PATIENT SPECIFIC FUNDING REQUEST FORTOFACITINIB WITHOUT METHOTREXATE FOR MODERATE TO SEVERE RHEUMATOID ARTHRITIS -

NICE TECHNOLOGY APPRAISAL (TA) 480

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 ONLYwhere the patient has exceptional clinical circumstances. Please check the commissioner websites for contact details of the IFR team.

Patient NHS No. / Trust: / GP Name:
PatientHospital 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, 5 & 7)
b) A change totofacitinib following inadequate response to at least 1 biological DMARD(complete sections 1, 2, 4, 5 & 7)
c) A clinical update requesting funding beyond 6 months(complete sections 6 & 7)
1. Diagnosis and Disease Severity:
Confirm this is an adult with moderate to severe active rheumatoid arthritis? Yes: No:
Confirm DAS-28 score >5.1 confirmed on at least 2 occasions (1 month apart)? Yes: No:
DAS28 score 1: Date: DAS28 score 2: Date:
2. Previous and Current Treatment
Confirm that patient is not receiving concomitant methotrexate? Yes No (if Noapply using separate with methotrexate form).
Confirm contra-indication/intolerance to methotrexate
Confirm there has been an inadequate response to an adequate trial of ≥2 DMARDs in combination, including methotrexate (unless contra-indicated/not tolerated), with at least 2 months at standard dose, unless significant toxicity has limited dose or duration? 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
  1. Biologic choice in biologic naïve patients
Treatment should usually be started with the least expensive appropriate biologic. Etanercept (biosimilar) is usual 1stline choiceTNF inhibitor choice.
Tofacitinib – 5mg once or twice daily
If tofacitinib has been chosen as first line biologic please indicate rationale:
  1. Change to tofacitinib following inadequate response to at least 1 biological DMARD
Confirm there has been an inadequate response to at least 1 biological DMARD as demonstrated by the clinical information provided in the table in section 2? Yes No
Tofacitinib – 5mg once or twice daily
  1. Response assessment and stopping of treatment
Confirm that:
  • treatment will stop if there has not been an adequate response(DAS28 improvement ≥1.2)by 6 months?Yes: No:
  • treatment will stop where an adequate response(DAS28 improvement ≥1.2)is not maintained? Yes: No:

  1. Treatment review – Please use this table to provide update on response and apply for continuation of funding
Confirm that there has been an adequate response (DAS28 improvement ≥1.2) to treatment by 6 months as demonstrated in the table below and so ongoing treatment is appropriate? Yes: No:
Duration of current treatment / 0 months
Date
DAS28 score
Change from baseline score
Adverse Event?
Drug
Dose
Frequency
Change treatment?
Date discontinued
Confirm that DAS 28 score and change from baseline will be monitored at 6 monthly intervals to ensure continued response? Yes: No:
Confirm that treatment will stop where an adequate response(DAS28 improvement ≥1.2) is not maintained? Yes: No:
Confirm that where there has been an adequate response to treatment by 6 months although there is no need to forward regular updates to commissioners, confirmation of treatment response will be supplied if requested in the future for audit purposes to confirm maintenance of an adequate response as per NICE criteria? Yes: No:
7. 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 rheumatology team.
I acknowledge & adhere to the cost effective use of biologics as advocated in the relevant NICE TA believe that within this Trust the above patient would be best managed using the biologic requested.
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 GroupsPage 1 of 3