North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Notes:
 This document is updated every 2 to 3 months; please check our website www.cancernorth.nhs.uk for latest version.
 This document does not all contain Interim Cancer Drugs Fund Decisions, i.e. decisions made as part of setting up Interim cancer
drug fund are not included, only new decision for CDF funding from April 2011. These can be found at::
http://www.cancernorth.nhs.uk/hpSite/groups/networkgroups/necdag/northeastcancerdrugfund/fundingpolicyprioritylists
 This contains a record of all decisions made by NECDAG since May 2006. It must be viewed in conjunction with the Network list of
approved cancer medicines and recent decisions by NICE.
 Section 2 of the document contains a summary of all NICE decisions implemented by NECDAG.
Drug(s)
Glucarpidase
(Varoxase®)
Indication
Methotrexate toxicity
Date considered
28 Nov
2012
Decision
Approved
Estimated Cost
Impact (NECN)
Comments
£36,000 per pt
-
Rituximab in
combination with
a standard NHL
induction regimen
Document1
DLBCL
28 Nov
2012
Page 1 of 27
Approved
Approx 10
patients, costing
£120K
For the treatment of toxic
plasma methotrexate
concentrations (>1
micromole per litre) in
patients with delayed
methotrexate clearance due
to impaired renal function, in
the following situations:
Delayed elimination of
methotrexate
Impaired renal function
Significant methotrexate
toxicity
Gold standard
chemotherapy for patients
with DLBCL is R-CHOP..
Rituximab with other
chemotherapy regimens is
an alternative treatment
option e.g. DECC, CVP for
this group of patients, as
part of their first line therapy
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
. Additionally Rituximab
would be added to the
MACOP-B regimen for the
small number of young
patients with DLBCL,
subtype Primary Mediastinal
B cell Lymphoma
Rituximab
Bendamustine with
rituximab
PEG
Asparginase
Document1
Hairy Cell Leukemia
Low Grade Non Hodgkins Lymphoma
Adult patients with ALL
28 Nov
2012
26 Sept 2012
26 Sept 2012
Page 2 of 27
Approved
Approved
Approved
Approx. 3
patients £27,000
£13,000 per
patient
5 patients per
annum, costing
£99,300
An unlicensed indication –
For the treatment of patients
with hairy Cell Leukaemia
(HCL) or Hairy cell
Leukaemia varian (HCL-v)
who:
- Relapse early after
purine analogue
therapy (< 2 years
post treatment)
- Are refractory to
purine analogues.
In combination with
bendamustine for patients with
either first line or relapsed Low
Grade Non Hodgkins
Lymphoma
Current practice in the
region for adult patients with
ALL is for them to be
entered in the UKALL 14
protocol. In one arm of this
protocol, patients are
administered Lasparginase. However, not
all patients are able to be
entered into this study, and it
is for these patients that
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
PEGasparginase will be
used. It is common practice
for paediatric patients as it is
less immunogenic than Lasparginase, and has more
prolonged activity
Gemcitabine
Rituximab
Ovarian cancer patients experiencing
progressive disease within 6 months of
platinum-based chemotherapy (
platinum-resistant ovarian cancer).
Gemcitabine is licensed for ovarian
cancer (in combination with
carboplatin)
Post Transplant Lymphoproliferative
disorders
26 Sept 2012
26 Sept 2012
Approved
Approved
(PTLD)
Rituximab with
salvage
chemotherapy
Document1
Patients relapsing > 12 months post
1st line therapy with R-CHOP
26 Sept 2012
Page 3 of 27
Approved
60 patients per
annum, costing
0.5million
Approx. 5
patients per
annum, costing
£29,340
There is a global shortage of
pegylated liposomal
doxorubicin (Caelyx). Caelyx
is the NICE recommended
second line treatment for
women with partially
platinum-sensitive, platinumresistant or platinumrefractory advanced ovarian
cancer
An unlicensed indication –
For rising EBV viral copy
numbers in patients after
allogenic bone marrow
transplant to pre-empt
development of Post
Transplant
Lymphoproliferative
disorders (PTLD).
This is an unlicensed
indication for rituximab.
Although it is common
practice in Europe and the
U.S for patients to receive
rituximab with salvage
treatment, there has been
evidence to suggest that
patients with refractory
disease or early progression
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(< 12 months) will not benefit
from re-exposure to
rituximab, but the situation is
said to be less clear for late
relapsers, hence it is
proposed to be only used in
patients relapsing > 12
months post 1st line therapy
with CHOP.
Bendamustine in
combination with
rituximab
High Grade Non Hodgkins lymphoma
(NHL).
Rejected
There is very limited data to
support its use in this setting.
26 Sept 2012
Approved
Approved for use in
combination with
bendamustine for patients
with CLL not fit for FCR
chemotherapy or for patients
who relapse within 2 years
of FCR chemotherapy and
not fit for alemtuzumab
(Campath®)
Rejected by NICE,
prior NECDAG
funding approval
withdrawn
26 Sept 2012
Bendamustine in
combination with
rituximab
Chronic Lymphocytic Leukaemia
Cetuximab
(Erbitux®)
(colorectal 3rd line
Colorectal Cancer – k-ras-wild type
metastatic:
THIRD line as a single agent or in
combination with FOLFIRI / Irinotecan
(Note single agent previously PCT
funded)
30.5.12
Rituximab + CHOP as Induction
Chemotherapy forr Mantle cell NHL and
25.01.12
Ritixumab
(mabthera®)
Document1
APPROVED from
CDF
Page 4 of 27
Approved
See CDF
Funding Priority
List (web link
above)
£335,250
For use in patients in Patients
unsuitable for NORDIC
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Erlotinib (Tarceva)
Bevacizumab*
Avastin
Imatinib (Glivec)
Vinorelbine
(Navelbine) and
Capecitabine
(Xeloda)
Document1
Rituximab as Maintenance Therapy
chemotherapy Schedule. Note
Not approved for use with FC
chemotherapy regimen)
1st line treatment advanced or
metastatic non-small cell lung cancer
(NSCLC) with EGFR activating
mutations.
