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Even after vowing to expand patients’ engagement in its process, the nation’s most active health technology assessment organization has shut them out.

Canceling Public Input

The Institute for Clinical and Economic Review, a health economics organization, canceled the only public meeting for its review of two drugs for the prevention of chemotherapy-induced neutropenia. The condition can occur after receiving chemotherapy for the treatment of cancer and can lead to increased risk of infection and other serious challenges. 

Why? According to the organization, it’s because the Food and Drug Administration asked the manufacturer of the unapproved drug to perform another clinical trial. The federal agency wants more documentation of plinabulin’s benefits before reconsidering it for approval.

Pressing On

But while ICER canceled patients’ opportunity to publicly weigh in, the health economists pressed on with assessing the drug in question. The organization omitted a “cost effectiveness” price for the drug from its recent draft report but kept other speculative elements.

That means the finalized report, despite its incomplete data, could be used to limit patients’ access in the future. ICER’s outcomes are being more frequently used by insurers to exclude coverage or justify restrictive policies like prior authorization, step therapy and specialty tier placement. Yet patients will have had no opportunity to speak out about the experience of living with chemotherapy-induced neutropenia or the value they see in new treatment options.

That includes patients like Ricki Fairley, a breast cancer survivor and founder of Touch, The Black Breast Cancer Alliance. The group focuses on getting more black women into clinical trials – an ongoing effort. And until minority representation in research increases, advocates like Fairley are left conveying their community’s experience through other avenues – like public meetings.

“We need access to more and different medications to combat breast cancer and its related conditions like neutropenia,” explained Fairley. “Depriving us the public meeting is akin to removing the voice of Black women, who experience the highest rate of breast cancer mortality of any racial or ethnic group.”

Even without a public meeting and an unprecedented change to its standard assessment process, ICER plans to issue a final evidence report in mid-March.

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