CurrentMass General Brigham Health PlanPolicy N/A

Bijuva (estradiol and progesterone) — Prior Authorization

Prior authorization and quantity/benefit management guidance for Bijuva prescribed to women with a uterus for moderate to severe vasomotor symptoms of menopause. Applies to Commercial/Exchange and MassHealth UPPL plan members under the Mass General Brigham Health Plan pharmacy benefit.

Policy Summary

PayerMass General Brigham Health Plan

PolicyBijuva (estradiol and progesterone) — Prior Authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective Date09/01/2025

Next Review DateN/A

Key ActionObtain prior authorization and document member age, diagnosis of moderate to severe vasomotor symptoms, and prior therapy history or continuity of care evidence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+min age

90 dayslookback

12 monthsapproval dur.

Commercial/Exchange, MassHealthplan applicability

Pharmacybenefit

Policy Summary

PayerMass General Brigham Health Plan

PolicyBijuva (estradiol and progesterone) — Prior Authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective Date09/01/2025

Next Review DateN/A

Key ActionObtain prior authorization and document member age, diagnosis of moderate to severe vasomotor symptoms, and prior therapy history or continuity of care evidence.

SourceLink

On This Page

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Approval criteria

Authorization may be granted if EITHER of the following conditions is met:

Current therapy continuity: Member is new to the plan within the past 90 days AND is currently receiving treatment with the requested medication (excluding when the product is obtained as samples or via manufacturer’s patient assistance programs)90 days

Continuity of care provision

New initiation or non-continuity

Member has diagnosis of moderate to severe vasomotor symptoms due to menopause
Member has had an inadequate response, intolerance, or contraindication to an estrogen and progesterone formulation taken concurrently as separate agents

Members who are obtaining the medication exclusively as samples or through a manufacturer's patient assistance program are excluded from the policy's "current therapy continuity" authorization pathway. In other words, continuity-of-care approval for members new to the plan within the past 90 days applies only when the member is actively receiving commercially dispensed product, not when the therapy consisted solely of samples or program-provided supplies.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Prior authorization is required for Bijuva (estradiol and progesterone). Requests may be approved for members who are new to the plan within the past 90 days and are currently receiving Bijuva (does not apply to samples or medications obtained through manufacturer patient assistance programs).

Applies to Pharmacy Benefit; Program Type: Quantity Limit, Step Therapy noted
Contact: AII Plans Phone: 877-519-1908 Fax: 855-540-3693; Non-Specialty All Plans Phone: 800-711-4555 Fax: 844-403-1029

Step Therapy

Step Therapy (Informational)

Step therapy is listed as a program type for this medication. Specific step edits are not detailed in this policy; treat this as an informational note — verify any plan-level step therapy edits in the pharmacy benefit management system or via the plan's prior authorization resources before submitting a request.

Step therapy may be enforced at point-of-sale or through prior authorization rules
If step edits exist, documentation must show why step therapy is inappropriate or was not tolerated

Documentation Required

Required Documentation

Documentation Required — Include clinical records to support member age, diagnosis, and prior therapy history. Provide progress notes, prior medication trials (dates, doses, outcomes), and any test results or consult notes that justify use.

Proof of age (chart note or ID) showing >= 18 years
Clinical documentation of moderate to severe vasomotor symptoms due to menopause
Documentation of prior trial(s) of separate estrogen and progesterone agents with reason for failure/intolerance/contraindication

Denial Risk

Triggers for Denial

Denial Triggers — Authorization may be denied if required criteria or documentation are not met.

Member is under 18 years of age
No diagnosis of moderate to severe vasomotor symptoms due to menopause documented
No documentation of prior adequate trial, intolerance, or contraindication to concurrent separate estrogen and progesterone therapy
Request for medication obtained only via samples or manufacturer patient assistance program without additional supporting clinical documentation

Background

Bijuva (estradiol and progesterone) is a combined oral estradiol and progesterone product indicated for treatment of moderate to severe vasomotor symptoms (hot flashes/night sweats) in women with a uterus. The plan's prior authorization policy permits coverage under a continuity of care provision for members who are new to the plan within the past 90 days and are currently receiving the requested medication, provided the supply was not obtained solely as samples or through a manufacturer's patient assistance program.

Definitions

Moderate to severe vasomotor symptoms — definition and qualification

DefinitionModerate to severe vasomotor symptoms due to menopause: symptomatic hot flashes and/or night sweats attributed to menopause that require pharmacologic management.

Age requirementMember must be 18 years of age or older to qualify for pharmacologic treatment for vasomotor symptoms.

Qualification for pharmacologic treatment (continuity)Authorization may be granted for members new to the plan within the past 90 days who are currently receiving the requested medication (continuity of care); samples or manufacturer patient assistance program supply are excluded from this pathway.

Qualification for pharmacologic treatment (new initiation)Authorization may be granted when member is ≥18, has a diagnosis of moderate to severe vasomotor symptoms due to menopause, and has had inadequate response, intolerance, or contraindication to estrogen and progesterone given concurrently as separate agents.

OpenPayer

Bijuva (estradiol and progesterone) — Prior Authorization

Coverage Criteria

Provider Actions and Authorization Requirements

Background

Definitions