NOTIFICATION ONLY
For Commencing Treatment with ADALIMUMAB or INFLIXIMAB for the treatment of Crohn’s Disease, NICE TAG 187, issued May 2010
Please note “Notification Only” means that if the patient fulfils the proforma / NICE criteria then provider Trusts can commence treatment without the need to wait for
CCG acknowledgement / approval.
Patient NHS No.
Trust:
GP Name:
Patient Hospital Number:
Consultant Making
Request:
Consultant Contact
Details:
GP code /
Practice code:
GP Post code:
Patient initials & DoB:
Please indicate whether or not patient meets NICE TA 187 criteria
Please indicate below, the type of Crohn’s Disease requiring treatment:
Adult with severe active Crohn’s Disease
Defined in NICE TA187 as patients in very poor general health and one or more symptoms such as
weight loss, fever, severe abdominal pain and usually frequent (3-4 or more) diarrhoeal stools daily.
People with severe active Crohn’s disease may or may not develop new fistulae or have extraintestinal manifestations of the disease. This clinical definition normally, but not exclusively,
corresponds to a Crohn’s Disease Activity Index (CDAI) score of 300 or more, or a HarveyBradshaw score of 8 to 9 or above AND
Patient has not responded to maximum tolerated doses of conventional therapy (including
immunosuppressive and/or corticosteroid treatments) given for an adequate period or who are
intolerant of or have contraindications to conventional therapy.
1.
Harvey-Bradshaw Index of 8/9:
Adult with active fistulising Crohn’s Disease
Defined in NICE TA187 as disease that has not responded to conventional therapy (including
antibiotics, drainage and immunosuppressive treatments), or where the patient is intolerant of or has
contraindications to conventional therapy.
Child (aged 6-17 years) with severe active Crohn’s disease
Defined in NICE TA187 as disease that has not responded to conventional therapy (including
corticosteroids, immunomodulators and primary nutrition therapy), or where the child is intolerant of
or has contraindications to conventional therapy.
2. Please specify which drugs the patient has previously received, including immunosuppressives,
corticosteroids, antibiotics, drainage, and primary nutrition as appropriate in line with the
requirements of NICE TA187:
Start date
Stop date
Adalimumab
Induction starting at 160mg or 80mg (please ring)
Maintenance to be given at 40mg every 2 weeks
Infliximab
 Yes
State score: ………..……… Date: …../……/…….
Treatment
Management Plan
Please tick
 No
Please indicate which brand of infliximab will be
used:
REMSIMA®

