April 24, 2012

expert reaction to Novartis suing NHS for using Avastin

The drug company Novartis decided to pursue legal action against the NHS for use of Avastin, a cheaper alternative to its drug Lucentis, to treat a common cause of vision loss.

Donald RJ Singer, Professor of Clinical Pharmacology and Therapeutics, Division of Metabolic and Vascular Health, Warwick Medical School, said:

“This is a complex issue and hinges in part on whether drugs which appear similar in function but are chemically different should be considered equivalent. When considering risks and benefits for patients when prescribing drugs, medicines that are unlicensed, ‘off-label’, or outside standard practice should only be used if the prescriber is satisfied that an alternative medicine would not meet the patient’s needs. This decision will need to include consideration of evidence of safety and efficacy.”

Neal Patel, Royal Pharmaceutical Socity spokesperson, said:

“Putting patients at the heart of decisions around therapy choice is what should drive NHS organisations and clinicians to make the right decisions about difficult issues.

“Avastin and Lucentis, although similar, are not the same medicine. NICE has ruled that Lucentis is a cost effective and clinically effective therapy for wet AMD1.

“Indeed, in the future we believe that decisions by NICE will lead to approved medicines being more rapidly and consistently available in to NHS patients in England.

“The medicines regulator, the MHRA, has approved Lucentis for use in this condition which means compelling evidence for safety, efficacy and quality has been received by the regulator allowing it to decide the benefit of use of the medicine outweighs the risks.

“Neither organisation have assessed Avastin on the same terms. This means patients, clinicians and the NHS do not have the same level of information on which to make a decision about the use of Avastin versus Lucentis at the current time, although clinical trials are ongoing.

“One way through this would be if the manufacturer of Avastin chose to apply for a licence for wet AMD.

“We understand that the NHS is under tremendous cost pressures and there is a finite amount of money for treatment, commissioners have to weigh up the relative value of one medicine against other interventions. Cost though is only one factor that should drive decisions about therapies, quality and safety must also be considered. We hope that the Government’s drive to introduce a new pricing system for the NHS – so called “value based pricing” – will incentivise the pharmaceutical industry and NHS commissioners to consider how best they can meet the needs of patients within cost that is acceptable to both parties.”

Professor John Harris, Institute for Science Ethics and Innovation, University of Manchester, said:

“Companies like Novartis should not be in the position to block moves to more cost-effective treatments in order to maximise their profits.

“It is legitimate for healthcare providers to appraise and approve off-label treatments which are significantly more cost-effective than those pharma are prepared to licence.

“Industry should recognise and be responsive to the social and economic context in which they operate

“Health systems in some countries may be able to afford treatment at the higher cost, this will inevitably divert resources from other areas, with negative results for patients and the system as a whole.”

Sir John Sulston, Institute for Science Ethics and Innovation, University of Manchester, said:

“Pharma spends only a small fraction (15% or so) of its revenue on new research, so claims that high prices are needed for innovation are spurious.”