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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 

07-01-2024            

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:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. 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) exceeds 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_QL _ProgSum_ 07-01-2024