PATIENT SPECIFIC FUNDING REQUEST FOR USTEKINUMAB FOR MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE AFTER PREVIOUS TREATMENT – NICE TECHNOLOGY APPRAISAL (TA) 456 ISSUED JULY 2017
https://www.nice.org.uk/guidance/ta456
Only fully completed forms will be accepted for consideration
The completed form must be sent by the hospital commissioning team to the High Cost Drugs Team at:
NHS Herts Valleys CCG:
NHS East & North Hertfordshire CCG:
If the patient does not fulfil routine commissioning criteria
· The responsible commissioner will not normally fund any treatment where the patient does not meet the agreed criteria as outlined in this patient specific funding application form.
· Following a clinical trial, the responsibility for ongoing funding remains with the provider or pharmaceutical company. The commissioner will only fund treatment that meets the commissioned pathway.
· Applications can be made via the Individual Funding Requests process ONLY where the patient has exceptional clinical circumstances. Please check the commissioner websites for contact details of the IFR team.
Patient NHS No. / Trust: / GP Name:Patient Hospital No. / Consultant Making Request: / GP Practice code:
Patient initials & DoB: / Consultant Contact Details: / GP Post code:
Please complete form in full.
Confirm stage of treatment application
a) A patient who is biologic naïve (complete sections 1, 2, 3 or 4, 5 & 9)
b) A change to 2nd line ustekinumab due to intolerance to TNFi (complete sections 1, 2, 3 or 4, 5 & 9)
c) A change to 2nd line ustekinumab due to lack/loss of response to TNFi (complete sections 1, 2, 3 or 4, 5, 6 & 9)
d) A clinical update requesting funding beyond 12 months (complete sections 6 & 9)
e) Request for initial temporary period of dose escalation (complete sections 6, 7 & 9)
f) Request for extended period of dose escalation (complete sections 6, 8 & 9)
1. Diagnosis and Disease Severity:
adult with severe active Crohn’s disease
adult with fistulising Crohn’s disease
· Severe active Crohn’s disease is defined as very poor general health and one or more symptoms such as weight loss, fever, severe abdominal pain and usually frequent diarrhoeal stools (≥3 daily).
· People with Severe Active Crohn’s Disease may or may not develop new fistulae or have extra-intestinal manifestation of the disease.
· This clinical definition normally, but not exclusively, corresponds to:
o Crohn’s disease activity index (CDAI) score ≥300
o Harvey-Bradshaw (HBI) score of ≥ 8-9.
Confirm Weight Loss
Weight loss in kg: Time period of weight loss: Current weight:
Confirm HBI score ≥ 8-9 or CDAI score ≥300
HBI score: Date measured:
CDAI score: Date measured:
Where HBI/CDAI is not a relevant indicator of disease severity specialist judgement confirmed with alternative objective measures (e.g. colonoscopy, MRI, stoma output, CRP, ESR, faecal calprotectin) to be provided that demonstrate severe active Crohn’s Disease (these will also be used to monitor treatment response):
2. Previous Treatment
Severe Active Crohn’s Disease – confirm that there has there been lack/loss of response, intolerance or contraindication to optimised conventional therapy taken for an adequate period, including immunosuppressive and/or corticosteroid treatments: Yes: No:
Fistulising Crohn’s disease – confirm that there has there been lack/loss of response, intolerance or contraindication to conventional therapy taken for an adequate period, including antibiotics, drainage and immunosuppressive treatment: Yes: No:
Please specify which treatments (including biologics where relevant) the patient has previously received:
Start date / Stop date / Treatment, Dose, Route and Frequency / Reason for stopping (if due to intolerance, please provide details of intolerance) or ongoing
3. Severe active Crohn’s disease – biologic choice
Treatment should normally be started with the least expensive drug (taking into account drug administration costs, required dose and product price per dose). This may need to be varied for individual patients because of differences in the method of administration and treatment schedules. Usual first line biologic choice is adalimumab
USTEKINUMAB
single intravenous infusion at induction (dose based on weight see below) followed by subcutaneous injections as maintenance (90mg at week 8, then every 12 weeks).
Initial intravenous dosing (from SPC)
Body weight of patient at the time of dosing / Recommended dosea / Number of 130 mg Vials
≤ 55 kg / 260 mg / 2
> 55 kg to ≤ 85 kg / 390 mg / 3
> 85 kg / 520 mg / 4
a Approximately 6 mg/kg
If ustekinumab has been chosen as first line biologic please indicate rationale
4. Active fistulising Crohn’s disease – biologic choice
Usual first line biologic choice for fistulising disease is infliximab
USTEKINUMAB
single intravenous infusion at induction (dose based on weight see below) followed by subcutaneous injections as maintenance (90mg at week 8, then every 12 weeks).
