2014/15PBR Exclusions - Funding Application forFluocinolone acetonide intravitreal implant forDiabetic Macular Oedema

(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 No:
Patient’s birth year: / (yyyy) / Consultant Making Request: / GP code / Practice code:
Confirm patient status:
(* select 1 option) / NHS Private Overseas / Consultant Contact Details: / GP Post code:
Please indicate whether patient meets the following criteria /

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.Is the patient aged 18 years or over? / Yes / No
2.The patient has chronic diabetic macular oedema / Yes / No
3.The patient had insufficient response to laser photocoagulation and anti-VEGF therapies / Yes / No
4.The implant is to be used in an eye with an intraocular (pseudophakic) lens / Yes / No
5.One of these options applies (please tick)::
Patient has not had fluocinolone acetonide intravitreal implant for diabetic macular oedema before
Patient requires retreatment of the same eye (after 12 months) because of decreased vision or an increase in retinal thickness secondary to recurrent or worsening diabetic macular oedema
Patient has had fluocinolone acetonide intravitreal for one eye in the past (more than 36 months ago) and now requires treatment for the other eye (note that administration in both eyes concurrently is not recommended) / Yes / No
6.Please confirm which eye is to be treated and its current visual acuity (BCVA)
Left eye- BCVA:Right eye- BCVA:
7.All prescribing, administration and monitoring will be carried out by the hospital Ophthalmology team / Yes / No
8.What is acquisition cost of implant (including VAT if applicable)
Commercial in confidence in NHS (CCG/CSU&Hospital) / £/
190 microgram implant
FOR CCG/CSU USE ONLY
Funding approved for 1 implant only / Yes / No / A new application is required for:
  • Repeat treatment of the same eye because of decreased vision or an increase in retinal thickness secondary to recurrent or worsening diabetic macular oedema. Note: Funding will only be re-approved if the patient has shown an improvement of visual acuity
  • Treatment of the other eye

Fluocinolone acetonide intravitreal implant for treating chronic diabetic macular oedema after an inadequate response to prior therapy (rapid review of technology appraisal guidance 271) (NICE TA 301: November 2013)

1.1Fluocinolone acetonide intravitreal implant is recommended as an option for treating chronic diabetic macular oedema that is insufficiently responsive to available therapies only if:

  • 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.

2.1Fluocinolone acetonide intravitreal implant (Iluvien, Alimera Sciences) contains a corticosteroid that has anti-inflammatory and anti-vascular endothelial growth factor (anti-VEGF) properties. It is administered by intravitreal injection. Each implant contains 190 micrograms of fluocinolone acetonide, releasing 0.2 micrograms/day for approximately 36 months. Fluocinolone acetonide intravitreal implant has a marketing authorisation for 'the treatment of vision impairment associated with chronic diabetic macular oedema considered insufficiently responsive to available therapies'. The summary of product characteristics states that administration in both eyes concurrently is not recommended.

Summary of Product Characteristics- Fluocinolone acetonice intravitreal implant (Iluvien®)(ref: Accessed 23rd March 2014; SPC last updated 18/02/2014)

The recommended dose is one ILUVIEN implant in the affected eye. Administration in both eyes concurrently is not recommended (see Section 4.4 of SPC).

An additional implant may be administered after 12 months if the patient experiences decreased vision or an increase in retinal thickness secondary to recurrent or worsening diabetic macular oedema (see Section 5.1 of SPC).

Retreatments should not be administered unless the potential benefits outweigh the risks.

Only patients who have been insufficiently responsive to prior treatment with laser photocoagulation or other available therapies for diabetic macular oedema should be treated with ILUVIEN.

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