A new treatment for treatment-resistant depression is offering hope to millions of patients that have struggled in vain to find some relief from their crippling depression.

“I was in the worst depressed mood, not wanting to live,” patient Madelin Manso told her hometown Sun-Sentinel. That was until she tried a new nasal spray that is specifically designed for patients with severe, treatment-resistant depression.

“My first treatment worked within an hour,” she explained. “When I got up from the infusion, I was a different person.”

The treatment, known as esketamine, is heralded as “a major breakthrough for people living with treatment-resistant depression” because it “operates via a different mechanism in the brain.”

“This is a game changer,” says Dr. John Krystal, chief psychiatrist at Yale Medicine and one of the country’s leading experts on the breakthrough therapy.

As Manso experienced, the treatment is also fast-acting.

“What is most exciting about esketamine is that it has an acute effect,” Dr. Anil Malhotra, director of the division of psychiatry research at Zucker Hillside Hospital, told Newsday. “Patients report almost an immediate effect within hours and not longer than days.”

Game Changer for Treatment Resistant Depression

More than 16 million Americans – 6 percent of the entire population – have experienced a major depressive episode, according to data from the National Institute of Mental Health. Of these patients, experts believe a third live with treatment-resistant depression, so-called because traditional antidepressant medications fail to show any improvement.

Treatment Resistant Depression

16 million Americans have experienced a major depressive episode.

When the FDA approved esketamine in March 2019, it immediately offered hope for patients living with treatment-resistant depression.

“What’s so exciting is if this takes off, it could help millions of people,” said Dr. Daniel Bober, chief of the Department of Psychiatry at Memorial Regional Healthcare System in South Florida. “The excitement is because this works for people who have shown to be treatment-resistant.”

FDA Approval Doesn’t Mean Insurance Coverage

Now, just weeks after the FDA approval, patients with treatment-resistant depression are seeing their dreams dashed — this time by insurance obstacles and barriers to access.

“Thank goodness we now have something with a different mechanism of action than previous antidepressants,” Dr. Erick Turner, a former F.D.A. reviewer and an associate professor of psychiatry at Oregon Health & Science University, told the New York Times.

He adds, “But I’m skeptical of the hype, because in this world it’s like Lucy holding the football for Charlie Brown: Each time we get our hopes up, the football gets pulled away.”

ICER Blocking Patient Access

The entity leading the effort to pull the drug away from patients: the Institute for Clinical and Economic Review, an insurance-backed cost arbiter that is currently undergoing its own cost analysis of the drug.

Officially, ICER is a private entity with no government authority. However, powerful health care industry players turn to ICER to decide which treatments get covered – and which medications are denied.

“Depression can be a devastating chronic condition that affects individuals, families, and communities,” says Terry Wilcox, co-founder and executive director at Patients Rising NOW, a national patient advocacy non-profit that battles denials and other barriers to access. “ICER’s short-sighted and incomplete report puts insurance profits over patients’ health.”

Patients Rising NOW, a national patient advocacy non-profit, is battling denials and other barriers to access.

Unlike the public review by the FDA that focused on patient safety, ICER’s calculations focus strictly on cost – and how the drug affects the bottom line of pharmacy benefit managers and insurance companies.

“Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, explained of the FDA’s process.

Patients Rising NOW Urges Patients to Take Action

To counter ICER’s influence, patient advocates are taking action. Patients Rising NOW submitted a detailed objection to ICER’s latest analysis, and is urging patients to make their voices heard using the hashtag: #ICERWatch.

“ICER’s Draft Report on treatment resistant depression inadequately reflects patients’ perspectives,” says Terry Wilcox, co-founder and executive director at Patients Rising NOW. 

“Together, patients must make our voices heard about why patients need access to potentially life-saving treatments for depression.”

Patient Advocates: 3 Ways to Take Action

  1. Post on Social Media: Patients can make their voices heard about the importance of access by using the hashtag: #ICERWatch.
  2. Share Your Story: Are you living with depression? Patients can share their stories with Patients Rising NOW by clicking here.
  3. Attend ICER Meeting: ICER will host a meeting on treatment-resistant depression on May 23, 2019 in Rosemont, Illinois.