Doctors appeal to prescribe Avastin off-label
pharmafile | February 25, 2015 | News story | Sales and Marketing | Lucentis, NHS, NICE, Novartis, Roche, bevacizumab, wet AMD
NHS Clinical Commissioners have called for the removal of barriers preventing CCGs from prescribing Roche’s Avastin to treat wet age-related macular degeneration.
The campaigning doctors who represent around 60% of England’s CCGs, have even asked health secretary Jeremy Hunt and NHS chief Simon Stevens to step in and find a solution, adding to a move the ABPI has labelled as ‘completely inappropriate’.
But Dr Amanda Doyle, co-chair of NHS Clinical Commissioners, says: “This is a long standing issue within the NHS, and the numbers of CCGs who have united behind this shows the strength of feeling there is to ensure that we have all the available options to be able to deliver the best possible care for our patients.”
Off-label prescribing of Avastin (bevacizumab) for the debilitating wet AMD eye condition has been relatively common even though the drug – unlike the more expensive Lucentis (ranibuzimab), which is co-marketed by Novartis and Roche – is not approved for this licence.
But the brands are chemically similar, and by prescribing Avastin off-label health authorities can save a considerable amount of money. Novartis and Roche have both courted controversy over the issue previously.
Last year European Union regulators considered taking action over allegations of anti-competitiveness involving both firms, as they were accused of colluding to stop Roche’s cancer drug Avastin from being used to treat wet AMD.
Both have consistently denied that there is any such agreement between them. Now on this latest development, UK pharma body the ABPI has stepped into the frame to offer its industry comment.
Paul Catchpole who is the ABPI’s director of Value and Access, says the rigorous safety testing and medicines licensing requirements exist in the UK in order to protect the public’s interests, and that they’re there for a reason.
He adds: “Be in no doubt – seeking to bypass the regulatory system by calling for local clinical commissioning groups to prescribe an unlicensed medicine on the grounds of cost alone potentially threatens patient safety. In this case, there are a number of MHRA and NICE approved licensed medicines available to treat this condition.
Noting that the MHRA and NICE are the ‘proper authorities’ to issue guidance to the NHS on the safety, quality and clinical and cost-effectiveness of medicines – he points out that commissioners are legally obliged to implement NICE guidance.
He goes further, adding: “Patients’ right to access treatments recommended by NICE are included in the NHS Constitution. NHSCC’s call to bypass national guidance on economic grounds is completely inappropriate, particularly so, when under the terms of the current PPRS Agreement, the pharmaceutical industry has recognised the financial challenge faced by the NHS and is currently underwriting the NHS branded medicines bill, within agreed limits, until 2018.”
Roche has told the BBC in a statement: “Avastin was developed and approved only for the treatment of patients with cancer. Avastin is not licensed for wet age-related macular degeneration because it is not developed and manufactured to meet intraocular standards.”
It adds it would take years of more trials and to get Avastin ready for such licensing and that efforts would be better spent exploring new potential eye medicines instead.
A Department of Health spokesperson concludes: “Avastin is not licensed for this purpose [wet AMD] and whilst only the manufacturer is able to apply for a new license, doctors are free to prescribe unlicensed medicines and licensed products off-label if they feel they are clinically appropriate for their patients.”
Brett Wells
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