Early collaboration with healthcare payers could be a solution to address the lack of knowledge regarding the precise nature of risk in biopharmaceutical development and the strategies and tools employed to reduce it, according to a new report.
Their insight into balancing risk and benefit at an early stage in the drug development process "could serve as a wake-up call to the biopharmaceutical industry," according to John Doyle, vice president and managing director with consulting at Quintiles, which commissioned the report.
There are stark differences in how risk is perceived by the different stakeholders in the provision of new medicines, according to the New Health Report 2012, which is based on interviews with more than 1,350 patients and executives from pharmaceutical companies, payers and the investment community.
For example, two-thirds of biopharma executives polled for the report said that the industry's risk exposure should be limited or maintained, while more than half of payers and investors felt that the sector should absorb more risk to improve biopharmaceutical agents and the public health.
Moreover, there was little agreement among biopharma executives about the level of risk that they should bear, split fairly evenly between those who felt it should be reduced, increased or maintained.
A majority (60 per cent-plus) felt that regulators should accept more risk, while more than half of the investors surveyed said difficulties in securing approval for new drugs was the biggest challenge facing the biopharma industry.
The survey reveals a lack of understanding and collaboration on risk-management that is holding back the ability of all stakeholders to make better risk/value decisions.
At the heart of that problem is a pressing need for new metrics to assess risk and benefit, as current tools "remain rather rudimentary", according to the report.
"With more robust sources of data, healthcare players can plan the pathways to the next generation of lower-risk, higher-benefit medications that balance the needs of all stakeholders," said Quintiles.
There are encouraging signs that a more collaborative environment is possible, with 63 per cent of US payers, 73 per cent of UK payers and 55 per cent of biopharma executives agreeing that risk-sharing agreements between biopharmaceutical companies and payers would lead to more innovative and effective therapies.
In addition, more than 70 per cent of biopharma executives and payers said that pre-competitive collaborations among biopharma companies would lead to more innovative and effective therapies.
"Biopharma must find a way to work with a stakeholder that is better versed in risk/benefit tools and methods," said Doyle.
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