CurrentCentenePolicy CP PMN.258

Conjugated estrogens/bazedoxifene (Duavee)

Defines Centene medical necessity criteria for coverage of Duavee (conjugated estrogens/bazedoxifene) for vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis, including initial and continuation requirements, dosing limits, contraindications, and therapeutic alternatives.

Policy Summary

PayerCentene

PolicyConjugated estrogens/bazedoxifene (Duavee)

Policy CodePolicy CP PMN.258

Change TypeAnnual review (revised)

Effective DateMar 1, 2021

Next Review Date

Key ActionProvider must submit documentation (e.g., chart notes, lab results) supporting that member has met all approval criteria.

POLICY UPDATE CHANGES

1Q 2024 annual review: added 'generic' before alendronate in osteoporosis initial criteria and removed estropiate from Appendix B due to product unavailability; references updated.

1Q 2025 annual review: no significant changes; references reviewed and updated (Date = 10.22.24).

2Covered Indications

6Initial approval (months)

12Continued approval (months)

1Max tablets/day

Coverage Summary

Scope: Defines Centene medical necessity criteria for coverage of Duavee (conjugated estrogens/bazedoxifene) for treatment of moderate-to-severe vasomotor symptoms in women with a uterus and prevention of postmenopausal osteoporosis, including initial and continuation requirements, dosing limits, contraindications, and therapeutic alternatives (Policy Number: CP PMN.258; Effective Date: 03.01.21; Last Review: 02.25).

Coverage stance: Covered with criteria. High-level indications and limits: approved for vasomotor symptoms and osteoporosis prevention when specific criteria are met; maximum dose 0.45 mg conjugated estrogens / 20 mg bazedoxifene per day and maximum 1 tablet per day.

Initial Therapy — Vasomotor Symptoms

Initial Approval Criteria - Vasomotor Symptoms

Duavee is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of vasomotor symptoms associated with menopause
Member has not undergone a hysterectomy
Failure of 2 formulary estrogen products (not contraceptives, see Appendix B), unless contraindicated or clinically significant adverse effects are experienced
Dose limit (a): Dose does not exceed 0.45 mg conjugated estrogens/20 mg bazedoxifene per day0.45 mg conjugated estrogens / 20 mg bazedoxifene per day
Dose limit (b): Dose does not exceed 1 tablet per day1 tablet per day

Initial Therapy — Prevention of Postmenopausal Osteoporosis

Initial Approval Criteria - Prevention of Postmenopausal Osteoporosis

Duavee is medically necessary for prevention of postmenopausal osteoporosis when ALL of the following are met:

ALL of the following

Prescribed for the prevention of postmenopausal osteoporosis
Member has not undergone a hysterectomy
Oral bisphosphonate trial: Failure of a 12-month trial of an oral bisphosphonate (see Appendix B; generic alendronate is preferred) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced12-month trial at up to maximally indicated doses
generic alendronate preferred
Raloxifene trial: Failure of a 12-month trial of raloxifene, unless contraindicated or clinically significant adverse effects are experienced12-month trial
Dose limit (a): Dose does not exceed 0.45 mg conjugated estrogens/20 mg bazedoxifene per day0.45 mg conjugated estrogens / 20 mg bazedoxifene per day
Dose limit (b): Dose does not exceed 1 tablet per day1 tablet per day

Other Diagnoses / Initial Indications

Other Diagnoses/Indications

For other uses, one of the following must be met:

ANY of the following

Formulary/PDL pathway: For drugs on formulary/PDL: follow the applicable 'no coverage criteria' policy (HIM.PA.33 for marketplace; CP.PMN.255 for Medicaid)
Non-formulary pathway: For drugs NOT on formulary/PDL: follow the non-formulary policy (HIM.PA.103 for marketplace; CP.PMN.16 for Medicaid)
Off-label pathway: If the requested use is not listed under section III and initial criteria do not apply, refer to the off-label use policy (HIM.PA.154 for marketplace; CP.PMN.53 for Medicaid)

Continuation Therapy Criteria

Continued Therapy - All Indications

Continued therapy is approved when ALL of the following are met:

