2014/15 PBR Exclusions – Funding Application for DOSE ESCALATION ofAdalimumab or InfliximabforCrohn’s Disease

(Final version 1: last updated 01/04/14)

Before providing patient identifiable data on this form, please 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 and/or CSU for processing this funding request and validating subsequent invoices. Consent given: Yes
Patient NHS No. / Trust: / GP Name:
Patient Hospital Number:
Patient’s birth year: / (yyyy) / Consultant Making Request: / GP code / Practice code:
Confirm patient status:
(* select 1 option) / NHS Private Overseas / Consultant Contact Details: / GP Post code:

Please indicate which aspect of NICE applies for this patient

/

Please tick

/ Only fully completed forms will be accepted by CCGs/CSUs for consideration.
If the answer to any of these questions is NO, please consider if there are patient specific exceptional clinical circumstances demonstrated. If so, a full individual funding request (IFR) form will need to be completed. This may be obtained from the named contact at the relevant CCG/CSU/Trust. Please refer to the individual CCG IFR policy for further details.
Contact details:
Form completed by:
Email:
Phone:
Date of completion:
Additional Information:
  1. Patient is aged 18 years or over
/ Yes / No
  1. Patient is currently receiving either adalimumab or infliximab for severe active Crohn’s disease (please list)
/ Yes / No
Drug / Dose and frequency / Start date
Adalimumab
Infliximab
  1. Patient has shown an improvement in symptoms but response has subsequently declined.
/ Yes / No
Pre-treatment score / Date / On-treatment score / Date
To indicate initial response / Current score / Date
To indicate declined response
Crohn’s Disease Activity Index / / / / / /
Harvey Bradshaw Index / / / / / /
Alternative QoL / / / / / /
  1. Proposed intervention to recapture remission is within agreed commissioning arrangements:
Adalimumab 40mg can be given weekly for up to 12 weeks. Infliximab can be increased to 10mg/kg (for three doses) or interval reduced to six or four weeks at 5mg/kg for up to 12 weeks. Please indicate: / Yes / No
Drug / Dose and frequency / Intended length of dose escalation (in weeks)
Adalimumab
Infliximab / (patient weight:kg)
  1. After planned period of dose escalation, dose will revert to the usual maintenance level with patient’s needs reassessed
/ Yes / No
  1. What is the acquisition cost of drug (including VATif applicable)?
Please note that CCGs will not pay more than the London Procurement Programme list price. / £/ month(s)
FOR CCG/CSU USE ONLY
Funding is approved for temporary dose escalation ONLY for:
up to 12 weeks for weekly adalimumab
three doses of infliximab 10mg/kg
up to 12 weeks for six/four weekly infliximab 5mg/kg / Yes / No / Ongoing dose escalation for maintenance is not routinely commissionedand will require submission of an individual funding request demonstrating that patient specific exceptional clinical circumstances exist. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment.

Infliximab (review) and adalimumab for the treatment of Crohn’s (NICE TA 187: May 2010)

1.1Infliximab and adalimumab, within their licensed indications, are recommended as treatment options for adults with severe active Crohn’s disease (see 1.6) whose disease has not responded to conventional therapy (including immunosuppressive and/or corticosteroid treatments), or who are intolerant of or have contraindications to conventional therapy. Infliximab or adalimumab should be given as a planned course of treatment until treatment failure (including the need for surgery), or until 12months after the start of treatment, whichever is shorter. People should then have their disease reassessed (see 1.4) to determine whether ongoing treatment is still clinically appropriate.

1.3Infliximab, within its licensed indication, is recommended as a treatment option for people with active fistulising Crohn’s disease whose disease has not responded to conventional therapy (including antibiotics, drainage and immunosuppressive treatments), or who are intolerant of or have contraindications to conventional therapy. Infliximab should be given as a planned course of treatment until treatment failure (including the need for surgery) or until 12months after the start of treatment, whichever is shorter. People should then have their disease reassessed (see1.4) to determine whether ongoing treatment is still clinically appropriate.

3.3For severe, active Crohn's disease, infliximab is given as a 5-mg/kg intravenous infusion over a 2-hour period followed by another 5-mg/kg infusion 2weeks after the first. If a person's disease does not respond after two doses, no additional treatment with infliximab should be given. In people whose disease responds, infliximab regimens include maintenance treatment (another 5-mg/kg infusion at 6weeks after the initial dose, followed by infusions every 8weeks) or re-administration, otherwise known as episodic treatment (an infusion of 5-mg/kg if signs and symptoms of the disease recur) in line with the marketing authorisation. In adults, dose escalation is an option for people whose disease has stopped responding. According to the SPC, continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment

3.9The adalimumab induction treatment dose regimen for adults with severe Crohn's disease is 80mg via subcutaneous injection, followed by 40mg 2weeks later. If there is a need for a more rapid response to therapy, a dose of 160mg followed by 80mg 2weeks later can be used, though the risk of adverse events with this higher dose is greater during induction. After induction treatment the recommended dose is 40mg every other week. This can be increased to 40mg every week in people whose disease shows a decrease in response to treatment. According to the SPC, continued therapy should be carefully reconsidered in patients whose disease does not respond within 12 weeks of initiating treatment

Summary of Product Characteristics

  • Adalimumab (Humira®)(ref: accessed 01/04/14, last updated on the eMC: 27/03/14)
/
  • Infliximab (Remicade®) ®) (ref: accessed 01/04/14, last updated on the eMC: 07/08/13)

Some patients who experience decrease in their response may benefit from an increase in dose intensity to 40 mg Humira every week. / Although comparative data are lacking, limited data in patients who initially responded to 5 mg/kg but who lost response indicate that some patients may regain response with dose escalation (see section 5.1). Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment.

1