NICE has recommended Lucentis (ranibizumab) for the treatment of visual impairment due to Retinal Vein Occlusion (RVO).

In a Final Appraisal Determination, the last stage before published guidance, NICE approved the Novartis drug for use in patients with either central or branch RVO where laser treatment is not suitable.

The recommendation means that Lucentis has NICE recommendation for the three leading causes of disease-related blindness: wet AMD, diabetic retinopathy and RVO.

Lucentis is the only anti-VEGF (vascular endothelial growth factor) drug licensed to treat RVO. VEGF is produced excessively by damaged retinal cells and triggers further cell damage.

About 17,000 people each year in the UK are diagnosed with RVO, and final NICE guidance recommending Lucentis would mean the drug became available to many of these patients.

Injected into the eye, Lucentis can be administered at a personalised dosage level. Clinical trials have shown that it can achieve significant and lasting improvements in vision-related functions.

Ian Pearce, Consultant Ophthalmologist and Vitreo-Retinal Surgeon at Royal Liverpool Hospital, described the NICE decision as “great news” for people with RVO, whose quality of life is often significantly affected by the disease.

“Ranibizumab is an established and well-tolerated treatment which when used to treat RVO can lead to rapid and significant gains in vision,” he said. “The impact of this cannot be underestimated as it can make the difference in a person’s ability to carry out everyday tasks such as reading and driving.”

Lucentis was developed by Genentech and Novartis in partnership. Genentech markets the drug in the US, while Novartis markets it in the rest of the world.

The National Institute for Health and Clinical Excellence (NICE) has provisionally decided not to recommend Novartis’ injectable eye care drug Lucentis (ranibizumab) for use in a new indication.

The draft guidelines state that the evidence for the cost-effectiveness of Lucentis as a treatment for visual impairment caused by retinal vein occlusion (RVO) suffers from “gaps and uncertainties”.

Lucentis is already approved and prescribed for treatment of wet age-related macular degeneration (AMD).

NICE’s appraisal committee criticised the case made by Novartis for the drug’s new indication, saying it was “not a true reflection of clinical practice or the efficacy of ranibizumab”.

Specifically, it challenged the accuracy of Novartis’ claimed incremental cost-effectiveness ratio (ICER) for Lucentis in central RVO relative to the currently approved drug, Allergan’s implantable Ozurdex (dexamethasone).

Ozurdex was recommended by NICE earlier this year as a cost-effective treatment for the same indication.

NICE recognised that both drugs have the potential to save sight in this indication, but so far does not accept that Lucentis is the better alternative.

Dr Carole Longson, Director of NICE’s Health Technology Evaluation Centre, said: “The independent Appraisal Committee recognises the profound effect that RVO can have on everyday life. However, in order for NICE to recommend any drug or technology, we have to be sure that it is both clinically effective and good value for money.”

NICE will now consult on the draft guidance for Lucentis. Final guidance is planned for March 2012.

Allergan’s intravitreal implant Ozurdex (dexamethasone) has been recommended by NICE in final guidance for the treatment of macular oedema following central retinal vein occlusion (CRVO).

The final guidance also recommends the implant following branch retinal vein occlusion (BRVO) under certain circumstances.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, says patients affected by both conditions “will welcome this decision”.

Macular oedema can lead to severe visual impairment. Ozurdex is injected directly into the eye once every six months and suppresses inflammation in the retina.

“RVO can be debilitating and can have a significant impact on everyday life,” said Dr Carole Longson. “NICE is therefore pleased to recommend dexamethasone intravitreal implant for this condition.

“Today’s guidance provides clear advice to the NHS and patients, no matter where they live in England and Wales, on how this treatment can add value.”

Novartis has received the thumbs up for Gilenya (fingolimod) and Lucentis (ranibizumab) in Europe.

The European Commission has granted approval for Gilenya as a disease modifying therapy for relapsing-remitting multiple sclerosis (RRMS).

The CHMP has also given a positive opinion on Lucentis to treat visually impaired patients due to macular oedema secondary to retinal vein occlusion (RVO).

David Epstein, Head of Novartis Pharmaceuticals (pictured), said the company was “dedicated to bringing innovative new treatments to patients where there is significant unmet need” and was pleased with both decisions.

The convenient Gilenya capsule 0.5 mg daily has been granted approval for patients with RRMS patients despite treatment with beta interferon, or in patients with rapidly evolving severe RRMS.

Its approval was based on the largest clinical trial program submitted to date for a new MS drug. Data from the studies showed significant efficacy in reducing relapse, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI).

Professor Hans-Peter Hartung, Professor and Chairman, Dept. of Neurology, Heinrich-Heine University, Germany, says Gilenya’s approval is “an important step forward” for patients.

Lucentis’ positive opinion was also based on data from two Phase III studies in patients with Branch RVO (BRAVO) and Central RVO (CRUISE). Studies showed that nearly 60% of BRVO and almost half (48%) of CRVO patients treated with monthly Lucentis gained at least 15 letters of visual acuity at six months, compared with 29% and 17% of those treated according to current standard practice, respectively.

“If approved, Lucentis would be the first anti-VEGF therapy licensed for the treatment of RVO in Europe,” said David Epstein.

“This would be in addition to the Lucentis approvals for patients with wet age related macular degeneration and patients with vision loss due to diabetic macular edema.”

Lucentis is currently licensed in more than 85 countries for the treatment of wet age-related macular degeneration (AMD) and in the European Union for visual impairment due to diabetic macular edema.

NICE has asked Allergan for more information on its dexamethasone (Ozurdex) intravitreal implant for the treatment of macular oedema secondary to retinal vein occlusion (RVO).

The independent Appraisal Committee has requested additional data on the clinical and cost effectiveness of the treatment compared with Avastin (bevacizumab).

Dr Carole Longson, Health Technology Evaluation Centre Director, NICE, said the initial evidence presented by Allergan was “not clear” on the cost or clinical benefits of Ozurdex.

Avastin is currently being used outside its licensed indication for eye conditions by some NHS trusts as an alternative to Lucentis (ranibizumab) – currently licensed for AMD and recommended by NICE since 2008.

As part of preliminary recommendations, the Committee has also requested a submission of a revised base case for the cost effectiveness of dexamethasone, as well as further detail on the location and extent of macular haemorrhage for the subgroup of patients for whom laser treatment was not considered appropriate.

No prevalence or incidence data has ever been identified for England and Wales. However, a recent US study reported a 15 year incidence of 500 new cases per 100,000 population for central retinal vein occlusion and 1800 cases per 100,000 for branch retinal vein occlusion.

Final guidance is likely to be published in June 2011.