After a two and a half year battle led by RNIB, NICE (the National Institute for Health and Clinical Excellence) guidance published on 27 August 2008 now means that all patients in England and Wales with wet age-related macular degeneration (AMD) will be eligible to get the sight-saving drug Lucentis on the NHS.
The Campaign
2006-7: frustration and delay
In August 2006 guidance was issued by the Scottish Medicines Consortium (SMC) for Macugen to be used in treatment of AMD. Although this was a major step forward in the battle for licensed treatment options in Scotland it added to the frustrating delay being experienced by many thousands of patients in other parts of the UK.
In January 2007 in England RNIB supported recently retired Labour MP Alice Mahon who was diagnosed with wet AMD but refused treatment by her PCT. While battling her case through an NHS appeals process, Alice's sight deteriorated further resulting in loss of sight in one eye, with her consultant expecting she would also lose sight in the other. Alice said:
"Everyone has a right to free treatment on the NHS for a condition that results in blindness and devastates lives. Supporting people who are blind or partially sighted, who may need home help and suffer injuries from falls, is far more expensive than the treatment."
In July 2007 NICE received over 20,000 responses from individuals and organisations expressing their concerns over the draft guidance. On final day of consultation, a global alliance led by RNIB hand delivered over 10,000 of these letters to Andrew Dillon, Chief Executive at NICE.
In August 2007 NICE announced that it would not be issuing the guidance on Lucentis in the autumn as expected. Instead there would be a second consultation period, lasting for eight months before the issuing of a second set of preliminary guidance (known as an appraisal consultation document or ACD) for consideration.
This further extended the period of frustration and delay for patients in urgent need of treatment.
Read RNIB and the Macular Disease Society's joint response to this second appraisal consultation document (ACD) (Word, 120KB)
2008: barriers to treatment start to come down
The long awaited Final Appraisal Determination (FAD) was published in April 2008. Under this guidance even patients with significant sight loss (up to visual acuity 9/96) will be able to receive treatment.
On the publication of this document Steve Winyard, Head of Campaigns said; 'Today we move a step closer to achieving justice for 19,000 patients in England and Wales who develop wet AMD each year. Countless patients have either been robbed of their sight, or stripped of their life savings to pay for treatment. Today marks a crucial turning point in the way patients with wet AMD will be treated.'
Read more about the Final Appraisal Determination
Judicial Review
In July 2008 prior to NICE issuing guidance on the use of Lucentis to treat wet AMD, RNIB backed three patients who took High Court legal action against Warwickshire Primary Care Trust (PCT) in their struggle to get treatment for wet AMD.
The case ended successfully for the patients when, encouraged by Mr Justice Forbes, the PCT and drug manufacturer Novartis agreed a deal which meant that Warwickshire PCT would agreed to change its restrictive funding policy on the sight-saving anti-VEGF drug Lucentis, agreeing to provide the first 14 injections on the NHS with Novartis funding the drug cost of treatments required beyond this for each patient.
The Outcome
After further delays when two parties made an appeal against the guidance, final guidance was published on 27th August 2008 meaning all patients in England and Wales with wet Age-related Macular Degeneration (AMD) were now eligible to get the sight-saving drug Lucentis on the NHS.
Although a fantastic result for all those diagnosed with wet AMD, a three month implementation period at the start of the guidance meant further delays for those waiting to begin NHS treatment with Lucentis.
Lack of capacity and long waiting times for some new patients means there is still work to be done to ensure prompt, effective NHS treatment for all those diagnosed with wet AMD.