Specialty Pharmacy

Featured Health Business Daily Story, April 19, 2010

Health Reform Law Creates, Funds Comparative Effectiveness Research Institute 

Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers manage costs more aggressively and deliver biotechs, infusibles and injectables more effectively.

By Angela Maas, Managing Editor
(amaas@aishealth.com)

With the health reform law, comparative effectiveness research (CER) has gotten a second boost in a little more than a year. And based on an Institute of Medicine report released last summer, biologics may be one of the first classes on which the efforts are focused.

The reform law creates the nonprofit Patient-Centered Outcomes Research Institute. The organization’s purpose is “to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis that considers variations in patient subpopulations, and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of” any medical treatments, services and items used to treat, manage, diagnose or prevent illnesses or injuries.

The bill also establishes the Patient-Centered Outcomes Research Trust Fund, which includes appropriations of $10 million for fiscal 2010, $50 million for fiscal 2011 and $150 million for fiscal 2012.

The bill clarifies that it is not authorizing use of the data “to deny coverage of items or services under such title [XVIII, of the Social Security Act, Health Insurance for the Aged and Disabled] solely on the basis of comparative clinical effectiveness research.”

The institute will identify priorities for research, and it will “take into account the potential for differences in the effectiveness of health care treatments, services, and items as used with various subpopulations, such as racial and ethnic minorities, women, age, and groups of individuals with different comorbidities, genetic and molecular sub-types, or quality of life preferences and include members of such subpopulations as subjects in the research as feasible and appropriate.”

Coalition Hails Significance of Law

According to the Personalized Medicine Coalition, this is “the first time the principles of personalized medicine were formally voted on and passed by both houses of Congress and signed into law by a president. Also significant is the bill’s alignment of personalized medicine with the conduct and use of comparative effectiveness research (CER).”

More and more research is revealing that drugs already approved by the FDA, many of them specialty therapies, have a genetic component to them. For example, studies have shown that patients with colorectal cancer with mutated KRAS tumors do not respond to the commonly prescribed Erbitux (cetuximab) and Vectibix (panitumumab), but patients with wild-type KRAS tumors have a better response rate to the drugs and longer progression-free survival. Data presented at a January 2009 American Society of Clinical Oncology meeting showed that checking patients’ mutation status before treating them with these drugs could save more than $600 million annually. In addition to the costs saved by not treating patients with a drug that won’t do them any good, patients are not exposed to a toxic drug that could produce adverse side effects.

The American Recovery and Reinvestment Act of 2009, the stimulus bill that President Obama signed into law in February 2009, allocated $1.1 billion to CER. Of that total, $400 million will go to the National Institutes of Health, $300 million to the Agency for Healthcare Research and Quality, and $400 million to HHS. The law also established the Federal Coordinating Council for Comparative Effectiveness Research, a group consisting of 15 federal employees that will make HHS spending decisions on research.

The Patient-Centered Outcomes Research Institute will have a standing methodology committee of no more than 15 members appointed by the comptroller general of the United States to “develop and improve the science and methods of comparative clinical effectiveness research.” The group will develop and update methodological standards for research and a “translation table” that will act as a reference to determine research methods.

According to Genia Long, managing principal of Analysis Group, an economic consulting firm, “a lot of eyes are going to be watching how those seats are filled and where the initial priorities will be.” She tells SPN that a number of factors will influence the group’s initial focus, including spending concerns and “perceived gaps in evidence that are clinically meaningful.”

She points out that “while there certainly may be a lot of impact that the new institute will have,” such as where it prioritizes efforts and what kind of information it generates, “private plans have been thinking about comparative effectiveness for a long time. The focus on value-based purchasing has been out there for some time, and the whole attitude has permeated the industry.”

And all of the attention that stakeholders are giving to subpopulation analysis will affect CER priorities, Long says. CER will not be about “whether a given therapeutic is effective at all, but rather under what circumstances and for what populations” will it be effective, she says.

View the health reform bill at http://dpc.senate.gov/dpcdoc-sen_health_care_bill.cfm.

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