Comparative Effectiveness Research by States

San Francisco—Jenny Gaffney, a senior manager with Avalere Health in Washington, said at the AMCP meeting that over the past few years comparative effectiveness research (CER) has been utilized increasingly by states looking to improve the efficiency of their healthcare delivery and administration. In a Contemporary Issues session titled Use of Effectiveness Research by States: Current Trends and Emerging Models, Ms. Gaffney highlighted Avalere’s recent report on why public CER falls short of meeting the needs of Medicaid pharmacy programs.

In the past decade, the federal government has significantly increased its investment in CER. As a result of the Medicare Modernization Act (MMA) in 2003, the Agency for Healthcare Research and Quality has doubled its CER budget to $30 million annually. The office of the secretary of Health and Human Services and the National Institutes of Health have allocated $1.1 billion over 2 years to CER, and the Obama Administration has projected a total of $6 billion in combined public and private funding over the next 10 years as part of the Patient Protection and Affordable Care Act (ACA).

This investment has yielded research in several therapeutic areas—oncology, surgery and procedures, primary care and internal medicine, obstetrics/gynecology, neurology and infectious disease—all of which have been the subjects of the majority of CER reports. Though stakeholders have specific reasons and goals for their CER enterprises, there is no clear mechanism to ensure that the evidence and knowledge gained is meeting the needs of stakeholders.

Medicaid enrollment is expected to significantly increase in 2014 due to provisions in the ACA, and, by 2016, Medicaid coverage will have expanded to 17 million people who are <65 years of age, do not receive Medicare, and have incomes <133 percent of the federal poverty level. At the same time, the majority of states are projecting budget deficits for 2013.

In 2011, Ms. Gaffney said, “Avalere and the Kaiser Family Foundation (KFF) conducted a study that examined how state Medicaid programs were applying clinical evidence in their pharmaceutical policies. The goals of the study were to determine what types of research states need to make decisions, what challenges states face in using publicly available CER, and from whom are states obtaining their research. Avalere conducted research on 7 state Medicaid pharmacy directors and 3 Medicaid managed care plans.”

The study found that state Medicaid programs defaulted to the net price of drugs to refine their preferred drug lists (PDLs) due to a perceived lack of compelling evidence of comparative benefit. In addition, states do not use publicly available sources of CER because they have no information on cost, length, or timing of the analyses, and a majority of states rely on the same pharmacy benefit manager (PBM) to help them make decisions on pharmacy benefits.

According to Ms. Gaffney, there are 4 models for clinical research support. The most popular model is the approach used by Louisiana’s state Medicaid program—the private contractor PBM serves as a one-stop shop for claims processing, negotiating supplemental rebates, and conducting clinical and cost reviews with PDL recommendations. Other options include using a managed care provider (New York and Ohio Medicaid), a public HTA organization (Washington state Medicaid) or a local academic affiliate (MassHealth). Ms. Gaffney suggested that the best utilization of CER would be to combine different aspects of all 4 models.

In the same presentation, Steven D. Pearson, MD, MSC, president of the Institute for Clinical and Economic Review in Boston, discussed how his organization, which is based at Massachusetts General Hospital’s Institute for Technology Assessment, translates federal CER reviews to support payer policy decisions. The goal of his initiative was to use data from evidence reviews from the Agency for Healthcare Research and Quality (AHRQ) to meet the needs of state and regional payers to enhance the application of evidence in policy and practice.