CurrentMass General Brigham Health PlanPolicy N/A

Bijuva (estradiol and progesterone)

Prior authorization policy for Bijuva (estradiol and progesterone) under the pharmacy benefit for Commercial/Exchange members, defining eligibility criteria, limitations, and approval duration.

Policy Summary

PayerMass General Brigham Health Plan

PolicyBijuva (estradiol and progesterone)

Policy CodePolicy N/A

Change TypeRevised language (non-material)

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionPrior authorization is required under the pharmacy benefit for Bijuva; submit clinical documentation that member meets age, diagnosis, and prior inadequate response/intolerance/contraindication to concurrently administered separate estrogen and progesterone agents, or evidence member is new to plan and currently receiving the medication (not via samples or manufacturer assistance).

SourceLink

POLICY UPDATE CHANGES

Updated language for members who are new to the plan to allow authorization for those new within the past 90 days who are currently receiving treatment with the requested medication.

12 monthsApproval duration

>=18Minimum age (years)

90 daysNew-to-plan continuity window

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Prior authorization policy for Bijuva (estradiol and progesterone) under the pharmacy benefit for Commercial/Exchange members. Authorization is required and applies to members meeting the policy criteria. Eligibility and limitations: authorization may be granted for members new to the plan within the past 90 days who are currently receiving the medication (excluding products obtained as samples or via manufacturer's patient assistance programs), or when all of the following are met: member is ≥ 18 years of age; has a diagnosis of moderate to severe vasomotor symptoms due to menopause; and has had an inadequate response, intolerance, or contraindication to an estrogen and progesterone formulation taken concurrently as separate agents. Approvals will be granted for 12 months. Indication: treatment of moderate to severe vasomotor symptoms due to menopause in women with a uterus. See the prescribing information (Therapeutics MD, Inc; November 2023) and clinical guidance from AACE/ACE, ACOG, and Cochrane reviews referenced in the policy.

Quick policy thresholds and facts

Minimum age>= 18 years

New-to-plan continuity window<= 90 days

Approval duration12 months

Effective date2025-09-01

Last review2025-08-13

Authorization Criteria (Initial / Continuity)

Authorization Criteria

Authorization may be granted when ALL of the following are met:

ALL of the following

Allow continuity for members new to plan
- 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)New-to-plan window <= 90 days
  Definition: New to the plan = Member enrolled in the plan within the past 90 days.
- Failure/intolerance pathway: Member is 18 years of age or olderMember age >= 18 years
- Failure/intolerance pathway: Member has diagnosis of moderate to severe vasomotor symptoms due to menopause
- Failure/intolerance pathway: Member has had an inadequate response, intolerance or a contraindication to an estrogen and progesterone formulation taken concurrently as separate agents

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Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required under the pharmacy benefit for Bijuva. Submit clinical documentation that the member meets the age requirement (≥18 years), has a diagnosis of moderate to severe vasomotor symptoms due to menopause, and either (a) has had an inadequate response, intolerance, or contraindication to an estrogen and progesterone formulation taken concurrently as separate agents, or (b) is new to the plan (enrolled within the past 90 days) and is currently receiving the requested medication. Continuity for members new to the plan does not apply when the product was obtained as samples or via the manufacturer's patient assistance programs.

Documentation Required

Document prior therapies and intolerance/contraindication

When seeking authorization under the failure/intolerance pathway, document prior use of an estrogen and a progesterone formulation taken concurrently as separate agents and provide evidence of inadequate response, intolerance, or a contraindication to that therapy.

Billing Rule

Approval duration

Approvals will be granted for 12 months.

Clinical Evidence & References

Evidence and references include the prescribing information: Therapeutics MD, Inc; November 2023, and clinical guidance sources cited in the policy background: AACE/ACE position statement on menopause, ACOG Practice Bulletin No. 141, and the Cochrane review on long-term hormone therapy.

Background

Background: Bijuva (estradiol and progesterone) is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause in women with a uterus. The policy references the Bijuva prescribing information (Therapeutics MD, Inc; November 2023) and clinical guidance including AACE/ACE, ACOG, and Cochrane reviews.

Definitions: New to the plan — Member enrolled in the plan within the past 90 days.

Revision History

2025-08-13policy_updateLatest

Updated language clarifying continuity allowance for members new to the plan, excluding products obtained as samples or via manufacturer's patient assistance programs; no clinical changes.

2025-09-01effective_date

Policy changes effective, including updated continuity language allowing authorization for members new to the plan within the past 90 days who are currently receiving the medication (excludes samples or manufacturer patient assistance programs); no clinical changes.