Cost Neutral
There is a degree of
uncertainty regarding average
drug costs; what is apparent is
that there will be a very low
additional budget impact as
erlotinib would be used instead
of existing Gefitnib (Iressa)
treatment.
Approved
£533,084
The dosing schedule NECDAG
agreed was the 7.5mg/kg IV
three weekly dose from the
ICON-7 Trial. Given until
disease progression,
unacceptable toxicity or a
maximum of 12 months. This
is administered with
carboplatin and paclitaxel for
5-6 courses and then a further
12 course as monotherapy.
(total doses=18).
Approved
£157,320 year 1,
£534,888 year 2
rising to
£755,136
For patients only with a
significant risk of relapse,
NECDAG considered it likely
that the Cost per ICER QALY
for this indication lies in the
region of £20-30k.
Cost Neutral
Combination instead of
sequentially for selected
patients where a higher
chance of response than with
the individual drugs important.
(Ovarian) In combination with carboplatin
and paclitaxel for up to 6 cycles, then
single agent
Adjuvant treatment of adult patients with
GIST Treatment at 400mg daily for 3
years.
Metastatic Breast Cancer
25.01.12
25.01.12
30.11.11
30.11.11
Page 5 of 27
Approved
Approved
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Weekly Carboplatin and
paclitaxel
Heavily pretreated
platinum-resistant
recurrent ovarian cancer,
good performance
status(0-1)
Cisplatin and Vinorelbine
(chemoradiation)
Non Small Cell Lung
Cancer.
30.11.11
FOLFIRINOX Oxaliplatin,
Leucovorin, Irinotecan,
5FU
Management of selected
patients with inoperable
pancreatic cancer
2.11.11
Gemcitabine and
Capecitabine
Management of
advanced pancreatic
cancer
2.11.11
Degarelix (Firmagon)
1st line advanced
hormone-dependent
prostate cancer at with a
PSA > 20ng/l
2.11.11
Lenalidomide (Revlimid)
for Myelodysplastic
syndrome with the 5q
minus cytogenetic
abnormality
2.11.11
&
25.2.12
Dexrazoxane (Savene TM)
Treatment of
extravasation
Dasatinib (Sprycel) and
1st line Chronic Myeloid
Leukaemia (CML)
Document1
Cost Neutral
Weekly dose dense paclitaxel and
carboplatin regime has been reported to
have high response rate & tolerable
toxicity.
Approved
Cost Neutral
Change to Concurrent Chemo with RTx
as standard treatment to appropriately
selected patients, instead of sequential
treatment.
Approved
£148,500
First line for inoperable pancreatic
cancer in patients with performance
status 0-1.
REJECTED
£206,250
The committee was of the view that the
clinical evidence was weak, with 3 RCT
trials, two of which did not show any
statistically significant benefit for the
combination vs. gemcitabine.
Approved
Cost Neutral
This expands a previous restricted
approval (see decision below on 17.2.10
REJECTED
£250,000
The committee considered and appeal
(for CDF) as there was a lack of
haematology expertise to advise the
committee at original meeting. On
appeal there were still safety concerns
and lack of evidence.
13.7.11
Agreed to add to
NECN Guidance
See comments
Considered part of Tariff by NECN
commissioners
25.5.11
REJECTED
See comments
NECDAG’S view is there is already an
effective 1st line treatment and these
30.11.11
Approved
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
drugs as yet offer no long term survival
advantage over imatinib. These agents
are approved 2nd line in NHS North
East, first line approval would remove
the option of 2nd line treatment
Nilotinib (Tasigna)
Sorafenib (Nexavar)
Bendamustine (Levact®)
Thyroid Cancer
1st line treatment of chronic
lymphocytic leukemia
(Binet stage B or C) in
patients for whom
Fludarabine combination
chemotherapy is not
appropriate.
Currently unlicensed and a clinical trial
was noted as being available.
25.5.11
REJECTED
19.1.11
Approved
£132,380
None
Following 1st line chemotherapy, given
as maintenance therapy every 8 weeks
for 2 years (12 doses)
First-line maintenance in
follicular non-Hodgkin’s
lymphoma
19.1.11
Approved
Year 1 £712,913
rising to
£1,425,827 year 2
onwards
Ritixumab (mabthera®)
Newly diagnosed mantle
cell NHL in fit patients aged
<60years old
6.10.10
Approved
Maximum £98K
None
Lapatinib (Tyverb®)
plus an
Aromatase Inhibitor (AI)
(HER2) positive
postmenopausal women
with hormone receptor
positive (HR+) metastatic
breast cancer
Rejected
None
As not being
implemented
The committee concluded that Lapatinib+
AI did not meet the current NICE criteria
for cost effectiveness.
Net cost of £73 to
£147K
NECDAG recognises that standard
docetaxel and paclitaxel remain the first
choice taxanes for metastatic breast
cancer, however Abraxane will offer
significant advantages for those patients
who clinicians feel are unable to tolerate
Ritixumab (mabthera®)
Nab-paclitaxel (Abraxane)
Document1
'Paclitaxel albumin
(Abraxane) is accepted for
restricted use within its
current license for
metastatic breast cancer
patients who cannot
6.10.10
14.07.10
Approved with
restrictions
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tolerate standard taxanes
Faslodex (Fulvestrant®)
solution for injections
Ritixumab (mabthera®)
Drug(s)
Traztusumab
(herceptin®) with
cisplatin and
fluorouracil/capecitabine
Degarelix (Firmagon)
Capecitabine + irinotecan
Document1
Post-menopausal and
ER+ve , with
Advanced/Metastatic
Breast Cancer Patients:
Nodular lymphocytepredominant Hodgkin
lymphoma (NLPHL)
Indication
1st line metastatic or
locally advanced
inoperable gastric
cancers which over
express HER-II (IHC +++
or IHC +++ FISH
1st line advanced hormonedependent prostate cancer
with: PSA > 50ng/l or
urether obstruction or
symptoms of spinal cord
compression
Metastatic colorectal
the taxanes treatment regimens or for
patients that experience an adverse
reaction to a standard taxane
14.07.10
Update of
decision of
April 2009
Approved with
restrictions
14.07.10
Approved
Date
considered
Decision
12th May
2010
Approved
Additional
expenditure of
£150k.
