NICE turnaround completed!
Patient advocacy efforts appear to have had a strong impact, with the National Institute for Clinical Excellent (NICE) releasing positive final guidance for Lucentis on April 2, 2008. The following treatment guidelines were stipulated by NICE:
"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)
- the cost of treatment beyond 14 injections in the treated eye is met by the manufacturer. "
NICE did not recommend treatment of pegaptanib (Macugen), a decision which the manufacturer Pfizer is reported to be appealing. More information about the NICE decision is available here http://www.nice.org.uk/
We accolade the courage and determination of the national organizations, RNIB Macular Disease Society (UK) in achieving compensation for the authenticated treatment of wet MD. We also add our sincere and grateful thanks to you, the members and members of the public, who supported these organizations on a global basis - the response to our request was magnificent. Again a terrific victory for patients thanks to this collaborative effort. THANK
Original article from 07.06.22
NICE U-turn is an international victory for those with AMD
NICE, (National Institute for Healthcare and Clinical Excellence) has reversed its ill advised and controversial recommendations to limit AMD treatment to second eye only after sight is lost in one eye. Revised draft guidance published on December 14 by NICE recommends that anti-VEGF drug Lucentis® is now made available to treat AMD patients with all sub types of AMD, and, for both eyes.
Congratulations to our members in the UK –RNIB and Macular Disease–for their national leadership in this campaign, and warmest thanks to all our AMDAI members and public supporters around the world for rallying to support those with AMD who will ultimately benefit from treatment and avoid needless blindness.
Led by AMD Alliance International, the strong voice of the global AMD community played an important role in this success, letting regulators know that people with AMD around the world will join forces to express outrage at wrong decisions. The mobilization of AMDAI members worldwide supported a strong national advocacy campaign which was unfortunately needed to make NICE to revise its initial ill-considered recommendations.
It is important to note however that the decision won’t take place until Spring 2008, and in the meanwhile AMD patients in the UK are forced to rely on individual decisions from their Primary Care Trust. Our UK members, RNIB and The Macular Disease Society will continue their essential advocacy to support those with AMD. Their advocacy with PCTs will be very important from now until the decision takes effect. Click the following links to download the MDS press release on this decision, and the urgent letter to PCTs.
Download MDS press release >
Download letter to PCTs >
AMD Alliance International Chairman, MacDonald (Don) Curran, himself an AMD patient, expresses heartfelt gratitude to all members for this global effort. The positive outcome of this campaign strengthens the Alliance’s commitment to engage its international community of organizations in unified actions that will protect and defend AMD patients’ rights around the globe.
Record breaking response to NICE consultation.
December 14 2007 Update: NICE reversal welcome news for all. more...
According to reports from Britain, the tremendous engagement of organizations and individuals world-wide had the effect of creating what NICE called the largest consultation response in their history. Outraged responses poured in from around the world, urging NICE to reconsider its preliminary guidance. RNIB estimates that some 20,000 responses were generated.
The most successful grassroots campaign ever seen by NICE started with a request for help from our AMDAI members in Britain, RNIB and MDS. They wrote to inform us that the health watchdog in England and Wales (National Institute for Health and Clinical Excellence, NICE) issued stringent preliminary guidance that would deny proven effective anti-VEGF treatments to 80 percent of patients with wet AMD in England and Wales. Said RNIB, "Just one in five "lucky" patients will be offered treatment - but only after they've gone blind in one eye. If this ill-considered decision is not over-turned very soon, over 20,000 people a year will be denied access to these important anti-VEGF treatments and will suffer from degenerating eyesight and potential blindness in the UK."
Hearing of the outcry and massive counter attack in Britain, our members in the USA asked a simple question, "How can we help you?", giving birth to a highly successful grassroots campaign conceived and delivered with a punch in less than three weeks. As our AMD Alliance International (AMDAI) Chair Don Curran said, "I live with AMD myself and it's too late for treatment for me. However, it is never too late to help ensure others don't share the same fate as me. That is why we're particularly pleased that AMDAI members and friends around the world have immediately recognised this as an issue which goes beyond British borders and have rallied to support those living with AMD here." In addition to being essential to prevention of blindness and access to treatment, the strength of the NICE campaign, and the solid involvement of AMDAI members worldwide has also given us the opportunity for learning and relationship building. A more detailed report of key learnings is available upon request.
NICE are expected to issue their final guidance to NHS this autumn or early winter. We won't know until then if the preliminary guidance will change. However there can be no doubt that the voice of people with AMD was heard - loudly and clearly. Said NICE CEO Andrew Dillon in his automated response to those writing in, "I know that these proposals have disappointed many people living with this distressing condition, as well as those who care for and who treat them. What you say does matter."
On behalf of those with AMD who turn to us for hope and help, please know that your input is greatly appreciated. While we of course fervently hope the final NICE guidance will be good news for people with AMD, no matter what happens, your input has made a significant impact, thank you.
Pictured below (LtoR): AMDAI Chair Don Curran, RNIB Vice Chair Kevin Carey, and RNIB Head of Public Policy Stephen Winyard at NICE on July 12, 2007
INPUT AND ACTION NEEDED URGENTLY!
