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ph-91184

Topical Estrogen Quantity Limit Program Summary

Policy Number: PH-91184

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
01-01-2025

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Day Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist

Alora ; Dotti ; Lyllana ; Minivelle ; Vivelle-dot	estradiol td patch twice weekly	0.025 MG/24HR ; 0.0375 MG/24HR ; 0.05 MG/24HR ; 0.075 MG/24HR ; 0.1 MG/24HR	8	Patches	28	DAYS
Climara ; Menostar	estradiol td patch weekly	0.025 MG/24HR ; 0.05 MG/24HR ; 0.06 MG/24HR ; 0.075 MG/24HR ; 0.1 MG/24HR ; 14 MCG/24HR ; 37.5 MCG/24HR	4	Patches	28	DAYS
Climara pro	estradiol-levonorgestrel td patch weekly	0.045-0.015 MG/DAY	4	Patches	28	DAYS
Combipatch	estradiol-norethindrone ace td pttw	0.05-0.14 MG/DAY ; 0.05-0.25 MG/DAY	8	Patches	28	DAYS
Divigel ; Elestrin ; Estrogel	estradiol gel ; estradiol td gel	0.06 % ; 0.25 MG/0.25GM ; 0.5 MG/0.5GM ; 0.75 MG/0.75GM ; 1 MG/GM ; 1.25 MG/1.25GM	30	Packets	30	DAYS
Elestrin	Estradiol Gel 0.06% (0.52 MG/0.87 GM Metered-Dose Pump)	0.06 %	1	Pump	30	DAYS
Estrace	Estradiol Vaginal Cream 0.1 MG/GM	0.1 MG/GM	6	Tubes	365	DAYS
Estring	estradiol vaginal ring	2 MG ; 7.5 MCG/24HR	1	Ring	90	DAYS
Estrogel	Estradiol Gel 0.06% (0.75 MG/1.25 GM Metered-Dose Pump)	0.06 %	1	Pump	30	DAYS
Evamist	estradiol transdermal spray	1.53 MG/SPRAY	5	Bottles	93	DAYS
Femring	estradiol acetate vaginal ring	0.05 MG/24HR ; 0.1 MG/24HR	1	Ring	90	DAYS
Imvexxy maintenance pack ; Imvexxy starter pack	estradiol vaginal insert ; estradiol vaginal insert starter pack	10 MCG ; 4 MCG	8	Units	28	DAYS
Imvexxy starter pack	Estradiol Vaginal Insert Starter Pack 10 MCG	10 MCG	18	Units	180	DAYS
Imvexxy starter pack	Estradiol Vaginal Insert Starter Pack 4 MCG	4 MCG	18	Units	180	DAYS

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Alora ; Dotti ; Lyllana ; Minivelle ; Vivelle-dot	estradiol td patch twice weekly	0.025 MG/24HR ; 0.0375 MG/24HR ; 0.05 MG/24HR ; 0.075 MG/24HR ; 0.1 MG/24HR	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Climara ; Menostar	estradiol td patch weekly	0.025 MG/24HR ; 0.05 MG/24HR ; 0.06 MG/24HR ; 0.075 MG/24HR ; 0.1 MG/24HR ; 14 MCG/24HR ; 37.5 MCG/24HR	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Climara pro	estradiol-levonorgestrel td patch weekly	0.045-0.015 MG/DAY	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Combipatch	estradiol-norethindrone ace td pttw	0.05-0.14 MG/DAY ; 0.05-0.25 MG/DAY	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Divigel ; Elestrin ; Estrogel	estradiol gel ; estradiol td gel	0.06 % ; 0.25 MG/0.25GM ; 0.5 MG/0.5GM ; 0.75 MG/0.75GM ; 1 MG/GM ; 1.25 MG/1.25GM	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Elestrin	Estradiol Gel 0.06% (0.52 MG/0.87 GM Metered-Dose Pump)	0.06 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Estrace	Estradiol Vaginal Cream 0.1 MG/GM	0.1 MG/GM	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Estring	estradiol vaginal ring	2 MG ; 7.5 MCG/24HR	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Estrogel	Estradiol Gel 0.06% (0.75 MG/1.25 GM Metered-Dose Pump)	0.06 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Evamist	estradiol transdermal spray	1.53 MG/SPRAY	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Femring	estradiol acetate vaginal ring	0.05 MG/24HR ; 0.1 MG/24HR	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Imvexxy maintenance pack ; Imvexxy starter pack	estradiol vaginal insert ; estradiol vaginal insert starter pack	10 MCG ; 4 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Imvexxy starter pack	Estradiol Vaginal Insert Starter Pack 10 MCG	10 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Imvexxy starter pack	Estradiol Vaginal Insert Starter Pack 4 MCG	4 MCG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
	Quantity limit for the Target Agent(s) will be approved when ONE of the following is met: The requested quantity (dose) does NOT exceed the program quantity limit OR The requested quantity (dose) exceeds the program quantity limit AND ONE of the following: BOTH of the following: The patient has a diagnosis of gender dysphoria/gender incongruent AND The requested agent is ONE of the following: Alora (estradiol) Climara (estradiol) Divigel (estradiol) Elestrin (estradiol) Estrogel (estradiol) Evamist (estradiol) Menostar (estradiol) Minivelle (estradiol) Vivelle Dot (estradiol) OR BOTH of the following: The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication OR BOTH of the following: The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR BOTH of the following: The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication Length of Approval: up to 12 months

Module

Clinical Criteria for Approval

Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:

The requested quantity (dose) does NOT exceed the program quantity limit OR
The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
1. BOTH of the following:
  1. The patient has a diagnosis of gender dysphoria/gender incongruent AND
  2. The requested agent is ONE of the following:
    1. Alora (estradiol)
    2. Climara (estradiol)
    3. Divigel (estradiol)
    4. Elestrin (estradiol)
    5. Estrogel (estradiol)
    6. Evamist (estradiol)
    7. Menostar (estradiol)
    8. Minivelle (estradiol)
    9. Vivelle Dot (estradiol) OR
2. BOTH of the following:
  1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication OR
3. BOTH of the following:
  1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
  2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
4. BOTH of the following:
  1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

Commercial _ PS _ Topical_Estrogen_QL _ProgSum_ 01-01-2025