Download finasteride 1 mg (generic, Propecia®), dru474

Medication Policy Manual
Policy No: dru474
Topic: finasteride 1 mg (generic, Propecia®)
Date of Origin: December 16, 2016
Committee Approval Date: April 14, 2017
Next Review Date: July 2018
Effective Date: May 1, 2017
IMPORTANT REMINDER
This Medication Policy has been developed through consideration of medical necessity, generally
accepted standards of medical practice, and review of medical literature and government approval
status.
Benefit determinations should be based in all cases on the applicable contract language. To the
extent there are any conflicts between these guidelines and the contract language, the contract
language will control.
The purpose of Medication Policy is to provide a guide to coverage. Medication Policy is not
intended to dictate to providers how to practice medicine. Providers are expected to exercise their
medical judgment in providing the most appropriate care.
Description
Finasteride 1 mg (generic, Propecia) is an oral medication used as part of the hormonal
treatment for gender transition for patients with gender dysphoria. Finasteride 1 mg is also
used for hair loss (alopecia); however, hair loss is generally a benefit not covered by member
contracts regardless of medical necessity.
Finasteride in a higher dose (5 mg) is also used in the treatment of treatment of benign
prostatic hypertrophy (BPH). This policy does NOT apply to finasteride 5 mg (generic,
Proscar).
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Policy/Criteria
I.
Most contracts require prior authorization approval of finasteride 1 mg prior to coverage.
Finasteride 1 mg may be considered medically necessary for a diagnosis of gender
dysphoria when all of the following criteria are met:
A. Clinical records document that the patient has the capacity to make fully informed
decisions and consent for treatment.
AND
B. A licensed behavioral health professional has diagnosed gender dysphoria as defined
by the current DSM criteria.
AND
C. At least one of the following criteria must be met for a period of three or more months
prior to the initiation of therapy
1. Documentation of living as the desired gender
AND/OR
2. Psychotherapy with a licensed behavioral health professional.
II.
III.
Administration, Quantity Limitations, and Authorization Period
A.
OmedaRx considers finasteride 1 mg to be a self-administered medication.
B.
Authorization may be reviewed at least annually to confirm that current medical
necessity criteria are met and that the medication is effective.
Finasteride 1 mg is considered not medically necessary when used for the following
conditions:
A.
Hair loss (alopecia), except when criteria in Section I. are met.
B.
Benign prostatic hypertrophy (BPH)
Position Statement
Summary
-
-
The intent of the policy is to cover finasteride 1 mg for males with gender dysphoria, as
part of a comprehensive treatment plan.
Finasteride and dutasteride are 5-alpha reductase inhibitors. Both block conversion of
testosterone to 5-alpha-dihydrotestosterone, a more active form, and are therefore may
be useful in males transitioning to females (MTF), for antiandrogen effects and
feminization of the body.
Guidelines recognize the use of antiandrogens as part of hormonal therapy for gender
dysphoria and MTF transition; however, only after appropriate evaluation, diagnostic
confirmation, and counseling by health care providers with expertise in the care and
treatment of transgender patients.
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-
-
The use of finasteride 1 mg for the treatment of hair loss (alopecia) is considered not
medically necessary and is excluded from coverage, unless criteria for gender dysphoria
are met.
The use of finasteride 1 mg for the treatment of benign prostatic hypertrophy (BPH) is
considered not medically necessary and is excluded from coverage. Generic finasteride 5
mg, the dose shown to be safe, effective, and FDA-approved for BPH, is coverable
without prior authorization.
Clinical Efficacy [1-5]
-
Treatments for gender dysphoria typically include psychotherapy, hormone therapy, and
in some cases surgical sex reassignment procedures. Psychotherapy followed by hormone
therapy is often the first medical treatment sought, although not all transgender
individuals on hormone therapy choose to undergo gender-confirming surgery.
Psychotherapy
*
Psychotherapy provided by a mental health professional typically includes an
initial assessment of gender identity and dysphoria, the historical development of
gender dysphoric feelings, and severity of resulting stress caused by the
condition.
