PharmExec Blog

Budgeting for Patient Outcomes Research

By Marylyn Donahue.

The Patient-Centered Outcomes Research Institute (PCORI) has approved a two-year commitment to spend more than $1 billion in funding for comparative effectiveness research (CER) projects.

Critics had been clamoring for its research agenda to be more strategic, so it could address research questions that comparative effectiveness research would answer quickly and decisively. So the board also accepted a revised version of its methodology report, which provides a road map for conducting scientifically comparative clinical effectiveness research.

Some of the money will focus on product-to-product comparisons, according to a new analysis by the California Healthcare Institute and reported by John Reichard of the Commonwealth Fund. But most of the money will go to paying for studies on how to improve teamwork among doctors, for example, or the ways in which doctors communicate with patients about potential treatments.

But is it the right funding?
“Insiders refer to such approaches as ‘systems interventions’,” said David L. Gollaher, president of the California Healthcare Institute, which sees itself as the “the voice of the California biomedical community in Sacramento and Washington, DC”. Its members include biotech, device and diagnostics companies as well as universities.

That funding approach differs from the original vision many promoters of comparative effectiveness research had for the field — one in which studies would be focused predominantly on investigating which drug, device or other treatment worked best for a particular condition. The two fields — treatment comparisons and system interventions — can work hand in hand, however.

According to PCORI, its fiscal 2014 budget includes up to $528 million in research funding commitments and $182 million in expenditures. PCORI said it can commit far more in research support because funds for multiyear studies will be paid out incrementally over several years. The board’s vote on the funding commitment level gives the institute flexibility to approve funding for a range of high-quality comparative effectiveness research studies.

In September, PCORI approved 71 new projects to receive more than $114 million in funding over three years from the CER entity. PCORI’s funding priorities include improving health-care systems, addressing health disparities and assessing prevention, diagnosis and treatment options, among others.

A new strategic plan for PCORI also adopted by the Board has three main goals:

substantially increase the quantity, quality and timeliness of useful, reliable evidence to improve health-care decision making;

speed the implementation and use of findings from patient-centered outcomes research;

influence clinical and health-care research funded by others to be more patient-centered.

And a revised methodology report outlines the groundwork for the standards and types of research methods that can be used to develop comparative effectiveness research.

According to Gollaher, PCORI’s budget will increase from $320 million in 2013 to $650 million in next year because of a surcharge on Medicare premiums and premiums charged by commercial insurers under the health law, the study says. Because of the surcharge, PCORI’s budget will remain at that high level and grow incrementally in the years after 2014, Gollaher noted.

“This is an enormous increase in funding in an area that up until 2009 received very little federal funding,” Gollaher told the Commonwealth Fund. His assessment was the the funding jumped that year because of appropriations under the economic stimulus law (PL 111-5) — the increase being due to the surcharge.

Between 2010 and 2019 PCORI will have between $4.5 billion and $6 billion to spend on comparative effectiveness research, according to the institute’s analysis. PCORI is “going go to be by far the most well funded health technology assessment organization in the world, way beyond what’s happening in the UK, or Germany or France or anywhere else,” said Gollaher.

As to what the money is being slated for, Gollaher said that a lot was focused on the patient centered part. “In other words, grants that are going to programs within universities and health systems and so forth to enhance communications between doctors and patients, to get patients more involved in clinical decision-making, things we would describe as health systems interventions.

“Overall PCORI is devoting about two-thirds of its budget to health systems interventions,” Gollaher added. About 35 percent goes to study medical interventions. The Agency for Healthcare Research and Quality will spend 91 percent of the about $100 million it will spend in 2014 on comparative effectiveness research looking at medical interventions.”

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