When a proactive approach can head off malpractice lawsuits

UK ophthalmologists will soon be able to offer verteporfin (Visudyne) photodynamic therapy for patients in public hospitals.

The development follows a decision by a regulatory watchdog to recommend use of PDT for all patients with exudative age-related macular degeneration (wet AMD) with classical subfoveal choroidal neovascularisation (CNV).
With the decision, Britain becomes the last European Union country and one of the last in the developed world to approve PDT for wet AMD.

The new recommendation represents an about-face on a recommendation drafted in May of last year by Britain’s regulatory watchdog, the National Institute for Clinical Excellence — known by the acronym ’NICE’.

NICE had formerly restricted PDT to those wet AMD patients with predominantly classic subfoveal CNV who were part of a clinical study, who had visual acuity of 6/36 in the eye to be treated and who were virtually legally blind in the other eye.

Intense pressure from ophthalmologists, ophthalmic nurses, GPs, geriatricians, patient groups and verteporfin manufacturer Novartis Ophthalmics, however, forced NICE to alter its recommendation. Such success bodes well for pacts between physicians, patients, and industry to overcome future government limits on medical services throughout Europe.

Under the new NICE recommendation, ophthalmologists in Britain’s National Health Service hospitals will be able to offer PDT to patients who meet two requirements:
• Wet AMD with no occult subfoveal CNV
• Best-corrected visual acuity 6/60 or better

The guidelines add that PDT “should be carried out only by retinal specialists with expertise in the use of this technology”.
By contrast with the original guidelines, wet AMD patients with classic CNV will be able to receive PDT without having to be a member of a clinical trial. Also, there is no pre-requisite for the untreated eye.

For wet AMD patients with predominantly classic CNV — defined as less than 50% classic but with some occult lesions — there will still be a significant restriction. According to NICE, PDT should be used in patients with predominantly classic CNV “only as part of ongoing or new clinical studies that are designed to generate robust and relevant outcome data, including data on optimum treatment regimens, long-term outcomes, quality of life and costs”.

For patients with predominantly occult CNV associated with wet AMD, NICE said it made no recommendation because verteporfin “was not licensed for this indication when this appraisal began”.
About 5,000 patients a year in Britain are diagnosed with wet AMD with classic CNV and no occult lesions.

The extension of treatment to those wet AMD patients with predominantly classical CNV would involve another 2,500 to 3,000 patients per year in the UK.
Extension of treatment to those wet AMD patients with predominantly occult CNV would involve a further 15,000 new patients per year in the UK.
Novartis and the Royal National Institute for the Blind have appealed the NICE recommendation.

Kathrin Wyss, global communication manager for Visudyne at Novartis, insists that verteporfin has proven itself in improving the quality of patients’ vision and in halting loss of visual acuity in patients with predominantly classical CNV. "The basis of our negotiations with NICE is clinical practice," she says.

She adds that she would welcome a UK-based study on extending verteporfin PDT for wet AMD patients with predominantly classical CNV as long as the government was prepared to fund the study.

She adds that the use of verteporfin PDT for primarily occult CNV would also be cost-effective. In particular, studies indicate that PDT for such patients leads to a 50% reduction in progression towards legal blindness and a 50% reduction in the progression of classical CNV.

“Because Visudyne halts disease progression, the earlier you get to a patient, the better the chance you have to obtain the optimum benefit,” Ms Wyss says.
In appealing the NICE decision, the Royal National Institute for the Blind denounced the recommendation process as “perverse”.

“The advice of the experts who were called in was ignored. Throughout the review process, NICE has looked at basically the same evidence and come up with two different recommendations. If treatment wasn’t effective before, how is it effective now?,” says the Institute's Joe Korner.
He adds that the NICE analysis of PDT failed to look at a number of benefits of the verteporfin PDT, including its effect in halting the loss of contrast and depth perception. He notes that deterioration of contrast and depth perception leads to falls and thus to huge expense in health care costs and damage to quality of life.
An expert review panel was to hold an appeal hearing with Novartis and the Institute on March 17. A final decision about the appeal is expected in May.

Although the NICE recommendation will legally apply only to ophthalmologists practicing in the National Health Service in England and Wales, NHS officials in Scotland and Northern Ireland are expected to adopt the recommendations as their own guidelines.
The Royal College of Ophthalmologists has said it is “pleased” with the NICE decision. Please see related article for the College’s full response to the NICE decision.

The debate over expanding verteporfin PDT began almost two years when the Department of Health in England and Wales requested NICE to review the cost-effectiveness of verteporfin PDT. According to the National Health Service formulary, verteporfin costs about E1,400 per 15mg. Each treatment also incurs another E500 to €700 in professional fees, clinic charges and laser use.
Current studies indicate that wet AMD would receive an average of 3.5 PDT treatments in the first year, 2.3 treatments in the second year, 1.1 treatments in the third year and 0.4 treatments in the fourth year. Five-year data should be available in May, according to Novartis.

NICE estimates that PDT for every 1,000 patients with wet AMD costs about E6m per year in the first year of treatment, ultimately rising to about E12m per year by the third year.

National Institute for Clinical Excellence
www.NICE.org.uk
Novartis Ophthalmics
www.novertisophthalmics.com
Visudyne
www.visudyne.com
Royal National Institute for the Blind
www.rnib.org.uk
Royal College of Ophthalmologists
www.rcophth.ac.uk

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