Download Harpreet S Kohli - Scottish Medicines Consortium

Embargoed until 22 April 2002 - Draft
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22 April 2002
2002/nd6
Dr Harpreet S Kohli
0141 225 6988
[email protected]
Dear Colleague
NICE Technology Appraisal Guidance - No. 33
The Health Technology Board for Scotland (HTBS) is delivering this National Institute for Clinical
Excellence (NICE) Guidance to health professionals in NHSScotland with the following authoritative
Comment on its use in Scotland. This HTBS Comment should be read in conjunction with the NICE
Guidance.
HTBS advises that the NICE Technology Appraisal Guidance - No. 33: Guidance on the use of
irinotecan, oxaliplatin and raltitrexed for the treatment of advanced colorectal cancer is as valid for
Scotland as for England and Wales.
It is enclosed for use in NHSScotland.
The NICE recommendations are shown below.
1.1 On the balance of clinical and cost-effectiveness, neither irinotecan nor oxaliplatin in combination with
5-fluorouracil and folinic acid (5FU/FA) are recommended for routine first-line therapy for advanced
colorectal cancer.
1.2 Oxaliplatin should be considered for use as first-line therapy, in combination with 5FU/FA, in advanced
colorectal cancer in patients with metastases that are confined solely to the liver and may become
resectable (‘down staged’) following treatment.
1.3 Irinotecan monotherapy is recommended in patients who have failed an established 5-fluorouracil
containing treatment regimen.
1.4 On the balance of evidence relating to its clinical and cost effectiveness, raltitrexed is not recommended
for the treatment of advanced colorectal cancer. Its use for this patient group should be confined to
appropriately designed clinical studies.
1.5 It is likely that patients currently receiving irinotecan or oxaliplatin in combination with 5FU/FA or
raltitrexed could suffer loss of well being if their treatment is discontinued at a time they did not
anticipate. Because of this, patients and their consultants may wish to continue therapy until they
consider it is appropriate to stop.
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HTBS anticipates that implementing this NICE Guidance in Scotland will have the following implications
for NHSScotland:
Service Issues

The Clinical Standards Board for Scotland (CSBS) Clinical Standards for Colorectal Cancer
published in January 2001 (www.clinicalstandards.org) defines the standards to which colorectal
cancer care should be delivered in Scotland. The Scottish Intercollegiate Guidelines Network
(SIGN) is currently reviewing its guidelines on colorectal cancer and will publish these in 2002
(www.sign.ac.uk).

Clinicians with responsibility for treating people with advanced colorectal cancer should review their
current practice in line with this guidance. In particular, on the basis of the current evidence patients
should not be started on irinotecan or oxaliplatin in combination with 5FU/FA for routine first-line
therapy or raltitrexed for advanced colorectal cancer.

To enable clinicians to audit their own compliance with this guidance it is recommended that local
protocols are adapted or, if none exist, developed and implemented locally. This information should
be collected as part of the CSBS standards for colorectal cancer audit.

Any individual who is currently receiving irinotecan or oxaliplatin in combination with 5FU/FA or
raltitrexed for advanced colorectal cancer may wish to continue treatment until the individual and
his/her consultant consider it appropriate to stop.
Impact

In 1998 approximately 3,300 new colorectal cancers were reported in Scotland. The incidence of
colorectal cancer is higher in Scotland than England and Wales. The incidence and mortality is
higher in males than females. It is a disease of old-age with the highest incidence rates being in the
oldest age-groups with the peak age-group for incident cases being 70-74.

Colorectal cancer is second only to lung cancer as a cause of cancer death in Scotland in the
combined male and female population. For the period 1995-9, 1,800 people died from it each year.
It is likely that the incidence of colorectal cancer will remain constant over the next 10 years and that
there will be a marginal decrease in mortality in males and a larger decrease in mortality in females.

Given the higher levels of deprivation and the generally higher level of co-morbidity among
colorectal cancer patients in Scotland, patients may be less likely to be fit for second-line therapy if
first-line therapy fails.

The additional cost of providing first line oxaliplatin with 5FU/FA instead of 5FU/FA alone to
patients with metastases confined solely to the liver is estimated to be £2.36m per annum. This is
based upon 3,300 new cases of colorectal cancer each year, of whom 363 (11%) have metastases in
the liver alone that are suitable for “down staging” and receive first line oxaliplatin at a cost of
£6,000 per patient. Among these patients an additional 15 (4% of 319) will become suitable for
surgery which costs £12,000 per patient.
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
The additional cost of providing second line irinotecan monotherapy instead of outpatient based
5FU/FA is estimated to be £3.26m per annum. This is based upon 3,300 new cases of colorectal
cancer each year, of whom 1,815 (55%) are likely to present with advanced colorectal cancer and a
further 743 (22.5%) will subsequently develop advanced disease (Section 2.3 of NICE Guidance).
Of those with advanced colorectal cancer 1,919 (75%) are likely to receive second line treatment
during the first year at a cost of £1,700 per patient. Some patients may receive second line treatment
beyond one year but this will be a small group who will not affect the cost calculation greatly. If
second line irinotecan monotherapy replaces inpatient based 5FU/FA rather than outpatient based
5FU/FA, the cost increase is likely to be considerably less than £3.26m per annum.
NHSScotland should take account of advice and evidence from HTBS and ensure that recommended drugs
or treatments are made available to meet clinical need.
This HTBS Comment is the result of a consideration of possible contextual differences in Scotland,
according to the following categories:
 Principles and values of NHSScotland
 Epidemiology (frequency and distribution)
 Structure and provision of services in Scotland
 Other implications for the Scottish Health Service.
No important differences were identified for this NICE Technology Appraisal Guidance. The process used is
available on request or from the web (www.htbs.org.uk).
An Understanding HTBS Advice is also being distributed on this topic and is available from the HTBS
website or office.
HTBS would like to thank NICE for its cooperation in delivering this Comment. HTBS is also grateful to the
experts in Scotland who provided input to this Comment.
Yours sincerely
Harpreet S Kohli
Medical Director
Enc 1
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