By the close of 2012 two key questions regarding the Affordable Care Act were finally addressed: one, whether the health care reform law is constitutional and, two, whether it would be repealed under a new administration. With these two questions now clearly resolved by the Supreme Court and the November elections, respectively, health care stakeholders are now turning their attention to another big question: How will the law be implemented?


National Pharmaceutical Council, Dan Leonard, comparative effectiveness research, CER, health care reform, Affordable Care Act, Patient-Centered Outcomes Research Institute, PCORI, state health exchanges, health care, accountable care organizations


































































































































































































































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Inside This Issue - Opinion

NPC examines CER as health reform takes hold

January 6th, 2013
by Dan Leonard

By the close of 2012 two key questions regarding the Affordable Care Act were finally addressed: one, whether the health care reform law is constitutional and, two, whether it would be repealed under a new administration. With these two questions now clearly resolved by the Supreme Court and the November elections, respectively, health care stakeholders are now turning their attention to another big question: How will the law be implemented?

Dan Leonard

Tackling that question alone would require a book-length answer and possibly a crystal ball, so I’ll narrow the focus of my answer to several components of the law that the National Pharmaceutical Council (NPC) is following with more interest. These components include comparative effectiveness research, state health exchanges and benefits, and value-based health care environments such as accountable care ­organizations.

Comparative Effectiveness Research

Comparative effectiveness research (CER) isn’t a new concept, but its use is growing because the Patient-Centered Outcomes Research Institute (PCORI), the agency created under the health care law to coordinate national CER efforts, is spending up to $500 million annually to fund new studies.

In its most basic definition CER is the comparison of two or more treatment options, with the results intended to help patients and their care providers make more informed decisions about their health care options.

Given the millions of dollars being spent on CER each year, CER that is conducted in a rigorous and high-quality manner has the potential to greatly improve health outcomes for patients. And that’s a powerful thought. Patients need better information to guide them in their decisions, especially in areas that science has not fully addressed, such as patients with chronic conditions and those who face multiple health challenges.

But CER’s success will depend on several factors. First, patients need to understand what CER is and why it matters to them. PCORI and others are making strides on this front, but more work remains to be done to engage patients in developing research that matters to them.

Second, how the research is conducted is very important. Asking the right questions to inform decision making, using the right type of study to answer the question, utilizing the best possible research methods, and then developing high-quality research is necessary so that, in theory, the studies will produce good, meaningful results that can be adopted into clinical practice and utilized for decision making.

But how do we define “good research?” Although randomized controlled trials (RCTs) have long been considered the gold standard of scientific studies, many researchers agree that observational studies — which use data pulled from electronic health records or claims databases, for example — play a central role in answering certain types of questions, particularly regarding real-world behavior.

Many researchers, including NPC, are working on a set of standards to help ensure the best conduct of observational studies and to help payers evaluate them.

Third, once the research is completed, how will it be translated and disseminated to end-users? Given how complex some of the research is, it can be challenging to explain it in a clear manner. Additionally, the evidence derived from CER often takes nearly two decades to be adopted into clinical ­practice.

And with dissemination comes another challenge. In today’s health communications landscape, the growth of digital information has made it possible for a variety of players — including payers, academics, health care providers and patient advocates — to comment on the effectiveness of treatment options.

But concern over industry bias has led to restrictive communications rules that limit industry’s ability to share information in many situations when the company is in the best position to provide facts important to health care decision making. One solution, as many health care stakeholders have suggested, is to develop a set of voluntary communications guidelines and have everyone play by the same rules.

Developing State Exchanges

The issue of individual treatment effects also is gaining attention as state policy makers develop the marketplaces where uninsured and underinsured people will buy insurance under health care reform. Policy makers are preparing blueprints for these marketplaces, known as state health insurance exchanges, for submission to the Department of Health and Human Services.

Under one design option the state health insurance exchanges would cover only one drug to treat a given condition. By pushing a standardized treatment for every patient, this model could lead to poor outcomes for the patients who see limited or no benefit from that particular drug. States are wrestling with this issue as they decide whether to cover a single drug, several drugs or the full range of medications for a health ­condition.

The evidence has shown us that “one size fits all” approaches, like those being considered by some state insurance exchanges, can mean poor outcomes for key subgroups of patients. When individual patients respond poorly due to heterogeneity, the health care system in turn must devote more time and money to making them well.

A CER study of antipsychotic drugs provides an example of how this dynamic plays out. Although the Clinical Antipsychotic Trials in Intervention Effectiveness (CATIE) found that first-generation antipsychotic drugs were as effective at treating schizophrenia as newer, more expensive medications, a follow-up study conducted by the Manhattan Institute for Policy Research and funded by NPC determined that a hypothetical policy denying Medicaid patients coverage for second-generation drugs would lead to higher overall health costs. For the 75% of patients who do not respond to first-generation antipsychotics, such a restrictive coverage policy would take a huge toll on their health. The study illustrates why failing to tailor care to individual patients’ needs can worsen the divide between those who have ready access to quality care and those who do not.

Establishing A Value Base

Finally, value-based health care environments. As health care providers set up accountable care organizations and other value-based care programs, pharmaceuticals offer one avenue to help minimize overall costs and meet recognized standards for quality patient care.
Providers are shifting to value-based care models to provide better care for individuals, improve population health and slow cost growth. Many of these models, such as the Centers for Medicare & Medicaid Services’ Medicare Shared Savings Program, include quality benchmarks and incentives for reducing costs.

As providers evaluate optimal care for their patient populations in these new models, prescription medications should be thoughtfully integrated into the process. That’s because when medications are appropriately used they can contribute significantly to improving patient outcomes and reducing overall costs.

If decision makers and policy influencers can come together in 2013 and address these issues, NPC believes that CER can be a valuable tool in improving quality and containing costs. We are prepared to do our part and call on all of those with a role to do the same.

DAN LEONARD is president of the National Pharmaceutical Council (NPC).

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