Download Etanercept and Infliximab for the treatment of Rheumatoid Arthritis

NOTIFICATION ONLY
For commencing treatment with Certolizumab pegol for Rheumatoid Arthritis after TNF inhibitor. NICE technology appraisal guidance [TA415] October 2016
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.
Patient Hospital Number:
Patient initials & DoB:
1.

2.
Trust:
GP Name:
Consultant Making Request:
GP code / Practice code:
Consultant Contact Details:
GP Post code:
Please indicate which aspect(s) of NICE TA 375 applies for this patient
Please specify which agent is to be prescribed (please tick):
Please tick
certolizumab pegol with methotrexate
 certolizumab pegol monotherapy
Please confirm that the patient is an adult with severe active rheumatoid arthritis and has had an
inadequate response to, or has an intolerance of, other DMARDs, including at least one TNF
inhibitor. Please specify which drugs patient has previously received, how long they were used for
and the reason for stopping:
Start date
Stop date
Drug and length of treatment
Reason for stopping
 Yes
3.
Please ensure this form is countersigned by Trust Chief
Pharmacist (or deputy) before onward transmission to
CCG.
Only fully completed forms will be accepted for
consideration by the CCGs.
Please provide the current DAS28 score:
DAS28 Score ……………………..… Date: ………………
4. For use of certolizumab pegol (please tick):
 With methotrexate, please confirm that rituximab is contraindicated or not tolerated.
 Prescribed as monotherapy, please confirm that the patient cannot take methotrexate because it is
5.
contraindicated or because of intolerance?
Please confirm that the patient has been entered into the Certolizumab Patient Access Scheme.
6.
What is acquisition cost of drug including VAT (if applicable)?
7.
Give cost/ code of activity associated with treatment?
 Yes
 Yes
 No
 No
 No
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 Coordinator.
Bedfordshire Clinical Commissioning Group
(BCCG): Bedfordshire Clinical Commissioning
Group (BCCG): e-mail (Preferred method):
[email protected] or telephone 01494
555530. IFR team, South, Central and West CSU,
Albert House, Queen Victoria Road, High
Wycombe, HP11 1AG.
Luton Clinical Commissioning Group (LCCG) email (Preferred method): [email protected]; The
Lodge, 4 George St West, Luton, Beds, LU1 2BJ
Drug dose + frequency: ..……………………………
£……...…/month
Trust contact e-mail in case of CCG query:
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)
Trust Chief Pharmacist (or deputy) signature (electronic signature acceptable)
Date
Date
LCCG: This form should be returned to [email protected]; (e-mail preferred method), The Lodge, 4 George St West, Luton, LU1 2BJ. BCCG: This form should be returned to: e-mail (Preferred
method): [email protected] or telephone 01494 555530. IFR team, South, Central and West CSU, Albert House, Queen Victoria Road, High Wycombe, HP11 1AG. Document1
For Notification of Continuation of Therapy
Treatment should only be continued after 6 months if the patient has had a moderate response as measured
using the European League Against Rheumatism (EULAR) criteria i.e. an improvement of DAS28 score of
> 1.2; and if the patient is not suffering from any severe drug related toxicity.
Please confirm that the patient has responded to treatment: moderate EULAR response at 6 months or
give present DAS28 score__________
Please confirm patient has not suffered severe drug related toxicity.
 Yes
 Yes
 No
 No
 Yes
 No
On-going treatment beyond the initial 6 month review:
In patients who have had an initial response within 6 months, treatment should be withdrawn if a
moderate EULAR response is not maintained.
Has a moderate EULAR response been maintained?
CCG notified of first 6 months treatment?
CCG notified of continued treatment after 6 months and / or at
12 monthly intervals?
 Yes
 Yes
FOR CCG USE ONLY
 No
 No
Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor
Technology appraisal guidance 415, Published: 26 October 2016, nice.org.uk/guidance/ta415
1.1 Certolizumab
pegol, in combination with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose
disease has responded inadequately to, or who cannot tolerate, other disease-modifying antirheumatic drugs (DMARDs) including at least 1
tumour necrosis factor-alpha (TNF-alpha) inhibitor, only if:
 disease activity is severe and
 rituximab is contraindicated or not tolerated and
 the company provides certolizumab pegol with the agreed patient access scheme.
1.2 Certolizumab pegol, as monotherapy, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has
responded inadequately to, or who cannot tolerate, other DMARDs including at least 1 TNF-alpha inhibitor, only if:
 disease activity is severe and
 rituximab therapy cannot be given because methotrexate is contraindicated or not tolerated and
 the company provides certolizumab pegol with the agreed patient access scheme.
1.3 Continue treatment only if there is at least a moderate response measured using European League Against Rheumatism (EULAR) criteria
at 6 months. After an initial response within 6 months, withdraw treatment if at least a moderate EULAR response is not maintained.
1.4 This guidance is not intended to affect the position of patients whose treatment with certolizumab pegol was started within the NHS before
this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for
them before this guidance was published until they and their NHS clinician consider it appropriate to stop.
Comparing the DAS28 from one patient on two different time points, it is possible to define improvement or response. The EULAR
response criteria are defined as follows:
DAS28 improvement →
Present DAS28↓
≤ 3.2
> 3.2 and ≤ 5.1
> 5.1
> 1.2
> 0.6 and ≤ 1.2
≤ 0.6
good response
moderate response
moderate response
moderate response
moderate response
no response
no response
no response
no response
Source: http://www.das-score.nl/das28/en/difference-between-the-das-and-das28/importance-of-das28-and-tight-control/eular-response-criteria.html
LCCG: This form should be returned to [email protected]; (e-mail preferred method), The Lodge, 4 George St West, Luton, LU1 2BJ. BCCG: This form should be returned to: e-mail (Preferred
method): [email protected] or telephone 01494 555530. IFR team, South, Central and West CSU, Albert House, Queen Victoria Road, High Wycombe, HP11 1AG. Document1