Does TRICARE Cover Finasteride? Coverage, Prior Auth, and Appeal Guide
At a glance
- Drug class / 5-alpha reductase inhibitor that blocks conversion of testosterone to DHT [3]
- 1 mg tablet / Propecia, NDA 020788, approved 12/19/1997; male pattern hair loss in men only [1][3]
- 5 mg tablet / Proscar, NDA 020180, approved 06/19/1992; symptomatic BPH [2][4]
- Generics / FDA-approved ANDAs for both strengths, with the same labeled risks
- Other forms / Drugs@FDA entries list oral tablets; no FDA-approved topical or injectable finasteride [1][2]
- Prescription status / Prescription-only [1][2]
- TRICARE coverage / Not addressed in the FDA records or labels
Two tablets, two approvals, two indications
Finasteride is a competitive inhibitor of Type II 5-alpha-reductase, the enzyme that converts testosterone to dihydrotestosterone. It has no affinity for the androgen receptor [3].
In the United States it is sold as two distinct approved products with different indications. The 1 mg tablet is Propecia (NDA 020788), first approved 12/19/1997 and held by Organon [1]. It is indicated for male pattern hair loss in men only [3]. The 5 mg tablet is Proscar (NDA 020180), first approved 06/19/1992 and held by Organon [2]. It is indicated for symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate [4]. Both are prescription-only [1][2].
A 1 mg prescription and a 5 mg prescription name different products, different strengths and different labeled uses.
What the 1 mg tablet is labeled for
Propecia, the label for finasteride 1 mg, is indicated for male pattern hair loss (androgenetic alopecia), and efficacy in bitemporal recession has not been established [3]. The dose is one 1 mg tablet once daily, with or without meals. Daily use for three months or more is usually necessary before benefit is observed, and continued use is recommended to sustain benefit [3].
Pregnancy is a contraindication to finasteride, and contact with crushed or broken tablets can pose a risk to a male fetus [3].
In two 1-year trials of 1,553 men aged 18 to 41, hair count in a 1-inch (5.1 cm2) circle of balding vertex scalp rose 107 hairs above placebo at one year and 138 above placebo at two years, from a baseline of 876 hairs (P<0.001); the placebo group continued to lose hair [5].
What the 5 mg tablet is labeled for
Proscar is indicated to improve symptoms of BPH, reduce the risk of acute urinary retention, and reduce the risk of surgery including TURP and prostatectomy; with the alpha-blocker doxazosin it is indicated to reduce the risk of symptomatic BPH progression [4]. The label states a limitation of use: Proscar is not approved for the prevention of prostate cancer [4].
The dose is one 5 mg tablet once daily, with or without meals [4].
Generics and other forms
Generic finasteride 1 mg and 5 mg are FDA-approved under many ANDAs, and generics carry the same labeled risks as the brands. Drugs@FDA lists only oral tablets for finasteride, and no topical or injectable finasteride is FDA-approved [1][2].
Frequently asked questions
Which finasteride strength is approved for hair loss?
Which finasteride strength is approved for BPH?
Is generic finasteride the same as the brand?
Is topical finasteride FDA-approved?
References
- Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
- Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
- U.S. National Library of Medicine, DailyMed. Propecia (finasteride 1 mg) tablets, Organon prescribing information. Propecia (finasteride 1 mg) tablets, Organon label
- U.S. National Library of Medicine, DailyMed. Proscar (finasteride 5 mg) tablets, Organon prescribing information. Proscar (finasteride 5 mg) tablets, Organon label
- Kaufman KD, Olsen EA, Whiting D, Savin R, DeVillez R, Bergfeld W, et al. Finasteride in the treatment of men with androgenetic alopecia. Finasteride Male Pattern Hair Loss Study Group. J Am Acad Dermatol. 1998;39(4 Pt 1):578-89. Finasteride in the treatment of men with androgenetic alopecia. Finasteride Male Pattern Hair Loss Study Group