Previously approved 29.04.09, the
licensed dose has now changed from
250mg monthly to 500mg monthly, with
a 50% increase in costs. The new dose
and costs were acceptable to NECDAG
£98K to £293K
per anum
NECDAG concluded whilst there was no
robust clinical evidence, e.g. phase III
RCTs, there are technical and biological
reasons to support its use for a limited
number of patients rather than clinicians
using Exceptional Circumstance
Estimated Cost
Impact (NECN)
Comments
£468,432 per
anum
NECDAG found the cost per QALY to
be in the
region of £52-66k per QALY gained.
The treatment was thought likely to
meet the NICE end of life criteria.
NECDAG noted that trastuzumab is
available for treatment of metastatic
breast cancer with similar survival
improvements and costs.
17.2.10
Approved
Cost neutral
Approved for restricted patients on the
condition that the manufacturer either
discounts or rebates the cost to be
equivalent to the cost of gosarelin.
2.12.09
Approved
Cost neutral
As an alternative to FOLFIRI (Modified
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
(CAPIRI)
Cetuximab
(Erbitux®)
cancer
3rd Line single agent in
KRAS wild-type
metastatic colorectal
cancer patients.
de Gramont + irinotecan). CAPIRI has
comparable efficacy and tolerability to
FOLFIRI, however, CAPIRI is more
patient-friendly in that it does not
require a central line and reduces visits
to hospital.
17.11.09
Gemcitabine
Adjuvant treatment for
pancreatic cancer
Gateway Sub
Group 9.9.09
Gemcitabine and Cisplatin
Palliative treatment for
biliary tract cancers
Gateway Sub
Group 9.9.09
Document1
Approved
£260,884 to
£489,158
The committee felt that the strong
evidence of improved survival
(4.7months) for 3rd line single agent
combined with a PAS scheme to
reduce costs (the same pas NICE
approved for 1st line cetuximab)
allowed the drug to be approved under
the NICE end of life ruling.
Approved
Max cost to
NECN £187,000
per anum
Trials confirm survival advantage for
adjuvant Gem compared to
observation in patients who had had
their pancreatic cancer treated
surgically.
Approved
Cost neutral,
potentially cost
saving
This regimen would involve adding
cisplatin to gemcitabine which is
already approved in upper GI cancers
or replacing existing ECX.
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Drug(s)
Capecitabine and
streptozocin
Indication
Neuroendocrine tumours
(NET)
Aprepitant (EMEND)
and Palonosetron
(Aloxi®)
Chemotherapy induced
nausea & vomiting (CINV)
Rituximab in
combination with
Fludarabine &
Cyclophosphamide
For patients with CLL –
Binet stage B or C, as
treatment of relapsed
disease
Lapatinib
(Tyverb)
Breast cancer
Plerixafor
(Mozobil®)
Stem cell mobilisation in
the management of
patients failing first
mobilisation with multiple
myeloma & lymphoma
Bevacizumab
(Avastin®)
Metastatic colorectal
cancer patients with
unresectable liver only
metastases with mutated
KRAS
Document1
Date
considered
Gateway Sub
Group 9.9.09
Gateway Sub
Group 9.9.09
September 09
September 09
September 09
1st July 2009
Decision
Estimated Cost
Impact (NECN)
Comments
Cost neutral
Strepotozocin is already in use in an alternative
schedule at centres treating NET. The approval
allows replacement of 5FU/ Folinic Acid with
Capecitabine.
Included in tariff
Palonosetron as an option for prevention of
chemotherapy induced nausea & vomiting (CINV)
in selected patients receiving moderate (ME) or
highly emetogenic (HE) chemotherapy. Aprepitant
as an option for prevention CINV in selected
patients receiving HE chemotherapy
£181,600
NECDAG has previously approved the use of FCR
as first line treatment of CLL .However, this
additional approval allows access for those patients
who are at a later stage of treatment.
Not Approved
None
In comparison with trastuzumab after progression
lapatinib could be cost effective, however, NICE
does not recommend trastuzumab be continued
beyond progression. In comparison with standard
chemotherapy the QALY is above the limits set by
NICE hence the committee were unable to approve
Approved
£78,128 to
£117,192
The use of plerixafor appears to significantly
improve the chance of successful stem cell
transplant (Tx) in a small number of patients who
fail conventional transplant conditioning regimens.
Rejected
None
As not being
implemented.
The committee concluded that the clinical evidence
was not of the level of benefit normally required for
acceptance into clinical practice and noted the
suggestion that a randomised trial was needed to
confirm benefit.
Approved
Approved
Approved
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Drug(s)
Indication
yttrium-90
radiolabelled
ibritumomab tiuxetan
(Zevalin®)
Consolidation therapy
after remission induction
in previously untreated
patients with follicular
lymphoma
Gateway Sub
Group 10th
June 2009
Deferasirox
(Exjade®)
Iron Chelation for patients
with Myelodysplastic
Syndrome (MDS)
Gateway Sub
Group 10th
June 2009
Cisplatin and
Etoposide
For induction concurrent
Chemoradiotherapy To
Superior Sulcus
carcinomas of lung
Gateway Sub
Group 10th
June 2009
Bortezomib
(Velcade)
First line therapy for
multiple myeloma patients
who have renal failure
requiring haemodialysis or
in whom use of
‘melphalan’ is prohibited
Gateway Sub
Group 10th
June 2009
Approved
Ritixumab (CLL) with
Fludarabine and
Cyclophosphamide
First Line treatment of
Chronic Lymphocytic
Leukaemia in combination
with FC Chemotherapy.
