A Troubling Policy Proposal

Last week, IGT joined many organizations in expressing concern about a policy proposal that would restrict patients’ access to certain life-saving treatments. The Centers for Medicare and Medicaid Services is currently considering a request from the state of Oregon’s Medicaid program to waive their federal requirement to cover all drugs approved under the accelerated approval pathway.


As stated in our comment letter to CMS, “[t]his proposal represents a fundamental misunderstanding of the accelerated approval pathway, ignores FDA’s precedential authority over drug approval, and overlooks the limited impact of accelerated approval drugs on state Medicaid budgets, including Oregon’s.”


For 30 years, the accelerated approval pathway has enabled earlier FDA approval of drugs that treat an unmet medical need for serious or life-threatening conditions, like HIV/AIDS, many types of cancer, and a number of rare diseases. The expedited timeline is made possible by studying the treatment’s effects on a so-called surrogate endpoint, like a lab measure, a radiographic image, or a physical sign. When the FDA determines that the surrogate endpoint is likely to predict a clinical benefit for the patient, it can significantly shorten the time to approval – by years in many cases. This is valuable time for severely ill patients who don’t have other options.


If CMS were to grant Oregon a waiver and allow the state to limit coverage of accelerated approval drugs for its Medicaid patients, the agency would be setting a troubling precedent that threatens to exacerbate health inequities not only in Oregon, but across the country. In the end, the savings gained would be miniscule, but the harm done would be significant.


You can read IGT’s comment to the Application for Renewal and Amendment to the Oregon Health Plan Section 1115 Demonstration Waiver here.

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