Initial intravenous dosing (from SPC)
Body weight of patient at the time of dosing / Recommended dosea / Number of 130 mg Vials
≤ 55 kg / 260 mg / 2
> 55 kg to ≤ 85 kg / 390 mg / 3
> 85 kg / 520 mg / 4
a Approximately 6 mg/kg
If ustekinumab has been chosen as first line biologic please indicate rationale
5. Planned course and stopping of treatment
Confirm that:
· treatment will be given as a planned course of treatment until treatment failure (including the need for surgery), or until 12 months after the start of treatment, whichever is shorter: Yes: No:
· treatment will only continue after 16 weeks if there has been an adequate response: Yes: No:
· patients starting treatment have been/will be informed that there will be an attempt to withdraw treatment at 12 months, if disease is in stable clinical remission and that this has been/will be recorded in patients notes: Yes: No:
6. Treatment review – Please use this table to provide update on response and apply for continuation of funding
Complete table with relevant available clinical information and confirm that there has been an adequate response and ongoing treatment rather than a trial withdrawal is indicated for the following reason(s):
· there is clear evidence of ongoing active disease
· there is intolerance/contraindication to maintenance immunosuppressive treatment & only maintenance treatment option is a biologic
· disease has relapsed on previous trial withdrawal
Date
Time on treatment / 0 / 12 weeks / 6 months / 12 months / months / months / months
Drug name / dose / frequency
HBI
Well being (0-4)
Abdo pain (0-3)
No. Liquid Stools
Abdo Mass (0-3)
Complications
TOTAL
CRP / ESR / / / / / / / / / / / / / /
Calprotectin
Colonoscopy
MRI
Stoma output
Treatment Plan
(Continue? Dose
escalate? Planned withdrawal?) / In remission?
Trial without treatment considered?
Yes / No / In remission?
Trial without treatment considered?
Yes / No / In remission?
Trial without treatment considered?
Yes / No / In remission?
Trial without treatment considered?
Yes / No
Harvey Bradshaw Index (HBI):
· General well-being (0 = well, 1 = slightly below par, 2 = poor, 3 = very poor, 4 = terrible)
· Abdominal pain (0 = none, 1 = mild, 2 = moderate, 3 = severe)
· Number of liquid stools per day
· Abdominal mass (0 = none, 1 = dubious, 2 = definite, 3 = definite and tender)
· Complications: arthralgia, uveitis, erythema nodosum, aphthous ulcers, pyoderma gangrenosum, anal fissure, new fistula, abscess (score 1 per item)
7. Initial dose escalation/interval reduction to recapture remission
Confirm that there has been an initial response to treatment but there has subsequently been a loss of response as demonstrated by the clinical information provided in the table in section 6: Yes: No:
Confirm dose escalation schedule to be used:
Ustekinumab 90mg by subcutaneous injection every 8 weeks for 2 doses
Confirm that following dose escalation if there is no response treatment will stop, or where clear objective evidence of response is shown the dose will be de-escalated to standard dose: Yes: No:
8. Extended dose escalation/interval reduction
Confirm that there has been clear objective evidence of response to escalated dose & loss of response on de-escalation to standard dose as demonstrated by the clinical information provided in the table in section 6: Yes: No:
Confirm dose escalation schedule to be used:
Ustekinumab 90mg by subcutaneous injection every 8 weeks
Confirm that:
· following dose escalation if there is no response treatment will stop: Yes: No:
· patient will be reassessed after 6 months & then at least every 12 months to determine if ongoing escalated dose is still clinically appropriate (update to be provided to commissioner): Yes: No:
· A trial of de-escalation in patients without active disease in stable clinical remission will be undertaken (patients whose disease subsequently relapses after trial de-escalation may continue escalated dose): Yes: No:
9. Clinician’s Declaration
I confirm that I have discussed with the patient and that they understand and consent to their personal information being shared with commissioning and commissioning support organisations for the purposes of funding approval and for drug charge validation. I have also recorded this discussion in the patient’s notes.
I confirm the risks and benefits of treatment have been fully discussed with the patient and documented.
I confirm that funding approval is subject to initiation and follow up of treatment response being undertaken by a specialist gastroenterology team.
I acknowledge & adhere to the cost effective use of biologics as advocated in the relevant NICE TA & local pathway & believe that within this Trust the above patient would be best managed using the biologic requested.
I confirm that when using HBI and CDAI scores to inform conclusions about whether severe active Crohn’s disease is present or to make a decision about whether to continue treatment I have been mindful of the need to secure equality of access to treatment for patients with disabilities and patients from different ethnic groups.
Name of supervising consultant:
Signature: Date: / If this patient is being jointly managed by a second consultant, please state name here:
Name:
Date:
Signature (or email confirmation) by Trust Chief Pharmacist (or deputy)
Name:
Signature:
Date:
Pharmacy and Medicines Optimisation Teams, NHS East & North Herts and NHS Herts Valleys Clinical Commissioning Groups Page 1 of 5