Quintiles' New Health Report Evaluates the Risk Equation in Biopharmaceutical Medicine

Quintiles' New Health Report Evaluates the Risk Equation in Biopharmaceutical Medicine

RESEARCH TRIANGLE PARK, NC – May 22, 2012 – The constellation of stakeholders in the healthcare industry most responsible for the progress of medicine do not agree on a common lens from which to view risk for their own purposes, nor for the other stakeholders they are dependent upon. A clearer, shared understanding of risk is vital to help all stakeholders make better risk/value decisions to improve public health.

Better risk/value decisions are the essence of a more effective healthcare delivery system, according to the New Health Report 2012 commissioned by Quintiles, the world's leading biopharmaceutical services company. Among the results, The New Health Report 2012 finds 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 U.K.
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 commercialization. The issues examined are central to an industry under immense pressure to demonstrate product value and make better risk/value decisions in order to drive improvement in public health. This year's report surveyed more than 1,350 U.S.- and U.K.-based biopharmaceutical executives, executives from payer organizations, life-science investors and patients being treated for a chronic illness.

These healthcare stakeholders have different perceptions of risk and benefit. The New Health Report highlights that more than half of U.S. payers, National Health Service (NHS) executives and investors agree that biopharma needs to take on more risk to improve biopharmaceutical agents and public health. In contrast, 65% of biopharmaceutical 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. Biopharmaceutical companies, U.S. payers and NHS executives say the metrics they use currently to assess risk/value tradeoffs 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 tradeoffs 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 organization's biggest challenge. Another 20% consider access to capital as their primary challenge. Investors agree, with 56% citing a more difficult Food and Drug Administration 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 U.S. and the U.K. want more involvement at every stage of the drug development process. For preclinical testing, for instance, only 18% of the U.K. payers claim current involvement, but 43% – nearly two and a half times as many – say that they should be involved. This sentiment also is shared among U.S. 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 biopharmaceutical industry," said John Doyle, Vice President and Managing Director with Consulting at Quintiles. "Biopharma must find a way to work with a stakeholder that is better versed in risk/benefit tools and methods."

Patients with a chronic health condition have a point of view on risk, too. Seventy-two percent of U.S. 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 U.K., patients show a greater tolerance for risk, as 81% shared this sentiment.

The results suggest ways forward to help stakeholders mitigate risk throughout the drug development lifecycle. For example, U.S. payers (63%), U.K. payers (73%) and biopharmaceutical executives (55%) feel risk-sharing agreements between biopharmaceutical companies and payers would lead to more innovative and effective therapies. In addition, more than 70% of biopharma executives, U.S. payers and U.K. payers believe that pre-competitive collaborations among biopharma companies would lead to more innovative and effective therapies.

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 commercialization 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 commercialization, biopharma can employ risk-sharing deals in order to ensure that their product is available to those who can benefit."

About The New Health Report

The New Health Report is based on a survey of biopharmaceutical executives, managed care executives in the U.S, National Health Service executives in the U.K., patients living with a chronic disease in both the U.S. and U.K., and investors who focus on the healthcare sectors. Richard Day Research of Evanston, Ill., USA, a Market Probe company, conducted the survey on behalf of Quintiles and was responsible for all survey design, data analysis and data reporting. Data for this survey were collected online and by phone between January 8 and March 14, 2012. Survey sample respondents included 102 biopharmaceutical executives at the director level or above, 75 managed care executives in the U.S. at the director level or above, 72 NHS executives (director or above) in the U.K., 509 U.S. and 500 U.K. adults ages 18+ diagnosed with a chronic health condition who are receiving treatment, and 100 investment professionals (vice president and above) employed in private equity firms, investment banks, or venture capital firms that focus on the healthcare/biopharma sector. Access the complete results of the survey at: http://www.quintiles.com/newhealthreport.

About Quintiles

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of more than 25,000 professionals in 60 countries has an eye on the future while delivering results today with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies develop and commercialize products to improve and lengthen patients' lives while demonstrating value to stakeholders. Visit www.quintiles.com for more information and www.quintiles.com/news for additional company news.

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