NWL CCG Use Only
Date Received:
Contact:
CCG:
Ref:
2014/15 Request for funding of a biologic for Rheumatoid Arthritis outside of NICE guidance
(for NWL CCG patients)
F.A.O:
PbR Excluded Drugs Team
North West London Collaboration of Clinical Commissioning Groups
E-mail: NWLCSU.NWLmedmgt@nhs.net
From:
Your designation:
Your contact details:
Date (dd/mm/yy):
Tel:
E-mail:
Before providing patient identifiable data below, I can confirm that the patient (or in the case of a minor or vulnerable adult
with the parent/legal guardian/carer) has given appropriate explicit consent for sensitive personal information on this form to
be passed to the CCG for processing this request for further funding and validating subsequent invoices.
Consent given: ☐Yes (please note, we will be unable to process this form if this box is not ticked)
I would like to request funding for the following:
Indication:
Rheumatoid arthritis (use London-wide tick box form for patients who are eligible under NICE)
Drug name:
☐ Abatacept
☐ Adalimumab
☐ Certolizumab
☐Etanercept
☐ Golimumab
☐Infliximab
☐Rituximab
☐Tocilizumab (please tick one)
Drug dose & frequency:
Patient weight (if used for drug dosing):
Kg
Patient NHS number:
Hospital no:
Patient birth year:
GP Practice Code:
GP Practice Postcode:
Note: This funding request form is only applicable for biologic treatment outside of current NICE guidance – please refer to
the agreed NWL commissioning pathway on pages 2 to 4 of this document for full details (use format dd/mm/yy for dates).
1. Please provide details of why this patient cannot have the standard intervention (as per NICE guidance):
☐ Contraindication* to the biologic(s):
because:
☐ Adverse effect(s) – please detail in section 3
☐ Inefficacy – please detail in section 3
2. Does the patient have active rheumatoid arthritis which had a DAS score >5.1, confirmed on at least 2 occasions 1
month apart while on disease modifying anti-rheumatic drugs (DMARD) but before any biologic drugs was started?
Baseline DAS28 score 1:
Date:
Baseline DAS28 score 2:
Date:
DMARD
Methotrexate
Start date
Stop date
Reason for stopping or not starting (detail)
3. Patient had inadequate response to previous/current biologic for rheumatoid arthritis (go to section 4 if first biologic):
Biologics (list all)
DAS28 at start date
DAS28 at stop date
Current DAS28
Reason for stopping (detail)
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
4. If available, patient access scheme confirmed for the requested drug?
☐ Yes
5. What is the acquisition cost of the drug (including VAT) if applicable?
£
☐ No
☐ N/A
/month
Additional information:
[12.12.14 v1] Refer to use of rituximab and newer biologics in RA – PDG agreed on October 2014
Page 1 of 4
NWL CCG Use Only
Date Received:
Contact:
CCG:
For NWL CCG use only:
Funding approved for first 6 months
Funding approved for 2 x 1g doses of rituximab
Ref:
☐ 1st line
☐ 1st line
☐2nd line
☐2nd line
☐3rd line therapy
☐3rd line therapy
Key to terms:
*Contraindications – absolute and relative
Absolute contraindications
 Previous history of cancer (within 5 - 10 years).
 Heart failure - NYHA III/IV
 Pulmonary fibrosis/ILD (some suggested that this is a relative contraindication, and could be
decided upon depending the patient’s lung function e.g. FEV<70% would be a contraindication)
 Demyelination
 Chronic infections (excluding HIV/hepatitis). Examples may be chronic ulcers, recurrent infections,
TB risk, HSV, recurrent pneumonias.
Relative contraindications
 Patients with ANA (there is some evidence to suggest that lupus may worsen with an anti-TNF
agent). It was suggested that if a patient had a very high titre e.g. ANA titre < 1:640, this could be a
threshold for avoiding an anti-TNF.
 Patients with an overlapping connective tissue disease.
*
For the pathways below:
DAS28: disease activity score
DMARD: disease-modifying anti-rheumatic drug
MTX: methotrexate
TA: NICE technology appraisal
TNF: tumour necrosis factor
Note: Sections coloured blue are based on NICE commissioning algorithm (May 2013).