Dear Friend:
People with age-related macular degeneration (AMD) are facing a draconian situation in England and Wales right now, and your INPUT AND ACTION IS NEEDED URGENTLY!
The health watchdog in England and Wales (National Institute for Health and Clinical Excellence, NICE) issued stringent preliminary guidance that will deny proven effective anti-VEGF treatments to 80 percent of patients with wet AMD in England and Wales. Just one in five "lucky" patients will be offered treatment - but only after they’ve gone blind in one eye. If this ill-considered decision is not over-turned very soon, over 20,000 people a year will be denied access to these important anti-VEGF treatments and will suffer from degenerating eyesight and potential blindness in the UK.
Our colleagues in the UK - RNIB and the Macular Disease Society - have publicly declared their outrage at this decision, and have mounted a massive counter attack. YOUR HELP IS NEEDED IN THIS CAMPAIGN!
in this campaign!
Here’s what you must do:
-
NICE have said: "we are very keen to hear from people with AMD and those who care for them, and as always, our committee will take these views into account when making final recommendations." PLEASE VOICE YOUR OUTRAGE AT THIS PRELIMINARY DECISION. Please click on this link to send an email/letter of protest to NICE: nice@nice.org.uk. Here is the postal address if you prefer to send a print letter:
Mr. Andrew Dillon, CEO
National Institute for Health and Clinical Excellence
MidCity Place
71 High Holborn
London WC1V 6NA
Phone +44 (0) 20 7067 5800
THE DEADLINE FOR COMMENTS IS JULY 12, 2007, SO PLEASE ACT NOW.
for comments is
July 12, 2007,
so please act now.
In your email/letter please reference:
- That your country has approved and reimbursed anti-VEGF treatments and you are shocked at the lack of concern for people facing blindness in England, Northern Ireland and Wales.
- NICE acknowledges the efficacy and ground-breaking vision improvements seen in patients treated with anti-VEGF treatments. Briefly highlight personal stories - insightful, real life quotes are important to communicate.
- The cost effectiveness of AMD treatments, and improved quality of life for people with AMD is clearly documented by multiple studies. The costs to individuals and society of allowing people to go blind are extensive.
- It is inhumane to deny treatment to these patients - some of whom are the most fragile in our societies - when treatment is available.
- TIMELY ACCESS to treatment is the right of all who will be helped by the treatment, and is imperative due to the rapid deterioration of sight in wet AMD patients.
- Only retinal specialists can decide the timing of treatment and the medicines that help the patient. When a medicine has been tested and found to be safe, then the final decision as to what is used is between doctor and patient. Making health decisions on any other basis is an invasion of the most basic relationship a patient can have, that is the trust that they will be well cared for by a physician who may use all the tools at their disposal for the good of the patient.
YOUR HELP IS NEEDED IN THIS ESSENTIAL SIGHT-SAVING BATTLE! There is no reason why people with AMD should be left to go blind when proven anti-VEGF treatments are available. Furthermore, there is no reason why people in England, Northern Ireland and Wales should not get what is readily available in, for example, Scotland, Australia and Switzerland - namely affordable access to the treatments which will prevent blindness.
We have an opportunity and a responsibility to reverse an ill-informed decision, and bring some hope and help to those who live with AMD. GET INVOLVED NOW! SEND A LETTER TO nice@nice.org.uk
Send a letter to nice@nice.org.uk and share your strong concern!
Click here for more detail on the NICE Guidance on treatment of macular degeneration: http://www.nice.org.uk/page.aspx?o=435210
Click here for details on the RNIB campaign re the NICE decision: http://www.rnib.org.uk/xpedio/groups/public/documents/publicwebsite/public_nice.hcsp
For further information, please contact our colleagues in Britain, Steve Winyard at swinyard@rnib.org.uk or the AMD Alliance International at info@amdalliance.org.
Sample letters of protest sent by others
Read the letters sent by others who have already voiced their strong concern. Your help is needed in this essential sight-saving battle! The deadline for comments in July 12, 2007 so please send your letter of protest today!
PLEASE SEE THE LIST BELOW TO READ OR DOWNLOAD SAMPLE LETTERS:
- Macdonald Curran – read this letter or download file
- Wanda Hamilton, AMD Alliance – read this letter or download file
- Dr. Charles Mossop – read this letter or download file
- William Rowland, President: World Blind Union – read this letter or download file
- David Herman, Executive Director: The Seniors Coalition – read this letter or download file
- Dr Paul Beaumont, Chairman, Medical Committee & Professor Paul Mitchell, National Research Advisor: MD Foundation (Australia) – read this letter, download file, or download the referenced attachment (Blue Mountains Eye Study)
- Stephen Rose, Ph.D., Chief Research Officer: The Foundation Fighting Blindness – read this letter or download file
What you can do to help prevent blindness:
- Write to nice@nice.org.uk and share your strong concern!
- Post this information in public forums
- Speak to friends and colleagues and ask them to write
- Post this information on your website
- Phone NICE +44 20 7067 5800 protesting this poor guidance
- Forward this email to others you think should be aware and involved
- Include this information in your newsletters
- Tell us what you’ve done, so we can share success when our combined strength changes this situation!! Please send your news to info@amdalliance.org
