The Daily Rise: Thursday, July 21

What is ICER and Why Does It Matter?

What is ICER and why does it matter?

After all, the Institute for Clinical and Economic Review – aka ICER – is not a real regulatory body in the true sense. So, what is all the fuss? They can put out their reports, but who is really going to listen?

Terry Wilcox, our co-founder and executive director, answers those questions in a new post on our Patients Rising blog. She warns that increasingly, insurance companies and even government-managed health care programs, such as Medicare and Medicaid, are turning to groups like ICER to cut costs at the expense of patients. As Terry puts it, “I worry that ICER cares most about the bottom line of insurers.”

Last week, Terry attended her first ICER public meeting — New England CEPAC in Portland, Maine — for the discussion around a recently approved medicine for PBC liver disease, Obeticholic Acid (OCA).

“It’s hard not to notice how ICER purposefully schedules their meetings around the time new medications for an indication are being approved,” Terry explains. “ICER’s reports give the insurance industry more negotiating leverage, and in many instances, this could lead to stifling access to the medications before patients who meet the prescribing criteria are even allowed to try it.”

Read her entire piece at our Patients Rising blog.

Biosimilar: Approval is Great, Now Where are the Guidelines?

Last week, an FDA panel recommended approval for two biosimilars for arthritis. But, many patients are asking: where are the guidelines?

Roll Call looks at the FDA’s slow process for adopting biosimilar guidelines “for determining whether the drugs are indeed fully interchangeable with the original product.” Even though biosimilar treatments are deisgned as replacements for name-brand biologics, it’s not as simple as swapping medications. That’s because unlike most drugs that use chemical compounds, biologics use cells and living cultures.

“Patients are indeed concerned about switching because there has not been substantial or sufficient studies or evidence about what happens when you switch,” Seth Ginsburg, co-founder of an arthritis support organization, told Roll Call.

From the patient’s perspective, proper guidelines are absolutely necessary for patients to evaluate which treatment is right for them.

Quote of the Day: Congressional Inaction

“Public health used to be a bipartisan endeavor. No longer. And not only on policy issues, but now funding.” — Bill Pierce, a former spokesman for HHS in the Bush administration.

That quote comes as Congress has been slow to act this year on major public health issues, including funding for Zika virus research. Public health used to be a topic that bridged the political divide. Check out the rest of Morning Consult’s story on whether congressional inaction on public health is the new normal.

Rest in Peace: Rep. Mark Takai

Congressman Mark Takai of Hawaii died Wednesday after battling pancreatic cancer for the past nine months.

As the Washington Post notes, “In late October, he announced he had been diagnosed with a small tumor on his pancreas after experiencing stomach pains. At that time, Takai referred to his prognosis as “very good thanks to early detection.” He underwent surgery to remove the tumor in November.”

Our thoughts and prayers are with the Takai family.

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