*
The goal of therapy is to assess, diagnose, and discuss treatment options, if
needed, and is typically required prior to hormone therapy and/or surgical
treatment.
Hormone Therapy
*
Hormone therapy is undertaken in order to feminize or masculinize individuals’
bodies to conform to their desired genders.
*
*
For transgender individuals, hormone replacement therapy (HRT) causes the
development of many of the secondary sexual characteristics of their desired sex.
Prescribed hormones differ depending upon the natal gender of the individual.
-
*
-
For MTF individuals, hormone treatment may include estradiol, finasteride,
and spironolactone.
For FTM individuals, hormone treatment may include androgenic hormones
such as testosterone.
5-alpha reductase inhibitors (finasteride and dutasteride) are antiandrogens, by
blocking conversion of testosterone to more active forms. 5-alpha reductase
inhibitors affect hair loss, body hair growth, sebaceous glands, and skin
consistency in MTF individuals. Other antiandrogens include spironolactone and
cyproterone acetate (CPA), which is not available in the U.S.
Use of estrogen therapy with or without anti-androgens to feminize the body for MTF
transition in patients with gender dysphoria is consistently supported by standard of
care guidelines, after appropriate evaluation, diagnostic confirmation, and counseling by
health care providers with expertise in the care and treatment of transgender patients.
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-
Choice of specific antiandrogen is guided by clinical experience, safety profile, and cost.
Only the World Professional Association for Transgender Health (WPATH)
guidelines specifically mention the use of 5-alpha reductase inhibitors (finasteride and
dutasteride) as antiandrogens. [1]
[1-4]
Cross References
Transgender Services, Medical Policy. Medicine, Policy No. 153.
http://blue.regence.com/trgmedpol/medicine/med153.pdf
Testosterone cypionate, testosterone enanthate, Medication Policy Manual, Policy No. dru395
Non-preferred non-transdermal testosterone replacement therapy products, Medication Policy
Manual, Policy No. dru297
Preferred transdermal testosterone replacement therapy products (AndroGel®, AndroGel Pump®),
Medication Policy Manual, Policy No. dru411
Non-preferred, transdermal testosterone replacement therapy products, Medication Policy
Manual, Policy No. dru415
References
1.
World Professional Association for Transgender Health (WPATH). Standards of Care for the
health of transsexual, transgender, and gender-nonconforming people. [cited 11/28/16];
Available from: http://www.wpath.org/site_page.cfm?pk_association_webpage_menu=1351
2.
Hembree, WC, Cohen-Kettenis, P, Delemarre-van de Waal, HA, et al. Endocrine treatment of
transsexual persons: an Endocrine Society clinical practice guideline. J Clin Endocrinol
Metab. 2009; 94:3132-54. PMID: 19509099. [cited 11/28/16]; Available from:
http://press.endocrine.org/doi/pdf/10.1210/jc.2009-0345
3.
American College of Obstetricians and Gynecologists (ACOG), Committee on Health Care for
Underserved Women. Committee Opinion no. 512: health care for transgender individuals.
Obstet Gynecol. 2011 Dec;118 (6):1454-8. PMID: 22105293. [cited 11/28/16]; Available from:
http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-HealthCare-for-Underserved-Women/Health-Care-for-Transgender-Individuals
4.
American Psychological Association.. Guidelines for psychological practice with transgender
and gender nonconforming people. Am Psychol. 2015 Dec;70(9):832-64. PMID: 26653312.
[cited 11/28/16]; Available from: https://www.apa.org/practice/guidelines/transgender.pdf
5.
Tangpricha V, Safer JD, et al. Transgender women: Evaluation and management (Literature
review current through October 2016). In: Synder PJ, 25.0 (Ed). UpToDate, Waltham, MA,
2016.
Revision History
Revision Date
Revision Summary
4/14/2017
Clarify the use of finasteride 1 mg for BPH is not medically necessary.
12/16/2016
New policy
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