Biopharmaceutical services company Quintiles has commissioned New Health Report 2012. Now in its third year, The New Health Report offers perspective and insight into key topics to help the healthcare industry’s key stakeholders better understand the dramatic changes occurring within drug development and commercialisation. This year’s report surveyed more than 1,350 US- and UK-based biopharma executives, executives from payer organisations, life-science investors and patients being treated for a chronic illness.
The New Health Report 2012 has found out that: There is no consensus within biopharma about whether companies should accept more risk; Better metrics are needed to assess risks and benefits accurately for all stakeholders; Pre-competitive alliances and risk-sharing agreements, supported by both biopharma, payers and providers, are seen as having potential to produce more innovative and effective therapies; Many patients with chronic diseases are willing to accept greater risks for greater benefits –especially in the UK.
The New Health Report highlights that more than half of US payers, National Health Service (NHS) executives and investors agree that biopharma needs to take on more risk to improve biopharma agents and public health. In contrast, 65 per cent of biopharma company executives believe that they should either reduce their current risk profile or maintain it.
Further findings suggest that key stakeholders need to work together to overhaul risk assessment methods and tools. Biopharma companies, US payers and NHS executives say the metrics they use currently to assess risk/value trade-offs of potential new medications are inadequate. The majority of the stakeholder groups surveyed report using patient-reported outcome measures, minimum clinical efficacy or quality-adjusted life years to assess risk, yet these groups do not believe these tools are enough.
New metrics to assess the risk/value trade-offs also may help to improve navigation through what is perceived to be a challenging regulatory environment. Despite eight out of 10 biopharma executives being optimistic about the quality of prescription medications in 10 years, the greatest number cite a more difficult regulatory approval process as their organisation’s biggest challenge. Another 20 per cent consider access to capital as their primary challenge. Investors agree, with 56 per cent citing a more difficult FDA approval process or rigid regulatory environment as the biggest challenge facing the biopharma industry.
Despite the perceived difficulty in securing drug approval, large numbers of payers in both the US and the UK want more involvement at every stage of the drug development process. For preclinical testing, for instance, only 18 per cent of the UK payers claim current involvement, but 43 per cent – nearly two and a half times as many – say that they should be involved. This sentiment also is shared among US payers.
“Payers’ interest in early involvement in the drug development process, complemented by their experience in balancing risk and benefit, could serve as a wake-up call to the biopharma industry. Biopharma must find a way to work with a stakeholder that is better versed in risk/benefit tools and methods,” said John Doyle, Vice President and Managing Director with Consulting at Quintiles.
Patients with a chronic health condition have a point of view on risk, too. 72 per cent of the US patients believe that they should be able to choose to take a potentially risky medication — even if it is not approved for use – if they feel it is their only chance to improve their health. In the UK, patients show a greater tolerance for risk, as 81 per cent shared this sentiment. The results suggest ways forward to help stakeholders mitigate risk throughout the drug development lifecycle.
Dean Summerfield, Vice President and Managing Director with Consulting at Quintiles in Europe, said, “Biopharma can take steps today and in the future to mitigate risk at each stage of the development and commercialisation process. Pre-competitive alliances can assist in accelerating the development of innovative medicines. Working in collaboration with both payers and providers during development can help to ensure that collected data meet their priorities in terms of demonstrating value. In commercialisation, biopharma can employ risk-sharing deals in order to ensure that their product is available to those who can benefit.”
EP News Bureau – Mumbai
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