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Our Take: FDA panels recommend approval for novel depression treatment

Feb 19, 2019

Two FDA advisory panels last week recommended approval of a single-use nasal spray device to deliver esketamine (Spravato, Janssen Pharmaceutical Cos.) in patients with treatment-resistant depression. The Psychopharmacologic Drug Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted that the drug’s benefits and safety profile outweigh its risks. The committees agreed that the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program be deployed.

The panels voted 14-2, with one abstention, in favor of the drug’s effectiveness and 15-2 that the company had adequately demonstrated esketamine’s safety.

The drug will not be available for use by patients at home, according to the REMS program; instead, it will be given in a health provider setting, where patients can be monitored for two hours after administration.

Our TakeIn a week in which the health care news cycle was dominated by HIMSS, news of this groundbreaking drug’s near-approval may have been overshadowed. It’s the top story of the year as far as we’re concerned, at least to date.

Esketamine is related to ketamine, an NMDA receptor antagonist that some Gen X ravers might know as “Special K.” Ketamine has been around for decades, used primarily for starting and maintaining anesthesia. It is on WHO’s List of Essential Medicines. Physicians have been experimenting with ketamine to treat depression for some time, and in 2017 a consensus statement was issued regarding its off-label use.

Ketamine clinics have become a cottage industry, with dozens of sites offering infusions for depression and pain. Some are reputable and under the umbrella of an academic institution. Others, not so much, as a STAT investigation found last year. Infusions can cost up to $1,800 per session, and insurance won’t cover experimental treatments.

One thing that makes esketamine attractive is that it’s fast-acting. With most SSRIs and other drugs used to treat depression, it can take weeks before a patient knows whether the drug is working.

In a press release, Janssen said evidence from two Phase III trials shows that “esketamine nasal spray plus a newly initiated oral antidepressant provided statistically significant, clinically meaningful, rapid and sustained improvement of depressive symptoms in this difficult-to-treat population.”

Medscape reported that Dr. Walter Dunn, a professor of psychiatry at UCLA and a voting advisory panelist, had this to say at the meeting: “I voted yes because esketamine has the potential to be a game changer in the treatment of depression; I use the term ‘game changer’ because they’ve demonstrated the rates of response in this treatment-resistant population [are] better than what we’ve seen for any of our current modalities. Number two, the rapid timeline of response is unprecedented; there’s nothing currently approved that gets patients better this fast.”

Dr. Dunn also noted that esketamine has a novel mechanism of action, which means it works differently than currently available treatments for depression.

If esketamine is indeed a “game changer,” as Dr. Dunn says, here are three facts to keep in mind:

  • According to the Centers for Disease Control and Prevention, suicide is the 10th leading cause of death in the U.S., with nearly 45,000 lives lost in 2016—a number that has been steadily rising since 2001.
  • An estimated 16.2 million adults in the U.S.—6.7 percent of all U.S. adults—had at least one major depressive episode in 2016, according to the National Institute of Mental Health.
  • 300 million people worldwide suffer from major depressive disorder, Janssen said in the press release. (We confirmed that number in a 2012 systematic review paper by Ferrari and others.)
If approved, esketamine would be available to patients who have failed to respond to two other therapies for depression. The FDA is also recommending that patients who receive esketamine be enrolled in a registry, as part of the REMS agreement.

Janssen would prefer to roll out the product without the burden of a REMS plan, as the related restrictions will undoubtedly limit the drug’s sales potential. But, having a new, effective treatment for depression is a major advancement for patients who suffer from the disorder.

What else you need to know
Intermountain has come out in support of Utah’s new cannabis law, allowing the health system’s physicians to recommend medical marijuana treatment for eligible new patients. In December, the state passed the Utah Medical Cannabis Act, and since then Intermountain has been “actively connecting” with patients and providers about their needs and the requirements of the law, the health system said in a press release. Intermountain now has a process in which a form letter is given to eligible patients explaining that they have an eligible condition and could benefit from treatment with medical cannabis. “We have a great responsibility to care for and partner with patients as best we can, support our physicians, advanced practice clinicians, nurses and pharmacists, and help everyone comply with the Utah law,” said Intermountain’s chief physician executive, Dr. Mark Briesacher. Morhere.

The Center for Medicare and Medicaid Innovation (CMMI) announced a new payment model for ambulance suppliers and providers, under the Emergency Triage, Treat, and Transport (ET3) model. Under ET3, ambulance providers will receive payment for transport of a Medicare beneficiary to a health care practitioner (either in person at a clinic or through a telehealth visit) or for an unscheduled emergency transport to an alternative destination, such as a 24-hour clinic. CMMI said Medicare currently pays for ambulance services when patients are delivered to a hospital emergency room, “creating an incentive to transport all beneficiaries to the hospital even when an alternative treatment option may be more appropriate.” The five-year program will start in 2020. Morhere.

Johnson & Johnson (J&J)’s Ethicon unit entered into a definitive agreement to acquire Auris Health Inc. for approximately $4.3 billion in cash. J&J said up to $2.35 billion in additional payments could be made upon reaching certain predetermined milestones. Auris develops robotic technologies, with a current focus on lung cancer. J&J said Auris’ Monarch Platform robotic technology will “play an important role” within the company’s Lung Cancer Initiative, “enabling the development of a differentiated digital solution that addresses key steps in the lung cancer care journey, from diagnosis to early-stage intervention.” The deal is subject to antitrust and other customary closing conditions. More here.

Executive moves
UnitedHealth Group announced that Dr. John Noseworthy has joined its board of directors. Dr. Noseworthy was the CEO of Mayo Clinic from 2009 to his retirement in 2018.

Altamonte Springs, Fla.-based AdventHealth named Dr. Jayaram Brindala as vice president and chief medical officer for its Population Health Services Organization. Dr. Brindala was most recently senior medical director at UPMC.

Novant Health UVA Health System named Al Pilong Jr. as its senior vice president and CEO, effective April 1. Mr. Pilong is currently chief operating officer for Traverse City, Mich.-based Munson Healthcare and president of Munson Medical Center.

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