29th April
2009
Approved
with
restrictions
Azacitidine (Vidaza®)
Document1
Myelodysplastic
Syndrome (MDS)
Date
considered
29th April
2009
Decision
Estimated Cost
Impact (NECN)
Comments
Rejected
None
As not being
implemented.
The committee did not feel there was currently
sufficient clinical evidence to support use in the
previously untreated setting, as patients locally
would have received rituximab as part of their
indication therapy.
Approved
with
restrictions
Net Cost to
NECN =
£10,000
The committee approved the recommendation to
use defarasirox rather than less evidence based
approaches such as transfusion of chelating agents
immediately following transfusion.
Approved
Drug costs
maximum £200
per patient.
The committee felt that a 10% five year survival
benefit off-set a very small financial cost.
Rejected
Page 11 of 27
Expected to be
cost neutral
The committee considered that any additional costs
from re-sequencing the treatment would be offset
by reducing dialysis costs.
Net Cost of
adding Rituximab
to FC (with VAT)
£271,170
Review decision on publication
of final NICE Guidance
None
As not being
implemented.
The committee concluded the health economic
case resulted in a QALY greater than the normal
NICE threshold. This treatment fits the NICE End of
Life Treatment criteria, however, the committee
were concerned that the economic uncertainties
and higher than normally acceptable QALY would
result in a negative opinion from NICE.
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Drug(s)
Bevacizumab
(Avastin®)
Faslodex
(Fulvestrant®)
solution for injections
Oral Topotecan
(Hycamtin®)
Docetaxel
(Taxotere®) with
carboplatin
Indication
Metastatic Breast Cancer
Post-menopausal and
ER+ve , with
Advanced/Metastatic
Breast Cancer Patients:
Relapsed Small Cell Lung
Cancer (SCLC) in patients
for whom re-treatment
with 1st-line regime is not
considered appropriate.
Ovarian cancer: for
patients that have
demonstrated an allergic
reaction to paclitaxel
(CTC grade 3 or above
hypersensitivity
Date
considered
29th April
2009
Gateway Sub
Group 1st
April 2009
4th February
2009
4th February
2009
Decision
Document1
First Line Non Small Cell
– Non Squamous
Histology- Lung Cancer
(2nd line see comments)
3 December
2008
&
4th February
2009
Comments
Rejected
None
As not being
implemented.
The committee were unable to approve at this time
because the limited overall survival advantage, and
limited evidence of a difference in utility between
the control arm and treatment arms of the trial
meant it impossible to develop a health economic
model which could produce a QALY value under
the normal limits approved by NICE.
Approved
with
restrictions
Net Cost to
NECN =
£62,688 to
£83,584
Treatment to be administered in primary after
administration of the first cycle in secondary care.
Restricted to patients who/with:
1. Relapsed on AI therapy in advanced disease
2. Severe joint pains exacerbated by AI therapy.
3. Compliance issues
Approved
Net Cost
£55,008 for the
Network.
The committee concluded that oral topotecan is at
least as effective as VAC with the added benefit of
improved symptom control and significant benefits
in terms of quality of life and ease of administration.
Approved
Net Cost to
NECN =
£91,863 to
£137,794
The committee considered if the reported paclitaxel
hypersensitivity reaction was an issue that could be
resolved by switching from generic paclitaxel to the
non-contract branded equivalent. The safest
approach for patients was to switch to docetaxel.
Approved
First line
£341,334 for the
Network.
(2nd line cost
neutral with
refund scheme)
Replacement of 1st line Gemcitabine +Cisplatin or
Carboplatin with Pemetrexed+Cisplatin or
Carboplatin for patients with Non-Squamous
Histology (Large Cell and Adenocarcinoma) adds 2
months to median survival. 2nd line use allowed
only for patients who started 1st line prior to
3.12.09 to allow equity of access.
rd
Pemetrexed
(Altimta®) with
Platinum
Estimated Cost
Impact (NECN)
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Drug(s)
Indication
Date
considered
Decision
Estimated Cost
Impact (NECN)
Comments
Lenalidomide
(Revlimid)
Relapsed/ Refractory Multiple
Myeloma
24th September
2008
Rejected
None – as not
being
implemented.
The committee were unable to approve at this time
as the economic case had not been demonstrated,
but noted that NICE was due to review the
treatment. Lenalidomide is the most expensive
cancer medicine on the market, it would cost an
average of £48,268 per patient for 11 months
treatment and potentially £2,461,668 for network.
Sorafinib
(Nexavar®)
Treatment of hepatocellular
cancer
24th September
2008
Rejected
None – as not
being
implemented.
The committee were unable to approve as the
economic case had not been demonstrated.
Docetaxel
(Taxotere® ) and
Cyclophosphamide
(TC)
Adjuvant node positive Breast
cancer unsuitable for
anthracyline
24th September
2008
Approved
£5,000 to £15,000
per PCT
As an option for the adjuvant treatment of women
with early operable node positive breast cancer
(stages 1-3) who have a history of cardiac disease
making them unsuitable for standard anthracycline
based adjuvant chemotherapy
MP-T (Thalidomide
in combination with
Melphalan and
Prednisolone)
First line therapy for multiple
myeloma patients
Gateway Sub
Group 9th
September 2008
Approved
Cost Neutral
Negligible impact as systems are already in place to
provide Thalidomide on a ‘Third Line’ therapeutic
basis.
EOX Epiribicin,
oxaliplatin,
capecitabine
Inoperable oesophagogastric
cancer.
Gateway Sub
Group 9th
September 2008
Approved
Max cost across
NECN will be
£126,053.
To replace ECX and EcarboX in suitable patients.
Dasatinib
(Sprycel)
Chronic Myeloid Leukaemia
with resistance or intolerance
to prior therapy including
imatinib
24th September
2008
Approved
with
restrictions
See nilotinib costs
Following nilotinib’s approval dasatinib was
accepted as an alternative for patients intolerant to
nilotinib. Dasatinib must not be used after failure on
nilotinib. (Clinicians have freedom to choose most
appropriate agent nilotinib or dasatinib)
Document1
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Date
considered
Decision
Estimated Cost
Impact (NECN)
Comments
Patients with Imatinibresistant or intolerant
Chronic Phase Chronic
Myeloid Leukaemia (CML)
9th July 2008
Approved with
restrictions
£265,422 for the
Network.
