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  • The new postpartum depression drug Zurzuvae is now available in the U.S., however, only 17 of 1000+ insurers (less than 1%) and one PBM have published coverage guidelines.
  • Only one of the six largest insurers, Centene, has issued coverage guidelines however, with restrictions on coverage.
  • Without an insurer’s published coverage guidelines, prescribing providers and patients are more likely to experience delays and restrictions accessing this new treatment.
  • Of the 17 insurers with published coverage guidelines, five are requiring patients to try another drug first, three limit whether an Ob/Gyn can prescribe, three require a comprehensive evaluation inconsistent with DSM-5 guidelines, and one requires a diagnosis of severe depression.

Zurzuvae™, the new first-of-its-kind 14-day postpartum depression pill, recently available in the United States. Zurzuvae is a pill that is taken for 14 days and has been shown to provide rapid improvements in depressive symptoms by day 15, and as early as day 3, according to the drug’s developer, Sage Therapeutics. This is a substantive improvement over the 4-6 weeks to potentially see improvement with standard depression drug treatments.1

This report offers the first insights into how insurance companies are considering coverage for the drug, analyzing insurers’ publically available coverage policies and prior authorization drug policies, for Zurzuvae. Coverage policies and prior authorization policies are documents insurers publish to provide guidance to prescribing providers regarding the conditions that must be met for a drug to be covered and whether prior approval is needed from the insurance company (referred to as prior authorization). An insurer’s internal medical directors also reference these policies when making decisions about whether to cover a drug for a particular patient. It’s important to note, that lack of a coverage policy does not mean an insurer will not cover Zurzuvae. Prescribing providers can submit prior authorization requests to learn whether the insurer will cover the drug and with what limitations.

It’s important to note, that a lack of a coverage policy does not mean an insurer will not cover Zurzuvae. Prescribing providers can submit prior authorization requests to learn whether the insurer will cover the drug and with what limitations.

Because it’s the only treatment of its kind, it is expected that insurance companies will include Zurzuvae on their drug formularies, which are listings of drugs the insurer will cover. It’s likely that the drug will be listed on the third tier of drug formularies, given that it is a brand-name drug with a relatively high cost. Patient co-pays, or cost-shares, are generally higher on this tier than the first or second-level formulary tiers.

Only 17 Insurers and One PBM Have Coverage Policies

Our analysis of publicly available insurance company coverage policies via Policy Reporter2 found only seventeen insurers and one pharmacy benefit manager (PBM), Prime Therapeutics, have published coverage policies. Prime Therapeutics represents 19 Blue Cross and Blue Shield Plans.

This represents less than 1% of the over 1,000 private health insurers in the United States. Just one of the six largest health insurers by market share, Centene, has published a coverage policy for Zurzuvae. The remaining 5 largest health insurers don’t have coverage policies addressing Zurzuvae: Kaiser Permanente, Elevance Health (Anthem), HCSC, UnitedHealth Group, and CVS Health (Aetna). See Table 1.0.

Table 1.0

Analysis of Coverage Requirements and Limitations

Five Insurers Require Patients to Try Another Drug First

Of the few (18) insurers/PBMs with coverage policies, five require patients to try another drug first, which is referred to as a “fail-first” or “step-therapy” requirement. These policies require a trial of a drug such as a selective serotonin reuptake inhibitor (SSRI) or an antidepressant for four weeks.

One Insurer Requires a Severe Postpartum Depression Diagnosis

Although Zurzuvae is approved by the FDA for postpartum depression regardless of severity, one insurer, Uniform Medical, which covers government employees in Washington state, requires the patient to be diagnosed with severe postpartum depression.

