Estrogens – Essential Formulary

Restricted Product(s)

• Alora® (estradiol) Patch 
• Depo® -Estradiol (estradiol cypionate) injection 
• Elestrin® (estradiol) gel 
• Evamist® (estradiol transdermal spray) 
• Menest (esterified estrogens) tablet 
• Menostar® (estradiol) patch

FDA Approved Use

• Various hormone replacement therapies

Criteria for Approval of Restricted Product(s)

1. The requested medication is being used for an FDA indication: AND 
2. The prescribing provider must certify to Blue Cross NC that up to TWO available therapeutic equivalent alternative non-restricted access medications (or medically appropriate medications, if no therapeutic equivalents exist) for treatment of the same condition have been detrimental to the members health or ineffective in the treatment of the condition for which it is prescribed; OR 
3. The member has a documented intolerance or contraindication to the un-tried, non-restricted access medications; AND 
4. For members seeking coverage for hormone therapy, related to Gender Identity Dysphoria :
   1. The member has satisfied criteria points 2-3 of the Restricted Access Utilization Management Criteria (above); AND 
   2. ONE of the following: 
      1. The patient is 18 years of age or older; AND 
         1. The patient has persistent, well-documented gender dysphoria; AND 
         2. The patient has the capacity to make a fully informed decision and to consent for treatment; AND 
         3. Mental health concerns, if present, are reasonably well controlled; OR 
      2. The patient is under the age of 18 years of age; AND 
         1. ALL of the following 
            1. A qualified mental health provider* has confirmed: 
               1. The persistence of gender dysphoria; AND
               2. Any coexisting psychological, medical, or social problems that could interfere with treatment (e.g., that may compromise treatment adherence) have been addressed, such that the adolescent’s situation and functioning are stable enough to start sex hormone treatment; AND 
               3. The patient has sufficient mental capacity to estimate the consequences of this (partly) irreversible treatment, weigh the benefits and risks, and give informed consent to this (partly) irreversible treatment; AND 
            2. The patient has been informed of the (irreversible) effects and side effects of treatment (including potential loss of fertility and options to preserve fertility); AND 
            3. The patient has given informed consent and the parents or other caretakers, or guardians have consented to the treatment and are involved in supporting the adolescent throughout the treatment process; OR 
         2. The treating clinician must submit information indicating why it would be clinically inappropriate to require the candidate to meet these criteria (medical record documentation required).

References

All information referenced is from FDA package insert unless otherwise noted below.

World Professional Association for Transgender Health. Standards of care for gender identity disorders. http://wpath.org/publications_standards.cfm (Accessed on September 15, 2021)

Hembree WC, Cohen-Kettenis PT, Gooren L, et al. Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2017; 102:3869.

Policy Implementation/Update Information

December 2021: Criteria change: Updated gender dysphoria criteria. Remove requirement of letter of medical necessity.
January 2020: Criteria update: Removed Delestrogen, Estrogel, Divigel, Minivelle, and Climara from policy.
April 2019: Added MSC O products to the criteria - Minivelle
January 2019: Added MSC O products to the criteria – Climara, Estrace, Delestrogen, Vivelle November 2018: Moved Minivelle from restricted to unrestricted
July 2018: Added criteria point 3 to clarify the intent of the letters.
May 2018: Delestrogen 10mg/ml added to criteria (previously on Restricted Access Criteria)
Mar 2018: Reviewed for 2018 Essential formulary. Elestrin and Menest moved from General Restricted Access program to Estrogens program.
Feb 2017: Placed requirement for letter of medical necessity on patients under the age of 18 years of age.
Jan 2017: Gender Identity Dysphoria criteria added to the restricted access criteria to create a standalone policy.