Nilotinib will replace higher doses of imatinib in
patients who are resistant to imatinib, and be used
as an alternative treatment for patients unable to
tolerate imatinib
Cisplatin and 5FU:
Neoadjuvant setting in head
and neck cancer.
Gateway
Sub Group
18th June
2008
Approved
Cost neutral
This treatment is currently offered after radiotherapy
this is simply a switch in sequencing.
TIP: (Paclitaxel,
Ifosfamide
Cisplatin)
Second-line (post-BEP)
salvage chemotherapy for
patients with metastatic
germ cell cancer.
Gateway
Sub Group
18th June
2008
Approved
Cost neutral
Accepted as standard practice.
Thyrotropin Alpha
(Thyrogen
diagnostic tool for serum
thyroglobulin testing in
tracking patients with
thyroid cancer.
Gateway
Sub Group
18th June
2008
£232 per dose
Has been available as standard practice some parts
of Network but not others. Gateway agreed it is
accepted as standard practice and should be
available across network
Irinotecan
Advanced colorectal cancer
23 January
2008
Approved
Cost Neutral
Addition of weekly single agent irinotecan as option
for treatment of advanced colorectal cancer, for
those patients not suitable for NICE approved 3
weekly regimen
Topotecan
(Hycamtin) (in
combination with
cisplatin)
Carcinoma of the cervix
recurrent after radiotherapy
and for patients with Stage
IVB disease.
23 January
2008
Approved with
restrictions
£37,500 for the
Network.
Restricted to patients who have been cisplatin free
for a period of at least 12 months. Use without
GCSF Support
2nd line Sunitinib
(Sutent®) for GIST
Gastrointestinal Stromal
Tumours (GIST) after
Imatinib Failure
23 January
2008
Approved
£130,163 for the
Network.
Approved using reduced costs from Sunitinib risk
share scheme to achieve cost effectiveness.
Drug(s)
Indication
Nilotinib (Tasigna)
Document1
Approve
Page 14 of 27
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Drug(s)
Indication
Date
considered
Decision
Estimated Cost
Impact (NECN)
Comments
2nd Line FOLFIRI
(Irinotecan
Modified
DeGramont)
Advanced colorectal cancer
7 November
2007
Approved
£38,400 for the
Network.
FOLFIRI is approved as 2nd line therapy following
1st line treatment with FOLFOX.
£4,931 per patient
(125 days
treatment)
In theory implementation is cost neutral since
patients who would have received docetaxel will
receive erlotinib at equivalent price. The committee
acknowledged the convenience of the oral dose
form and favourable side effect profile may mean
that patients eligible for docetaxel who will received
erlotinib who would not have tolerated docetaxel.
Approved
£12,420
Restricted to patients unsuitable for standard
therapy with ECF or ECX regimens due to potential
toxicity with fluoropyrimidine based chemotherapy.
Certain Trusts in NECN purchase Neulasta via a
price deal with Amgen based on replacing existing
GCSF usage with Neulasta® (pegfilgrastim). NECN
asked the manufacturers to provide the same offer
of price deal to all Trusts in the Network. (Not for
use in patients with the CML & MDS)
Approved as
an alternative
to 2nd line
docetaxel
(Taxotere).
Erlotinib
(Tarceva®)
Non Small Cell Lung Cancer
2nd Liner as an alternative to
docetaxel (Taxotere)
7 November
2007
Cisplatin &
Docetaxel
(Taxotere® )
Advanced Oesophago-gastric
Cancer for patients unsuitable
for ECX/ECF
7 November
2007
Neulasta®
(pegfilgrastim)
6mg solution for
injection
Reduction in the duration of
neutrophenia and the
incidence of febrile
neutropenia (FN) in
chemotherapy patients
7 November
2007
Approved
Up to £502,634
(However
potentially cost
neutral dependant
on current GCSF
usage)
Oral Vinorelbine
(Navelbine)
A single agent or in
combination for the treatment
of advanced breast cancer
7 November
2007
Approved
£165,000
Used for patients with stage 3 and 4 relapsing after
or refractory or anthracycline containing regimen.
Aprepitant
(Emend®)
Prevention of Chemo Induced
Nausea & Vomiting in patients
receiving high dose cisplatin &
patients who fail standard antiemetic
Clinical
Approval*
1 cycle of
treatment costs
£47.42. Typical
cost per patient
around £280.
*To be funded by Trusts as commissioners view is
costs for supportive care are covered within tariff
individual costs per PCT or Trust have not been
calculated
Document1
23 July
2007
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Drug(s)
Indication
Date
considered
Decision
Estimated Cost
Impact (NECN)
Comments
Ritixumab
(Follicular
Lymphoma)
Relapsed/ refractory
follicular lymphoma
responding to induction
chemotherapy with or
without Rituximab.
23 July 2007
Approved
Year 1 - £268,514
Year 2 - £537,028
Further work ongoing defining the patient pathway
for follicular lymphoma.
Approved
£674,600 per year
+
(a non-recurrent
cost of £202,620*)
*NE NHS Chief Executives agreed the small
number of patients who have already received first
line treatment with interferon prior to this decision
may be able to receive Sunitinib if clinically
appropriate. (Approx 12). This is not approval for
2nd line use but recognition that there are some
patients who may benefit.
Rejected
£10,356.30 per
patient per year.
None – as not
being
implemented.
Reject upon review in March 2007. Decision will be
subject reviewed in September 2008
Likely to be £45K per year as a number of patients
already treated
Sunitinib
(Sutent®)
First line for Renal Cell
Carcinoma
Zevaline®
(Yttrium-90
labelled
Ibritumomab
tiuxetan)
The treatment of adult
patients with CD20+
follicular B-cell nonHodgkin’s lymphoma (NHL)
resistant to/ relapsed after
Rituximab.