Three Insurers Require Comprehensive Psychological Assessment

Three insurers’ coverage policies indicate patients must be “diagnosed with a structured clinical interview” or “SCID.” However, the American College of Obstetricians and Gynecologists (ACOG) Clinical Practice Guideline titled “Screening and Diagnosis of Mental Health Conditions During Pregnancy and Postpartum” describes how Ob/Gyns can diagnose postpartum depression, and the use of a structured clinical interview is not required.3

American College of Obstetrician and Gynecologists’ Clinical Practice Guidelines: Diagnosis of Perinatal Mental Health Disorders

Although PHQ-9 and EPDS total scores correlate with depression severity (10-14 mild, 15-19 moderate, and >19 severe), they are screening and not diagnostic tools. A diagnosis of depression requires the patient must be experiencing five or more symptoms during the same 2-week period, and at least one of the symptoms should be either (1) depressed mood or (2) loss of interest or pleasure. The diagnostic criteria for depression are not different in the perinatal period compared with other times and are consistent with the Diagnostic and Statistical Manual of Mental Disorders, Text Revision (Fifth Edition).

  1. Depressed mood most of the day, nearly every day.
  2. Markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly every day.
  3. Significant weight loss when not dieting or weight gain, or decrease or increase in appetite nearly every day.
  4. A slowing down of thought and a reduction of physical movement (observable by others, not merely subjective feelings of restlessness or being slowed down).
  5. Fatigue or loss of energy nearly every day.
  6. Feelings of worthlessness or excessive or inappropriate guilt nearly every day.
  7. Diminished ability to think or concentrate, or indecisiveness, nearly every day.
  8. Recurrent thoughts of death, recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide.

These are the criteria that the DSM-5 and ACOG require to make a diagnosis of major depressive disorder, including postpartum depression. The use of the Structured Clinical Interview (SCID) is not required.

Three Insurers Don’t Allow Coverage if an Ob/Gyn Alone Prescribes

Three insurers will not cover Zurzuvae if Ob/Gyns prescribe the drug, instead limiting coverage to prescriptions written by or in consultation with a psychiatrist. However, this drug is specific for the treatment of PPD – which Ob/Gyns and other obstetric providers are qualified to treat.

Further, ACOG addresses the detection, diagnosis, and treatment of postpartum depression in its clinical practice guideline, titled “Treatment and Management of Mental Health Conditions During Pregnancy and Postpartum.”  This includes prescribing neurosteroids that target the GABA-A receptor, such as Zurzuvae.4 Limiting coverage to prescriptions written by or in consultation with a psychiatrist is unnecessary and very likely to delay treatment.

Blue Shield of California and Oscar both specifically address the fact that Ob/Gyns are providers which are appropriate prescribers of this treatment.

The table below details these findings.

Table 2.0

Recommendations:

Insurance Companies Should Publish Coverage Policies on an Urgent Basis with Minimal or No Limitations

  1. Insurance companies should publish coverage policies for Zurzuvae on an urgent basis, so prescribing providers and patients understand coverage requirements.
  2. Insurance companies should provide coverage without step-therapy/fail-first requirements. Zurzuvae is the only FDA-approved drug approved specifically for postpartum depression and has relatively immediate effects.
  3. Insurance companies should remove requirements to assess with the SCID, which is not necessary for diagnosis under the DSM-5 and American College of Obstetricians and Gynecologists (ACOG) Clinical Practice Guidelines
  4. Insurance companies should not limit coverage to prescriptions made by psychiatrists or in consultation with psychiatrists, as postpartum depression is a disorder that obstetric providers, including Ob/Gyns, treat.

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.

References
  1. National Institute of Mental Health. (2021). Depression. Bethesda, MD. ↩︎
  2. Policy Reporter. (2023). [Internet]. Chicago (IL). [cited 2023 Dec 12]. About. Available at: https://www.policyreporter.com ↩︎
  3. Screening and Diagnosis of Mental Health Conditions During Pregnancy and Postpartum: ACOG Clinical Practice Guideline No. 4. (2023). Obstetrics and gynecology, 141(6), 1232–1261. https://doi.org/10.1097/AOG.0000000000005200 ↩︎
  4. Treatment and Management of Mental Health Conditions During Pregnancy and Postpartum: ACOG Clinical Practice Guideline No. 5. (2023). Obstetrics and gynecology, 141(6), 1262–1288. https://doi.org/10.1097/AOG.0000000000005202 ↩︎