The Government appears to have ruled out the use of Avastin to treat macular diseases saying it would be unlawful and against the wider public interest to do so.
Earlier this year, clinical leaders across 120 Clinical Commissioning Groups urged the GMC, Department of Health and NHS England to consider commissioning eye care services using the drug Avastin ‘off licence’.
Avastin (bevacizumab) has been found in clinical trials to be safe and effective for patients with wet age-related macular degeneration. It is also cheaper than the officially approved treatment, Lucentis (Ranibizumab).
Avastin is licensed for the treatment of some cancers, but does not have a licence for use in AMD.
In a letter to Steven Hulme, Director of Medicines Management at NHS Southern Derbyshire Clinical Commissioning Group, George Freeman, Minister for Life Sciences, said he cannot support the use of an unlicensed drug for the treatment of age-related macular degeneration on the basis of cost alone and would not risk spending public money to fight for it.
Freeman's remit includes the National Institute for Health and Care Excellence (NICE), the Medicines and Healthcare products Regulatory Agency (MHRA) and research and innovation in the NHS.
The correspondence was dated 23 March 2015.
Freeman said under European and domestic law it is illegal to manufacture and supply any unlicensed products unless there is a special need for an individual patient. He added that both Lucentis and Eylea are licensed to treat AMD and both are “cost-effective” options.
He added: “The use of Avastin to treat AMD is an unlicensed one and setting a policy for routine use of Avastin on ground of cost alone is not something I can support, nor would it be prudent for me to risk public funds by underwriting it.”
NICE is currently working on developing clinical guidelines on the diagnosis and development of macular degeneration that will be open for consultation next month. He said that: “NICE will propose that guideline refers to Avastin as well as Lucentis for treating AMD.”
Cathy Yelf, Chief Executive of the Macular Society, said: “We welcome the clarity from the Government after years of debate. Drug licensing exists for the protection of patients and should not be disregarded for short term gains.”