NICE has published final guidance recommending ocriplasmin (Jetrea, ThromboGenics) as an option for treating some people with the rare eye condition, vitreomacular traction.

Vitreomacular traction occurs when the vitreous, the gel-like substance in the eye, pulls abnormally on the retina, the light-sensitive layer of tissue at the back of the inner eye, which is responsible for processing visual images. The pulling of the gel disturbs the retina, causing swelling and distorted vision, and sometimes a hole in the macular area. It can occur as a result of ageing.

NICE has recommended ocriplasmin as an option for treating vitreomacular traction in adults, only if an epiretinal membrane is not presentⁱ, and they have a stage II macular holeⁱⁱ (full thickness with a diameter of 400 micrometres or less) and/or they have severe symptoms.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: "Vitreomacular traction is a serious eye condition, which can lead to loss of vision in the long run. Ocriplasmin injection represents a new and welcome option for patients with this condition and their clinicians, as it provides an alternative to 'watch and wait' and/or surgery. NICE is pleased to recommend ocriplasmin as an option for this condition in final guidance."

The final guidance can be found from 00:01hrs on Wednesday 23 October 2013 on the NICE website.

This is NICE's final guidance on this technology and now replaces local recommendations across the country.

Ends

Notes to Editors

References and explanation of terms

i. An epiretinal membrane is a thin sheet of fibrous tissue that can develop on the surface of the macular area of the retina and cause a disturbance in vision. It is a complication of vitreomacular traction.

ii. A macular hole occurs if the vitreous, the gel-like substance in the eye, pulls on the centre of the retina (the macula). There are four stages to a macular hole:

• Stage I - Intraretinal splitting at the fovea causes a pseudocyst or a foveal detachment.
• Stage II - Full thickness breaks in the retina, less than 400 micrometres (µm).
• Stage III - Larger than 400 µm, retain some vitreous attachment.
• Stage IV - No vitreous attachment, complete separation from retina (PVD: posterior vitreous detachment).

The size of the hole and its location on the retina determine how much it will affect a person's vision.

About the final guidance

1. The final guidance is available from 00:01hrs on Wednesday 23 October on the NICE website.

2. Ocriplasmin (Jetrea, ThromboGenics) is a truncated form of human plasmin, manufactured using recombinant DNA technology. It is indicated ‘in adults for the treatment of vitreomacular traction (VMT), including when associated with macular hole (MH) of diameter less than or equal to 400 microns'. It is administered by intravitreal injection at a dose of 0.125 micrograms. Repeated injections into the same eye are not recommended.

3. The cost of ocriplasmin injection is £2500 (excluding VAT) (0.5 mg in 0.2 ml solution; MIMS, July 2013). Because repeat injections are not recommended, this is the cost for a full course of treatment. Costs may vary in different settings because of negotiated procurement discounts.

4. The Committee concluded that ocriplasmin was clinically effective in the subgroups VMT without ERM (vitreomacular traction with no epiretinal membrane and without a stage II macular hole) and VMT with MH (vitreomacular traction with a stage II macular hole), but not in the subgroup VMT with ERM (vitreomacular traction with a epiretinal membrane, and without a stage II macular hole), and was unlikely to be clinically effective in those in the VMT with MH subgroup who had an epiretinal membrane.

5. The Committee considered the use of ocriplasmin for treating vitreomacular traction without an epiretinal membrane or a stage II macular hole, and concluded that the ICER was likely to be no greater than £20,900 per QALY gained (as presented by the Evidence Review Group). It agreed therefore that ocriplasmin was a cost-effective use of NHS resources for treating vitreomacular traction in people with no epiretinal membrane.

6. For people with vitreomacular traction and a stage II macular hole, having taken into account all of the evidence submitted (from the manufacturer and the Evidence Review Group), and comments received during consultation, the Committee concluded that on balance, the ICER was likely to be lower than £30,500 per QALY gained, and therefore ocriplasmin was a cost-effective use of NHS resources for treating people with vitreomacular traction and a stage II macular hole without an epiretinal membrane.

7. The incidence of vitreomacular traction in the UK is not known.

8. The Scottish Medicines Consortium has not recommended ocriplasmin for treating vitreomacular traction for use within NHS Scotland.

9. NICE technology appraisals apply across the NHS in England and Wales.

10. For further details on NICE technology appraisals, please see the NICE website.

About NICE

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