Local proposals from RA workshop held 4th November 2013 have been incorporated in green
[12.12.14 v1] Refer to use of rituximab and newer biologics in RA – PDG agreed on October 2014
Page 2 of 4
NWL CCG Use Only
Date Received:
Contact:
CCG:
Ref:
NWL biologic monotherapy pathway (for patients intolerant to/inappropriate for MTX) for
rheumatoid arthritis
Contraindications* to NICE recommended anti TNFs?
1st line
1st line
YES
NO
Use the least expensive anti TNF as monotherapy:
 Adalimumab (TA130) or
 Certolizumab pegol (TA186)
 Etanercept (TA130)
Use the most cost-effective clinically appropriate
alternative biologic as monotherapy:
 Tocilizumab (licensed) or
 Rituximab (unlicensed) or
 Abatacept (unlicensed)
[Use London-wide tick box form]
YES consider
alternative anti-TNF
[Use local agreement form]
Has 1st line therapy been withdrawn because of an
adverse event?
YES consider
alternative biologic
NO
Adequate response to treatment at 6 monthly review
(DAS28 score improvement ≥ 1.2)?
2nd line
YES
NO
Use as monotherapy for 2nd line therapy:
Adalimumab (TA130); or Etanercept (TA130);
[Use London-wide tick box form] or
Tocilizumab (licensed); or Rituximab (unlicensed); or
Abatacept (unlicensed) [Use local agreement form]
YES consider
alternative biologic
Continue same treatment and monitor
every 6 months as per NICE criteria for
continuation of a biologic
Has 2nd line therapy been withdrawn because of an
adverse event?
NO
Inadequate response to 2nd line therapy?
3rd line
YES
NO
Use as monotherapy for 3rd line therapy:
Adalimumab or Etanercept; or
Tocilizumab (licensed); or Rituximab (unlicensed); or
Abatacept (unlicensed)
[Use local agreement form]
YES consider
alternative biologic
Continue same treatment and monitor
every 6 months as per NICE criteria for
continuation of a biologic
Has 3rd line therapy been withdrawn because of an
adverse event?
NO
Inadequate response to 3rd line therapy?
YES
STOP biologic therapy
Subsequent or other biologic requests require an IFR
NO
Continue same treatment
[12.12.14 v1] Refer to use of rituximab and newer biologics in RA – PDG agreed on October 2014
Page 3 of 4
NWL CCG Use Only
Date Received:
Contact:
CCG:
Ref:
NWL MTX and biologic combination therapy pathway for rheumatoid arthritis
Contraindications* to NICE recommended biologics?
1st line
NO
YES
1st line
Consider rituximab + MTX
Use least expensive biologic with MTX:
Abatacept (TA280) or Adalimumab (TA130) or Certolizumab
(TA186) or Etanercept (TA130) or Golimumab (TA225) or
Infliximab (TA130) or Tocilizumab (TA247)
[Use London-wide tick box form]
[Use local agreement form]
Has 1st line therapy been withdrawn because of an
adverse event?
YES consider
alternative biologic
NO
Adequate response to treatment at 6 monthly reviews
(DAS28 score improvement ≥ 1.2)?
NO
YES
Continue current treatment and
review every 6 months
2nd line
Use least expensive biologic with MTX for 2nd line therapy:
Abatacept or Adalimumab or Certolizumab or Etanercept or
Golimumab or Infliximab or Tocilizumab [Use local agreement form]
or Rituximab [T195] [Use London-wide tick box form]
Has 2nd line therapy been withdrawn because of an
adverse event?
YES consider
alternative biologic
NO
Inadequate response to 2nd line therapy?
YES
NO
Continue current
treatment
3rd line
Use least expensive biologic with MTX for 3rd line therapy:
Abatacept or Adalimumab or Certolizumab or Etanercept or
Golimumab or Infliximab or Tocilizumab or Rituximab
Has 3rd line therapy been withdrawn because of an
adverse event?
YES consider
alternative biologic
Inadequate response to 3rd line therapy?
NO
Continue current treatment
YES
STOP biologic therapy
Subsequent or other biologic requests require an IFR
[12.12.14 v1] Refer to use of rituximab and newer biologics in RA – PDG agreed on October 2014
Page 4 of 4