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ph-1184

Topical Estrogen Quantity Limit Program Summary

Policy Number: PH-1184

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
1/1/2023

FDA APPROVED INDICATIONS AND DOSAGE

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

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Agent GPI	Agent Names	Strength	QL Amount	Dose Form	Days Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist	Effective Date

240000350087	ALORAestradiol td patch twice weekly ; DOTTIestradiol td patch twice weekly ; ESTRADIOLestradiol td patch twice weekly ; LYLLANAestradiol td patch twice weekly ; MINIVELLEestradiol td patch twice weekly ; VIVELLE-DOTestradiol td patch twice weekly	0.025 MG/24HR ; 0.0375 MG/24HR ; 0.05 ; 0.05 MG/24HR ; 0.075 MG/24HR ; 0.1 MG/24HR	8.0	PATCHS	28	Days		1. The patient has a diagnosis of gender dysphoria/gender incongruent.
240000350088	CLIMARAestradiol td patch weekly ; ESTRADIOLestradiol td patch weekly ; 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	4.0	PATCHS	28	Days		1. The patient has a diagnosis of gender dysphoria/gender incongruent.
249930025888	CLIMARA*estradiol-levonorgestrel td patch weekly	0.045 MG/DAY	4.0	PATCHS	28	Days
249930021287	COMBIPATCH*estradiol-norethindrone ace td pttw	0 ; 0.05 MG/DAY	8.0	PATCHS	28	Days
240000350040	DIVIGELestradiol td gel ; ELESTRINestradiol gel ; ESTRADIOLestradiol td gel ; ESTROGELestradiol 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	30.0	PACKTS	30	Days		1. The patient has a diagnosis of gender dysphoria/gender incongruent.
24000035004008	ELESTRIN*Estradiol Gel 0.06% (0.52 MG/0.87 GM Metered-Dose Pump)	0.06 %	1.0	PUMP	30	Days		1. The patient has a diagnosis of gender dysphoria/gender incongruent.
55350020003705	ESTRACE*Estradiol Vaginal Cream 0.1 MG/GM	0.1 MG/GM	6.0	TUBES	365	Days				01-01-2023
553500200090	ESTRING*estradiol vaginal ring	2 MG	1.0	RING	90	Days
24000035004010	ESTROGEL*Estradiol Gel 0.06% (0.75 MG/1.25 GM Metered-Dose Pump)	0.06 %	1.0	PUMP	30	Days		1. The patient has a diagnosis of gender dysphoria/gender incongruent.
240000350020	EVAMIST*estradiol transdermal spray	1.53 MG/SPRAY	5.0	BOTTS	93	Days		1. The patient has a diagnosis of gender dysphoria/gender incongruent.
553500201090	FEMRING*estradiol acetate vaginal ring	0.05 MG/24HR ; 0.1 MG/24HR	1.0	RING	90	Days
55350020009930	IMVEXXY STARTER PACK*Estradiol Vaginal Insert Starter Pack 10 MCG	10 MCG	18.0	UNITS	180	Days
55350020009910	IMVEXXY STARTER PACK*Estradiol Vaginal Insert Starter Pack 4 MCG	4 MCG	18.0	UNITS	180	Days
553500200099	IMVEXXYestradiol vaginal insert ; IMVEXXYestradiol vaginal insert starter pack	10 MCG ; 4 MCG	8.0	UNITS	28	Days

CLIENT SUMMARY – QUANTITY LIMITS

Agent Names	Strength	Client Formulary
ALORAestradiol td patch twice weekly ; DOTTIestradiol td patch twice weekly ; ESTRADIOLestradiol td patch twice weekly ; LYLLANAestradiol td patch twice weekly ; MINIVELLEestradiol td patch twice weekly ; VIVELLE-DOTestradiol td patch twice weekly	0.025 MG/24HR ; 0.0375 MG/24HR ; 0.05 ; 0.05 MG/24HR ; 0.075 MG/24HR ; 0.1 MG/24HR	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
CLIMARAestradiol td patch weekly ; ESTRADIOLestradiol td patch weekly ; 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*estradiol-levonorgestrel td patch weekly	0.045 MG/DAY	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
COMBIPATCH*estradiol-norethindrone ace td pttw	0 ; 0.05 MG/DAY	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
DIVIGELestradiol td gel ; ELESTRINestradiol gel ; ESTRADIOLestradiol td gel ; ESTROGELestradiol 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	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 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
IMVEXXYestradiol vaginal insert ; IMVEXXYestradiol vaginal insert starter pack	10 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) is greater than 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 Information has been provided to support 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 Information has been provided to support 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) is greater than the maximum FDA labeled dose for the requested indication AND Information has been provided to support 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) is greater than 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. Information has been provided to support 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. Information has been provided to support 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) is greater than the maximum FDA labeled dose for the requested indication AND
  2. Information has been provided to support 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 Quantity Limit _ProgSum_ 1/1/2023