemotherapy given identify
reasons, i.e. too frail, received
radiotherapy, palliative care only, or
patient preference
Identify newly diagnosed ovarian
cancer patients in July to Dec 2003
and review notes
Lead oncologist has comprehensive
records on 2nd line treatments that
will be used to provide evidence
regarding local 2nd line treatment
Were patients presenting with
advanced ovarian cancer offered
the choice of single or combination
therapy (with Paclitaxel) for 1st line
treatment?
End
of
December 2004
What treatment combinations were
offered for 2nd line treatment? Was
25
second line treatment for women
who have not received it
previously as part of their second
line treatment.
practice
this chemotherapy as per NICE
indication?
Peg Lip Dox: Should be
considered as one option for the
second-line (or subsequent)
treatment, where disease is
initially resistant or refractory to
first line platinum based
chemotherapy.
Topotecan:
Should
be
considered as one option for the
second-line
(or
subsequent)
treatment, where disease is
initially resistant or refractory to
first
line
platinum
based
chemotherapy.
7.
Dr Ayed
Eden
Fludarabine in
B-cell Chronic
Lymphocytic
leukaemia
Oral preparation recommended as
second-line therapy for B-cell CLL,
for patients who have failed or
are intolerant of first line
chemotherapy, and who
otherwise would have received
combination chemotherapy of
either CHOP, CAP or CVP (COP)
Identify all patients diagnosed with
B-cell CLL (few in number) between
July to December 2003 and review
case notes
Were patients who had failed or
were intolerant to first line
chemotherapy, offered fludarabine
as second-line therapy as per the
specific NICE indication for each
drug?
End of February
2004
8.
Dr Alan
Lamont
Temozolomide
in
malignant
Glioma
Recommended for recurrent
disease who have failed first-line
chemotherapy.
Not recommended for first line
chemotherapy outside the context
of a clinical trial
Not
licensed
for
adjuvant
treatment of malignant glioma.
Identify from prescription records
patients given CCNU (1st line
Glioma treatment) in first 6 months
of 2003 and review names against
death. If patient lived longer than 2
months review notes
Did patients receive the drug for
recurrent disease having failed firstline chemotherapy?
End
of
December 2004
FINAL: 24th Nov 2004
26