ALL of the following

Continuation or prior meeting of initial criteria: Member is currently receiving medication via Centene benefit OR member has previously met initial approval criteria
Response to therapy: Member is responding positively to therapy
Dose increase limit (a): If request is for a dose increase, new dose does not exceed 0.45 mg conjugated estrogens/20 mg bazedoxifene per day0.45 mg conjugated estrogens / 20 mg bazedoxifene per day
Dose increase limit (b): If request is for a dose increase, new dose does not exceed 1 tablet per day1 tablet per day

Continued Therapy - Other Diagnoses/Indications

For other continued uses, follow applicable formulary/non-formulary/off-label policies as in Initial section

ANY of the following

Formulary/PDL continued use: For formulary/PDL uses: HIM.PA.33 (marketplace) or CP.PMN.255 (Medicaid)
Non-formulary continued use: For non-formulary uses: HIM.PA.103 (marketplace) or CP.PMN.16 (Medicaid)
Off-label continued use: If use not listed in disallowed diagnoses and initial criteria do not apply: refer to HIM.PA.154 or CP.PMN.53

Unapproved Indications / Exclusions

Diagnoses/Indications Not Authorized

Coverage is NOT authorized for:

Non-FDA approved indications not addressed in this policy unless there is sufficient documentation per off-label policies or evidence of coverage documents

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization required with evidence of failed therapies or contraindications as specified in the initial criteria. Approval durations: 6 months for initial therapy and 12 months for continued therapy.

Documentation Required

Submit supporting documentation

Provider must submit documentation (such as chart notes, lab results or other clinical information) supporting that the member has met all approval criteria.

Billing Rule

Dose / billing limit

Do not exceed 1 tablet per day (maximum daily dose 0.45 mg conjugated estrogens / 20 mg bazedoxifene).

Documentation Required

Failure of alternatives required for osteoporosis indication

Document a 12-month trial of an oral bisphosphonate (generic alendronate preferred) at up to maximally indicated doses, and a 12-month trial of raloxifene, unless contraindicated or clinically significant adverse effects occurred.

Clinical Evidence & References

Evidence: Duavee Prescribing Information, Wyeth Pharmaceuticals Inc.; March 2024.

Boxed warnings and contraindications (see prescribing information and Appendix C): boxed warnings include risks related to endometrial cancer, cardiovascular disorders, and probable dementia. Contraindications include: undiagnosed abnormal uterine bleeding; known, suspected, or past history of breast cancer; known or suspected estrogen-dependent neoplasia; active or past history of venous or arterial thromboembolism; hypersensitivity to estrogens, bazedoxifene, or ingredients; known hepatic impairment; known thrombophilic disorders (protein C, protein S, antithrombin deficiency); and pregnancy, women who may become pregnant, and nursing mothers.

Background & Definitions

Duavee is a combination product of conjugated estrogens and bazedoxifene indicated in women with a uterus for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and for the prevention of postmenopausal osteoporosis.

The bazedoxifene component is an estrogen agonist/antagonist that reduces the risk of endometrial hyperplasia associated with the conjugated estrogens component.

The policy includes boxed warnings and contraindications (see Appendix C) addressing risks such as endometrial cancer, cardiovascular events, probable dementia, and thromboembolic disorders; clinicians should follow the prescribing information and policy criteria when considering therapy.

Definitions:

Duavee — Combination product of conjugated equine estrogens and bazedoxifene, tablet strength 0.45 mg conjugated estrogens / 20 mg bazedoxifene (1 tablet per day).

Revision History

2024-02-24annual_review

1Q 2024 annual review: added 'generic' before alendronate in osteoporosis initial criteria and removed estropiate from Appendix B due to product unavailability; references updated.

2025-02-25annual_reviewLatest

1Q 2025 annual review: no significant changes; references reviewed and updated.

Policy Summary

PayerCentene

PolicyConjugated estrogens/bazedoxifene (Duavee)

Policy CodePolicy CP PMN.258

Change TypeAnnual review (revised)

Effective DateMar 1, 2021

Next Review Date

Key ActionProvider must submit documentation (e.g., chart notes, lab results) supporting that member has met all approval criteria.

On This Page

OpenPayer

Conjugated estrogens/bazedoxifene (Duavee)

Coverage Summary

Initial Therapy — Vasomotor Symptoms

Initial Therapy — Prevention of Postmenopausal Osteoporosis

Other Diagnoses / Initial Indications

Continuation Therapy Criteria

Unapproved Indications / Exclusions

Applicable Codes

Provider Actions & Requirements

Clinical Evidence & References

Background & Definitions

Revision History