INFLECTRA® 
REMICADE® 
Patient weight:
Starting infliximab dose
_______________ kg
______________ mg
Maintenance dose ___________ mg every 8 weeks
The patient will be reviewed regularly to ensure
ongoing clinical and mucosal remission using
Appendix 1.
Reason for stopping
Service Manager: __________________
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3. Dose escalation
Dose escalation will be allowed for a period no longer than 6 months (ie. 3x infliximab 10mg/kg
infusions, 6x infliximab 5mg/kg monthly or adalimumab 40mg weekly) after which the dosage will
revert back to their usual maintenance level and the patients’ need to be assessed.
If dose escalation fails to achieve clinical remission or mucosal healing, this should be seen as a
treatment failure and either the biological should be stopped, or those on infliximab could be
considered for a switch to adalimumab.
4. Treatment Failure
I acknowledge the guidance offered in Appendix 2 and where applicable I will adhere to the
recommendations.
5. Discontinuation
Infliximab or adalimumab should be given as a planned course of treatment until treatment failure
(including the need for surgery), or until 12 months after the start of treatment, whichever is shorter.
Exceptions to this and criteria for treatment failure can be found in Appendix 3.
Where the patient’s TREATMENT IS DISCONTINUED BETWEEN 12 WEEKS TO 1 YEAR of
initiation please document reasons for discontinuation.
6. Stopping
I acknowledge the guidance offered in Appendix 3, and where applicable, I will adhere to the
recommendations.
7. I acknowledge and adhere to the cost effective usage of biologicals as advocated in
NICE TA187, and believe that within this Trust the above patient would be best managed
using the biological requested above.
Signature -
Signature
Reason for discontinuation……………………….
Date of discontinuation…………………………….
Signature
-
Signature
-
NICE TA187 states that treatment should normally be started with the less expensive drug
(taking into account drug administration costs, required dose, product price per dose, clinical
effectiveness, potential need for dose escalation, risk of adverse events, additional clinical reviews,
and patient choice)
8. What is acquisition cost of drug for induction treatment including VAT (if applicable)?
9. What is the acquisition cost of drug for maintenance treatment including VAT if applicable?
£…………………….
£…………………….
10. Give cost/ code of activity associated with treatment?
I confirm that the patient (or in the case of a minor or vulnerable adult where the parent/guardian or
legal carer) has given consent for the patient identifiable data on this form to be shared with the
CCG Medicines Management / Optimisation or Contracts Team. This data may then be used 1. In
the interests of the care of the patient 2. For clinical audit purposes 3. To validate against
subsequent invoices.
Consultant signature (electronic signature acceptable)
Signature (or email confirmation) by Trust Chief Pharmacist (or deputy)
Date:
Date:
National Institute of Clinical Excellence – Technology Appraisal (No: 187) May 2010 available at www.nice.org.uk/TA187
Only fully completed forms will be accepted for consideration by the CCGs.
If the answer to any of these questions is NO, then a full Individual Funding Request form will need to be completed and these may be obtained from the
relevant Individual Funding Co-ordinator. Bedfordshire Clinical Commissioning Group (BCCG): Christine Garrett, Individual Funding Co-ordinator, BCCG
(christine.garrett@nhs.net); Secure Fax – 01525 864425; Suite 2, Capability House, Wrest Park, Silsoe, Bedfordshire MK45 4HR.
Luton Clinical Commissioning Group (LCCG) luton.itp@nhs.net; Secure fax: 01582 511054, The Lodge, 4 George St West, Luton, Beds, LU1 2BJ
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Appendix 1. Monitoring Sheet
For CCG Use
CCG Informed:
For:
Patient Initials…….………………………… ………
Date……………….............by:……………………………
D.O.B ………………NHS Number…………………
12 months following initiation of treatment:
Funding will only be approved after the first 8 weeks and 6 months if the patient has shown evidence of therapeutic benefit.
Continued treatment after 12 months will only be funded where
1) There has been clinical improvement (using clinical indices) but clear evidence of ongoing active disease as determined by objective biological markers,
colonoscopy or histology
2) Patients are in stable clinical remission but withdrawal from treatment could have a significant deleterious effect e.g.
a) repeated small bowel surgery - at risk of short bowel syndrome or sb transplant
b) complex peri-anal or rectal IBD - where surgery will lead to major anatomical changes, with no chance of ever achieving bowel continuity
Date
Months
Treatment Recommendation
0
2
6
12
24
36
48
HBS / mUCDAI
CRP
ESR
Calprotectin
Colonoscopy
Patients who do not meet the agreed eligibility criteria
The CCG will not normally fund any Crohn’s patient’s adalimumab or infliximab treatment where the patient does not meet the agreed criteria as outlined in this form. If
the consultant gastroenterologist wishes to treat with adalimumab or infliximab, the funding for the therapy would have to be borne from within the Trust’s existing drug
budget, subject to local hospital approval mechanisms.
Payment Authorisation
Bedfordshire CCG: This form should be returned to Christine Garrett, Individual Cases Panel Co-ordinator, Bedfordshire CCG (christine.garrett@nhs.net) {Secure Fax –
01525 864425}, Suite 2, Capability House, Wrest Park, Silsoe, Bedfordshire MK45 4HR)
Luton CCG: This form should be returned to Luton Clinical Commissioning Group (LCCG) Lutonnotification.proforma@nhs.net; Secure fax: 01582 511054, The
Lodge, 4 George St West, Luton, Beds, LU1 2BJ
Payment by the CCG will only be made if the completed form is received no later than 15 days after INITIAL treatment commences.
TA 187 sets out that people whose disease relapses after treatment is stopped should have the option to start treatment again. At that point an updated form must be
completed and returned to the CCG.
Where treatment is stopped, the CCG must be informed by 15th of the month following that in which treatment cessation occurred.
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Appendix 2 - Guidance on withdrawal of anti-TNF therapy in Crohn’s disease
Infliximab

