Download Patient Criteria for Starting Treatment

NHS HERTFORDSHIRE
Funding Request for Group Prior Approval for RITUXIMAB for the Treatment of REFRACTORY VASCULITIS
or SYSTEMIC LUPUS ERYTHEMATOSUS
NHS Hertfordshire will not normally fund any treatment where the patient does not meet the agreed criteria as outlined in this Group Prior Approval. If the
consultant wishes to treat outside the terms of this GPA, the funding for the therapy would have to be borne from within the Trust’s existing drug budget,
subject to local hospital approval mechanisms.
Where a patient has been entered into a clinical trial and receives a non standard treatment for this condition, it is expected that where the patient derives
benefit and requires further treatment, following termination of the trial, that future funding of the therapy is the responsibility of the Trust where the trial was
conducted and such patients will not be eligible for treatment under this group prior approval.
If a patient has received non standard treatment within a clinical trial, has not received a standard treatment before and now requires further treatment then, for
the purpose of this group prior approval, the trial treatment will be disregarded and the patient considered against the treatment criteria in this group prior
approval for treatment with a standard drug.
Payment Authorisation
The completed form must be sent by the hospital commissioning team to High Cost Drugs Co-ordinator, Liz Goodwin, or nominated delegate in her
absence. Email: ([email protected] ). Payment by the PCT will only be made if the completed form is received no later than 15 days after
INITIAL treatment commences.
Patient NHS No.
Patient Hospital Number:
Patient initials & DoB:
Trust:
GP Name:
Consultant Making
Request:
Consultant Contact
Details:
GP code /
Practice code:
GP Post code:
EAST OF ENGLAND PROFORMA 2009/10 PBR Drug Exclusions (modified by NHS Bedfordshire 4.3.09 & NHS Hertfordshire 22.03.2011)
NHS Hertfordshire: Ritiximab for the Treatment of Refractory Vasculitis or Systemic Lupus Erythematosus
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This treatment will only be funded for the 1st treatment cycle for patients confirmed as meeting ALL of the following criteria:
Patient Criteria for Starting Treatment
1. Confirm Details of Diagnosis:
Patient has a diagnosis of refractory vasculitis or Systemic Lupus Erythematosus
(SLE).
2. Has the patient been tried on cyclophosphamide regimens and where possible
maintenance therapy on low dose steroids and methotrexate/azathioprine.
How does the patient fit the criterion for treatment? (Please advise
of any deviation from the patient criteria and rationale for this
deviation)
Yes
No
Yes
No
Yes
No
Patient has received at least 6m 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.]
3. Did the patient complete of at least six months of conventional combination
treatment?
4. If the answer to (3) is “NO”, please state which of the following reason applies:
1) Disease worsened despite at least 3 months treatment, or failed to be fully
controlled despite at least 6 months therapy;
2) Previous cyclophosphamide has worked, there is now a relapse on maintenance
therapy, and there is a desire to avoid more cyclophosphamide exposure
3) Cyclophosphamide intolerance (allergy, intractable nausea and vomiting,
myelosuppression, severe infection or haemorrhagic cystitis)
4) 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).
5) Other reasons – please define.
Yes
No
1.
2.
Yes
Yes
No
No
3.
Yes
No
4.
Yes
No
5. Please state:
EAST OF ENGLAND PROFORMA 2009/10 PBR Drug Exclusions (modified by NHS Bedfordshire 4.3.09 & NHS Hertfordshire 22.03.2011)
NHS Hertfordshire: Ritiximab for the Treatment of Refractory Vasculitis or Systemic Lupus Erythematosus
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5. Please provide information regarding the second line immunosuppressive agents used in this patient:
Name of Drug
Minimum duration of treatment required to
Duration of treatment
assess response
Reason for cessation of treatment
6. 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
Yes
No
Yes
No
7. What is the extent of major organ involvement (please stipulate which of kidney,
lung, heart, brain or motor peripheral nervous system are involved).
8. What is the objective evidence for progressive function loss?
9. 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]
Only fully completed forms will be accepted for consideration by the PCT.
If the answer to any of these questions is NO, then a full Individual Cases Panel form will need to be completed. These may be obtained
from Individual Cases Panel Co-ordinator, NHS Hertfordshire ([email protected] ) ; Charter House, Parkway, Welwyn Garden City, Herts, AL8
6JL Secure Fax – 01707 361286
EAST OF ENGLAND PROFORMA 2009/10 PBR Drug Exclusions (modified by NHS Bedfordshire 4.3.09 & NHS Hertfordshire 22.03.2011)
NHS Hertfordshire: Ritiximab for the Treatment of Refractory Vasculitis or Systemic Lupus Erythematosus
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Please note that this group prior approval is subject to initiation and follow up of
treatment response being undertaken by a specialist rheumatology team.
I acknowledge and adhere to the cost effective use of rituximab, and believe that
within this Trust the above patient would be best managed using rituximab as
requested above:
If the patient is being jointly managed by a second consultant, please state name
here:
Name:
Date:
Name of supervising consultant:
Signature:
Date:
For PCT Use
PCT Informed:
Signature (or email confirmation) by Trust Chief Pharmacist (or deputy)
Date:
by:
Name:
Signature:
Date:
Treatment Evaluation
10. 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.
Initial treatment (2g)
Status 3m post dose
Status 6m post dose
6m dose (1g)
12m dose (1g)
18m dose (1g)
Notification of Treatment Cessation and transfer to Best Supportive Care.
Date:
Reason for stopping:
EAST OF ENGLAND PROFORMA 2009/10 PBR Drug Exclusions (modified by NHS Bedfordshire 4.3.09 & NHS Hertfordshire 22.03.2011)
NHS Hertfordshire: Ritiximab for the Treatment of Refractory Vasculitis or Systemic Lupus Erythematosus
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