The Institute for Clinical and Economic Review, the Boston-based not-for-profit whose reports assess the value of drugs for patients, published proposed updates Wednesday to the framework it uses in these evaluations. Those proposals are open for public comment until April 3.
ICER's work entails gauging and reporting on drugs' comparative effectiveness, cost-effectiveness and potential budget impact with the broader goal of helping healthcare in the U.S. evolve into a higher-value system. It began releasing those reports in September 2015.
The value framework lays out the concepts and scientific methods ICER uses in its assessments. The proposed changes are based on several years of experience, including stakeholder input and comments and suggestions, and will affect reports for the two-year period beginning in April 2017.
The ICER value framework takes a population-level perspective, the framework explains, in analyzing evidence supporting policies such as care guidelines, pricing and insurance coverage. It weighs the long-term value of a drug—including its effectiveness—for its price, and its short-term affordability, with the broader goal of fostering sustainable access and high-value care for all.
Questions that the framework considers include whether new drugs offer benefits greater than those of existing drugs and whether drugs ultimately reduce costs by helping patients stay healthy or instead drive up costs. It uses the value framework to help calculate value by weighing evidence.
"We look at the whole picture so that we can help patients, doctors and insurers understand the true value of a new drug," ICER's website explains. "And the anchor to any determination of value is the evidence on how much better the drug is at improving patients' health."
Proposed changes to the framework included changes to the way it evaluates "ultra-orphan" drugs, devices, diagnostic tests and delivery system interventions by taking into account their unique nature or circumstances. The changes also broadened the range of cost-effectiveness thresholds when assessing long-term value for money.
Patient advocates, clinical societies, bioscience companies, drug benefit managers and insurance companies weighed in on the original framework.
An analysis by Avalere Health of previous stakeholder comments led the consultancy to conclude that the updated framework would include greater patient involvement and more diverse data sources, including real-world evidence. It would also be more transparent about ICER's processes and improve upon existing budget impact calculations, Avalere said.
