Justice For Thousands Facing Blindness

Main Category: Eye Health / Blindness
Article Date: 28 Aug 2008 - 3:00 PDT

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Guidance published yesterday by the National Institute for Health and Clinical Excellence (NICE) will save the sight of thousands affected by the UK's leading cause of blindness, says the Royal National Institute of Blind People (RNIB). The long awaited final guidance on anti-VEGF drugs means that patients in England and Wales with wet Age-related Macular Degeneration (AMD) will get sight-saving treatment on the NHS.

The 'technology appraisal guidance', published by NICE after extensive consultation, means that Primary Care Trusts (PCTs) in England and Local Health Boards in Wales will now have to fund the anti-VEGF drug Lucentis for patients who have wet AMD in either eye. PCTs are normally given three months to implement NICE's guidance.

RNIB has led a two-and-a-half-year battle to make sight-saving treatments available on the NHS to all patients with wet AMD. Steve Winyard, Head of Campaigns at RNIB said: "We've been waiting for this for over two years. It is a victory for thousands, bringing overwhelming relief to desperate people across the country. Finally the torment faced by elderly people forced to either spend their life savings on private treatment or go blind, is over."

There are 26,000 new cases of wet AMD in the UK each year. The condition can lead to blindness in as little as three months if left untreated.

In June 2007 RNIB spearheaded a mass campaign in response to draft guidance issued by NICE proposing that people go blind in one eye before qualifying for treatment with anti-VEGF drugs. The campaign generated a record response from over 13,000 outraged people demanding that NICE rethink their proposals.

NICE performed a U-turn in December last year, issuing revised draft recommendations for consultation. This stated that the sight-saving drug Lucentis should be available to most patients who develop wet AMD in either eye. Despite this, many PCTs continued to follow restrictive funding policies, creating a post-code lottery for treatment of wet AMD across the UK.

Today's breakthrough has thrown a lifeline to patients like 82-year-old Joan Armstrong from Wandsworth in London, whose requests for funding have been refused four times by Wandsworth PCT. Joan said: "I'm so happy. I have been fighting to get treatment for over a year and a half, so this is the best news I've had since I started to lose my sight. What I now need is for Wandsworth PCT to contact me with my first appointment - I'll then be able to look forward to the future."

RNIB's Steve Winyard said: "NICE's guidance will finally bring an end to a cruel postcode lottery. There is now nowhere left for PCTs to hide - we want them to implement NICE guidance immediately. RNIB is also calling on hospitals to ensure they build capacity as a matter of urgency, so they can save the sight of patients without further delay."

Since the NICE appraisal began, RNIB and the Macular Disease Society have supported almost 1,000 patients in their battles against PCTs for sight-saving treatments. In July, RNIB also backed three pensioners in landmark High Court action against Warwickshire PCT for denying them treatment.

While Lucentis will be available to patients on the NHS, NICE has not recommended another anti-VEGF drug Macugen. However, RNIB hopes that this drug will also be made available for patients in exceptional circumstances who for medical reasons won't be able to use Lucentis.

Any patients with questions about AMD and anti-VEGF treatments should call RNIB's Helpline on 0845 766 9999 or the Macular Disease Society Helpline on 0845 241 2041.

Notes

Extract from NICE Technology Appraisal Guidance 155, page 3,"Guidance". Words in [ ] have been inserted by RNIB.

Beginning of extract:

Ranibizumab, [Lucentis] within its marketing authorisation is recommended as an option for the treatment of wet age-related macular degeneration if all of the following circumstances apply in the eye to be treated:

- the best-corrected visual acuity is between 6/12 and 6/96
- there is no permanent structural damage to the central fovea
- the lesion size is less than or equal to 12 disc areas in greatest linear dimension
- there is evidence of recent presumed disease progression (blood vessel growth, as indicated by fluorescein angiography, or recent visual acuity changes)
- and the cost of ranibizumab [Lucentis] beyond 14 injections in the treated eye is met by the manufacturer [Novartis UK].

It is recommended that treatment with ranibizumab [Lucentis] should be continued only in people who maintain adequate response to therapy. Criteria for discontinuation should include persistent deterioration in visual acuity and identification of anatomical changes in the retina that indicate inadequate response to therapy.

It is recommended that a national protocol specifying criteria for discontinuation is developed.

Pegaptanib [Macugen] is not recommended for the treatment of wet age related macular degeneration.

People who are currently receiving it for any lesion type should have the option to continue therapy until they and their clinicians consider it appropriate to stop.

Additional notes

1. Wet AMD is the leading cause of sight loss in the UK and can lead to blindness in as little as three months. People need prompt treatment if they are to minimise the risk of permanent sight loss.

2. Anti-VEGF treatments target VEGF (vascular endothelial growth factor), a protein involved in the formation of new blood vessels. In the eye, high levels of VEGF can cause proliferation of blood vessels and fluid leakage. The number of times patients require treatment with an anti-VEGF drug varies - some patients require injections for two years or more.

3. Two anti-VEGF treatments are licensed for use in the UK: Macugen, marketed by Pfizer, was licensed for use in May 2006, and Lucentis, marketed by Novartis was licensed for use in January 2007. Another anti-VEGF drug, Avastin, is also available, but is currently unlicensed to treat wet AMD.

4. NICE has been appraising Macugen and Lucentis for use on the NHS since February 2006.

5. In England more than half of PCTs are already providing sight-saving treatment to patients who need it, but many others still have unacceptably restrictive funding policies.

6. The Governments in Northern Ireland and Wales recently announced provision of £8million and £5million respectively to ensure that all patients with wet AMD who are likely to benefit from treatment will get it. In Scotland, anti-VEGF drugs have been available on the NHS since June 2007.

7. Every day another 100 people will start to lose their sight. There are around two million people in the UK with sight problems. RNIB is the leading charity working in the UK offering practical support, advice and information for anyone with sight difficulties. If you, or someone you know, has a sight problem, RNIB can help. Call the RNIB Helpline on 0845 766 9999.

Royal National Institute of Blind People