UK to reimburse Lucentis

Lucentis (ranibizumab; Novartis) is to be made available to patients of the National Health Service (NHS) in England and Wales. The final appraisal document (FAD) has been published ahead of a final decision, expected in June 2008.

Initial guidance issued in June 2007 made Lucentis available through the NHS only to treat wet age-related macular degeneration (AMD) in the second eye following AMD-induced blindness in the first: this covered approximately 15–20% of the country’s AMD sufferers. Strong opposition, both by the public and the industry, caused Britain’s medical reimbursement governing body, the National Institute for Health and Clinical Excellence (NICE), to review its controversial decision.

One issue highlighted by critics of NICE’s original guidance was that treating only the second eye could mean losing the chance to preserve vision if it was affected by untreatable vision loss or didn’t respond to treatment. Although NICE issued revised guidance in December 2007 recommending Lucentis be available for patients with wet AMD in the first eye to come to clinical attention, many primary care trusts (PCTs) continued to follow the initial guidance. The new guidance will now be implemented across all PCTs.

Will Avastin now be abandoned?
The revision of the recommendation has been widely welcomed but how much, if at all, will the new guidance really impact on ophthalmologists’ practice, especially the practice of those ophthalmologists currently using the cheaper alternative Avastin (bevacizumab)? Ophthalmology Times Europe spoke with Professor Andrew Lotery of Southampton General Hospital and the University of Southampton in the UK to discuss how the new ruling will affect him.

“We find Avastin very effective,” he said. “What is needed is a proper randomized clinical trial to demonstrate whether there are any clinical benefits of Lucentis over Avastin, or vice versa. We are one of about 20 centres here in the UK participating in the IVAN trial, which is hoping to answer this question,” he added.

The IVAN (Inhibit VEGF in Age-related choroidal Neovascularisation) trial is a randomized controlled trial estimating the relative effectiveness of Avastin and Lucentis.

“[Choosing whether to continue to administer Avastin now Lucentis is to be reimbursed] is a decision for the commissioners of our local health service. We will continue to use Avastin in new and existing patients until funding is obtained for Lucentis and until our commissioners advise on any new plans. I am aware that our local commissioners are considering using Avastin, despite NICE guidance, to keep costs down,” Professor Lotery confirmed.

Although hailed as a revolution in the treatment of AMD, anti-VEGF therapies are not without their disadvantages. Frequent dosing regimes, expanded eligible patient base and the recommended long-term follow-up schedule will impact the organization of all clinics choosing to implement this therapy.

“The implications of fully implementing NICE guidance are huge. We estimate that we will require an additional 60 clinics per week and nine additional medical staff, 11 additional nurses, three additional photographers and three additional clerical staff. Significant investment in infrastructure will be needed to deliver this service,” admitted Professor Lotery. If we consider the broader implications, the costs to the NHS of using Lucentis “will probably exceed £200 million (around €250 million) per year. These costs would be considerably less if Avastin were used instead. It is not clear how health commissioners will be able to afford this service or whether they will choose to use Avastin instead purely for financial reasons. If they choose to do this, they will need to take legal responsibility for doing so,” he added.

Should Macugen be forgotten?
Rival AMD treatment Macugen (pegaptanib; Pfizer), although approved in Europe as well as by the Scottish Medicines Consortium, has not been recommended for use by NICE. Mr Winifried Amoaku, Associate Professor & Honorary Consultant Ophthalmic Surgeon at University Hospital, Queen’s Medical Centre, Nottingham, voiced his opposition to this decision in an interview with Ophthalmology Times Europe earlier this year. “I believe Macugen should be allowed as a second-line treatment for patients who, for whatever reason, are not benefiting from Lucentis,” he said.

Professor Lotery agrees. “I accept that in most cases doctors will use a pan-VEGF blocker as first choice because of the clear benefits in efficacy,” he said. “However, it would have been useful to have Macugen available as a second-line agent in rare cases where patients may for example have an inflammatory reaction after taking another drug.”

Lucentis will now be made available in all PCTs throughout Britain. Following final guidance, the NHS will fund the initial 14 treatments for each eye, with Novartis covering the cost of any further injections under a “dose-capping” scheme. A course of 14 injections spanning two years costs around £10,700 (approximately €13,380) per patient. NICE Chief Executive Andrew Dillon commented, “Fourteen injections should result in stable vision for most patients and improved vision for around a quarter of patients. This proposal therefore represents a good use of NHS resources.”

The newly published FAD recommends Lucentis for the treatment of all eyes with wet AMD and best corrected visual acuity between 6/12 and 6/96.