Patients with a disease which causes blindness could be treated with an unlicensed drug in Yorkshire in a ground-breaking move by health chiefs.
GP leaders in the Vale of York risk putting themselves on collision course with regulators and pharmaceutical giants over the treatment they claim could save the NHS £800 million.
They are next week expected to back plans to draw up a business case for hospital specialists to replace drug therapy Lucentis used for wet age-related macular degeneration (AMD) with cancer drug Avastin.
They say it could save £4m a year in the area - enough to pay for the community nursing service for nearly a year, or community hospitals for 12 months, or the local A&E unit for six months.
Avastin was orginally created to treat cancer but was found to be effective against the eye disease, which is the leading cause of blindness in the elderly. The pharmaceutical firm which developed it created a second related drug Lucentis and no application has ever been made for a licence to use Avastin for eye complaints, leaving the NHS to use Lucentis, which is around 10 times more expensive.
Doctors can only prescribe Avastin “off-licence” to eye patients, triggering concerns it could put them in conflict with General Medical Council guidelines which say they should use unlicensed drugs only if “there is no suitably licensed medicine that will meet the patient’s need”.
Officials at the Vale of York Clinical Commissioning Group (CCG) will be asked to draw up an open letter to GMC bosses calling for a change in guidance around prescribing unlicensed medicines to allow doctors to comply with separate advice from the regulator which states: “You must make good use of the resources available to you.”
The CCG is hoping others will join it in putting pressure on the GMC. But it could also put them in conflict with drug firm Novartis, which markets Lucentis, and has taken legal action over previous efforts by NHS chiefs to use Avastin.
In a statement, the CCG said trials showed both drugs were equally effective and safe.
A new service saving £4m a year could be created using Avastin if the GMC altered its guidance and a national appraisal of the drug was carried out. “In order to give an idea of what this could purchase, it is enough to pay for 5,000 cataract operations or fund an eight-bed neonatal intensive care unit for a year,” it said.
Cathy Yelf, of the Macular Society, said given the savings, it was not surprising the CCG was considering Avastin but doctors should not be pressured to use it without “proper legal protection”.
She said: “Currently it is individual doctors who are legally accountable if an unlicensed drug is prescribed. If it is in the national interest to use Avastin instead of Lucentis then a decision should be made by an accountable body – the Government.”
Prof Carrie MacEwen, president of the Royal College of Ophthalmologists, which last week called for Avastin to be formally appraised by regulators, although it put likely NHS savings at £100m, said it acknowledged CCGs were looking at its use.
“However, the royal college is not asking for ophthalmologists to work outside of the guidelines recommended by the GMC or to use a non-licensed, unapproved drug, but for the regulators to find a way to license a drug or for the National Institute for Clinical Excellence to consider an off-label drug which is not being sponsored or submitted for appraisal by the company which owns it.”
A GMC spokesman said: “We support the argument for making efficient use of NHS resources. However, it is European law – and not GMC guidance – which states that prescribing an unlicensed medicine on cost grounds where a suitable licensed medicine is available, is unlawful. Clearly, we cannot issue guidance that might lead doctors to act unlawfully.”
In a statement, drug firm Roche, which holds patents for Avastin and Lucentis, said Avastin was not manufactured to meet standards for use in the eye.
“We strongly believe that a development programme for Avastin for intraocular use would not offer added medical benefit over the products that are already approved by health authorities... for wet AMD.”
Novartis said the unlicensed use of drugs should be limited to cases where there was an unmet medical need.