Patients are scheduled to receive infliximab induction course of 0, 2 and 6 week infusions of 5mg/kg and then 2 monthly thereafter

First assessment between week 8-10
o
If no symptomatic response ( improvement in clinical symptoms, or fall of HBI <2 points, or no reduction in fistulae drainage )

o
If remission achieved (total HBI score <4 – correlates with CDAI<150; or >50% improvement in fistula drainage)

o
=> then continue with 8 weekly infusions and re-evaluate after next infusion.
If remission achieved (total HBI score <4)

o
=> continue with 8 weekly infusions
If partial response (fall of HBI >3 points – correlates with fall of CDAI of >100 - but no remission)

o
=> no further infliximab; consider surgery
=> continue with 8 weekly infusions
If HBI >5 consider dose escalation or switching to Adalimumab prior to surgery
Adalimumab

Patients are scheduled to receive adalimumab induction course of 160mg then 80mg at 2 weeks then 40mg every other week.

First assessment between week 8-10
o
If no symptomatic response to first 4 doses ( improvement in clinical symptoms, or fall of HBI <2 points, or no reduction in fistulae drainage )

o
If remission achieved (total HBI score <4 – correlates with CDAI<150; or >50% improvement in fistula drainage)

o
=> then give ‘week 8’ and week 10 doses and re-evaluate at week 12.
If remission achieved (total HBI score <4)

o
=> continue with 40mg adalimumab every other week
If partial response (fall of HBI >3 points – correlates with fall of CDAI of >100 - but no remission)

o
=> no further adalimumab; consider surgery if appropriate
=> continue with 2 weekly injections
If HBI >5 consider dose escalation prior to surgery.
NB 1 - CRP should also be monitored to corroborate HBI every 8 weeks (+/- faecal calprotectin where available)
NB 2 - To avoid waste ensure that only the appropriate amount of adalimumab is delivered by CCG’s designated homecare provider e.g. ‘Healthcare at Home’ – (e.g. 8 x 40mg doses only in 1st instance to
cover 160, 80, 40, 40)
NB 3 - As for the CDAI, the HBI score can be disproportionately influenced by the ‘number of liquid stools per day’. Some discretion may be required here particularly in patients who have loose stools when
in remission.
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Appendix 3. Criteria for stopping biologicals at 1 year with monitoring plan.




All patients starting anti-TNF therapy should be warned that there will be an attempt to wean this at 1 year.
From 8 months patients should be established on an optimised dose of immunomodulator therapy (azathioprine 2.5 mg/kg; 6MP 1.5 mg/kg; methotrexate
15-25mg/kg)
Situations in which the ‘1 year wean’ should be attempted include:
o Patients not previously treated with optimised dose of immunomodulator therapy prior to starting infliximab (eg may happen in the context of acute
severe steroid-refractory Crohn’s disease)
o Patients with surgically amenable Crohn’s disease: most commonly this will be limited ileo-caecal disease - ie where limited surgical resection
(ideally laparoscopic) would remove diseased segment without expectation of stoma or short bowel syndrome
o Patients in ‘’deep remission’’ – normal CRP, normal colonoscopy +/- normal calprotectin
 Patients in deep remission but who have had particularly troublesome Crohn’s prior to starting anti-TNF therapy (eg pan-enteric, severe
peri-anal disease etc) – consider stretching interval between doses as prelude to stopping (e.g. stretch interval to 10, 12 then 14 weeks – if
no relapse at 14 weeks then stop)
 Likewise for patients who have been on anti-TNF therapy long-term, with no previous discussion about stopping, may find the concept of
interval stretch with a view to stopping easier than just stopping
All patients in whom anti-TNF therapy is stopped should be monitored closely for evidence of relapse. Only by careful documentation, including continuing
HBI, and CRP 3-6 monthly +/- colonoscopy / faecal calprotectin + number of hospitalizations / surgeries / days off work will we understand the impact of
implementing a ‘stopping strategy’. The aim would be to pool data and write up after 2/3/5 years.
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