ICER Weekly View: May 10, 2019

From the desk of David Whitrap

Good morning, and happy early Mothers’ Day to all the moms out there.

Before we dive into this week’s health care news, it’s only right that we first acknowledge the passing of the New York Times’ longtime reporter Robert Pear, a journalistic giant whose attention to detail and fairness earned the respect of DC policymakers, health care executives, and PR professionals like me. He surely knew his byline could move markets and legislation, and he was careful in how he wielded that power. He was the rare policy wonk who could write with clarity, and the rest of us will spend our careers just trying to catch up. Rest in peace, Mr. Pear.

This morning, we’ll look at:

  • ICER in the News: Our review of esketamine, an interview with our new CSO, the potential approval of a gene therapy for SMA, and our use of IPD Analytics’ data and insights.
  • Pharmaceutical News: The Senate Judiciary Committee’s latest hearing on drug pricing, finalized regulations requiring the disclosure of list prices in drugs’ TV ads, Florida’s plan to import less expensive drugs, how an old treatment for LEMS became new, and recognition of how far science has come in the fight against AIDS.

ICER in the News

Yesterday, ICER published our revised Evidence Report assessing the comparative clinical effectiveness and value of esketamine (Spravato), Janssen’s nasal spray approved by the FDA in March as a therapy for treatment-resistant depression (TRD). Esketamine is one of the two mirror-image molecules (enantiomers) that make up ketamine, an anesthetic that is commonly used off-label to treat TRD. The Midwest CEPAC will deliberate on the overall value of esketamine during a May 23 public meeting.

ICER’s Evidence Report Finds Esketamine May Benefit Patients with Treatment-Resistant Depression but Exceeds Cost-Effectiveness Thresholds

The Pink Sheet sat down with our new Chief Scientific Officer Dr. Pamela Bradt to learn how her unique background and expertise will help broaden the impact of ICER’s work.

ICER Chief Scientific Officer Bradt Brings Pharma Perspective
(The Pink Sheet)

Previewing the potential FDA approval of the gene therapy Zolgensma, the Wall Street Journal cited our assessment of the treatments for spinal muscular atrophy.

A $2 Million Drug Is About to Hit the Market
(The Wall Street Journal)

Also this week, we announced we will begin using IPD Analytics’ insights into the pharmaceutical pipeline to supplement our own horizon scanning efforts and to help inform our approach of selecting drug assessment topics.

ICER Will Now Leverage Data and Insights From IPD Analytic

Pharmaceutical News

On Tuesday, the Senate Judiciary Committee conducted a hearing of patient advocates, academics, and a representative of the pharmaceutical industry. Kaiser Health News recaps the hearing, summarizes four proposed drug pricing bills, and identifies areas of bipartisan consensus.

Drug Industry Patents Go Under Senate Judiciary Committee’s Microscope
(Kaiser Health News)

Meanwhile, HHS Secretary Alex Azar on Wednesday said the Trump administration has finalized regulations requiring drug companies advertising on TV to disclose list prices of medications costing more than $35 for a month’s supply.

TV pitches for prescription drugs will have to include price (The Associated Press)

As Florida moves closer to importing prescription drugs from Canada and other countries, this week Governor Ron DeSantis met with President Trump and Secretary Azar to discuss the program.

Drug Importation Fight Moves To Washington (Health News Florida)

For decades, the family-run Jacobus Pharmaceuticals charged LEMS patients $0 for the unapproved drug amifampridine. Then, Catalyst Pharmaceuticals licensed certain rights to the drug, scored an FDA nod, and set a $375,000 per year price for the treatment under the brand Firdapse. Predictably, an outcry ensued. But the FDA may have just found a workaround on Monday by approving Jacobus’ own branded version of the drug, Ruzurgi, for a slightly different patient population. No word yet on what the list price of Ruzurgi will be, or how physicians may prescribe these two treatments.

First, a pricing scandal for Catalyst’s Firdapse. Next, off-label competition? (FiercePharma)

Since the 1980s, more than 77 million people have become infected with HIV, and nearly half of these individuals have died from AIDS. A European study just published in the Lancet brings the good news that antiretroviral drugs not only suppress HIV, but also can prevent sexual transmission of the virus.

AIDS drugs prevent sexual transmission of HIV in gay men (Reuters)


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