Why Comparative Effectiveness Research is a market opportunity

Pharma firms must actively shape the design and use of Comparative Effectiveness Research (CER), not wait for policy makers to do it for them.

Pharma firms must actively shape the design and use of Comparative Effectiveness Research (CER), not wait for policy makers to do it for them.

In a new report, Rewarding Innovation and Value: What Is The Role of Comparative Effectiveness Research? , Quintiles Consulting asserts that pharmas have a unique opportunity to take the lead in establishing a valuation system for their products that compensates innovation fairly by building and extending the concept of Comparative Effectiveness Research (CER).

Calls for cost-effectiveness of pharma treatments are louder than ever and are coming from a broad range of stakeholders, including politicians, public and commercial payers, providers and patients, Quintiles points out.  In fact, in an August 2009 New England Journal of Medicine article, a Stanford University research team proposed that the US Food and Drug Administration (FDA) require CER data be included on a products label to separate those that truly improve outcomes from those that do not.

CER is an approach in which products are evaluated in a true-to-life setting against the current standard of care. As defined in June 2009 by the Federal Coordinating Council for Comparative Effectiveness Research, CER is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in real world settings. Quintiles says CER invariably includes an implicit appraisal of value in areas such as safety, effectiveness, quality of life and convenience.

Health Technology Assessments (HTAs), structured analyses based on retrospective reviews of evidence and modeling practices, are a form of CER that has emerged globally as a tool to help payers, providers and policy makers make informed decisions on coverage, payment and patient care. HTA proponents say the approach brings together information on the clinical, economic and humanistic qualities of a product in a systematic, transparent, unbiased and robust manner.

CER has been in the spotlight since US President Barrack Obama signed the countrys stimulus bill into effect in February 2009. The bill allocated $1.1 billion in funding to CER and created the Federal Coordinating Council for CER to reduce duplication of activities within the Federal government and coordinate CER.

There is ongoing debate, Quintiles says, on whether the broad use of CER may be imposed by Washington or whether it may become decentralized and market-driven. But theres no debate that managed care organizations are beginning to demand a formal demonstration of value when considering a new product for formulary placement. And national provider organizations, staff model health maintenance organizations and integrated healthcare networks are reviewing cost-effectiveness and comparative effectiveness of various therapies.

Act now, or regret it later

The pharma industry cannot simply afford to wait passively for policy makers to dictate comparative effectiveness requirements, but must actively participate in the discussion concerning the proper design and use of CER, Quintiles says. By supporting the development of a standard set of guidelines, the industry could rightly earn a seat at the table if initiatives are launched at the federal level, the reports authors suggest.  A key argument in favor of engaging in these early discussions of CER and HTAs is to gain influence over the form this approach takes as it evolves into a more universally accepted, standardized format which could be used alongside a products traditional data demonstrations.

By examining the data which shows exactly how their medicines are being used, and by whom, pharma manufacturers will enable decisions all along the development process that are more rooted in real world data, the group says. In addition, the industry can develop new standards for myriad observational techniques to complement traditional clinical development in order to more fully develop the mosaic of comparative evidence supporting the adoption of their product, Quintiles says.

The industry should broaden its evidence gathering activities beyond traditional clinical research methods, focused predominately on placebo-controlled trials, by complementing the RCT clinical pathway with observational techniques, the group urges. Such a move would help to illuminate the shortcomings of current approaches and enable pharma manufacturers to refine development and product positioning pre-launch, while documenting real world patient experiences post-launch.

As Quintiles aptly points out, it is imperative for the economic efficiency of the healthcare industry to develop a universally accepted pharmaceutical valuation system based on a standard set of CER principles.  Ultimately, every manufacturer must communicate the value of its products to multiple stakeholders in a manner that allows for comparison to competing agents, they write. With drug development costs reaching new highs each year, the risk of standing on the sideline while comparative effectiveness evolves is untenable.

CER guidelines, Quintiles says, should focus on a holistic notion of value which encompasses a variety of treatment processes and outcome metrics measured by an array of research designs. And the pharma industry, the firm urges, should propose a standardized process for designing, implementing and reporting this array of study designs.

The responsibility for developing and demonstrating a products value rightfully falls to the biopharmaceutical manufacturers, the group says. But this should be regarded as a historical market opportunity, not as a burden. As a diversity of data is amassed under CER guidelines that include both observational and experimental research techniques measuring an array of outcomes, pharmaceutical companies should be able to present formidable evidence of their products value and, therefore, be properly rewarded for their innovations.

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