The Daily Rise: Thursday, June 9

Amplify the Patient’s Voice

MedCityNews covers the launching event for the ICER Watch patient portal — our ongoing effort to hold the Institute for Clinical and Economic Review accountable for its value framework.

“The fundamental goal is to broadcast and amplify the authentic voice of patients and the vital concerns we have about the barriers to access and to medicines and innovative therapies patients need and deserve,” our policy director Jonathan Wilcox, tells MedCityNews.

Last month, ICER published an initial draft report analyzing the value of treatment options for multiple myeloma, which the American Society of Hematology believes “will be used to limit the options for patients in receiving the best possible treatment.”

As Jonathan acknowledged to MedCityNews, cost is a concern, but it can’t be our only focus. As he put it, “The last way to address costs is to deny patients the medicines they need and deserve and to declare that some patients are too costly to treat and too expensive to save,

Less Debt

It isn’t all bad news on the cost front. Researchers at the Federal Reserve Bank of New York say that personal debt is lower in states that embraced Medicaid expansion.

“U.S. counties that had a particularly high uninsured rate prior to the implementation of the Affordable Care Act have seen the per capita collection balance fall if their state embraced the Medicaid expansion,” Bloomberg News reports. “If not, the collection balance continued to climb.

“While the full effects of the Affordable Care Act on financial health are yet to be seen, and while the effects of the ACA — positive or negative — are not restricted to financial health, we offer suggestive early evidence that the Medicaid expansion is fulfilling the goal of health insurance: providing ‘peace of mind’ by protecting against financial hardship,” note Federal Reserve analysts Nicole Dussault, Maxim Pinkovskiy, and Basit Zafar. .

Less Paperwork

While Medicaid expansion has helped reduce the amount of personal debt, the Food and Drug Administration has reduced some of the paperwork under its “compassionate use” policy, which provides a path for patients with life-threatening illnesses to obtain approval for experimental treatments.

The new FDA application form eliminated 15 questions in an effort to make a “pretty laborious process” a little bit easier for physicians. The FDA says that the new form can be completed in approximately 45 minutes and seeks information about individual patients.

We welcome any effort to reduce the paperwork burden on doctors and patients. As Vox’s Sarah Kliff recently argued in a piece we shared last week, “patients are the health care system’s free labor.”

“What I didn’t understand was the burden patients face in managing the health care system: a massive web of doctors, insurers, pharmacies, and other siloed actors that seem intent on not talking with one another,” she wrote. “That unenviable task gets left to the patient, the secret glue that holds the system together.”

The High Cost of FDA Regulation

Sherzod Abdukadirov, a research fellow in the Regulatory Studies Program at the Mercatus Center at George Mason University, contends that the FDA’s regulatory burdens have substantially increased the cost of developing new treatments.

Citing research from the Center for the Study of Drug Development, Abdukadirov details the ever-increasing cost of drug development. In 1991, the break-even point was $412 million (in 2013 dollars). In 2003, that number doubled to $1.047 billion. It now stands at $2.558 billion — a sixfold increase in three decades.

“The biggest drivers of this increase are higher clinical trial costs, especially phase III efficacy trials, along with a lower probability that the new drug will be approved by the FDA,” he argues. “In fact, the probability that a potential drug entering clinical trial stage will be eventually approved by the FDA decreased from 23 percent to 11.83 percent. This means that the FDA is asking drug makers to produce more and more data, yet it’s increasingly less likely to approve new drugs.”

Innovation should never be slowed down by burdensome regulations. We all want the FDA to approve new treatments that are safe and effective. But, we cannot create regulatory burdens that unreasonably delay approval.

Patients understand that the true cost of delays isn’t in dollars and cents — it’s the lack of access to potentially life-saving treatments.

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