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NICE rapid review of the use of fluocinolone acetonide for chronic DMO

1 October 2013

College Statment

Since the release of TA 2711 in January 2013, NICE has undertaken a rapid review of the use of fluocinolone acetonide for chronic diabetic macular oedema2 and has recently released the FAD document for this single technology appraisal3.

In the FAD document, the following guidance has been issued:

Fluocinolone 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

The Royal College of Ophthalmologists welcomes this positive recommendation by NICE as this technology should be of benefit to a significant group of patients with diabetic eye disease. It is also reassuring that NICE has only recommended Fluocinolone acetonide for eyes that have not responded sufficiently to other available therapies and are already pseudophakic. This provides ophthalmologists with the option of using intravitreal fluocinolone acetonide implants if other available therapies such as macular laser photocoagulation and repeated intravitreal ranibizumab (TA 274) have not produced sufficient reduction or stability of macular oedema.

The advantage of fluocinolone is the long duration of action of 36 months following a single intravitreal implant procedure but the risk of raised intra-ocular pressure requiring IOP lowering medication was reported to be 38.4% in the FAME study report4.

In order for this new technology to be used appropriately, it will be important for ophthalmologists to have the necessary guidelines to enable them to select patients with diabetic macular oedema which is chronic and deemed insufficiently responsive to available therapies.

References

  1. First appraisal and guidance on floucinolone acetonide November 2012
  2. Rapid review of floucinolone Acetonide January 2013
  3. NICE FAD
  4. Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Campochiaro PA, Brown DM, Pearson A, Chen S, Boyer D, Ruiz-Moreno J, Garretson B, Gupta A, Hariprasad SM, Bailey C, Reichel E, Soubrane G, Kapik B, Billman K, Kane FE, Green K; FAME Study Group. Ophthalmology. 2012 Oct;119(10):2125-32. doi: 10.1016/j.ophtha.2012.04.030. Epub 2012 Jun 21.