FUNDING REQUEST FOR BIOLOGICSIN THE TREATMENT OFADULTS WITH PSORIASIS – NICE TAs 103, 134, 146 and 180.

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

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:
First line biologic choice
Criteria for initiation of adalimumab or etanercept, fromNICE TAs 103 and 146: Therapy with adalimumab or etanercept is indicated for severe psoriasis, defined as a PASI score of 10 and a DLQI score of > 10. The psoriasis must also have failed to respond to standard systemic therapies including ciclosporin, methotrexate and PUVA, or the patient must be intolerant of, or have a contra-indication to these treatments. Funding will be for an initial 12 weeks (etanercept) or 16 weeks (adalimumab), with continuation beyond this time period dependent upon response defined below.
Criteria for initiation of ustekinumab, from NICE TA 180: Therapy with ustekinumab is indicated for severe psoriasis, defined as a PASI score of 10 and a DLQI score of 10. The psoriasis must also have failed to respond to standard systemic therapies including ciclosporin, methotrexate and PUVA, or the patient must be intolerant of, or have a contra-indication to these treatments.The manufacturer will provide the 90mg dose (two 45mg vials) for people who weigh more than 100kg at the same total cost as for a single 45mg vial. Funding will be for an initial 16 weeks, with continuation beyond this time period dependent upon response defined below.
Criteria for initiation of infliximab, fromNICE TA 134: Therapy with infliximab is indicated for very severe psoriasis, defined as a PASI score of 20 and a DLQI score of > 18. The psoriasis must also have failed to respond to standard systemic therapies including ciclosporin, methotrexate or PUVA, or the patient must be intolerant of, or have a contra-indication to these treatments. Funding will be for an initial 10 weeks with continuation beyond this time period dependent upon response defined below.
PASI score:
DLQI score:
Date measured: / Record of previous standard psoriasis treatments tried:
Start date / Stop date / Treatment dose and frequency / Reason for stopping
Indicate drug choice and dose:
  • Adalimumab 80mg wk 0, 40mg wk 1, thereafter 40mg 2 weekly:
  • Etanercept 25mgtwice weekly:
  • Etanercept 50mg weekly:
  • Ustekinumab 45mg/90mg at week 0, 4 and thereafter 12 weekly
Patient weight: kg (ustekinumab 90mg is commissioned for patients >100kg)
  • Infliximab dose 5mg/kg wk 0, 2 and 6, thereafter 8 weekly:
Patient weight: kg, Infliximab dose: mg / Date of initiation: / Cost to commissionerper dose (excl VAT):
Funding will be approved for an initial 10 weeks (infliximab), 12 weeks (etanercept) or 16 weeks (adalimumab/ustekinumab). Patients intolerant to the original choice biologic within the initiation period may switch to analternative biologic BUT the commissioner must be informed.
Date of switching due to intolerance to original choice of agent:
Alternative drug choice:
Dose:
Cost to commissionerper dose:
Funding will be approved for a further initiation period of 12 weeks for etanercept or 16 weeks for adalimumab/ustekinumab or 10 weeks for infliximab.
Continuation of funding is dependent upon adequate response at 10 weeks (infliximab), 12 weeks (etanercept),or 16 weeks (adalimumab/ustekinumab). Adequate response is defined as a 75% reduction in PASI score or a 50% reduction in PASI score AND a 5 point reduction in DLQI from when treatment was started.
PASI score:DLQI score:
Date assessed: / Patient response adequate for treatment continuation:
Yes/No
Second line biologic choice following primary or secondary failure
Hertfordshire routine commissioning agreement, September 2012: ustekinumab is funded in the following circumstances:
  • 1st line option as per NICE TA180 (as above)
  • Primary failure: Patients who do not respond to initial choice of biologic within 10 weeks (infliximab), 12 weeks (etanercept) or 16 weeks (adalimumab)
  • Secondary failure: Patients who respond to initial choice of biologic but subsequently lose response.
Note NICE TA180 states that patients weighing more than 100kg and thus requiring 90mg dose of ustekinumab will receive this dose at the same cost as one 45mg vial. Hertfordshire commissioners will only fund the first two doses after which time outcomes to be sent to the high cost drugs team for approval of ongoing treatment (i.e. approval for week 16 and ongoing doses).
Routine commissioning of a second line biologic after primary or secondary failure of 1st line ustekinumab has not been agreed locally and would require a business case to be submitted to the commissioning organisation via Hertfordshire Medicines Management Committee.
Patient weight: / Dose and frequency of ustekinumab: / Date of initiation: / Cost to commissioner per dose (excl VAT):
Continuation of funding for ustekinumab is dependent upon adequate response at 16 weeks. Adequate response is defined as a 75% reduction in PASI score or a 50% reduction in PASI score AND a 5 point reduction in DLQI from when treatment was started. Patient assessment must occur before a dose at 28 weeks will be funded.
PASI score:DLQI score:
Date assessed: / Patient response adequate for treatment continuation:
Yes/No
Updates for ongoing funding following initial demonstration of response
For etanercept, patients should be reassessed 24 weeks after initiation, and consideration given to stopping therapy. If therapy is to be continued annual updates are to be supplied to commissioner demonstrating continued response, in order to access continued funding.
For adalimumab, infliximab and ustekinumab, annualtreatment updates, demonstrating continued response must be submitted to the commissioner in order to access continued funding.
Treatment response and changes to treatment should be recorded in the table below.
Date / t=0
PASI score
DLQI
Drug
Dose
Continue therapy? Y/N
Clinician’s Declaration
I confirm that when using the DLQI score, any physical, sensory or learning disabilities, or communication difficulties that could affect the patient’s responses have been taken into account and any adjustments considered appropriate have been made.
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. 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 dermatology team and response is being assessed using PASI and DLQI scores.
I acknowledge and adhere to the cost effective use of biologics as advocated in NICE TAs103, 134, 146 and 180 and believe that within this Trust the above patient would be best managed using the biologic as requested above.
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 Team

East & North HertsClinical Commissioning Group (ENHCCG)