CER studies will shape coverage decisions


Comparative studies could alter coverage offerings.

PCORI spent the last year getting organized, hammering out definitions and seeking advice from all corners of the healthcare community, as required by health reform legislation. It aims to award initial grants this fall to start identifying medical products and practices with superior patient outcomes.

Added funds will evaluate strategies for improving healthcare systems and for assessing CER methods. In assessing projects, PCORI will weigh potential impact on medical practice and patient adherence, as well as prospects for reducing excessive care and costs. Although PCORI is constrained from using CER to make specific payment recommendations, researchers could evaluate how patient response would be affected by out-of-pocket outlays and other economic factors.

Strategies for ensuring the validity of observational studies and generalizability of data to broader populations are important for insurers looking to incorporate CER into reimbursement models. In addition to costs, payers are considering whether a new treatment demonstrates improvement over existing care and if clinicians will follow guidelines for appropriate use. Experts at the World Health Care Congress in April noted the need for CER in making value-based coverage decisions, particularly where randomized clinical trials are not possible.


Yet, Naomi Aronson, executive director of the BlueCross BlueShield Technology Evaluation Center, sees significant obstacles to assessing outcomes and their impact on health. Treatment affordability is key, she says. Even if a comparative study can document that some patients fare better on a certain therapy, the healthcare system might not be able to afford it.

Meanwhile, the quest for more patient subgroup analysis raises concerns among researchers and biopharmaceutical companies that larger and more costly CER studies will stifle innovation. To reduce outlays and risks, insurers, pharmacy benefit managers and drug makers are forming partnerships to evaluate a range of real-world strategies for treating patient subgroups and assessing diseases.

An important role for PCORI is to co-ordinate CER activities to avoid redundancies. Dissemination of results is key to drive findings into practice. PCORI will support communication activities by the Agency for Healthcare Research and Quality, which issues reports on effective treatments.

Jill Wechsler, a veteran reporter, has been covering Capitol Hill since 1994.

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