Dasatinib
(Sprycel®) for
Chronic Myeloid
Leukaemia
Adults with chronic,
accelerated or blast phase
chronic myeloid leukaemia
(CML) with resistance or
intolerance to prior therapy
including imatinib (Gilvec).
7 March
2007
Rejected
£31,714 per
patient per year.
None – as not
being
implemented.
Bexarotene
(Targretin®)
Skin manifestations of
advanced stage (CTCL)
cutaneous T-cell lymphoma
patients refractory to at
least one systemic therapy
7 March
2007
Approved with
restrictions
£90,000 per year
maximum.
Document1
23 July 2007
7 March
2007
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Drug(s)
Indication
Date
considered
Decision
Estimated Cost
Impact (NECN)
Comments
Sorafenib
(Nexavar®) and
Sunitinib
(Sutent®)
Second line for Renal Cell
Carcinoma
7 February
2007
Rejected
None -not being
implemented.
No published cost effectiveness data was available
PegylatedCytarabine
(Depocyte®)
Intrathecal treatment of
lymphomatous meningitis
7 February
2007
Approved
£29,275
Centre only treatment
Oral Uftoral®
(tegafur/uracil)
Advanced Colorectal
Cancer
1 November
2006
Approved
£3,500 for both
Oral Uftoral &
Folinic Acid.
Previously NICE approved. Unable to estimate
uptake, likely to be small and instead of existing
treatment option.
Temozolomide
(Temodal® )
Concomitant & adjuvant
temozomide with
radiotherapy at presentation
malignant glioma (brain
tumour) and good
performance status
1 November
2006
Approved
£564,960 per
year.
Subsequently NICE approved
Approved
Drug costs per
patient would be
around £5.3K plus
£3K for additional
costs giving totals
of £169,600 and
£96,000
NICE approved NICE estimates that 32 patients per
million population will be eligible for treatment with
this regimen.
Cost Neutral
Delivery cost should be neutral and capacity from
nursing and pharmacy time being freed would be
able to be redeployed for delivery of NICE Adjuvant
Colon Guidance.
Docetaxel
(Taxotere® )
FEC-T
Adjuvant use in patients
with Node Positive Breast
Cancer
Capecitabine
GI Cancers
(ECX regimen etc)
Document1
1 November
2006
5 July 2006
Approved
Page 17 of 27
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Drug(s)
Indication
Date
considered
Decision
Estimated Cost
Impact (NECN)
Alemtuzumab
(MabCampath®)
Chronic Lymphocytic
Leukaemia with disease
less than 5 cm
(Third Line)
5 July 2006
Approved
Approximately 15
patients per year
costing £65,000
Erlotinib
(Tarceva®)
Non Small Cell Lung
(Second or Third Line)
Oral Vinorelbine
(Navelbine)
Non Small Cell Lung (First
Line) NSCLC
Cetuximab
(Erbitux®)
Colorectal cancer
metastatic
Document1
5 July 2006
3 May 2006
Comments
Rejected
The Committee noted that no published cost
effectiveness data was available. An estimate Cost
per Life Year Gained and QALY had been made.
The Committee concluded that the economic case
had not been demonstrated.
SUPERCEDED by 7.11.07 DECISION
Approved
Equalising practice between CCA and NCN
(previously approved in NCN)
Rejected
Rejected due to lack of clinical evidence of
improvement in survival vs. standard treatment
(best supportive care) and High cost per QALY.
Decision superceded by nice TA118
Page 18 of 27
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Section 2: NICE Implementation
This section contains a summary of all positive NICE decisions discussed by NECDAG
Drug(s)
Indication
Date of
NICE
Guidance
Decision
Reference
Comments
Vemurafenib
As a possible treatment
for unresectable or
metastatic melanoma
with the BRAF V600
mutation.
Dec 2012
Approved
TA269
Currently funded by CDF. Will be funded from
CDF until 31st March 2013, (90 day post NICE
decision) at which time funding will switch to NHS
commissioners (PCT/CCGs)
Ipilimumab
A possible treatment for
people with previously
treated advanced
(unresectable or
metastatic) melanoma.
Dec 2012
Approved
TA268
Currently funded by CDF. Will be funded from
CDF until 31st March 2013, (90 day post NICE
decision) at which time funding will switch to NHS
commissioners (PCT/CCGs)
Abiraterone (Zytiga)
Prostate cancer
(metastatic, castration
resistant) - (following
cytotoxic therapy)
June 2012
APPROVED
TA258
Currently funded by CDF. Will be funded from
CDF until 27 September 2012, (90 day post NICE
decision) at which time funding will switch to NHS
commissioners (PCT/CCGs)
Erlotinib (Tarceva)
Lung cancer (non small
cell, EGFR-TK mutation
positive) - 1st line
June 2012
APPROVED
TA258
Previously Approved by NECDAG March 2012
Nilotinib (Tasigna)
Nilotinib and standarddose imatinib for the firstline treatment of chronic
myeloid leukaemia (
April 2012
APPROVED
TA251
Nilotinib has been added to approval for 1st line
therapy as part of review of NICE guidance TA70
due to manufacturer discounting drug to match
price of imatinib. However this has not yet been
implemented due to availability of Nilotinib in an
ongoing clinical trial
Nilotinib (Tasigna)
2nd line therapy after
standard dose imatinib in
Jan 2012
APPROVED
TA241
NICE did not recommend high-dose imatinib or
Dasatinib for people with Philadelphia-
Document1
Page 19 of 27
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
CML chronic myeloid
leukaemia
Rituximab
(MabThera®)
Document1
Follicular lymphoma
chromosome-positive chronic myeloid leukaemia
in the chronic, accelerated or blast-crisis phase
that has got worse after treatment with standarddose imatinib
Jan 2012
APPROVED
Page 20 of 27
TA243
Rituximab for the first-line treatment of stage IIIIV follicular lymphoma
is recommended in combination with certain
chemotherapies as a possible treatment for
people with stage III–IV follicular lymphoma (
(review of NICE TA110)
last Updated 09/02/2016
North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Drug(s)
Indication
Date of
NICE
Guidance
Decision
Reference
Comments
Mifamurtide (Mepact)
Osteosarcoma
Oct 2011
APPROVED
TA235
Mifamurtide is made available at a reduced cost
to the NHS under the patient access scheme.
