2014/15 PBR Exclusions – Funding Application for Adalimumab for Crohn’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 / 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 and is:
Biologic naïve; OR Being re-treated for a new episode of severe active Crohn’s disease / Yes / No
2.  Patient has severe active Crohn’s Disease defined as very poor general health and one or more symptoms such as weight loss, fever, severe abdominal pain & usually frequent (3-4 or more) diarrhoeal stools daily. / Yes / No
3.  Patient meets one or more of the following criteria:
§  Crohn’s Disease Activity Index score ³300: State score: Date: OR
§  Harvey-Bradshaw Index of ³8/9: State score: Date: OR
If these markers do not apply please give alternative QoL score: Date: / Yes / No
4.  Patient has previously received treatments as per NICE guidance below: / Yes / No
Treatment choices / Which treatments have been trialled in this patient (tick which applies) / Please indicate that the patient has either not responded/ is intolerant/has a contraindication to or is continuing on the marked treatments (please provide details)
Corticosteroids
Azathioprine
Mercaptopurine
Methotrexate
Other treatments (please list):
5.  What is the intended induction regimen? / 80/40mg / 160/80mg
6.  What is the monthly acquisition cost of drug (including VAT if applicable) at 40mg every other week? / £/month
FOR CCG/CSU USE ONLY
Funding is approved (for the induction course followed by 40mg on alternate weeks) for 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 /
Trial Withdrawal: Following the 12 months planned course, treatment should only be continued if there is clear evidence of ongoing active disease. According to NICE guidance there should be a trial withdrawal from treatment for all patients who are in stable clinical remission. (Section 2.9 A CDAI score of <150 is considered to be remission).
If continued treatment is appropriate: At 12 months, if a patient is to continue with treatment (rather than a trial withdrawal) the clinician is required to write to the CCG/CSU with a clinical update providing details that the patient has had a response to treatment but that they are not in stable clinical remission. The following should be provided at this point as per NICE commissioning algorithm:
·  Clinical symptoms (e.g. CDAI and/or HBI and/or alternative Quality of Life score)
·  Biological markers (e.g. CRP and / or faecalcalprotectin)
·  Other investigations as necessary (e.g. other luminal assessment or endoscopy if all other markers are normalised)
If patient relapses after trial withdrawal please complete an application to re-start treatment


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

1  Guidance

1.1  Infliximab 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.

1.2  Treatment as described in 1.1 should normally be started with the less 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.

1.3  Infliximab, 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.

1.4  Treatment with infliximab or adalimumab (see 1.1 and 1.3) should only be continued if there is clear evidence of ongoing active disease as determined by clinical symptoms, biological markers and investigation, including endoscopy if necessary. Specialists should discuss the risks and benefits of continued treatment with patients and consider a trial withdrawal from treatment for all patients who are in stable clinical remission. People who continue treatment with infliximab or adalimumab should have their disease reassessed at least every 12 months to determine whether ongoing treatment is still clinically appropriate. People whose disease relapses after treatment is stopped should have the option to start treatment again.

1.5  Infliximab, within its licensed indication, is recommended for the treatment of people aged 6–17 years with severe active Crohn’s disease whose disease has not responded to conventional therapy (including corticosteroids, immunomodulators and primary nutrition therapy), or who are intolerant of or have contraindications to conventional therapy. The need to continue treatment should be reviewed at least every 12 months.

1.6  For the purposes of this guidance, 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 (3–4 or more) diarrhoeal stools daily. People with severe active Crohn’s disease may or may not develop new fistulae or have extra-intestinal manifestations of the disease. This clinical definition normally, but not exclusively, corresponds to a Crohn’s Disease Activity Index (CDAI) score of 300 or more, or a Harvey-Bradshaw score of 8 to 9 or above.

1.7  When using the CDAI and Harvey-Bradshaw Index, healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect the scores and make any adjustments they consider appropriate.

1.8  Treatment with infliximab or adalimumab should only be started and reviewed by clinicians with experience of TNF inhibitors and of managing Crohn’s disease.

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NICE Crohn’s disease commissioning algorithm (26 May 2011)

(Ref: http://www.nice.org.uk/media/2BB/F5/CrohnsAlgorithm.pdf)

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