NOTIFICATION ONLY AND NOTIFICATION OF PATIENT ACCESS SCHEME FOR SECUKINUMAB

For Commencing Treatment with Secukinumab for the treatment of ankylosing spondylitis after treatment with NSAIDs or TNF inhibitors (NICE TA407, issued Sept 2016)

Please note “Notification Only” means that if the patient fulfils the proforma / NICE criteria then provider Trusts can commence treatment without the need to wait for CCG acknowledgement / approval.

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:

Please indicate which aspect of NICE TA407 applies for this patient

/

Please tick

/ Please ensure this form is countersigned by Trust Chief Pharmacist (or deputy) before onward transmission to CCG.
Only fully completed forms will be accepted for consideration by the CCGs.
If the answer to any of these questions is NO, then a full Individual Funding Request form will need to be completed and these may be obtained from the relevant Individual Funding Co-ordinator.
Bedfordshire Clinical Commissioning Group (BCCG): (e-mail preferred method) or telephone 01494 555530. IFR team, South, Central and West CSU, Albert House, Queen Victoria Road, High Wycombe, HP11 1AG.
Luton Clinical Commissioning Group (LCCG) ; IFR Co-ordinator, The Lodge, 4 George St West, Luton, Beds, LU1 2BJ
Dose and frequency: ……………………………
1.  The patient is an adult with active ankylosing spondylitis (AS) whose disease has responded inadequately to conventional therapy (non-steroidal anti-inflammatory drugs or TNF‑alpha inhibitors). / r Yes / r No
2.  Please list previous treatments with NSAIDs or TNF-alpha inhibitors:
Start date / Stop date / NSAID / TNF inhibitor Treatment / Reason for stopping
3.  Please confirm that the manufacturer will supply secukinumab with the discount agreed in the patient access scheme. / r Yes / r No
4.  What is the acquisition cost of drug including VAT (if applicable)? / £…………………….
5.  What is the cost/ code for activity associated with this treatment? / ______
For notification of continuation of therapy: Treatment should only be continued if the patient has responded after 16 weeks treatment. A response is defined as a reduction in the BASDAI score to 50% of the pre-treatment value or by 2 or more units and a reduction of the spinal pain VAS by 2 cm or more.
Pre-treatment BASDAI score ______Date ______
Post-treatment BASDAI score ______Date ______
Change in BASDAI score ______
Pre-treatment VAS score ______Date ______
Post-treatment VAS score ______Date ______
Change in VAS score ______
Please confirm that the patient has had an adequate response to therapy? / r Yes / r No
Please confirm that when using BASDAI and spinal pain VAS scores, any physical, sensory, or learning difficulties, or communication difficulties that could affect the response to the questionnaires has been taken into account and that any necessary adjustments have been made. / r Yes / r No
Trust contact e-mail in case of CCG query:
I confirm that the patient (or in the case of a minor or vulnerable adult where the parent/guardian or legal carer) has given consent for the patient identifiable data on this form to be shared with the CCG Medicines Management / Optimisation or Contracts Team. This data may then be used 1. In the interests of the care of the patient 2. For clinical audit purposes 3. To validate against subsequent invoices.
 Yes  No
Consultant Signature (electronic signature acceptable) / Trust Chief Pharmacist (or deputy) signature (electronic signature acceptable)
Date / Date
FOR CCG USE ONLY
CCG notified of first 16 weeks treatment? / r Yes / r No /
Treatment should only be continued if the patient:
·  Has responded (At 16 weeks there should be a 50% reduction of the baseline BASDAI score or by 2 or more units and a reduction of the spinal pain VAS by 2cm or more)
·  Maintains the above response after demonstrating an initial response at 16 weeks.
CCG notified of continued treatment at not less than 12 monthly intervals? / r Yes / r No
Secukinumab for active ankylosing spondylitis after treatment with nonsteroidal anti-inflammatory drugs or TNF-alpha inhibitors

Technology appraisal guidance 407, Published: 28 September 2016, nice.org.uk/guidance/ta407

1 Recommendations

1.1 Secukinumab is recommended, within its marketing authorisation, as an option for treating active ankylosing spondylitis in adults whose disease has responded inadequately to conventional therapy (non-steroidal anti-inflammatory drugs or TNF-alpha inhibitors). The drug is recommended only if the company provides it with the discount agreed in the patient access scheme.

1.2 Assess the response to secukinumab after 16 weeks of treatment and only continue if there is clear evidence of response, defined as:

·  a reduction in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score to 50% of the pre-treatment value or by 2 or more units and

·  a reduction in the spinal pain visual analogue scale (VAS) by 2 cm or more.

1.3 When using BASDAI and spinal pain VAS scores, healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect the responses to the questionnaires, and make any adjustments they consider appropriate.

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