One Year Later: How Insurers Are Covering  Zurzuvae, the First Postpartum Depression Pill

Background

Zurzuvae™ is the first Food and Drug Administration (FDA) approved oral postpartum depression drug treatment, and became available to prescribe in November 2023. Zurzuvae is a pill that patients take for 14 days.  

Both insurers and Medicaid agencies can take months and sometimes years to review newly FDA-approved treatments to determine whether and how they will cover these treatments. 

This report provides an update to the December 2023 report titled Zurzuvae, The New Postpartum Depression Drug Now Available: This Is How Insurers Have Responded. Specifically, this analysis includes an updated overview of six large insurers’ coverage guidelines and a new overview of state Medicaid agencies with restrictive guidelines. 

Methods

For this analysis, we re-reviewed the drug formularies/list, coverage policies, and prior authorization forms on the websites of the six largest insurers and their Pharmacy Benefit Managers (PBMs). 

These insurers included: UnitedHealth Group, Kaiser Permanente, Health Care Service Corporation (HCSC) which includes BCBS, Elevance Health (Anthem), Centene Corporation, and CVS Health Corporation (Aetna).

We analyzed a report from the platform Policy Reporter, to determine which, if any, Medicaid agencies failed to meet our standards for reasonable coverage. 

The criteria we have defined as being overly restrictive include requiring:

• A diagnosis of “severe” PPD. Zurzuvae is approved by the FDA for postpartum depression regardless of severity.
• A comprehensive psychological assessment (ie; “structured clinical interview”). The American College of Obstetricians and Gynecologists (ACOG) and DSM-5 do not require a “structured clinical interview” for a diagnosis of postpartum depression¹. 
• Step therapy This involves a trial of another antidepressant, which can take several weeks or months.
• Prescription by a psychiatrist. ACOG’s clinical practice guidelines permit and encourage OB/Gyns to prescribe medication for postpartum depression². 

Results

All Six Large Insurers Now Address Zurzuvae Coverage 

All six major insurers, UnitedHealthGroup, Kaiser Permanente, HCSC, CVS Health Corporation (Aetna), Centene Corporation, and Elevance Health (Anthem) now include Zuzurvae on their drug formularies or their Pharmacy Benefit Manager (PBM) drug formularies. Further, each insurer also now has a coverage policy that details prior authorization guidelines, including any restrictions for coverage, such as requiring a psychiatrist to prescribe or requiring a patient to try another drug treatment first, for example. Only one insurer, Centene, had a restrictive guideline. In 2023 our analysis illustrated only one major insurer, Centene, had published coverage criteria, which was overly restrictive.  See Table 1.0.

Table 1.0: Six Largest U.S. Insurance Companies Zurzuvae Formulary and Coverage Policies 

One of the Six, Centene, Has Overly Restrictive Coverage Requirements

Among the six major insurers, Centene still has a restrictive coverage policy, requiring the diagnosis of severe PPD, diagnosis using the DSM “structured clinical interview” (SCID), and failure of another drug (referred to as step therapy or fail-first prior authorization requirements). Since our last review of Centene’s policies in December 2023, Centene no longer requires a psychiatrist to prescribe the drug. Psychiatrists and OB/Gyns can prescribe, or any prescribing provider in consultation with a psychiatrist or OB/Gyn.

Further at least one Kaiser plan with  published criteria, Kaiser of the Northwest, requires a depression screening score of 15 or higher on the Patient Health Questionnaire (PHQ-9). 

State Medicaid Agencies

It is common for Medicaid agencies to take months or years to review newly FDA-approved treatments for coverage consideration. In the case of Zurzuvae, Medicaid coverage considerations are moving somewhat quickly, likely because Zurzuvae is the first PPD-specific treatment. Many states operate a single Medicaid agency-developed preferred drug list (PDL), which Medicaid plans are required to follow. These states often set the prior authorization requirements as well. In other states, Medicaid relies on the health plans to set their own requirements for coverage.

Several State Medicaid Programs Have Overly Restrictive Coverage Policies 

There are four Medicaid agencies with overly restrictive coverage requirements: 

• Alaska: Requires failure of one drug first (step therapy) after a 6-week trial, and the drug must be prescribed by or in consultation with a psychiatrist 
• Mississippi: Requires failure of one  drug first (step therapy) after a 4-week trial, and diagnosis of severe depression 
• North Carolina: Requires failure of two drugs first (step therapy)
• Alabama: According to an email received by the Policy Center from the Alabama Medicaid agency, it requires failure of two drugs first (step therapy) after a 30-day trial or documented allergy or contraindication to all preferred agents in the drug class

Conclusion

Swift access to this groundbreaking treatment can lead to quicker recovery and improved well-being for mothers experiencing postpartum depression and their infants and families. We urge Centene, and the Alabama, Alaska, Mississippi and North Carolina state Medicaid Agencies to reconsider their overly restrictive coverage policies, including their step-therapy requirements.