A much-awaited therapy for postpartum despair, zuranolone, hit the market in December, promising an accessible and fast-acting medicine for a debilitating sickness. However most non-public well being insurers have but to publish standards for when they’ll cowl it, in accordance with a brand new evaluation of insurance coverage insurance policies.

The shortage of steerage may restrict use of the drug, which is each novel — it targets hormone operate to alleviate signs as a substitute of the mind’s serotonin system, as typical antidepressants do — and costly, at $15,900 for the 14-day tablet routine.

Legal professionals, advocates, and regulators are watching intently to see how insurance coverage firms will form insurance policies for zuranolone due to how some dealt with its predecessor, an intravenous type of the identical drug referred to as brexanolone, which got here available on the market in 2019. Many insurers required sufferers to strive different, cheaper drugs first — often known as the fail-first strategy — earlier than they might be authorized for brexanolone, which was proven in early trials reviewed by the FDA to supply reduction inside days. Typical antidepressants take 4 to 6 weeks to take impact.

“We’ll must see if insurers cowl this drug and what fail-first necessities they put in” for zuranolone, mentioned Meiram Bendat, a licensed psychotherapist and an legal professional who represents sufferers.

Most well being plans have but to difficulty any tips for zuranolone, and maternal well being advocates fear that the few which have are taking a restrictive strategy. Some insurance policies require that sufferers first try to fail a typical antidepressant earlier than the insurer pays for zuranolone.

In different circumstances, tips require psychiatrists to prescribe it, fairly than obstetricians, doubtlessly delaying therapy since OB-GYN practitioners are normally the primary medical suppliers to see indicators of postpartum despair.

Advocates are most fearful in regards to the lack of protection steerage.

“When you don’t have a printed coverage, there may be going to be extra variation in decision-making that isn’t honest and is much less environment friendly. Transparency is actually essential,” mentioned Pleasure Burkhard, government director of the nonprofit Coverage Heart for Maternal Psychological Well being, which commissioned the examine.

With brexanolone, which was priced at $34,000 for the three-day infusion, California’s largest insurer, Kaiser Permanente, had such rigorous standards for prescribing it that consultants mentioned the coverage amounted to a blanket denial for all sufferers, in accordance with an NPR investigation in 2021.

KP’s written tips required sufferers to try to fail 4 drugs and electroconvulsive remedy earlier than they might be eligible for brexanolone. As a result of the drug was authorized just for as much as six months postpartum, and trials of typical antidepressants take 4 to 6 weeks every, the clock would run out earlier than a affected person had time to strive brexanolone.

An evaluation by NPR of a dozen different well being plans on the time confirmed Kaiser Permanente’s coverage on brexanolone to be an outlier. Some did require that sufferers fail one or two different medication first, however KP was the one one which really helpful 4.

Miriam McDonald, who developed extreme postpartum despair and suicidal ideation after giving delivery in late 2019, battled Kaiser Permanente for greater than a yr to search out efficient therapy. Her medical doctors put her on a merry-go-round of medicines that didn’t work and infrequently carried insufferable uncomfortable side effects, she mentioned. Her medical doctors refused to prescribe brexanolone, the one FDA-approved medicine particularly for postpartum despair on the time.

“No lady ought to endure like I did after having a toddler,” McDonald mentioned. “The coverage was utterly unfair. I used to be in purgatory.”

One month after NPR printed its investigation, KP overhauled its standards to advocate that ladies strive only one medicine earlier than changing into eligible for brexanolone.

Then, in March 2023, after the federal Division of Labor launched an investigation into the insurer — citing NPR’s reporting — the insurer revised its brexanolone tips once more, eradicating all fail-first suggestions, in accordance with inner paperwork not too long ago obtained by NPR. Sufferers want solely decline a trial of one other medicine.

“Since brexanolone was first authorized to be used, extra expertise and analysis have added to details about its efficacy and security,” the insurer mentioned in a press release. “Kaiser Permanente is dedicated to making sure brexanolone is accessible when physicians and sufferers decide it’s an applicable therapy.”

“Kaiser principally went from having probably the most restrictive coverage to probably the most strong,” mentioned Burkhard of the Coverage Heart for Maternal Psychological Well being. “It’s now a gold commonplace for the remainder of the trade.”

McDonald is hopeful that her willingness to talk out and the next regulatory actions and coverage adjustments for brexanolone will lead Kaiser Permanente and different well being plans to set patient-friendly insurance policies for zuranolone.

“This can forestall different ladies from having to undergo a yr of despair to search out one thing that works,” she mentioned.

Clinicians had been excited when the FDA authorized zuranolone final August, believing the tablet kind, taken as soon as a day at house over two weeks, shall be extra accessible to ladies in contrast with the three-day hospital keep for the IV infusion. Many perinatal psychiatrists instructed NPR it’s crucial to deal with postpartum despair as shortly as attainable to keep away from unfavorable results, together with cognitive and social issues within the child, nervousness or despair within the father or companion, or the demise of the mom to suicide, which accounts for as much as 20% of maternal deaths.

To date, solely one of many nation’s six largest non-public insurers, Centene, has set a coverage for zuranolone. It’s unclear what standards KP will set for the brand new tablet. California’s Medicaid program, often known as Medi-Cal, has not but established protection standards.

Insurers’ insurance policies for zuranolone shall be written at a time when the regulatory setting round psychological well being therapy is shifting. The U.S. Division of Labor is cracking down on violations of the Psychological Well being Parity and Dependancy Fairness Act of 2008, which requires insurers to cowl psychiatric remedies the identical as bodily remedies.

Insurers should now adjust to stricter reporting and auditing necessities meant to extend affected person entry to psychological well being care, which advocates hope will compel well being plans to be extra cautious in regards to the insurance policies they write within the first place.

In California, insurers should additionally adjust to a good broader state psychological well being parity legislation from 2021, which requires them to make use of clinically based mostly, expert-recognized standards and tips in making medical selections. The legislation was designed to restrict arbitrary or cost-driven denials for psychological well being remedies and has been hailed as a mannequin for the remainder of the nation. A lot-anticipated laws for the legislation are anticipated to be launched this spring and will provide additional steerage for insurers in California setting insurance policies for zuranolone.

Within the meantime, Burkhard mentioned, sufferers affected by postpartum despair shouldn’t maintain again from asking their medical doctors about zuranolone. Insurers can nonetheless grant entry to the drug on a case-by-case foundation earlier than they formalize their protection standards.

“Suppliers shouldn’t be deterred from prescribing zuranolone,” Burkhard mentioned.