bortezomib and
thalidomide
Multiple myeloma (first
line) -
July 2011
APPROVED
TA228
NECN Haematology NSSG asked to produce
treatment algorithm for MM
Rituximab
(MabThera®)
Follicular non-Hodgkins
lymphoma
(maintenance treatment
following response to
first-line chemotherapy)
June 2011
APPROVED
TA226
Previously approved by NECDAG Jan 2011
Bendamustine (Levact®)
Chronic lymphocytic
leukaemia
February
2011
APPROVED
TA216
Previously approved by NECDAG Jan 2011
Pazopanib
Traztusumab
(herceptin®)
Document1
Renal cell carcinoma
(first line metastatic)
HER2-positive
metastatic gastric
cancer
February
2011
APPROVED
TA215
NICE approval is on the basis of the average cost
of treatment being the same as sunitinib, with
similar clinical efficacy. However if average
treatment duration is generally shorter then the
cost of pazopanib is higher than sunitinib, as both
drugs have PASs which operate in different ways.
Current audit data in the North East suggest the
duration of treatment is shorter than seen in trials.
Trusts to assure themselves
November
2010
APPROVED
TA208
Previously approved by NECDAG May 2010
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Drug(s)
Indication
Gefitinib (Iressa)
Advanced/ metastatic
non-small-cell lung
cancer 1st line
Date of
NICE
Guidance
Decision
Reference
Comments
August 2010
APPROVED
TA191
Implemented in October 2010 after consideration
of issues surrounding EGFR testing and the PAS
scheme for prescribing the drug.
Pemetrexed (Alimita)
Maintenance treatment
of non-squamous nonsmall-cell lung cancer
June 2010
APPROVED
TA190
NICE does not allow use of maintenance therapy
for patients who have received 1st line
pemetrexed. It is anticipated that the majority of
non-squamous histology patients in NECN will
have already received pemetrexed as first line
combination, therefore use as maintenance
treatment in NECN will be limited
Sorafenib (Nexavar)
1st line treatement of
advanced and
metastatic
Hepatocellular
carcinoma
May 2010
Not recommended
TA189
Previously reviewed and rejected by NECDAG.
Trabectedin (Yondelis)
Advanced soft tissue
sarcoma
February
2010
APPROVED
TA186
Estimated very small numbers of patients who
would be treated at cancer centres.
TA184
NICE recommend use of topotecan is restrcited
to patients in whom re-treatment with the
previous treatment is not appropriate and there is
a medical reason why they cannot take (CAV)
cyclophosphamide, doxorubicin and vincristine.
NECDAG Previously approved for use as an
alternative to CAV due to decreased toxicity.
Clinicians are advised to use clinical judgement
on patients suitability to receive CAV.
Topotecan
Document1
Relapsed small cell
lung cancer
November
2009
APPROVED
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Drug(s)
Indication
Pemetrexed
first-line treatment of
non-small-cell lung
cancer
Sunitinib
Decision
Reference
Comments
September
2009
APPROVED
TA181
Previously Approved by NECDAG ( Dec 2008)
gastrointestinal stromal
tumours (GIST)
September
2009
APPROVED
TA179
Previously Approved by NECDAG ( Jan 2008)
Cetuximab
(Erbitux®)
Combination with 5-FU,
folinic acid & oxaliplatin
(FOLFOX) for first
line colorectal cancer
with potentially operable
liver metastases
August 2009
Approved
TA176
The manufacturer rebates 16% of the amount of
cetuximab used on a per patient basis by means
of a Patient Access Scheme (PAS).
Lenalidomide
(Revlimid)
Relapsed/ Refractory
Multiple Myeloma
Sunitinib (Sutent®)
First line for Renal Cell
Carcinoma
Erlotinib
(Tarceva®)
Document1
Non Small Cell Lung
Cancer
Date of NICE
Guidance
June 2009
Approved
TA171
NICE allowed use for patients who have received
at least one prior therapy and where a Risk Share
Scheme is in place to provide free drug for
patients who continue on treatment after 2 years.
March 2009
Approved for patients
suitable for interferon
with performance
status 0 or 1.
TA169
Already implemented in NECN.
TA162
NICE state. Erlotinib should be used only when
the manufacturer provides the drug at the same
overall treatment cost as docetaxel. In practice
NICE have accepted a scheme similar to one
approved by NECDAG in Nov 2007. Trusts should
not a slight increase in costs (from £1,182 to
£1,394 per month) as NICE did not obtain as
favourable a discount as NECDAG
November
2008
Approved as an
alternative to 2nd line
docetaxel (Taxotere).
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Drug(s)
Indication
Date of NICE
Guidance
Decision
Reference
Comments
TA145
The possible patient group is very restricted. Most
patients would be suitable for platinum based
chemotherapy in combination with radiotherapy
and there is currently no evidence of superiority of
cetuximab for this patient population.
Cetuximab
(Erbitux®) (in
combination with
radiotherapy)
Treatment of Head and
Neck Cancer
June 2008
Restricted approval
for locally advanced
squamous cell head
and neck cancer with
Karnofsky PS 90%
not suitable for
platinum chemo
Cetuximab
(Erbitux®)
Metastatic colorectal
cancer following failure
of oxaliplatin-containing
chemotherapy
June 2008
Not recommended
(Non-submission)
TA150
NICE was unable to recommend the use in the
NHS because no evidence submission was
received from the manufacturer.
