Download document - Herts Valleys CCG

Fluocinolone for treating diabetic macular oedema, NICE TA301, October 2013 (rapid review of TA271)
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 [email protected]
If the patient does not fulfil NICE criteria
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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.
Payment by the commissioner will only be made if the completed form is received no later than 15 days after INITIAL treatment commences
Patient NHS No.
Trust:
GP Name:
Patient Hospital
Number:
Patient initials
& Dob:
/
/
Consultant Making
Request:
GP code / Practice
code:
Consultant contact
details
GP Post code:
Criteria for initiation
(1) Which eye is to be treated?
Left eye
Right eye
(2) What is the visual acuity at baseline (Snellen
score)?
Left eye
Right eye
Date measured
(3) Please confirm that the patient has already received laser photocoagulation AND that the eye has
not shown an adequate treatment response, defined as no improvement in retinal thickness and
visual acuity.
Yes
(4) Please confirm that the patient has already received anti VEGF in the eye to be treated, AND that the
eye has not shown an adequate treatment response, defined as no improvement in retinal thickness
and visual acuity after 3 consecutive doses of anti VEGF.
Yes
(5) Is this the first fluocinolone treatment request for this patient?
Yes – go to (8)
No - go to (6)
Yes – go to (8)
No - go to (7)
(6) Has the patient previously received treatment in the requested eye AND did the visual acuity improve
by >5 letters following the previous implant? If so, state date treated. Re treatment is only
commissioned 3 years after previous treatment AND where the visual acuity improved by >5 letters
following previous injection.
(7) Has the patient previously received treatment with fluocinolone in the contralateral eye? If so, state
Date treated
Yes – go to (8)
No –go to (8)
date treated. Re treatment with fluocinolone is only commissioned 3 years or more after treatment in
contralateral eye.
Date treated
(8) What is the central retinal thickness (CRT) at the start of treatment for the eye being treated? (i.e. pre
laser treatment and anti VEGF treatment. Must be >400 micrometres).
micrometres
(9) Please confirm that this patient has had cataract surgery with a pseudophakic lens inserted in the
eye to be treated.
Yes
(10) Fluocinolone is supplied by the Trust at the discount price agreed in the current patient access
scheme.
Yes
(11) Please confirm that the treatment activity is charged as BZ23Z Vitreous retinal procedures cat 1 day case tariff for implant, and
outpatient follow up (in line with NICE Costing Template for TA 301).
(12) Please confirm that the treatment will not be repeated if there is no significant improvement in visual acuity (>5 letters
improvement) after the initial implant in the affected eye.
Clinician’s Declaration
Yes
Yes
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 invoice 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 ophthalmology team.
I acknowledge and adhere to the cost effective use of this treatment as advocated in NICE TA 301 and believe that within this Trust the above
patient would be best managed using the treatment as requested above.
Name of consultant (or clinician delegated by consultant):
Signature (electronic signature):
If this patient is being jointly managed by a second consultant, please
state name here:
Name:
Date:
Date:
/
/
Signature (or email confirmation) by Trust Chief Pharmacist (or nominated
deputy)
Name:
Signature:
Date:
/
/
COMMISSIONING ARRANGEMENTS FOR FLUOCINOLONE FOR DIABETIC MACULAR OEDEMA
NICE Recommendation:
Fluocinolone acetonide intravitreal implant is recommended as an option for treating chronic diabetic macular oedema that is insufficiently responsive to available
therapies only if:
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the implant is to be used in an eye with an intraocular (pseudophakic) lens and
the manufacturer provides fluocinolone acetonide intravitreal implant with the discount agreed in the patient access scheme.
If treatments are not provided in line with the criteria laid out in this document, HVCCG reserve the right to re-claim money from providers for
the relevant drug and activity costs. HVCCG will request an audit around patient outcomes on an annual basis.