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Category: Pharmaceuticals

Part 2: Bypassing Prior Authorizations

By NIRAN AL-AGBA, MD

A few weeks ago, I saw a young patient who was suffering from an ear infection. It was his fourth visit in eight weeks, as the infection had proven resistant to an escalating series of antibiotics prescribed so far. It was time to bring out a heavier hitter. I prescribed Ciprofloxacin, an antibiotic rarely used in pediatrics, yet effective for some drug-resistant pediatric infections.

The patient was on the state Medicaid insurance and required a so-called prior authorization, or PA, for Ciprofloxacin. Consisting of additional paperwork that physicians are required to fill out before pharmacists can fill prescriptions for certain drugs, PAs boil down to yet another cost-cutting measure implemented by insurers to stand between patients and certain costly drugs.

The PA process usually takes from 48-72 hours, and it’s not infrequent for requests to be denied, even when the physician has demonstrated an undeniable medical need for the drug in question.

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“Remember that Oath?”: EPCS and the Fight Against Opioid Abuse

By SEAN KELLY, MD

As doctors, we all took an oath when we graduated from medical school to “do no harm” to patients. It is, therefore, our duty to speak up and take action when there is an opportunity to prevent harm and improve patient care, safety and well-being. On average, the opioid crisis is killing more Americans on a monthly basis than traumatic injuries. It is time for the medical community to raise its voice even more loudly in support of proven technology that helps curb this crisis.

This month, California Governor Jerry Brown became the latest state lawmaker to embrace electronic prescribing for controlled substances (EPCS) — joining nearly a dozen other states that have passed legislation mandating that health care providers and pharmacies use the technology. The Golden State law was signed at the same time the U.S. Senate passed a bill requiring e-prescriptions for any reimbursement under Medicare Part D.

Clearly, EPCS is emerging as a key tool in the fight against opioid abuse. And legislators aren’t alone in driving the trend — corporations are playing a key role as well. Walmart, one of the nation’s largest pharmacy chains, is requiring EPCS by January 1, 2020. In their press release, it was noted that “E-prescriptions are proven to be less prone to errors, they cannot be altered or copied and are electronically trackable.”

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A Rosa Parks Moment is Coming in Phase 1 Cancer Trials

By DAVID C. NORRIS, MD

I want to tell you about the most exciting discovery I’ve made in 2+ years of research on dose individualization methods for phase 1 cancer trials. This discovery has nothing to do with any of the technical problems I’ve confronted and solved along the way. It involves no gigantic equation, no table of simulations results, and no colorful plot. Rather, it’s a discovery about sources of power to innovate in drug development.

In general, how would you describe the balance of power between Big Pharma and the individual patient? The question seems ludicrous—maybe even offensive—in light of ongoing scandals with price-hikes and shortages for critical drugs. But in the special area of trial methodology, I’ve got a real surprise for you…

One result from my DTAT research has been a clear demonstration that 1-size-fits-all dose finding in phase 1 cancer trials can cut the value of a drug in half, or even drop it to zero by setting the drug up for failure in phase 2 or 3. Although this economic argument has never been made quite so explicit and rigorous, I am certain the underlying principle comes as no surprise to anyone. (I note hardly anyone bats an eye when I detail the math.) Continue reading…

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