Carmustine
implants (Gliadel)
treatment of recurrent
glioblastoma multiforme
June 2008
Not recommended
(Non-submission)
TA149
NICE was unable to recommend the use in the
NHS because no evidence submission was
received from the manufacturer
Bevacizumab
(Avastin®)
non-small-cell lung
cancer
June 2008
Not recommended
(Non-submission)
TA148
NICE was unable to recommend the use in the
NHS because no evidence submission was
received from the manufacturer
Bevacizumab
(Avastin®) in
combination with
paclitaxel
first-line treatment of
metastatic breast cancer
June 2008
Not recommended
(Non-submission)
TA147
NICE was unable to recommend the use in the
NHS because no evidence submission was
received from the manufacturer.
Document1
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Drug(s)
Indication
Erythropoietin
analogues; epoetin
alfa & beta (Eprex
& NeoRecormon)
and darbepoetin
alfa (Aranesp)
Treatment of
symptomatic anaemia in
adults who are receiving
chemotherapy
Date of NICE
Guidance
Decision
Reference
Comments
TA142
There was some use of Erythropoietin analogues
currently in NECN, Trusts should disinvest as
appropriate. The NCN had previously produced
guidance on the use of Erythropoietin analogues,
this has now been officially withdrawn.
May 2008
Not recommended for
routine use. (Small
use in ovarian/
patients unable to
receive transfusions)
Rituximab
(MabThera®)
Relapsed or refractory
stage III or IV follicular
non-Hodgkin's
lymphoma
February
2008
Recommended for
1st line in
combination,
maintenance and last
line monotherapy
TA137
Rituximab is an option in combination with
chemotherapy to induce remission or alone as
maintenance therapy during remission.
Rituximab monotherapy is an option for relapsed
or refractory disease when all alternative treatment
options have been exhausted.
Pemetrexed
(Altimta®)
Mesothelioma
January 2008
Approved for PS 0 or
1 patients
TA135
NICE guidance matches prior approval by NE
Cancer Networks
Bortezomib
(Velcade)
Monotherapy for
relapsed multiple
myeloma
October 2007
Approved for patients
who relapse for the
first time after having
one treatment,
TA129
Approved following adoption of VRS scheme.
Patients tested for response after not more than
four cycles. If non responders then stopped and
NHS gets refunded.
Pemetrexed
(Altimta®)
2nd line locally advanced
or metastatic non-smallcell lung cancer
August 2007
Not recommended
TA124
Carmustine
(Gliadel®) Implants
and temozolomide
(Temodal® )
Glioma (newly
diagnosed and high
grade)
Document1
June 2007
Recommended with
restrictions
Page 25 of 27
TA121
Temozolomide for newly diagnosed glioblastoma
multiforme with PS 0 or 1 Carmustine implants for
newly diagnosed high-grade glioma only if 90% or
more of their tumour has been removed, only at
specialist centres/ James Cook and Newcastle .
last Updated 09/02/2016
North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Drug(s)
Indication
Date of NICE
Guidance
Decision
Reference
Comments
Fludarabine
Phosphate
(Fludara®)
first-line treatment of
chronic lymphocytic
leukaemia
February
2007
Not recommended
TA119
The manufacturer’s NICE submission included
fludarabine monotherapy and fludarabine plus
cyclophosphamide compared with chlorambucil
based on the results of the CLL4 trial. However
the combination regimen is unlicensed in the UK
therefore NICE declined to comment on it. NICE
only commented on the single agent Fludarabine
which is not as effective as combination.
Gemcitabine and
Paclitaxel
Metastatic breast cancer
January 2007
Recommended with
restrictions
TA116
Recommended as where two other treatments
could also be used as alternatives.
TA118
Bevacizumab with 5-fluorouracil plus folinic acid,
with or without irinotecan not recommended for
first line. Cetuximab with irinotecan not
recommended for patients who had previous
treatment that also included irinotecan.
TA112
NICE recommend all three drugs and state ‘there
is insufficient evidence to conclude that any one
aromatase inhibitor or treatment strategy is more
clinically effective than another’ NECN has
produced guidance on use of adjuvant AI’s.
Bevacizumab
(Avastin®) &
cetuximab
(Erbitux®)
Colorectal cancer
metastatic
Anastrozole
(Arimidex),
exemestane
(Aromasin) and
letrozole (Femara)
Hormonal therapies for
the adjuvant treatment of
early oestrogenreceptor-+ve breast
cancer
Document1
January 2007
Nov 2006
Not recommended
Recommended
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North of England Cancer Drugs Approval Group (NECDAG) – Cumulative Table of Decisions Jan 2013
Drug(s)
Indication
Rituximab
(MabThera®)
R- CHOP
Stage III or IV follicular
lymphoma
Docetaxel
(Taxotere® )
Paclitaxel
Adjuvant use in patients
with Node Positive
Breast Cancer
Adjuvant use in patients
with Node Positive
Breast Cancer
Date of NICE
Guidance
Decision
Reference
Comments
R CHOP regimen, ritxumab plus
cyclophosphamide, vincristine and prednisolone.
Sep 2006
Recommended
TA110
Sep 2006
Recommended
TA109
NICE recommend use of licensed FAC regimen
NECDAG have considered and approved
alternative FEC-T regimen
Sep 2006
Not recommended
TA108
Not found to be cost effective, docetaxel approved
as adjuvant taxanes.
Aug 2006
Recommended
TA107
Previously implemented in NECN area.
June 2006
Recommended
TA101
Trastuzumab
(Herceptin® )
Adjuvant use in patients
with HER2 Positive
Breast Cancer
Docetaxel
(Taxotere® )
hormone refractory
prostate cancer
Capecitabine and
oxaliplatin
adjuvant treatment of
stage III (Dukes' C) colon
cancer
April 2006
Recommended
TA100
Capecitabine on its own and oxaliplatin together
with 5-fluorouracil and folinic acid are
recommended as possible adjuvant treatments
after surgery for stage III (Dukes’ C) colon cancer,
when used in the following ways:
Denosumab
Prevention of skeletalrelated events in
adults with bone
metastases from solid
tumours
Oct 2012
Recommended
TA265
Previously available via CDF
Document1
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