PRIOR APPROVAL Funding Request for the use of RITUXIMAB for the Treatment of Refractory Vasculitis

Patient NHS No. / Trust: / GP Name:
Patient Hospital Number: / Consultant Making Request: / GP code / Practice code:
Patient initials & DoB: / Consultant Contact Details: / GP Post code:

1.  Please confirm which brand of rituximab will be used (please tick):

r Mabthera® brand rTruxima® brand r Rixathon® brand / Does the patient fit the criterion for treatment?
(Please advise of any deviation from the patient criteria and rationale for this deviation)
Patient Criteria for Starting Treatment
(Patients must meet all of the following criteria for treatment :-)
2.  Please confirm the patient’s diagnosis is refractory vasculitis and NOT ANCA-positive vasculitis, which is a NHS England commissioning responsibility. / r Yes r No
3.  Has the patient been tried on cyclophosphamide regimens and where possible maintenance therapy on low dose steroids and methotrexate/azathioprine.
Patient has received at least 6 months of conventional combination treatment with standard immunosuppressives/steroids.
[A 'standard' course of cyclophosphamide is of 3-6 months duration and comprises either 6 pulses of IV cyclophosphamide 15mg/kg (at 0, 2, 4,7,10 and 13 weeks, or daily. For patients who have shown a response by 13 weeks, treatment should be continued until 6m for a total of 10 pulses. The duration is determined by the speed of response).
For new patients, concomitant steroid dosing is prednisolone 1mg/kg/day tapering to 0.15mg/kg/day by 3 months and 0.1mg/kg/day by six months.
For relapsing patients, prednisolone treatment should rarely exceed three months and the dose should be started at 0.5mg/kg/day.] / r Yes r No
r Yes r No
4.  Did the patient complete of at least six months of conventional combination treatment? / r Yes / r No
5.  If the answer to (3) is “NO”, please state which of the following reason applies?
a.  Disease worsened despite at least 3 months treatment, or failed to be fully controlled despite at least 6 months therapy;
b.  Previous cyclophosphamide has worked, there is now a relapse on maintenance therapy, and there is a desire to avoid more cyclophosphamide exposure
c.  Cyclophosphamide intolerance (allergy, intractable nausea and vomiting, myelosuppression, severe infection or haemorrhagic cystitis)
d.  Young female in whom risk of infertility is directly related to cyclophosphamide exposure and they have failed at least 6 months of alternative immunosuppressives (including methotrexate, azathioprine or mycophenolate mofetil).
e.  Other reasons – please define. / a)  r Yes r No
b)  r Yes r No
c)  r Yes r No
d)  r Yes r No
e)  Please state:
6.  Please provide information regarding the second line immunosuppressive agents used in this patient
Name of Drug / Minimum duration of treatment required to assess response / Duration of treatment / Reason for cessation of treatment
7.  What is the goal of treatment for this patient in relation to disease status:
1)  Remission: No disease activity for 2 – 6 months and prednisolone at 10mg/day or below
2)  Partial remission: a greater than 50% reduction in disease activity compared to baseline after 2-6m and at a steroid dose at or below 10mg/day / r Yes r No
r Yes r No
8.  What is the extent of major organ involvement (please stipulate which of kidney, lung, heart, brain or motor peripheral nervous system are involved).
9.  What is the objective evidence for progressive function loss?
10.  What is the dosing schedule to be used for this patient?
[Dosing schedule agreed is for initial 2g treatment then maintenance doses at 6m, 12m, and 18 m]
11.  Has this application been peer reviewed by another consultant experienced in the therapeutic treatment of refractory vasculitis. / r Yes / r No
Name:……………………………………………..
Signature:……………………………………Date:…………
12. 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. /  Yes  No
Trust contact e-mail in case of CCG query:
Consultant signature (electronic signature acceptable): / Trust Chief Pharmacist (or deputy) signature (electronic signature acceptable):
DATE: / DATE:
For CCG Use
1.  Funding Approved for: / Patient identifier :……………………………………….
Treatment Evaluation
2.  Describe the patient’s status in relation to the stopping criteria at each dose.
Primary Rituximab failure would be judged, between 3 and 6 months, as a failure to reach at least partial remission (>50% reduction in disease activity).
Secondary Rituximab failure would be a failure to respond to repeat therapy. / Status 3m post dose / Status 6m post dose
Initial treatment (2g)
6m dose (1g)
12m dose (1g)
18m dose (1g)
Notification of Treatment Cessation and transfer to Best Supportive Care. / Date:
Reason for stopping:

Only fully completed forms will be accepted by The CCGs. Please ensure that this form is countersigned by the Trust Chief Pharmacist (or deputy) before onward transmission to the CCG.

Please Note: If the patient does not fulfil the agreed criteria for treatment, then a full Individual Funding Request form will need to be completed and these may be obtained from the Individual Funding Co-ordinator.

Bedfordshire Clinical Commissioning Group (BCCG): (e-mail preferred method) 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), (e-mail preferred method), The Lodge, 4 George St West, Luton, Beds, LU1 2BJ

BCCG: This form should be returned to Bedfordshire Clinical Commissioning Group (BCCG): (e-mail preferred method) or IFR team, South, Central and West CSU, Albert House, Queen Victoria Road, High Wycombe, HP11 1AG.

LCCG: This form should be returned to (e-mail preferred method), The Lodge, 4 George St West, Luton, Beds, LU1 2BJ. n:\medicines management\commissioning\proformas\2017_18 proformas\rituximab for refractory vasculitis beds v1.doc

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