Dexamethasone Intravitreal Implant Is Recommended As an Option for the Treatment of Macular

Patient Specific Funding Application for DEXAMETHASONE INTRAVITREAL IMPLANT (Ozurdex) for the treatment of MACULAR OEDEMA secondary to retinal vein occlusion, NICE TA 229, July 2011

Patient NHS No. Trust: GP name: Patient Hospital Consultant Making GP code/Practice Number: Request: code: Patient initials: Consultant Contact GP post code: Patient DoB: Details: 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  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.

Patients who do not meet the agreed eligibility criteria CCGs will not normally fund any treatment where the patient does not meet the agreed criteria as outlined in this patient application form.

Initiation Criteria Indicate form of RVO CRVO BRVO Eye to be treated Right eye Left eye BCVA in each eye Right eye Left eye Please note that the responsible commissioner will only fund treatment in the worse seeing eye, unless patient has no sight in one eye. Is this request for initiation or for retreatment? Initiation Retreatment

Further Initiation Criteria specific for CRVO/BRVO Central Retinal Vein Occlusion (CRVO) Branch Retinal Vein Occlusion (BRVO) OCT > 250microns Yes/ No OCT> 250microns Yes/ No  Laser coagulation has been tried and was unsuccessful, or Yes/ No  the extent of the disease makes laser coagulation Yes/ No unsuitable Retreatment criteria  Previous dexamethasone injection was 4-6 months ago  Previously treated eye showed a response to treatment of a BCVA improvement of >10 letters at day 60 post treatment (after first injection, eye must show an improvement but this may be <10 letters. Improvement for subsequent injection must be >10 letters)  Previously treated eye now has BCVA deterioration of >5 letters  Patient has not received >6 doses in the eye to be treated. Date of previous dexamethasone injection: Number of letters visual improvement following previous injection, measured at day 60 post (EDTRS) Date measured injection Deterioration of >5 letters from maximal improvement seen following previous injection Yes/ No Date measured Current BCVA in eye to be treated Date measured Total number of doses administered into requested eye to date

Costing information Drug cost to be charged for single injection including VAT £ Activity cost to be charged for administration £

Clinician’s Declaration If this patient is being jointly managed by a second consultant, please state I confirm that I have discussed with the patient and that they understand and name here: consent to their personal information being shared with commissioning organisations. I have also recorded this discussion in the patient’s notes. Name: I confirm the risks and benefits of treatment have been fully discussed with the patient and documented. Date: I confirm that funding approval is subject to initiation and follow up of Signature (or email confirmation) by Trust Chief Pharmacist (or deputy) treatment response being undertaken by a specialist ophthalmology team. Name: I acknowledge and adhere to the cost effective use of dexamethasone as Signature: advocated in NICE TA 229 and believe that within this Trust the above patient Date: would be best managed using the treatment as requested above. Name of supervising consultant:

Signature: Date: DEXAMETHASONE INTRAVITREAL IMPLANT (Ozurdex) for the treatment of MACULAR OEDEMA secondary to retinal vein occlusion, NICE TA 229, July 2011 Guidance Dexamethasone intravitreal implant is recommended as an option for the treatment of macular oedema: 1) following central retinal vein occlusion 2) following branch retinal vein occlusion when: • treatment with laser photocoagulation has not been beneficial, or • treatment with laser photocoagulation is not considered suitable because of the extent of macular haemorrhage. Commissioning criteria for initiation and retreatment These criteria are based on the NICE economic model, NICE costing template, GENEVA trial and Royal College of Ophthalmologists Interim guidance for the treatment of retinal vein occlusion, December 2010 and incorporates comments from local specialists. Initiation Criteria  Patient is over 18 years of age.  Treatment is for the worse-seeing eye only, unless patient is registered blind in one eye.  Visual acuity in the treated eye is between 6/12 and 6/96, (based on Royal College of Ophthalmologists Interim Guidelines for Management of Retinal Vein Occlusion Dec 2010).  Further initiation criteria are as follows: CRVO BRVO OCT >250 microns OCT >250 microns Laser coagulation has been tried and was unsuccessful, or the extent of the disease makes laser photocoagulation unsuitable. Re-treatment Criteria Re-treatment of an eye previously treated with dexamethasone is only commissioned:  At an injection interval of 4-6 months.  Where the treated eye shows a response to dexamethasone, assessed at day 60 after treatment, with best corrected visual acuity (BCVA) improvement of >10 letters. If there is an improvement which is <10 letters after the first dose (measured at day 60), a second dose may be administered between 4-6 months, but subsequent doses will only be commissioned if an improvement of >10 letters is reached after the second dose (measured day 60 post injection)  Where the BCVA has deteriorated by >5 letters from the BCVA measured at day 60 after previous treatment.  For a maximum of 6 doses. Further Criteria  In line with the activity costs included in the economic evaluation which informed the NICE TA recommendation, commissioners will only pay day case activity tariff for 2012/13. Thereafter outpatient activity tariff will be paid.  BCVA must be documented when treatment is given, 60 days after treatment and when treatment is repeated.

Pharmacy and Medicines Optimisation Team East & North Herts Clinical Commissioning Group (ENHCCG)