Eoe Priority Advisory Group Recommended Gpa

EOE PRIORITY ADVISORY GROUP RECOMMENDED GPA AGREEMENT EFFECTIVE FROM 29TH NOVEMBER 2010

NHS HERTFORDSHIRE TA 187: REQUEST FOR FUNDING OF INFLIXIMAB FOR CROHN’S DISEASE IN CHILDREN AGED 6-17 YEARS

Drug covered by this Group Prior Approval arrangement: Infliximab (anti TNF). For the purposes of this group prior approval this drug will be regarded as “standard biologic treatment”. This form to be used to notify the patient’s PCT of treatment initiation OR for prior approval of dose escalation

Patients who do not meet the agreed eligibility criteria NHS Hertfordshire will not normally fund any Crohn’s patient’s anti-TNF treatment where the patient does not meet the agreed criteria as outlined in this Group Prior Approval. If the consultant paediatric gastroenterologist wishes to treat with anti-TNF therapy 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. 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 and must be received and authorised BEFORE dose escalation.

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:

Patient Criteria for Starting Treatment For the purposes of funding all definitions are those set out in the NICE guidance that sets out the recommendations on use of these treatments Patient has the following diagnosis Please advise of any deviation from the patient criteria and rationale for proposing treatment with these drugs despite this deviation from the GPA: child (aged 6-17 years) with severe active Crohn’s disease Severe active Crohn’s disease in people aged between 6-17 years is defined Please specify which drugs patient has previously received (TA187) as disease that has not responded to conventional therapy (including corticosteroids, immunomodulators and primary nutrition therapy), or where the child is Start date Stop Treatment & Dose Reason for stopping intolerant of or has contraindications to conventional therapy. date

Current weight:

PCDAI score: Date:

TA 187 EoE PAC GPA recommendation Draft 1______Last printed Page 1 of 3 EOE PRIORITY ADVISORY GROUP RECOMMENDED GPA AGREEMENT EFFECTIVE FROM 29TH NOVEMBER 2010

CHOICE OF ANTI-TNF INFLIXIMAB:

NICE TA 187 recommends Infliximab 5mg/kg for children with severe active Crohn’s disease. Dose to be given: Induction regimen with doses at week 0, 2 and 6, thereafter maintenance at 8 weekly intervals Frequency of administration: STARTING TREATMENT Infliximab should be given as a planned course of treatment until treatment failure (including the need for surgery). Please indicate start date: INITIAL TREATMENT ASSESSMENT

Patient will be assessed for suitability for treatment continuation at 10-14 weeks after initiation. PCDAI score at 10-14 weeks after initiation:

Clinical response is defined as a PCDAI <30 and a reduction in baseline PCDAI of > 15 Date:

Clinical remission is defined as a PCDAI <10

Is the patient suitable for continuation of treatment? When stopped between 10 weeks and 1 year please give reason for discontinuation Yes / No

If patient does not meet clinical criteria for continuation, please give reasons for treatment Date of discontinuation: continuation:

DOSE ESCALATION OR INTERVAL REDUCTION TO RECAPTURE REMISSION PCDAI at time of proposed dose escalation: Commissioners will not routinely fund dose escalations. Date: Agreed dose escalation for infliximab is a single dose of 10mg/kg or 3 doses of 5mg/kg at 6 weekly intervals. Dose: For temporary dose escalation as described above, commissioners must be notified using the GPA proforma, but prior approval is NOT required Frequency:

Following dose escalation, the dosage will revert to the usual maintenance level with patients’ needs Length of dose escalation: reassessed. Rationale for dose escalation: Extended dose escalation will not be funded unless prior approval is sought on a patient -specific basis through the High Cost Drugs team at the PCT stating rationale, anticipated number of doses where dose is expected to be increased and the proposed new dose.

TA 187 EoE PAC GPA recommendation Draft 1______Last printed Page 2 of 3 EOE PRIORITY ADVISORY GROUP RECOMMENDED GPA AGREEMENT EFFECTIVE FROM 29TH NOVEMBER 2010

TREATMENT ASSESSMENT Funding will only be approved after the first 10-14 weeks and 6 monthly if the patient has shown evidence of therapeutic benefit.

Continued treatment after 6 months will usually only be funded if there is clear evidence of ongoing active disease as determined by symptoms, biological markers and investigation, including endoscopy if necessary. Treatment must be reviewed every 6 months. Discontinuation of treatment for responding patients is not usually considered in early or mid puberty due to the adverse effects on growth that a relapse is likely to cause.

Where treatment is stopped, the PCT must be informed by 15th of the month following that in which treatment cessation occurred. Treatment Evaluation at 6 months. Results of treatment assessment: Colonoscopy result: Continue treatment? Yes / No

PCDAI score: Date: Weight: Drug and dose:

Treatment Evaluation EVERY 12 months. Continue treatment? Yes / No Results of treatment assessment: Colonoscopy result:

PCDAI score: Date: Weight: Drug and dose: Treatment Evaluation EVERY 12 months. Continue treatment? Yes / No Results of treatment assessment: Colonoscopy result:

PCDAI score: Date: Weight: Drug and dose:

Please note that this group prior approval is subject to initiation and follow up of treatment response If this patient is being jointly managed by a second consultant being undertaken by a specialist paediatric gastroenterology team. please state name here: I acknowledge and adhere to the cost effective use of biologics as advocated in NICE TA187, and believe that within this Trust the above patient would be best managed using the biologic as requested Name: above: Date: Name of supervising consultant: Signature (or email confirmation) by Trust Chief Pharmacist (or deputy) Signature: Date: Name: Signature: For PCT Use PCT Informed: Date: by: Date:

S HERTFORDSHIRE PROFORMA 2010/11 DRUG EXCLUSIONS INFLIXIMAB FOR CROHN’S DISEASE IN CHILDREN AGED 6-17 YEARS; NICE TA 187

TA 187 EoE PAC GPA recommendation Draft 1______Last printed Page 3 of 3